Bibliotherapy for sexual dysfunction
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The objectives of this study are to evaluate the efficacy of bibliotherapy for sexual dysfunctions, when compared with waiting list (WL), placebo treatment (PT), or therapist‐delivered care (TC), and to compare the efficacy of minimal contact bibliotherapy (MCB) with totally self‐administered bibliotherapy (SAB).
Background
Epidemiological surveys have demonstrated high prevalence rates of sexual dysfunctions in both women and men (Laumann 1999). In men, prevalence of any sexual dysfunction has been estimated to be 31%. Premature ejaculation is reported by approximately 30% of men. Erectile problems are reported to increase with age (Feldman 1994). In women, prevalence of any sexual dysfunction has been estimated at 43%. The most common complaint is hypoactive sexual desire disorder (low or absent sexual desire), although sexual pain disorder is also suggested to be highly prevalent, especially in women between the ages of 18 and 29. Vaginismus, when penile‐vaginal intercourse is found to be impossible, is estimated to occur in 4% to 42% of women attending sexual dysfunctions clinics (Frenken 1987; O'Sullivan 1979).
The treatment of sexual dysfunction has been dominated since 1970 by directed‐practice behavioural approaches, to which the "sensate focus" therapy designed by Masters & Johnson (Masters 1970) gave great impetus. In later years, cognitive approaches to the treatment of sexual dysfunctions have been described (Munjack 1984; Everaerd 1985). Outcomes of treatment have not been adequately studied for all types of different sexual dysfunctions. When applying the generally accepted Diagnostic and Statistical Manual IV (DSM‐IV) criteria (APA 1994) for well established psychological treatments, only treatments for female orgasmic dysfunction and for male erectile dysfunction were found to merit this qualification (Heiman 1997).
Bibliotherapy refers to the treatment of mental and physical health problems in which written material plays a central role, typically a description of a specific treatment method (Glasgow 1978; Gould 1993; Marrs 1995; Rosen 1987; van Lankveld 1998). The written material used in bibliotherapy for sexual dysfunctions is based on methods and suggestions used in therapist‐administered sex therapy (Hawton 1995; Leiblum 1989; Masters 1970). Well known self‐help manuals in this domain have been written by Barbach (Barbach 1974), Heiman, Lopiccolo and Lopiccolo (Heiman 1976) and Zeiss and Zeiss (Zeiss 1978a). Bibliotherapy is often applied within treatment formats with minimal or absent therapist contact. It has also been applied as an adjuvant to therapist‐administered treatment for sexual dysfunctions (Dauw 1988; Gillan 1980; Halvorsen 1992; McCarthy 1984, McCarthy 1989; Price 1981).
In Gould and Clum's (Gould 1993) meta‐analysis of 40 studies, bibliotherapy for sexual dysfunctions had one of the largest mean effect sizes (MES, +1.86) when compared to other target problems (eg, smoking, MES 0.46; fear reduction, MES 1.11; depression, MES 0.74). This finding, however, rests on a single bibliotherapy study (Dodge 1982). The overall MES in this meta‐analysis was +0.76. Bibliotherapy for sexual dysfunctions also produced the highest effect size (+1.28) of all categories in Marrs' (Marrs 1995) meta‐analysis of bibliotherapy. The effect size for the sexual dysfunctions category was based on four studies, all of which were published in major journals. Marrs (Marrs 1995) arrived at an overall MES of +0.565 for all 70 studies included in the meta‐analysis. In another meta‐analysis, van Lankveld (van Lankveld 1998) found an average unweighted effect size of 0.68 (95% confidence interval (CI) 0.23, 1.14) measured at post‐treatment, and a medium strength average effect size (weighted for sample size) of 0.50 (95% CI 0.27, 0.72). However, the basic efficacy of bibliotherapy was not established for the majority of sexual dysfunctions, since 87% of the studies dealt with orgasmic disorders. Bibliotherapy for sexual dysfunctions had thus far reflected the directed‐practice approach of Masters and Johnson (Masters 1970) or modifications of this approach. Cognitive‐behavioural therapy in a bibliotherapy format for sexual dysfunctions has been examined in only one study (van Lankveld 2001a).
The aim is to provide a comprehensive review of all bibliotherapy approaches for sexual dysfunctions, and to update and expand the previously published evidence. From a societal point of view, the potential increase in cost‐effectiveness of bibliotherapy warrants efforts to establish the efficacy and effectiveness of bibliotherapy approaches to sexual dysfunctions.
Objectives
The objectives of this study are to evaluate the efficacy of bibliotherapy for sexual dysfunctions, when compared with waiting list (WL), placebo treatment (PT), or therapist‐delivered care (TC), and to compare the efficacy of minimal contact bibliotherapy (MCB) with totally self‐administered bibliotherapy (SAB).
Methods
Criteria for considering studies for this review
Types of studies
Studies eligible for inclusion will be randomised controlled trials (RCT), both published and unpublished. Quasi‐randomised controlled trials will not be included.
Types of participants
Inclusion criteria:
(1) Male and female.
(2) 16 to 65 years.
(3) Primary diagnosis of sexual dysfunction according to International Classification of Diseases 10th edition (WHO 1992) or Diagnostic and Statistical Manual IV (APA 1994) criteria, or previous editions of these classification systems. Sexual dysfunction will include male and female hypoactive sexual desire disorder, male erectile disorder, female sexual arousal disorder, female and male orgasmic disorder, male premature ejaculation, male and female dyspareunia and female vaginismus.
Sexual dysfunction that is attributable to pharmacotherapy adverse effects and to general medical conditions, as well as sexual dysfunction with comorbid mental disorders and with comorbid relationship difficulties will be included.
Types of interventions
The psychological bibliotherapy interventions to be examined are:
(1) Behaviour therapy (eg, differential reinforcement of desired behaviour, as in the treatment of female orgasmic disorder (Heiman 1988); exposure to feared conditions, such as systematic desensitisation for erectile disorder (Everaerd 1985) and female vaginismus (Shahar 1978)). A self‐help manual has been published for female orgasmic disorder (Heiman 1988).
(2) Cognitive‐behavioural treatment (eg, cognitive restructuring).
Studies providing bibliotherapy alone, as well as in conjunction with audiovisually presented therapeutic ingredients, will be included in the review. Studies providing bibliotherapy with limited (minimal) therapist contact (eg, through short telephone calls, through email, or through a small number of direct contacts with a therapist; altogether totalling a maximum of two hours per treated participant) will be included. Studies providing totally self‐administered bibliotherapy (with no therapist support at all) will be included, although contact may be required for assessment purposes.
The control group should receive:
(1) Wait list.
(2) Placebo treatment, in which active treatment is compared with interventions presumed to be inert, thus controlling for alternative explanations of treatment effects, including placebo effects, attention effects, expectancy effects, and so on. A plausible placebo treatment could, for instance, use written material with non‐specific suggestions, such as general relaxation.
(3) Therapist‐delivered sex therapy involving more intensive therapist support, such as sensate focus therapy (Masters 1970), or cognitive‐behavioral sex therapy, also involving more intensive therapist contact, and emphasising cognitive changes (eg, Carey 2001).
The main comparisons are:
(1) Bibliotherapy versus waiting list.
(2) Bibliotherapy versus placebo.
(3) Bibliotherapy versus therapist‐delivered care.
(4) Minimal contact bibliotherapy (MCB) versus totally self‐administered bibliotherapy (SAB).
Types of outcome measures
Primary outcome
The primary outcome measures in this review are sexual symptom level and continuation or remission of sexual dysfunction according to well‐established diagnostic criteria (eg, DSM‐IV (APA 1994). Sexual symptom level is usually measured using a range of rating scales, for example, self‐rating scales of duration of male penile erection (erectile disorder), attainment of orgasm or ejaculation (orgasmic disorder), latency time to ejaculation (premature ejaculation), successful or painless intercourse (in case of sexual pain disorder). Frequently used outcome measures are, among others, the Sexual Interaction Inventory, the Sexual History Form, the Derogatis Sexual Functioning Inventory and the Golombok Rust Inventory of Sexual Satisfaction.
Symptom levels may be presented as continuous (means and standard deviation (SD)) or dichotomous outcomes (recovery/non‐recovery). For dichotomous outcomes, improvement will be defined in accordance with the criteria used in each study.
Target outcome variables will be measured using patient, partner or clinician rated scales.
Secondary outcomes
(1) Psychometrically validated measures of sexual (dys)function, sexual satisfaction, sexual attitude or subjective sexual experience.
(2) Measures of relationship satisfaction.
(3) Quality of life.
(4) Acceptability of the intervention.
(5) Adherence to treatment requirements/protocol.
(6) Dropout from trials post‐randomisation.
For each outcome in included studies, articles will be scrutinised to identify the scales used, and whether alterations have been made to these scales. Established scales that have undergone minor modifications will be included in the review where an appropriate rationale and description of modifications is provided by trial authors.
Search methods for identification of studies
See: Collaborative Review Group search strategy
(1) Electronic bibliographic databases
CDANCTR‐Studies
Diagnosis = Sex* or Orgasmic or Ejaculat* or Impotence or Psychosexual
and
Free‐Text = (("self help" or self‐help or "self change" or self‐change or "self care" or self‐care or "self directed" or self‐directed or "minimal guidance" or "minimal contact" or bibliotherapy or written or manual* or computer* or internet or www or cd‐rom or "cd rom" or cd or cdrom or online or dvd or floppy or audio* or video* or Virtual) and (therap* or interven* or treatment* or instruct*))
CCDANCTR‐References (for those references not yet converted into study format)
Keyword = Sex* or Orgasmic or Ejaculat* or Impotence or Psychosexual
and
Free‐Text = (("self help" or self‐help or "self change" or self‐change or "self care" or self‐care or "self directed" or self‐directed or "minimal guidance" or "minimal contact" or bibliotherapy or vicarious or manual* or computer* or internet or www or cd‐rom or "cd rom" or cd or cdrom or online or dvd or floppy or audio* or video* or Virtual or written) and (therap* or interven* or treatment* or instruct*))
The Cochrane Library (Issue 4, 2005) will be searched using the following terms; Sexual‐Dysfunction‐Psychological
(2) The following journals will be handsearched:
Archives of Sexual Behavior (1971 ‐ 2005)
The Journal of Sex and Marital Therapy (1974 ‐2005)
The Journal of Sex Research (1965 ‐2005).
Sexual and Relationship Therapy (1986 ‐ 2005)
Sexual Dysfunction (1998)
(3) Reference lists of relevant articles will be searched. Social Sciences and Science Citation Index will be searched for all included studies.
(4) The first author on all included studies and experts in the field will be contacted for information regarding published and unpublished trials.
Data collection and analysis
Study selection
The principal review author (JvL) will inspect all titles and abstracts of studies identified by the electronic search strategies to see if studies are likely to be relevant. Selected articles will be obtained, and will be assessed independently by two of the three review authors (JvL and KW or VH) to ensure that they meet the previously defined inclusion criteria. In case of doubt or disagreement, the full article will be obtained for inspection.
Quality assessment
Two review authors (JvL and KW or VH) will independently assess the methodological quality of the selected trials using the criteria set out in the Cochrane Collaboration Handbook (Alderson 2004), which pays particular attention to the quality of the randomisation procedure, including allocation concealment. On this basis studies will be given a quality rating of A (adequate), B (unclear), and C (inadequate). Disagreement between the reviewers on the appropriate quality‐rating category will be resolved through discussion. Where adequate details of randomisation are not provided, the trial authors will be contacted in order to obtain further information.
A further quality assessment will also be performed using the Cochrane Collaboration Depression, Anxiety and Neurosis Group Quality Rating Scale (QRS) (Moncrieff 2001). The QRS consists of 23 items, including items on sample size, allocation, use of diagnostic criteria, compliance, attrition and statistical analysis. Total scores range from 0 to 46. Trial exclusions will not be made based on these criteria.
Data extraction and management
A standardised spreadsheet will be completed for every included trial, which records information on the study population, interventions, randomisation and blinding procedures, sample size, outcome data, follow up and methods of statistical analysis. Data will be extracted independently by two review authors (JvL and KW or VH). Any disagreements between the two review authors will be resolved through discussion with the third review author.
Data analysis
Data from included studies will be synthesised using Review Manager software.
Measures of treatment effect
Dichotomous outcomes: the Peto fixed‐effect method will be used. This allows the calculation of an estimate known as the 'typical' or pooled odds ratio, with its 95% confidence interval. The primary analysis will be conducted using available data (completer analysis). A fixed‐effects model will be used in the first instance to combine dichotomous data. Where there is evidence of statistical heterogeneity, results will be recalculated using a random‐effects model. The random‐effects model will tend to give a more conservative estimate, but where there is no heterogeneity, the results from the two models should agree. A fixed‐effects model will be used in the first instance to combine continuous and dichotomous data. Where there is evidence of statistical heterogeneity, results will be recalculated using a random‐effects model. The random‐effects model will tend to give a more conservative estimate, but where there is no heterogeneity, the results from the two models should agree.
Continuous outcomes: where studies use the same outcome measure for a comparison, data will be pooled by calculating the weighted mean difference (WMD). Where different measures are used to assess the same outcome for a comparison, data will be pooled by calculating the standardised mean difference (SMD). 95% confidence intervals will be calculated. Continuous data will be analysed on an endpoint basis, including only participants with a final assessment or with a last observation carried forward (LOCF) to the final assessment. As with dichotomous data outcomes, a fixed‐effects model will be used in the first instance to combine continuous data, and results will be recalculated using a random‐effects model where there is evidence of statistical heterogeneity.
Subgroup analyses
Where sufficient data are available, prespecified clinical characteristics will be examined in subgroup analyses to investigate their influence on the size of the treatment effect. Subgroup analyses will be performed for:
(1) Bibliotherapy alone and bibliotherapy plus audiovisual aids.
(2) Different age groups in the treatment of erectile dysfunction:
(a) Less than 50 years.
(b) 51 years and older.
Sensitivity analyses
Where sufficient data are available, prespecified sensitivity analyses will be conducted to test the robustness of the findings obtained, through excluding studies of lower quality, based on:
(1) Method of allocation concealment.
(2) Dropout rates.
(3) Inclusion of comorbid disorders.
(4) Intention to treat analysis (ITT), in which it will be assumed that patients who dropped out after randomisation had a negative outcome.
Testing for heterogeneity
Statistical heterogeneity will be formally tested using the natural approximate chi‐squared test, which provides evidence of variation in effect estimates beyond that of chance. Since the chi‐squared test has low power to assess heterogeneity where a small number of participants or trials are included, the p‐value will be conservatively set at 0.1. Heterogeneity will also be tested using the I square statistic, which calculates the percentage of variability due to heterogeneity rather than chance, with I square values over 50% indicating strong heterogeneity (Higgins 2003).
Potential sources of clinical heterogeneity will be examined through the use of subgroup analyses as specified above. Potential sources of methodological heterogeneity will be examined through use of sensitivity analyses, as specified above.
Publication bias
Funnel plots will be produced and inspected visually to test for publication bias.
