Methods

Randomised controlled trial

Participants

23 (of 37 initially recruited) participants (12 male), mean age 70.1 years (range 65 to 79), allocated to 2 groups: CBT (12 patients) and waiting list control (11 patients)

Inclusion criteria were:
(1) Patient should have problems with their tinnitus
(2) Duration of tinnitus for at least 6 months and
(3) Being able to attend the sessions, including walking up the stairs to attend the sessions

Exclusion criteria were:
(1) Previous psychological treatment for tinnitus
(2) Depression score above 22 on BDI
(3) A score above 2 on item 2 (hopelessness) and item 9 (suicidal ideation)
(4) Had medical reasons for not taking part in the treatment

Interventions

Two groups:
(1) A treatment group of CBT (12 patients)
(2) A waiting list control group (11 patients)

Outcomes

Four outcome measures:
(1) The Tinnitus Reaction Questionnaire (TRQ)
(2) The Hospital Anxiety and Depression Scale (HADS)
(3) The Anxiety Severity Index (ASI)
(4) A Visual Analogue Scale for tinnitus annoyance, loudness and quality of sleep

Comparisons were made at pre‐ and post‐treatment points. Also at 3 months follow up the outcomes were compared, but at this point the data were non‐experimental, as the waiting list group had also received CBT after the post‐treatment observations.

Notes

There were no drop‐outs. Outcomes were measured pre‐ and post‐treatment (6 weeks), then the waiting list group received the same treatment, so follow‐up results at 3 months cannot be used.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised controlled trial

Participants

60 (of 65 initially recruited) patients (52 male, mean age 64 years) allocated to 3 groups: 20 patients in each group

Inclusion criteria were:
(1) Chronic tinnitus of more than 6 months duration
(2) Tinnitus assessed by both otolaryngologist and audiologist
(3) Traditional treatments not recommended or had failed
(4) No hearing aid, masker or medication for tinnitus in the previous 6 months
(5) At least 17 points on the TRQ
(6) English literacy
(7) Willingness to participate in a research programme

Interventions

Three experimental conditions:
(1) Combined cognitive educational programme
(2) Education alone (both treatments involved a 90‐minute session per week for 6 weeks, given by the same clinical psychologists, in groups of 5 to 7 participants)
(3) A waiting‐list control

Outcomes

Self‐report questionnaires administered at pre‐treatment, post‐treatment and 12 months follow up: TRQ, THQ, TEQ, TCQ, TCSQ, TKQ, BDI, LCB and a Self‐Monitoring of Tinnitus record, including: loudness, notice and bother by tinnitus

Notes

The number of patients that were lost to the 12‐month follow up was 13 (4 in the 'cognitive education', 3 in the education alone and 6 in the waiting list group). Total drop‐out at 12‐month follow up = 13/60 = 21.66%. There were no adverse effects reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised controlled trial

Participants

72 (of initially 101 recruited) participants allocated into 2 groups: treatment group (50% female, mean age 45.9 years) and waiting list group (47% female, mean age 48.5 years)

Inclusion criteria were:

(1) Medical examination by ENT specialist or an audiological physician
(2) Tinnitus duration more than 6 months duration
(3) Ability to read and understand the self‐help book
(4) Must be likely to complete the self‐help process
(5) Above 18 years of age
(6) At least 10 points on the TRQ
(7) Score of 18 or below on both the anxiety and depression subscales of HADS

Interventions

Two groups:
(1) A treatment group of CBT (34 patients). This was administered by a self‐help book and 7 weekly phone calls from a therapist over a period of 6 weeks
(2) A waiting list control group (38 patients)

Outcomes

Self‐report questionnaires administered at pre‐treatment, post‐treatment and 12 months follow up: TRQ, THI, HADS, ISI and a daily diary recording of tinnitus on visual analogue scales, including loudness, distress and perceived stress during the day

Notes

Total drop‐out at 12‐month follow up = 12%. There were no adverse effects reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

Randomisation by coin tossing

Methods

Randomised controlled trial. Randomisation by drawing code numbers from a basket with the total sample.

Participants

43 (of 52 initially recruited) patients (60.5% male, mean age 48 years) allocated to 4 groups

Inclusion criteria were:
(1) Duration of tinnitus more than 6 months
(2) Impairment due to tinnitus > 4 on a 10‐point rating scale
(3) Hearing ability adequate for communication purposes
(4) No treatable organic or psychological pathology
(5) No current psychotherapy
(6) Completed medical examination
(7) Willingness to participate in the assessment and at least 8 to 10 treatment sessions

Interventions

Four experimental groups:
(1) Tinnitus Coping Training 1 (TCT1 = 7 patients)
(2) Tinnitus Coping Training 2 (TCT2 = 8 patients)
(3) Yoga training (9 patients)
(4) A waiting list control (WLC = 19 patients)

Each treatment group (TCT1, TCT2, yoga) consisted of 10 2‐hourly sessions; each group was conducted by a different qualified professional

Outcomes

The outcome measures included:
(1) Audiological: Tinnitus Sensation Level (TSL), Tinnitus Masking Level (TML)
(2) Self‐monitoring tinnitus diary: subjective loudness, tinnitus discomfort, sleep disturbance, interference with activity, control of tinnitus and hours per day of tinnitus ignored
(3) Self‐report questionnaires: TQ, and well‐being variables: depression, mood and symptoms

All assessments were completed at pre‐treatment, post‐treatment and 3 months follow up (the latter one except for audiological outcomes)

Notes

The number of patients that were lost was 9 (3 in TCT1, 2 in TCT2t, 1 in yoga and 3 in the WLC). Total drop‐out = 9/43 = 20.93%. There were no adverse effects reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

Randomisation by drawing code numbers from a basket with the total sample

Methods

Randomised controlled trial. Randomisation by drawing code numbers from the total sample and the sequential assignment to the treatment conditions until a pre‐set number of subjects was reached.

Participants

95 (of 116 initially recruited) patients (51.6% female, mean age 46.8 years) allocated to 4 groups

Inclusion criteria were:
(1) Age between 18 and 65 years
(2) Duration of tinnitus more than 6 months
(3) Medical diagnosis of 'idiopathic' (unknown) tinnitus
(4) Tinnitus being their main health problem, with subjective annoyance rating of > 40 (out 100) on 9 scales assessing disruptive effects of tinnitus

Exclusion criteria were:
(1) Ménière's disease
(2) Hearing loss preventing from participating in communication within groups
(3) Current psychotherapeutic treatment

Interventions

Four experimental groups:
(1) Tinnitus Coping Training (TCT = 43 patients)
(2) 'Minimal contact ‐ education' (MC‐E = 16 patients)
(3) Minimal Contact ‐ Relaxation (MC‐R = 16 patients)
(4) A waiting list control (WLC = 20 patients)

TCT comprised 11 sessions of 90 to 120 minutes duration, each group consisted of 6 to 8 patients and was conducted by 2 qualified psychologists
MC‐E comprised of 2 group sessions (of education and self‐help strategies for coping with tinnitus) 4 weeks apart while 'self‐help exercises' were undertaken
MC‐R consisted of an educational session in relaxation and distraction, followed by a second session were patients received audio cassettes with relaxing music and instructions, then a further 2 sessions to discuss progress. Patients in MC‐E and MC‐R were told they could join in TCT after post‐treatment assessment.

All assessments were completed at pre‐treatment, post‐treatment 6 and 12 months follow up

Outcomes

The outcome measures included:
(1) Self‐monitoring tinnitus diary (during 2 weeks period at pre‐, post‐treatment and 6 months follow up): loudness, tinnitus awareness and subjective control of tinnitus
(2) Psychometric questionnaires: TQ (only instrument used at 12‐month follow up), TDQ , a German coping inventory (COPE), SCL‐90R and a German depression scale (ADS), a questionnaire of subjective change in tinnitus‐related variables (loudness, disability, awareness, control, ignoring) and general well‐being variables: physical well‐being, activities, mood and stress coping). All assessments were completed at pre‐treatment, post‐treatment and 6 months follow up, Tinnitus Questionnaire was the only assessment used at 12 months follow up
(3) Audiological variables (tinnitus masking level, tinnitus sensation level) are only measured in the pre‐treatment period

Notes

The number of patients lost was 21 (13 in the TCT group, 4 in MC‐E and MC‐R each). Total drop‐out = 21/95 = 22.1%. There were no adverse effects reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised controlled trial. Randomisation by a list of random sequence.

Participants

43 (of 48 initially recruited) patients (46.75% female, mean age 46.75 years) allocated to 2 groups

Inclusion criteria were:
(1) Duration of tinnitus more than 6 months
(2) Participants agreed that the tinnitus was disturbing, with a subjective annoyance rating of > 3 (on a visual analogue scale from 0 to 10)

Interventions

Two experimental groups:
(1) Psychophysiologically‐oriented intervention (23 patients)
(2) A waiting list control (WLC = 20 patients)

The psychophysiologically‐oriented intervention comprised 9 sessions of 60 minutes duration conducted by 5 supervised graduate student psychologists

All assessments were completed at pre‐treatment, post‐treatment (8 weeks) and 6 months follow up

Outcomes

The outcome measures included:
(1) Psychometric questionnaires: TQ, STI, IDCL, SCL‐90R, self‐efficacy
(2) Tinnitus diary (3 times a day, during 1‐week period at pre‐, post‐treatment and 6 months follow up): subjective loudness, tinnitus awareness and subjective control of tinnitus

All assessments were completed at pre‐treatment, post‐treatment and 6 months follow up

Notes

The number of patients that were lost at the post‐treatment point was 1 (in the intervention group) and 1 more drop‐out (in the control group) occurred at the first follow‐up point. Total drop‐out = 2/43 = 4.65%. There were no adverse effects reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised controlled trial

Participants

111 (of 130 initially recruited) patients allocated to 2 groups: treatment group (44.2% female, mean age 49.46 years) and waiting list group (44.1% female, mean age 52.93 years)

Inclusion criteria were:
(1) Duration of tinnitus greater than 6 months
(2) Serious or severe tinnitus annoyance (TQ score = 47 or more)
(3) Between 16 and 75 years of age

Exclusion criteria were:
(1) Mild degree of tinnitus annoyance
(2) Tinnitus following Ménière's disease
(3) Patients with psychosis or seriously disabling brain damage

Interventions

Two experimental groups:
(1) Biofeedback‐based behavioural intervention (52 patients)
(2) A waiting list control (59 patients)

The biofeedback‐based behavioural intervention consisted of 12 individual therapy sessions of 60 minutes duration conducted by 4 trained therapists. Each session contained biofeedback as well as CBT elements following a structured manual.

Outcomes

The outcome measures included:
(1) Global tinnitus annoyance measured with TQ
(2) Tinnitus diary (for 1 week at each assessment point) on a Visual Analogue Scale (0 to 10) including: subjective loudness, sleep disturbance, impairment, distress due to tinnitus and feelings of controllability
(3) Psychometric questionnaires: BDI, SCL‐90‐R, GSI, TRSS, TRCS

All assessments were completed at pre‐treatment, post‐treatment and 6 months follow up

Notes

Total drop‐out at post‐treatment measurement = 19/130 = 14.61%. Results for the adverse effects subscale (M = 1.51; SD = 0.63; range 1 to 6) indicated that the majority of the patients did not experience negative side effects caused by the treatment. Results for the satisfaction with therapy subscale (M = 5.16, SD = 0.51; range 1 to 6) indicated that patients were quite content with the treatment.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

Randomisation using a computer‐generated random list

Methods

Randomised controlled trial. Randomisation by throwing dice.

Participants

77 (of 83 initially recruited) patients (66.6% male, mean age 53.8 years) allocated to 3 groups

Inclusion criteria were:
(1) Duration of tinnitus more than 3 months
(2) Absence of a treatable organic cause of tinnitus
(3) Absence of Ménière's disease
(4) Hearing capacity for communication within groups
(5) Tinnitus disability score > 25 on TQ
(6) No ongoing psychotherapy or masker treatment

Interventions

Three experimental groups:
(1) Tinnitus Coping Training (TCT = 29 patients)
(2) Habituation‐based treatment (HT = 31 patients)
(3) Educational intervention (EDU = 23 patients)

TCT comprised 11 sessions of 90 to 120 minutes duration, each group consisted of 6 to 8 patients. There was a 4‐week recess between the first and second session of TCT and HT to assess the effect of education alone, and then TCT and HT continued. HT was conducted in 5 sessions of 90 to 120 minutes (spaced over 6 months) to a group of 6 to 8 patients, where education, noise generator and counselling was conducted. Education consisted in a single session informing about the physiology and psychology of tinnitus. This session was identical to the first session for TCT and very similar to the HT one. Patients in EDU group were also offered a further treatment after 15 weeks should they wish.
All groups were conducted by 5 qualified psychologist therapists.

Assessments were carried out at 7 measurement periods: at pre‐treatment, post‐treatment, 6, 12 and 18 (21 for TCT) months follow up

Outcomes

The outcome measures included:
(1) Self‐monitoring tinnitus diary (3 times per day during 1‐week period): loudness, hours of tinnitus awareness and subjective control of tinnitus
(2) Psychometric questionnaires: TQ, Tinnitus Coping Questionnaire, QCC, QDC, JQ, a German questionnaire in changes in well‐being and adaptive behaviour (VEV), SSR, SCL‐90R and Minimal Diagnostic Interview of Psychological Disorders (DSM‐III‐R)

Most variables were assessed at pre‐ and post‐treatment periods; the TQ was the only one applied at every time period

Objective tinnitus parameters (pitch masking and masking measurements) were excluded from the study

Notes

The number of patients that were lost before the post‐treatment period was 6 (2 in the TCT group, 1 in HT group and 3 in EDU group). A further 2 drop‐outs (one in TCT and one in HT group) occurred at 18 months follow up (21 months for the TCT group). Total drop‐out = 8/77 = 10.38%. There were no adverse effects reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

Randomisation by throwing dice