Methods

Design: Randomised effectiveness trial

Participants

Setting: Participants were military veterans recruited from a VA outpatient substance use disorder clinic. Treatment was delivered on an outpatient basis.

Inclusion criteria: male veteran status and VA health care eligibility; a diagnosis of any current alcohol or drug use disorder; completion of an intake for outpatient SUD treatment at the participating mental health clinic; and meeting partial (i.e. defined as meeting criteria for 2 out of 3 PTSD symptom clusters, or at least 1 symptom in each symptom cluster) or full PTSD in clinical evaluation using CAPS.

Exclusion criteria: current participation in other day or inpatient mental health treatment; any contraindications communicated by the person’s primary clinician; and acute psychosis, mania, dementia, or suicidal intent.

Sample size: 125 individuals were assessed for eligibility; 117 were randomised; 8 participants were withdrawn after randomisation because they were found to meet 1 or more exclusion criteria; 98 attended at least 1 treatment session and were included in the analyses.

PTSD diagnosis: 90.8% participants met full diagnosis for PTSD as measured by the CAPS; 9.8% met subthreshold diagnosis for PTSD.

SUD type and diagnosis: All participants met diagnosis for SUD. Participants were polydrug users.

Mean age: Seeking safety 55.1 (SD = 9.2) years; treatment as usual 52.9 (SD = 10.0)

Gender: 100% male

Ethnicity: 60.2% African American; 19.4% white; 7.1% Hispanic; 2% Native American; 5.1% other.

Country: USA

Interventions

Group 1: Group‐based Seeking Safety plus treatment as usual: n = 54. Seeking Safety is a present‐focused, manualised, cognitive behavioural integrated treatment for PTSD and SUD, designed for both genders. Its primary goal is to reduce both PTSD and SUD by focusing on safe coping skills addressed through cognitive, behavioural, interpersonal, and case management domains. Participants were also able to access the treatment‐as‐usual interventions (described below). However, participants in this arm substituted SS groups and case management for the clinic’s core substance use‐focused group therapy and case management sessions. Groups were held twice weekly. Case management was based on the SS manual.

Group 2: Group‐based treatment as usual: n = 55. Treatment as usual involved participants entering twice‐weekly "recovery" groups, focusing on building abstinence and, after approximately 90 days of therapy, on maintaining abstinence. Participants attended additional groups on smoking cessation, sobriety support, cocaine recovery, alcohol recovery, dual‐diagnosis recovery, family therapy, anger management, cognitive behavioural therapy, fitness, relaxation, health education, hepatitis education, and developing outside activities as needed. All participants were assigned a case manager, and case management and individual therapy were available as deemed appropriate. Participants made use of clinic services as indicated by their treating clinician or as desired.

Experimental intervention modality: Integrated

Outcomes

PTSD: IES‐R

SUD: ASI drug and alcohol composite scores for the previous 30 days.

Treatment acceptability: Data are reported for the mean number of treatment sessions attended; participant satisfaction at 3‐month assessment based on the Client Satisfaction Questionnaire.

Other: Coping Responses Inventory

Follow‐up: End of treatment and at 3 months.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random allocation sequences were generated by the study statistician and implemented by use of sequentially numbered containers

Allocation concealment (selection bias)

Low risk

Random allocation sequences were generated by the study statistician and implemented by use of sequentially numbered containers

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Research staff who enrolled participants and conducted outcomes assessment were blind to treatment assignment. To maintain blinding, staff conducting outcomes assessment were password‐restricted from accessing data with information regarding treatment assignment, and participants were warned not to divulge information that might compromise blinding during interviews

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Treatment dropouts and withdrawals were clearly reported. Analysis of treatment outcomes was based on those participants available to follow‐up

Selective reporting (reporting bias)

Low risk

Primary outcomes are specified in the protocol registered with ClinicalTrials.gov

Other bias

Unclear risk

Insufficient information available to be able to assess

Methods

Design: RCT ‐ described as a laboratory‐based experiment. The authors tested the hypothesis that alcohol craving elicited by a trauma cue might be attenuated if trauma‐elicited negative emotion was reduced following trauma‐focused imaginal exposure

Participants

Setting: Participants were recruited from 2 outpatient substance use treatment programmes.

Inclusion criteria: Participants needed to meet current diagnosis for alcohol dependence and PTSD. All participants were involved in alcohol treatment.

Exclusion criteria: Individuals were excluded if they met current diagnostic criteria for a psychotic disorder or were currently experiencing a manic episode. Although current major depression was not an exclusion criterion, severe major depression was. Individuals were also excluded if their PTSD diagnosis stemmed from combat or if they were currently or had ever engaged in exposure‐based PTSD treatment.

Sample size: The number of individuals assessed for eligibility is not reported. 43 individuals were invited to take part in the study and were randomised and 31 (who attended at least 1 treatment session) were included in the analyses.

PTSD diagnosis: 43 (100%) of participants met full diagnosis for PTSD as measured by the CAPS.

SUD type and diagnosis: 43 (100%) of participants met diagnosis for alcohol dependence.

Mean age: 37.5 (SD = 8.0) years

Gender: 29 (67%) female

Ethnicity: 65% African American; 28% white; 5% Native American; 2% other

Country: USA

Interventions

Group 1: Individual imaginal exposure: n= 16. Participants assigned to the exposure condition took part in six 60‐min sessions of imaginal exposure targeting an index traumatic event. Participants were instructed to tell the story of their trauma by describing the event in the present tense from the first‐person perspective. Participants were encouraged to include emotions and cognitions in their verbal description of the event. Participants described their trauma repeatedly and continuously over the course of the six 60‐min clinical sessions. SUDS ratings were collected approximately every 5 min during each session. Each session was audiotaped, and participants were instructed to listen to the tape daily.

Group 2: Imagery‐based relaxation: n= 15. Participants assigned to the relaxation condition listened to an imagery‐based relaxation audiotape for the 60‐min session. As in the exposure condition, SUDS ratings were collected approximately every 5 min during each session. Participants were instructed to listen to the relaxation tape daily.

Experimental intervention modality: Concurrent

Outcomes

PTSD: IES‐R

SUD: A cue reactivity paradigm was used to assess alcohol craving prior to, and after completion of, the 6 clinical sessions.

Treatment acceptability: Attendance of 1, at least 4, and all 6 clinical sessions is described.

Other: The PANAS; emotional distress as measured by SUDS

Follow‐up: End of treatment.

Notes

43 participants were assessed and randomised. Outcome data is reported for 17 responders of 31 participants who attended 1 or more intervention session

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

The research assistant who conducted the assessment session and both laboratory sessions was unaware of the experimental condition to which participants had been randomly assigned. The research staff involved in the clinical sessions did not participate in the assessment session or either laboratory session

Incomplete outcome data (attrition bias)
All outcomes

High risk

Outcome data is reported for 17 responders of 31 participants who attended 1 or more intervention session

Selective reporting (reporting bias)

High risk

Data related to craving response was based on a subset of 12 participants who reported a craving response to the cues at the first or the second laboratory session. This appears to have been based on a post‐hoc decision

Other bias

Unclear risk

High attrition rates

Methods

Design: RCT

Participants

Setting: Participants were recruited from an unlocked residential SUD treatment facility.

Inclusion criteria: DSM‐IV diagnosis of both PTSD related to a non‐combat trauma and alcohol dependence; 1 heavy drinking day in the past 60 days, as defined by consumption of 4 standard drinks for women and 5 standard drinks for men; and age between 18 and 60.

Exclusion criteria: The presence of an acute psychotic disorder, bipolar disorder with an active manic episode (but not the presence of bipolar disorder, per se), imminent risk for suicide, prescription of craving‐reducing medications (e.g. naltrexone) or medications to reduce alcohol use (e.g. disulphiram), self reported use, or urine drug screen indicating use, of a benzodiazapine, judged to have a medical condition that might limit co‐operation or compromise the integrity of the data (e.g. organic brain syndrome, dementia, head injury, neuropathy, etc.), illiteracy in English, and being in an ongoing abusive relationship that resulted in a PTSD Criterion A event (but not a history of intimate partner violence, per se).

Sample size: 222 individuals were assessed for eligibility; 148 were randomised, but 28 were subsequently excluded. Reasons for exclusion included cognitive impairment, psychosis, medical issues, drug screening, moved away, refusal to participate, and in one case for unknown reasons. The remaining 120 participants attended at least 1 treatment session and were included in analyses.

PTSD diagnosis: All participants met full diagnosis for PTSD as measured by the CAPS.

SUD type and diagnosis: All participants met diagnosis for alcohol dependence and 98.3% met criteria for other drug dependence, as measured by the CDIS‐IV.

Mean age: 33.72 (SD = 10.25) years

Gender: 64 (53.3%) male; 56 (46.7%) female

Ethnicity: 18.3% African American; 80.0% white; 0.8% other

Country: USA

Interventions

Group 1: Trauma‐focused exposure therapy (EXP) + TAU: n = 82. EXP is a well‐described cognitive behavioural therapy that utilises imaginal and in vivo exposure techniques, either singly or in combination, to reduce the symptoms of PTSD resulting from a range of traumas. In addition to imaginal and in vivo exposure techniques, in the current study participants were provided psycho‐education about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. The imaginal exposures were audiotaped, and participants were instructed to listen to the tapes daily. 9 sessions of exposure were offered initially; if PTSD symptom severity did not decrease by at least 70%, an additional 3 sessions of EXP were offered. A number of adaptations were made to conventional exposure. Traditionally, exposure sessions are 90 minutes. The current study utilised 60‐min EXP sessions. Additionally, protocol contained added psycho‐education about the relationship between trauma and SUD symptoms and weekly check‐ins about SUD treatment progress. Finally, the protocol provides integration of care at the team level, rather than the individual provider level. All participants received standard TAU for substance abuse. TAU consisted of daily group therapy for approximately 3 hours each day, daily recreation therapy, AA and NA meetings, individual drug counselling sessions, and completion of drug counselling homework. The 6‐week TAU was provided by drug and alcohol counsellors unaffiliated with the current study.

Group 2: Healthy Lifestyles Sessions (HLS) + TAU: n = 38. HLS is a structured 9‐ to 12‐session intervention that provides education about a variety of health‐related topics. HLS was designed to involve a similar amount of therapist contact and between‐session homework as exposure. Topics covered included an introduction to treatment; sleep hygiene; progressive muscle relaxation; starting/maintaining an exercise programme; personal role identification; healthy eating and nutrition (2 sessions); diabetes (prevention or diabetes treatment adherence, depending on diabetes status); monitoring goals and values; cancer (a focus on breast cancer for women and colon cancer for men); HIV (reducing HIV risk or adhering to HIV treatment, depending on HIV status); and a final review session. Sessions included the provision of information, discussing participants’ understanding of information, and answering questions about the information provided.

Experimental intervention modality: Combined

Outcomes

PTSD: CAPS; IES‐R

SUD: TLFB, the primary outcome was per cent days abstinent; ACQ‐Now

Treatment acceptability: Number completing at least 8 treatment sessions

Other: BDI; BAI

Follow‐up: End of treatment; 3 and 6 months post‐treatment

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random sequence generation was undertaken by urn randomisation

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Assessors were blind to treatment allocation

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Treatment dropouts and withdrawals were clearly reported. An ITT approach was used to analyse data based on participants who attended at least 1 treatment session. A number of other participants were also excluded from the study postrandomisation, and it was unclear if some of these exclusions might have been due to intervention‐related factors

Selective reporting (reporting bias)

Unclear risk

All outcomes that were described were reported, but we were not able to identify a previously published protocol

Other bias

Unclear risk

28 individuals who were randomised were removed from the study. It is unclear whether this may have caused additional bias. Approximately half of the participants receiving the experimental intervention were also provided a session of motivational enhancement therapy for PTSD prior to beginning intervention. The other half of the experimental group and all of the HLS participants were provided a 60‐minute relaxation session prior to the first scheduled treatment session. No significant differences were found between the 2 experimental groups, and they were therefore collapsed into a single experimental condition

Methods

Design: RCT

Participants

Setting: Treatment‐seeking individuals were recruited through advertisements and professional referrals and treated on an outpatient basis.

Inclusion criteria: Current PTSD and alcohol dependence according to DSM‐IV; clinically significant trauma‐related symptoms, as indicated by a score of at least 15 on the PSS‐I; and heavy drinking in the past 30 days, defined as an average of more than 12 standard alcohol drinks per week with at least 1 day of 4 or more drinks determined by the TFBI.

Exclusion criteria: Current substance dependence other than nicotine or cannabis; current psychotic disorder (e.g. schizophrenia, bipolar disorder); clinically significant suicidal or homicidal ideation; opiate use in the month prior to study entry; medical illnesses that could interfere with treatment (e.g. AIDS, active hepatitis); or pregnancy or nursing.

Sample size: 657 individuals were assessed for eligibility; 165 were randomised, and all were included in the analyses.

PTSD diagnosis: All participants met full diagnosis for PTSD as measured by the CAPS.

SUD type and diagnosis: All participants met full diagnosis for alcohol dependence.

Mean age: prolonged exposure + naltrexone 40.1 (95% CI 36.7 to 43.5); prolonged exposure + placebo 44.7 (95% CI 41.8 to 47.7); supportive counselling + naltrexone 44.9 (95% CI 41.8 to 47.9); supportive counselling + placebo 41.2 (95% CI 38.6 to 43.9)

Gender: 108 (65.5%) male; 57 (34.5%) female

Ethnicity: 63% African American; 30% white; 4.2% Hispanic; 0.6% other

Country: USA

Interventions

Before randomisation to treatment, participants completed outpatient medical detoxification (at least 3 consecutive days of alcohol abstinence) with oxazepam as required to manage alcohol withdrawal symptoms.

Group 1: Prolonged exposure + naltrexone + supportive counselling: n = 40. Prolonged exposure therapy consisted of 12 weekly 90‐minute sessions followed by 6 biweekly sessions and included repeated imaginal exposure (i.e. revisiting and recounting traumatic memories) and processing the memory (i.e. discussing thoughts and feelings related to revisiting the memory). The target dose of naltrexone was 100 mg/d, starting with 50 mg/d for a minimum of 3 days and titrating up within 1 week. Supportive counselling was available as described below.

Group 2: Prolonged exposure + placebo + supportive counselling: n = 40. Participants received PE as described above. Supportive counselling was available as described below.

Group 3: Supportive counselling + naltrexone: n = 42. Supportive counselling was based on the BRENDA model, which combines medication management with compliance enhancement techniques based on motivational interviewing. Supportive counselling sessions were administered by a study nurse and lasted 30 to 45 minutes. Input included dispensing medication, monitoring compliance, assessing and providing education about alcoholism, and offering support and advice concerning drinking. Visits were weekly during the first 3 months and biweekly during the remaining 3 months.

Group 4: Supportive counselling + placebo: n = 43. Supportive counselling was as described above.

Experimental intervention modality: Combined

Outcomes

PTSD: PSS‐I

SUD: TLFB; PACS

Treatment acceptability: Reported in terms of the mean number of sessions attended for PE.

Other: ‐

Follow‐up: End of treatment and 6 months' post‐treatment

Notes

For the purpose of the review, we were interested in the comparison between prolonged exposure plus supportive counselling and supportive counselling

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not be blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Evaluators were blind to treatment group assignment

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Treatment dropouts and withdrawals were clearly reported. An ITT approach was employed using hierarchical linear and non‐linear modelling, which took into account dropouts and missing data

Selective reporting (reporting bias)

Low risk

Key outcomes are as specified in the protocol registered with ClinicalTrials.gov

Other bias

Low risk

There was no significant difference between the treatment groups on any demographic or baseline diagnostic characteristics. We identified no other potential biases

Methods

Design: RCT

Participants

Setting: Participants were recruited from amongst outpatients at 3 participating substance use disorder clinics.

Inclusion criteria: (a) a history of trauma that fulfilled the conditions for DSM‐IV PTSD criterion A, (b) a substance use disorder, and (c) DSM criteria for one of the following: PTSD, DESNOS plus at least 1 or more DSM‐IV Axis I disorders, or a diagnosis of major depressive disorder, dysthymic disorder, or dissociative disorder.

Exclusion criteria: Not specified.

Sample size: 274 individuals were assessed for eligibility; 213 were randomised

PTSD diagnosis: 202 (94.8%) of participants met full diagnosis for PTSD as measured by the CAPS. Of these, 72 (33.8%) met criteria for PTSD with DESNOS. 7 (3.3%) met criteria for DESNOS without PTSD, and 4 (1.9%) met criteria for other disorders, such as dissociative disorder and major depression.

SUD type and diagnosis: Participants met diagnosis for substance abuse and substance dependence. Participants were polydrug users.

Mean age: Intervention group: 37.84 (SD = 8.42) years; control group: 36.85 (SD = 8.44) years

Gender: 130 (61%) female

Ethnicity: 24.4% African American; 56.3% white; 10.3% Hispanic; 8.92% other

Country: USA

Interventions

Group 1: Group‐based trauma‐sensitive usual care plus Trauma Adaptive Recovery Group Education and Therapy (TARGET): n = 141

Participants randomised to TARGET treatment were offered 8 or 9 weeks of manualised group treatment. TARGET provided psycho‐education about the impact of traumatic exposure and PTSD on the body’s stress response system and the brain using the strength‐based concept of an adaptive psychobiological “alarm reaction”. Participants were taught 7 core skills: focusing, recognising stress triggers, emotion identification, evaluating cognitions, defining personal goals, making choices with options grounded in personal strengths, and making a contribution to restore a sense of hope, faith, and purpose in the wake of trauma and PTSD. Experiential exercises were used to teach, model, role‐play, and integrate skills and to use them to develop a coherent memory narrative of the client’s life that incorporates a range of experiences including but not limited to traumatic stress. To enhance retention in the groups, small incentives that also reinforced aspects of the TARGET model (e.g. pens, key chains) were handed out on 3 occasions during the group.

Group 2: Trauma‐sensitive usual care: n = 72

Participants received regular substance abuse treatment sessions. Counsellors providing this intervention received training on trauma‐sensitive care. Training workshops included information about the effect of traumatic events and disorders that trauma may cause or exacerbate. The counsellors also learned about the typical problems of trauma survivors and some of the ways in which past trauma can interfere with substance abuse recovery. Counsellors received literature about trauma, post‐traumatic stress, and substance abuse recovery that could be shared with clients.

Experimental intervention modality: Integrated

Outcomes

PTSD: GAIN‐traumatic stress symptoms; PTCI

SUD: GAIN subscales for substance use frequency, per cent drinking to intoxication, per cent using any drugs, and per cent abusing drugs or alcohol were used to assess changes in substance use and abuse.

Treatment acceptability: Mean number of sessions attended for the active intervention group and mean number of standard‐care sessions attended for both groups.

Other: GAIN for depressive symptoms, anxiety symptoms, and self efficacy

Follow‐up: 6 and 12 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

By cohort using a random number program

Allocation concealment (selection bias)

Unclear risk

Insufficient information to be able to assess

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

A trained research assistant conducted face‐to‐face interviews. No further information was available

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition and drop‐out are well described. Hierarchical linear modelling was used to enable estimation where data were unavailable

Selective reporting (reporting bias)

Unclear risk

Traumatic stress symptoms as indexed by GAIN were described in the methodology as a primary outcome, along with a number of other outcomes. However, this outcome is not reported, although other prespecified outcomes are reported

Other bias

High risk

The process of allocation was modified partway through the study, as delays in starting groups early on "meant that many participants received an insufficient dose". It was unclear as to why the number of participants randomised to the active intervention group was nearly double the number randomised to the control group. There was a high drop‐out rate. Counsellors to participants in the control condition could not be prevented from formally referring to the FREEDOM steps or using the handouts or other tangible materials from TARGET in non‐TARGET groups. This led study authors to conclude that there was "contamination of the comparison group treatment with TARGET principles and techniques".

Methods

Design: Partial RCT described as a "quasi‐experimental clinical trial"

Participants

Setting: Participants were recruited through advertisements and referred through substance use treatment programmes. Participants were treated on an outpatient basis.

Inclusion criteria: Current or subthreshold PTSD (defined as DSM‐IV criteria A, B, and E and the presence of either C or D) and current DSM‐IV substance dependence; if they reported using substances at least 3 times a week on the Substance Use Inventory; Mini‐Mental State Examination score greater than 21; age 18 to 55 years; female; and English‐speaking.

Exclusion criteria: Advanced‐stage medical disease (e.g. AIDS, tuberculosis) as indicated by global physical deterioration and incapacitation, organic mental syndrome (associated with chronic drug abuse), and psychiatric exclusions (current active suicidality; current Axis I diagnoses other than atypical bipolar, depressive, or anxiety disorders; and history of psychosis).

Sample size: 207 individuals were assessed for eligibility; 128 met full study eligibility criteria, 115 agreed to participate, and 96 of these were randomised. 32 of the 128 women became a non‐randomised community care comparison group. 75 of the 96 women who were randomised attended at least 1 treatment session and were included in the ITT analyses.

PTSD diagnosis: 88% of women met full diagnosis for PTSD as measured by the CAPS. The other 12% met criteria for subthreshold PTSD.

SUD type and diagnosis: Women were included on the basis that they met criteria for substance dependence. Women were polydrug users.

Mean age: 38.2 (SD = 9.1) for Seeking Safety; 33.8 (SD = 8.3) for relapse prevention. The difference in age was statistically significant.

Gender: 128 (100%) female

Ethnicity: 42.7% African American; 36% white; 20% Hispanic; 13.3% multiracial; 1.3% other

Country: USA

Interventions

Group 1: Individual‐based Seeking Safety plus standard care: n = 41. The intervention is not fully described but is introduced as a short‐term, manualised cognitive behavioural treatment that simultaneously addresses trauma and substance abuse. Women were offered two 1‐hour treatment sessions weekly over 12 weeks.

Group 2: Individual‐based relapse prevention plus standard care: n = 34. The intervention is not fully described but is introduced as an empirically validated cognitive behavioural therapy focusing on the identification of triggers and coping strategies for managing substance cravings and relapse.

Group 3: Standard community treatment: n = 32. The intervention is not described. Women in this arm were not randomised.

Experimental intervention modality: Integrated

Outcomes

PTSD: The primary PTSD outcome was a composite score from scores on the CAPS, IES‐R, and CGI Scale.

SUD: The primary SUD outcome was a composite score from scores on the Substance Use Inventory and CGI Scale.

Treatment acceptability: Data are reported for number of participants attending at least 25% of treatment sessions.

Other: Items from CGI Scale were used to assess global severity of psychiatric symptoms; Global Assessment Scale and the HDRS were also used.

Follow‐up: 3, 6, and 9 months postbaseline

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to be able to assess

Allocation concealment (selection bias)

Unclear risk

Insufficient information to be able to assess

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to be able to assess

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Treatment dropouts and withdrawals were clearly reported. An ITT approach was used, using last observation carried forward. However, ITT was based on participants attending at least 1 treatment session. It was unclear if those who were randomised but who did not attend any sessions were aware of their allocation (Fergusson 2002)

Selective reporting (reporting bias)

Unclear risk

Composite outcome scores for both PTSD and SUD were used as primary outcomes. The authors state that this was done to reduce the possibility of Type I error. It is unclear how composite scores were generated. Raw scores are reported for PTSD measures but not for SUD measures

Other bias

Unclear risk

Insufficient information to be able to assess

Methods

Design: RCT

Participants

Setting: Participants were enrolled in 7 community‐based substance abuse treatment programs (CTPs) across the USA.

Inclusion criteria: To be eligible, individuals needed to have had at least 1 traumatic event in their lifetime and to meet DSM–IV–TR criteria for either full or subthreshold PTSD (where they did not meet criteria for either category C (avoidance and numbing symptoms) or category D (symptoms of increased arousal) but met all other criteria). Other inclusion criteria were between 18 and 65 years of age, had used alcohol or an illicit substance within the past 6 months, had a current diagnosis of drug or alcohol abuse or dependence, and were capable of giving informed consent.

Exclusion criteria: Individuals were excluded if they had an advanced stage medical disease as indicated by global physical deterioration, impaired cognition, significant risk of suicidal/homicidal intent or behaviour, a history of schizophrenia‐spectrum diagnosis, a history of active (past 2 months) psychosis, or involvement in litigation related to PTSD. Individuals were also excluded if they did not speak English or if they refused to be video‐ or audiotaped.

Sample size: 1963 individuals were assessed for eligibility; 353 were randomised, and all were included in the analyses.

PTSD diagnosis: 80.4% of women met full diagnosis for PTSD as measured by the CAPS.

SUD type and diagnosis: Women met diagnosis for substance abuse and substance dependence. Women were polydrug users.

Mean age: 39.2 (SD = 9.2) years

Gender: 353 (100%) female

Ethnicity: 34% African American; 45.6% white; 6.5% Latina; 13.3% multiracial; 0.6% other

Country: USA

Interventions

Group 1: Group‐based Seeking Safety plus treatment as usual: n = 176. Seeking Safety is a structured cognitive behavioural treatment with both safety/trauma and substance use components integrated into each session. All sessions have the same structure: (a) check‐in, including reports of any unsafe behaviours and use of coping skills, (b) session quotation, a brief point of inspiration to affectively engage women and link to the session topic, (c) relating the material to the women’s lives, in which handouts are used to facilitate discussion and structured skill practice, and (d) check‐out, including a commitment to specific between‐session skills practice. Each session covered a different topic as follows: safety, taking back power from PTSD, when substances are in control, honesty, setting boundaries in relationships, compassion, healing from anger, creating meaning, integrating the split self, taking good care of oneself, red and green flags, and detaching from emotional pain (grounding). Seeking Safety treatment was abbreviated from 25 to 12 core sessions (75 to 90 minutes) delivered over 6 weeks to fit within a feasible time frame for community‐based outpatient treatment programs. However, because 2 women needed to be present to conduct the group, many women took longer than 6 weeks to complete the interventions. All study participants were enrolled in 1 of the participating community treatment programs and were asked to attend treatment as usual at the program during the 6‐week treatment phase of the study. Treatment as usual was not kept constant across sites but was allowed to vary. Outpatient treatment differed across sites in frequency and length of sessions per week, although most offered intensive outpatient services of 3 days per week or more. The treatment orientation of the programs also varied, but none of the programs provided trauma‐focused treatment to women during the study.

Group 2: Group‐based Women's Health Education plus treatment as usual: n = 177. Women’s Health Education (WHE) was intended to control for therapeutic time and attention. WHE is a psycho‐educational, manualised health curriculum focused on topics such as understanding the female body, human sexual behaviour, pregnancy and childbirth, sexually transmitted diseases, HIV, and AIDS. WHE was designed to provide equivalent therapeutic attention, expectancy of benefit, and an issue‐oriented focus, but without theory‐driven techniques (i.e. those of Seeking Safety) or any explicit focus on or psycho‐education specific to substance abuse or trauma. All WHE sessions followed a common format: (a) introduction of topic, (b) review of group rules and between‐session assignment, (c) topic presentation, (d) a video, storytelling, and/or text readings, and (e) topic exercises in a variety of formats to facilitate group discussion and application of session materials, and (f) setting between‐session goals. Treatment as usual for the WHE group was as described above.

Experimental intervention modality: Integrated

Outcomes

PTSD: CAPS total score; PSS‐SR total score

SUD: Substance use diagnosis as measured by the Composite International Diagnostic Interview for DSM–IV; quantity and frequency of substance use as measured by the Substance Use Inventory; biologically confirmed abstinence from drugs of abuse was obtained by use of the SureStep urine drug screen card; recent alcohol use was tested with the Alco Screen‐Saliva Alcohol Test.

Treatment acceptability: Data are reported for number of women attending at least 1 group treatment session and number attending at least 6 treatment sessions.

Other: None

Follow‐up: 1 week, 3, 6, and 12 months. The PSS‐SR and SUI were administered weekly during the treatment phase as well as at all other time points.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

A statistician generated 1 blocked randomisation list (block size known only to the statistician) for the entire study

Allocation concealment (selection bias)

Low risk

Each participating community‐based substance abuse treatment program received sets of 60 sealed, tamper evident security envelopes, containing 1 randomisation number and the corresponding treatment assignment

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Independent assessors who remained unaware of randomisation assignment performed all baseline and post‐treatment assessments

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Treatment dropouts and withdrawals were clearly reported. An ITT approach was employed using generalised estimating equations

Selective reporting (reporting bias)

Unclear risk

Follow‐up outcomes were obtained at 1 week and 3, 6, and 12 months. The summary of outcomes table reports average outcome scores for the follow‐up period of 3 to 12 months. Use of averaged outcome scores was not specified in the methodology. It is unclear how data from these time points were used in analyses. Some analyses are reported for the 12‐month follow‐up point. It is unclear if data were reported in this way at the request of the publishing journal or by decision of the research group

Other bias

Low risk

There was no significant difference between the 2 treatment groups on any demographic or baseline diagnostic characteristics. We identified no other potential biases

Methods

Design: RCT

Participants

Setting: Participants were new admissions to a community addiction treatment program and recruited from 1 of 7 participating community intensive outpatient or methadone maintenance programs.

Inclusion criteria: Participants were at least 18 years of age, were actively enrolled in outpatient addiction services, and met criteria for any substance use disorder. Participants were also required to have a diagnosis of PTSD verified by the CAPS with total symptom score equal to or greater than 44.

Exclusion criteria: Acute psychotic symptoms (people with a psychotic disorder were eligible if their symptoms were stable and they were receiving appropriate mental health services); psychiatric hospitalisation or suicide attempt in the past month, unless the hospitalisation or attempt was directly related to substance intoxication or detoxification and the person was currently stable; or unstable medical and legal situations such that ability to participate in the full duration of the study seemed unlikely.

Sample size: 77 individuals were assessed for eligibility; 53 were randomised, and 36 attended at least 1 treatment session. 53 were included in the analyses.

PTSD diagnosis: All participants met full diagnosis for PTSD as measured by the CAPS.

SUD type and diagnosis: All participants met diagnosis for a substance use disorder. Type of substance use and the number meeting substance dependence were not specified.

Mean age: Integrated CBT plus standard care group: 39.09 (SD = 11.32) years; individual addiction counselling plus standard care group: 35.48 (SD = 9.44) years

Gender: 23 (43.4%) male; 30 (56.6%) female

Ethnicity: 90.6% white; other ethnicities were not described

Country: USA

Interventions

Group 1: Integrated cognitive behavioural therapy (ICBT) plus standard care: n = 32. ICBT is a manual‐guided individual‐based therapy focusing on PTSD symptoms and substance use. It was designed for integration into routine community addiction treatment programming. Participants were required to be active in either intensive outpatient or methadone maintenance services. ICBT consisted of 8 modules: introduction to treatment, crisis and relapse prevention planning, breathing retraining, psycho‐education about PTSD primary symptoms, psycho‐education about additional associated symptoms, two cognitive restructuring modules, and generalisation training. ICBT was delivered in an individual format, within a weekly 45‐ to 50‐minute session, over approximately 12 to 14 sessions. A client workbook was to be used in conjunction with the therapist manual with practice handout items for homework in between treatment sessions. Standard care occurred in either methadone maintenance or intensive outpatient clinics. 2 of the 7 recruiting programs were methadone maintenance, and 5 were intensive outpatient programs.

Group 2: Individual addiction counselling (IAC) plus standard care: n = 21. IAC is a manual‐guided individual‐based therapy designed to be integrated into an addiction treatment or methadone maintenance program. IAC targeted substance use only and was considered complementary to a typical community addiction treatment program. IAC consisted of 5 modules: treatment initiation, early abstinence, maintaining abstinence, recovery, and termination. IAC was delivered in 10 to 12 weekly sessions. As with ICBT, individual addiction counselling had participant practice handouts for homework in between treatment sessions. Standard care was as described above.

Experimental intervention modality: Integrated

Outcomes

PTSD: CAPS

SUD: ASI alcohol and drug composites; toxicology: recent alcohol intake and drug metabolites for amphetamine, benzodiazepines, cannabis, cocaine, methamphetamine, and opiates were screened for using urine and breath samples gathered at each assessment period.

Treatment acceptability: This was described in terms of initiation (number of participants attending at least 1 treatment session), engagement (number completing at least 2 sessions), and completion (number attending at least 75% of sessions).

Other: BDI

Follow‐up: 3 and 6 months postbaseline

Notes

It is unclear as to why there is such sizeable difference between the numbers of participants randomised to the 2 conditions

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported

Allocation concealment (selection bias)

Unclear risk

Not reported. It is reported that research interviewers were blinded to treatment assignment at randomisation, but other information about the randomisation process is not provided

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Research interviewers were not blinded to treatment assignment at the follow‐up assessments

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Analysis was undertaken using generalised estimating equations analyses, which allowed analyses without excluding participants based on missing data points or drop‐out. However, the study only achieved a follow‐up rate of 53%, and as the authors acknowledge, this "reduces the power and the ability to detect differences between treatment conditions".

Selective reporting (reporting bias)

Low risk

Primary outcomes are specified in the protocol registered with ClinicalTrials.gov

Other bias

High risk

There were a number of minor differences between the 2 groups at baseline (e.g. PTSD severity). The effects of these differences are unclear. The number of treatment sessions provided to the intervention (12 to 14) was longer than that provided to the control intervention (10 to 12)

Methods

Design: RCT

Participants

Setting: Participants were seen on an outpatient basis and were recruited from substance use treatment services, media advertisements, and practitioner referrals.

Inclusion criteria: Past‐month DSM‐IV‐TR diagnoses of PTSD and substance dependence, age 18 years or older, and fluency in English.

Exclusion criteria: Individuals were excluded from participating if they were currently suicidal (expressed suicidal ideation accompanied by a plan and intent), had a recent history of self harm (past 6 months), had current active symptoms of psychosis, or experienced cognitive impairment severe enough to impede treatment.

PTSD diagnosis: All participants met full diagnosis for PTSD as measured by the CAPS.

Sample size: 334 individuals were assessed for eligibility; 103 were randomised, and all were included in the analyses.

SUD type and diagnosis: All participants were reported to be substance dependent. Participants were polydrug users and had used a mean of 4 drug classes in the previous month.

Mean age: 33.7 (SD = 7.9) years

Gender: 64 (62.1%) female

Ethnicity: Australian born: 87 (84.5%); 6 (5.8%) Aboriginal or Torres Strait Islander

Country: Australia

Interventions

Group 1: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE): n = 55. COPE is a modified version of Concurrent Treatment of PTSD and Cocaine Dependence. The model represents an integration of existing evidence‐based manualised CBT interventions for PTSD and substance dependence. Intervention consists of 13 individual‐based 90‐minute sessions (i.e. 19.5 hours) delivered by a clinical psychologist. Although designed to be delivered weekly, flexibility was permitted. Treatment components include motivational enhancement and CBT for substance use; psycho‐education relating to both disorders and their interaction; in vivo exposure; imaginal exposure; and cognitive therapy for PTSD. The final session was dedicated to providing a review of the treatment, devising an aftercare plan, and termination of therapy.

Group 2: Usual treatment: n = 48. Both the treatment and the control group were able to engage in usual treatment for substance dependence. As such, participants could access any type of substance use treatment currently available in the community, including outpatient counselling, inpatient or outpatient detoxification, residential rehabilitation, and pharmacotherapies (e.g. methadone, buprenorphine, buprenorphine plus naloxone, naltrexone).

Experimental intervention modality: Combined

Outcomes

PTSD: CAPS

SUD: CIDI

Treatment acceptability: Data are reported for number of participants attending at least 1 treatment session; number attending at least 1 imaginal exposure session; and number attending all sessions.

Other: BDI, STAI, IPDE

Follow‐up: 6 weeks, 3 and 9 months postbaseline

Notes

The study concluded with a lower sample size than planned due to a low recruitment rate. It is unclear why there is such sizeable difference between the numbers of participants randomised to the 2 conditions

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Block randomization was conducted in groups of 10, stratified according to sex ... "

Allocation concealment (selection bias)

Low risk

" ... by a person independent of the research."

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Interviews were administered by 2 trained research officers blinded to group allocation

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Outcome data were analysed on an ITT basis. Missing data were imputed using multiple imputation

Selective reporting (reporting bias)

Low risk

Key outcomes are as specified in the protocol registered with the World Health Organization's trials portal

Other bias

High risk

Participants in the control group were more likely to have reported a history of childhood sexual abuse. This was controlled for in analyses. There was considerable variability in the time taken to complete treatment, with some participants continuing treatment well beyond the planned treatment period of 13 weeks and at least 1 receiving treatment around the final follow‐up point

Methods

Design: RCT

Participants

Setting: Individuals with severe mental illness were recruited from community mental health centres.

Inclusion criteria: Minimum age 18 years; designation by the states of New Hampshire or Vermont as having a severe mental illness, defined as a DSM–IV Axis I disorder and persistent impairment in the areas of work, school, or ability to care for oneself; DSM–IV diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia; current DSM–IV diagnosis of PTSD; and legal ability and willingness to provide informed consent to participate in the study.

Exclusion criteria: Psychiatric hospitalisation or suicide attempt within the past 3 months; current DSM–IV substance dependence.

Sample size: 270 individuals were assessed for eligibility; 108 were randomised, and all were included in the analyses.

PTSD diagnosis: All participants met full diagnosis for PTSD as measured by the CAPS.

SUD type and diagnosis: Nature of substance abuse was not specified. 44 (40.7%) of participants met diagnosis for substance use disorder. Outcome data are available for this subgroup.

Mean age: 44.21 (SD = 10.64) years

Gender: 35/44 (79.5%) female

Ethnicity: 38 (86.4%) white; (4.5%) African American; (4.5%) American Indian/Alaska Native; (2.3%) Hispanic; (2.3%) Asian‐Pacific Islander

Country: USA

Interventions

Group 1: Individual CBT for PTSD: n = 17. Sessions included an introduction to the programme; crisis plan review; psycho‐education on core and associated symptoms of PTSD; cognitive restructuring; generalisation training; and termination. Participants were offered 12 to 16 sessions over 4 to 6 months.

Group 2: Treatment as usual: n = 27. Participants assigned to TAU continued to receive the usual services they had been receiving before enrolment in the program. None of the mental health centres offered either cognitive restructuring or exposure therapy treatments for PTSD, although supportive counselling for trauma‐related problems was available.

Experimental intervention modality: Treatment of PTSD only

Outcomes

PTSD: CAPS

SUD: ‐

Treatment acceptability: Data are reported for number of participants in the experimental condition attending at least 6 treatment sessions.

Other: PTCI; PTSD Knowledge Test; Brief Psychiatric Rating Scale; BDI‐II; BAI; 12‐Item Short Form Health Survey; client version of the Working Alliance Inventory

Follow‐up: End of treatment and at 3 and 6 months' post‐treatment

Notes

This study did not specifically aim to treat individuals meeting diagnosis for SUD. A subset of participants met SUD diagnosis, and study authors provided data for these individuals. These participants only met criteria for substance abuse; individuals meeting diagnosis for substance dependence were excluded

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation was conducted by a computer‐based randomisation program

Allocation concealment (selection bias)

Low risk

Randomisation was conducted at a central location in a research centre. Assignments were not known in advance by either clinical or research staff

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Assessments were conducted by blinded interviewers at all assessment points. Participants were instructed at the beginning of interviews not to talk about any treatments for trauma‐related problems they may have received. Interviewers were requested to inform the project co‐ordinator if the client broke the blind during an interview. Interviewers were not asked to guess clients’ treatment assignments, to avoid directly encouraging them to formulate hypotheses about how treatment may have affected clients’ symptoms, which could have influenced subsequent ratings. No specific instances of blind breaking were noted in the study

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Withdrawals are thoroughly described. ITT analysis was conducted to determine the effects of primary outcomes

Selective reporting (reporting bias)

Unclear risk

Outcomes were reported as specified in the methodology section, but we were not able to identify a previously published protocol

Other bias

Low risk

There were no differences between the groups on any demographic, diagnostic, or baseline measures or in the rates of follow‐up assessments

Methods

Design: RCT

Participants

Setting: Participants were adolescent girls who were treated on an outpatient basis and were recruited through posted fliers and active recruitment from local clinics, hospitals, schools, and clinicians.

Inclusion criteria: Participants met current DSM‐IV criteria for both PTSD and SUD. They also had to report active substance use within the past 60 days.

Exclusion criteria: Potential participants were excluded if they had a history of bipolar I disorder (mania), psychotic disorder, were mandated to treatment, or had characteristics that would interfere with treatment completion (mental retardation, homelessness, impending incarceration, or a life‐threatening illness).

Sample size: The number of individuals assessed for eligibility was not specified; 33 were randomised, and all were included in the analyses.

PTSD diagnosis: All participants met full diagnosis for PTSD as measured by the CAPS.

SUD type and diagnosis: Most participants (n = 31, 93.9%) met diagnosis for substance dependence. Participants were polydrug users.

Mean age: 16.06 (1.22)

Gender: 100% female

Ethnicity: 78.8% white; 12.8% Asian‐Pacific Islander; 3% Hispanic; 3% African American; 3% multiethnic

Country: USA

Interventions

Group 1: Individual‐adapted Seeking Safety plus treatment as usual: n = 18. This coping skills therapy targets current PTSD and SUD. The treatment manual has 25 topics representing cognitive, behavioural, and interpersonal domains. Each topic offers a safe coping skill relevant to both disorders, such as Asking for Help, Compassion, Setting Boundaries in Relationships, and Honesty. The treatment has five principles: (1) safety as the priority; (2) integrated treatment of both disorders; (3) a focus on ideals; (4) four content areas: cognitive, behavioural, interpersonal, and case management; and (5) attention to therapist processes. The original manual was modified to take account of the developmental level of adolescents. Participants were offered 25 50‐minute sessions over 3 months.

Group 2: Treatment as usual: n = 15. All participants were allowed to attend any concurrent treatments they naturalistically sought (e.g. Alcoholics Anonymous, psychotropic medication, and other individual and group psychotherapies).

Experimental intervention modality: Integrated

Outcomes

PTSD: Trauma Symptom Checklist for Children

SUD: Personal Experiences Inventory

Treatment acceptability: For the Seeking Safety group, the mean number of all treatment sessions attended and the number of Seeking Safety sessions attended were reported. Data were also reported for client satisfaction (see below).

Other: Beliefs About Substance Use; World Assumptions Scale; Adolescent Psychopathology Scale; CSQ; HAQ; Teen Treatment Services Review interview

Follow‐up: End of treatment and at 3 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Information about sequence generation and allocation concealment were provided by the lead study author. A statistician independent of the study generated the randomisation list prior to the first randomisation using a random number generator

Allocation concealment (selection bias)

Low risk

The list was administered "lock‐step", and the principal investigator and therapists were unable to influence randomisation

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

The process of outcome assessment was not described

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Dropouts were well reported. Authors employed a full intent‐to‐treat analysis using a random effects model to analyse data

Selective reporting (reporting bias)

High risk

The Personal Experiences Inventory was identified as the primary measure. This measure was described as having 2 subsections (chemical involvement problem severity and psychosocial problems), each with multiple subscales. More specific information about whether a total score, subsection score, or subscale score was the primary outcome was not given. Other outcome measures also had multiple subscales. Outcomes were not clearly reported. A table describing outcomes at intake, end of treatment, and 3 months' follow‐up only shows data for outcomes that were significant

Other bias

High risk

The TAU group had a higher level of psychopathology as measured at baseline. There was no attempt to control for this. The study describes a number of outcome measures, with a large number of subscales. We estimated 40 outcomes. It appears there were no attempts to correct for the use of multiple statistical testing

Methods

Design: RCT

Participants

Setting: Participants were female victims of interpersonal violence. They were recruited through flyers posted in community agencies that serve IPV victims and in primary care and psychiatry clinics.

Inclusion criteria: Female interpersonal violence victims over the age of 18, with at least 1 month out of the abusive relationship, met DSM‐IV criteria for PTSD and an alcohol use disorder, literate in English, had not changed psychotropic medications or dosages within the previous 2 months and agreed not to during the active phase (first 12 weeks) of the intervention, and had an identified primary care physician.

Exclusion criteria: Moderate or severe cognitive impairment as measured by a Mini‐Mental State Examination score less than or equal to 18, history of psychosis (women with histories of psychosis or mania were only included if their symptoms had been well managed by pharmacotherapy for the most recent 6‐month period).

Sample size: 78 individuals were assessed for eligibility, 35 were randomised, and 29 received at least 1 session of treatment or remained in contact with the research group and were included in analysis.

PTSD diagnosis: 25 (86.2%) of women met full diagnosis for PTSD as measured by the CAPS; other women met subthreshold diagnosis for PTSD.

SUD type and diagnosis: All women met diagnosis for alcohol use disorder.

Mean age: Seeking Safety: 45.27 (SD = 8.44); facilitated 12‐step: 37.38 (SD = 9.13)

Gender: 100% female

Ethnicity: 65.5% white; 6.9% African American; 24.1% Hispanic; 3.4% American Indian

Country: USA

Interventions

Group 1: Adapted group‐based Seeking Safety plus treatment as usual: n = 20. Seeking Safety plus Cognitive Trauma Therapy for Battered Women with PTSD (CTT‐BW) (Kubany 2004).The intervention was a 24‐session group treatment protocol delivered over 12 weeks, incorporating the following interventions: psycho‐education regarding PTSD and alcohol use disorders, skills to reduce self harm behaviours, behavioural activation, exposure to trauma, identifying and managing triggers, building social support, coping skills, assertive communication, managing affect, problem solving, grounding, and cognitive restructuring.

Group 2: 12‐step supportive group: n = 9. Therapist‐led supportive group using a 12‐step model where women were encouraged to discuss issues related to domestic violence and abstinence from alcohol.

Experimental intervention modality: Integrated

Outcomes

PTSD: CAPS, PCL‐C

SUD: TLFB, Conceptual Cues/Coping Questionnaire

Treatment acceptability: ‐

Other: Adult Attachment Interview, Motivation/Self Esteem Scale, Anxiety Sensitivity Index, BDI, CD‐RISC‐10, Negative Mood Regulation Expectancies Scale, Self Compassion Scale, Coping Skills

Follow‐up: End of treatment and at 3 and 6 months' post‐treatment

Notes

This study had originally intended to recruit 100 individuals but were unable to achieve this within the period that the study was funded. Investigators had great difficulty gathering data after the initial follow‐up

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation was computer generated

Allocation concealment (selection bias)

Unclear risk

Allocation was handled by the study co‐ordinator

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Assessors were not blind to allocation

Incomplete outcome data (attrition bias)
All outcomes

Low risk

ITT analysis was performed on women who attended at least 1 treatment session. Women who were randomised but did not attend any intervention sessions were unaware of their allocation (Fergusson 2002)

Selective reporting (reporting bias)

Low risk

Key outcomes are as specified in the protocol registered with ClinicalTrials.gov

Other bias

High risk

There was a significant difference in the average age of the two groups. It is unclear why there is such sizeable difference in the numbers of women randomised to the 2 conditions. There was also a sizeable, though non‐significant, difference in alcohol consumption at baseline, and notable differences in ethnic makeup between the 2 groups

Methods

Design: RCT

Participants

Setting: Participants were recruited from a range of services in metropolitan Sydney, Australia and seen on an outpatient basis.

Inclusion criteria: Individuals were eligible if they were 18 years of age or older, consumed alcohol at hazardous levels (men 29 or more and women 15 or more 10 g ethanol drinks per week) and met DSM‐IV diagnostic criteria for PTSD, determined by the CAPS. AUD diagnosis was determined by the Structured Clinical Interview for DSM‐IV. Individuals on stable doses (for 2 months or longer) of pharmacotherapy for depression or alcohol dependence were eligible, as were individuals who needed and completed alcohol withdrawal.

Exclusion criteria: People were excluded if they were 17 years or younger, had current psychosis, severe suicide risk, significant cognitive impairment, limited English comprehension, or severe substance dependence.

Sample size: 154 individuals were screened and 90 assessed for eligibility; 62 were randomised, and all were included in the analyses.

PTSD diagnosis: 58 (94%) of participants met full diagnosis for PTSD as measured by the CAPS.

SUD type and diagnosis: All participants met criteria for AUD.

Mean age: 41.18 (SD = 11.91) years

Gender: 33 (53%) female

Ethnicity: Not reported

Country: Australia

Interventions

Group 1: Integrated CBT for PTSD and AUD: n = 33. Participants in both conditions received the same treatment targeting AUD. This consisted of motivational interviewing, intervention focused on coping with cravings, cognitive intervention related to drinking and management of negative moods. Participants in this arm also received cognitive behavioural intervention for PTSD, based on a prolonged exposure model with cognitive restructuring. Treatment in both the experimental and control condition was manualised, and consisted of 12, once‐weekly 90‐minute individual sessions with structured daily homework tasks.

Group 2: CBT for AUD and supportive counselling: n = 29. In addition to the shared components described above, this group also received supportive counselling. Treatment in this arm targeted AUD symptoms only, not PTSD symptoms.

Experimental intervention modality: Combined

Outcomes

PTSD: CAPS, PDS

SUD: TLFB, SADQ

Treatment acceptability: Median sessions attended, number attending 1 or more sessions, 6 or more sessions, 9 or more sessions.

Other: Short Inventory of Problems, BDI, STAI

Follow‐up: Post‐treatment and 5 and 9 months' post‐treatment

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Randomisation was conducted according to a random number system by a person independent of the study ... "

Allocation concealment (selection bias)

Low risk

" ... and treatment was concealed."

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Follow‐up assessments were conducted by independent clinicians who were unaware of the participants’ treatment condition and did not have access to participant clinical or supervision notes or treatment allocation

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All analyses were based on intent‐to‐treat, including all participants who entered the trial

Selective reporting (reporting bias)

Low risk

Outcomes were reported as specified in the methodology section

Other bias

Low risk

There were no differences between the groups on any demographic, diagnostic, or baseline measures or in the rates of follow‐up assessments

Methods

Design: RCT

Participants

Setting: Treatment was conducted on the minimum‐security wing of a female prison. Participants were recruited from a voluntary residential substance abuse treatment program for women requesting intensive substance abuse treatment.

Inclusion criteria: DSM‐IV criteria for current PTSD or subthreshold PTSD (i.e. had at least 1 symptom from all 3 clusters that were associated with impairment/distress) within the previous month as determined by the CAPS; and DSM‐IV criteria for substance dependence 1 month prior to entering prison as determined by the Structured Clinical Interview for DSM‐IV.

Exclusion criteria: Women were excluded if they were actively psychotic at the time of recruitment, did not know English well enough to be able to understand the consent form or measures, or were diagnosed with organic brain impairment.

Sample size: 92 women were assessed for eligibility; 49 were randomised, and 44 were included in the analyses.

PTSD diagnosis: 83.5% of women met full diagnosis for PTSD as measured by the CAPS, and 16.5% met the subthreshold definition.

SUD type and diagnosis: Women were polydrug users. 87.8% met criteria for alcohol dependence prior to imprisonment, with another 4.1% meeting criteria for lifetime alcohol abuse. The percentages of women who had ever used a single substance at a level typically indicating dependence (10 or more times in 1 month) were 93.9% for cocaine, 75.5% for cannabis, 59.2% for heroin or other opioids, 38.8% for sedatives/hypnotics/anxiolytics, 30.6% for hallucinogens/PCP, and 26.5% for stimulants.

Mean age: 34.6 (SD = 7.4) years

Gender: 100% female

Ethnicity: 23 (46.9%) white; 16 (32.7%) African American; 7 (14.2%) Hispanic; and 3 (6.1%) other races/ethnicities

Country: USA

Interventions

Group 1: Group‐based Seeking Safety plus treatment as usual: n = 27. Seeking Safety is a present‐focused therapy to help people attain safety from trauma/PTSD and substance abuse. The treatment was designed for flexible use. SS is based on a number of key principles: safety, integrated treatment of both PTSD and substance abuse at the same time, a focus on ideals, and attention to clinician processes. Interventions are in the domain of cognitive, behavioural, interpersonal, and case management.

Seeking Safety consists of 25 topics that can be conducted in any order: Introduction/Case Management, Safety, PTSD: Taking Back Your Power, When Substances Control You, Honesty, Asking for Help, Setting Boundaries in Relationships, Getting Others to Support Your Recovery, Healthy Relationships, Community Resources, Compassion, Creating Meaning, Discovery, Integrating the Split Self, Recovery Thinking, Taking Good Care of Yourself, Commitment, Respecting Your Time, Coping with Triggers, Self‐Nurturing, Red and Green Flags, Detaching from Emotional Pain (Grounding), Life Choices, and Termination.

SS was conducted in group modality for 90 min, typically 3 times a week for 6 to 8 weeks while the women were in prison, with 3 to 5 women per group. After release from prison, each woman in SS was offered weekly individual 60‐min “booster” sessions for 12 weeks to reinforce material from the group sessions.

Group 2: Treatment as usual: n = 22. All women in this study were enrolled in a 28‐bed residential substance use treatment program in the minimum‐security wing (approximately 30 hours per week). Women typically attend this program for 3 to 6 months, depending on the length of their sentences. Substance use treatment was abstinence‐oriented, focused on the 12‐step model, and took place in a psycho‐educational large‐group format, with weekly individual case management and drug counselling. Psycho‐educational groups included attention to women's health, domestic violence, affect management, relapse prevention, career exploration, anger management, and parenting, conducted by the same clinicians who conducted the SS treatment. This program did not offer any treatment specifically for trauma. Prior to prison release, the women received case management services, although this discontinued once the women were released from prison. All women leaving prison were referred for further substance use treatment.

Experimental intervention modality: Integrated

Outcomes

PTSD: CAPS; Trauma Symptom Checklist 40

SUD: ASI; TLFB

Treatment acceptability: Treatment utilisation; CSQ; mean number of sessions attended

Other: Brief Symptom Inventory; legal composite score of the ASI (for criminal activity)

Follow‐up: 12 weeks after the start of the program and 3 and 6 months following release from prison

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

The study included data only from those who were available to follow‐up. The number of women who did not provide data at follow‐up was fairly small but slightly disproportionate to the SS group. We did not feel this difference was sufficient to have a clinically relevant impact on observed effect sizes

Selective reporting (reporting bias)

Unclear risk

Outcomes were reported as specified in the methodology section, but we were not able to identify a previously published protocol

Other bias

High risk

The authors acknowledge potential contamination of treatment and control conditions in the closed communal setting of a prison wing. Postrelease follow‐up dose was not equivalent. Women in the SS group were offered up to 12 booster sessions on release from prison. Women in the control group were referred for further substance use treatment