Dataset Information

Guided self-help cognitive behavioural therapy for depression in primary care: a randomised controlled trial.

ABSTRACT:

Background

Access to Cognitive behavioural therapy (CBT) for depression is limited. One solution is CBT self-help books. Trial Objectives: To assess the impact of a guided self-help CBT book (GSH-CBT) on mood, compared to treatment as usual (TAU).

Hypotheses

GSH-CBT will have improved mood and knowledge of the causes and treatment of depression compared to the control receiving TAUGuided self-help will be acceptable to patients and staff.

Methods and findings

Participants

Adults attending seven general practices in Glasgow, UK with a BDI-II score of ?14. 141 randomised to GSH-CBT and 140 to TAU.

Interventions

RCT comparing 'Overcoming Depression: A Five Areas Approach' book plus 3-4 short face to face support appointments totalling up to 2 hours of guided support, compared with general practitioner TAU.

Primary outcome

The BDI (II) score at 4 months. Numbers analysed: 281 at baseline, 203 at 4 months (primary outcome), 117 at 12 months.

Outcome

Mean BDI-II scores were lower in the GSH-CBT group at 4 months by 5.3 points (2.6 to 7.9, p<0.001). At 4 and 12 months there were also significantly higher proportions of participants achieving a 50% reduction in BDI-II in the GSH-CBT arm. The mean support was 2 sessions with 42.7 minutes for session 1, 41.4 minutes for session 2 and 40.2 minutes of support for session 3. Adverse effects/Harms: Significantly less deterioration in mood in GSH-CBT (2.0% compared to 9.8% in the TAU group for BDI-II category change).

Limitations

Weaknesses: Our follow-up rate of 72.2% at 4 months is better than predicted but is poorer at 12 months (41.6%). In the GSH-CBT arm, around 50% of people attended 2 or fewer sessions. 22% failed to take up treatment.

Conclusions

GSH-CBT is substantially more effective than TAU.

Trial registration

Controlled-Trials.com ISRCTN13475030.

SUBMITTER: Williams C

PROVIDER: S-EPMC3543408 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Guided self-help cognitive behavioural therapy for depression in primary care: a randomised controlled trial.

Williams Christopher C Wilson Philip P Morrison Jill J McMahon Alex A Walker Andrew A Allan Lesley L McConnachie Alex A McNeill Yvonne Y Tansey Louise L

PloS one 20130111 1

<h4>Background</h4>Access to Cognitive behavioural therapy (CBT) for depression is limited. One solution is CBT self-help books. Trial Objectives: To assess the impact of a guided self-help CBT book (GSH-CBT) on mood, compared to treatment as usual (TAU).<h4>Hypotheses</h4>GSH-CBT will have improved mood and knowledge of the causes and treatment of depression compared to the control receiving TAUGuided self-help will be acceptable to patients and staff.<h4>Methods and findings</h4><h4>Participan ...[more]

PMID: 23326352

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Project description:OBJECTIVES:To ascertain whether an ultrabrief intervention (UBI) improves mental health outcomes for patients in general practice with mild-to-moderate mental health concerns. TRIAL DESIGN:Two-arm cluster randomised controlled trial. METHODS:Participants: general practitioners (GPs) were invited based on working in a participating general practice. Patients were eligible to participate if aged 18-65 years, scored ?35 on the Kessler-10 (K10) and if meeting local mental health access criteria (based on age, low income or ethnic group). INTERVENTIONS:intervention arm GPs were trained on the UBI approach, with participating patients receiving three structured appointments over 5 weeks. GPs randomised to practice as usual (PAU) did not receive training, and delivered support following their existing practice approaches. OUTCOME MEASURES:primary outcome was patient-level K10 score at 6 months postrecruitment.Randomisation: GP practices were randomised to UBI training or PAU at the start of the study.Blinding: GPs were not blinded to group assignment. RESULTS:Numbers randomised: 62 GPs (recruiting 85 patients) were randomised to UBI, and 50 to PAU (recruiting 75 patients).Numbers analysed: 31 GPs recruited at least one patient in the UBI arm (70 patients analysed), and 21 GPs recruited at least one patient in the PAU arm (69 patients analysed). OUTCOME:K10 scores from an intention-to-treat analysis were similar in UBI and PAU arms, with a wide CI (mean adjusted K10 difference=1.68 points higher in UBI arm, 95% CI -1.18 to 4.55; p=0.255). Secondary outcomes were also similar in the two groups. CONCLUSIONS:the UBI intervention did not lead to better outcomes than practice as usual, although the study had lower than planned power due to poor recruitment. The study results can still contribute to the continuing debate about brief psychological therapy options for primary care and their development. TRIAL REGISTRATION NUMBER:ACTRN12613000041752; Pre-results.

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Project description:With a prevalence of 3 to 8% among women of reproductive age, severe premenstrual symptoms are very common. Symptoms range from emotional and cognitive to physical changes. Severe symptoms (that is, premenstrual syndrome) can have a strong impact on everyday functioning and quality of life. Impairment can be as serious as that of dysthymic disorders. Many affected women receive either no treatment at all or are unsatisfied with their treatment. Although there is some evidence for the reduction of distress through cognitive behavioural therapy, there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach. Thus, this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome.The study is conducted as a randomised controlled trial. The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview. Eligible women are randomly assigned to either a treatment or a wait-list control group. The intervention is based on cognitive behavioural therapy principles and is provided via the internet. It consists of 14 different modules on which participants work over 8 consecutive weeks. In addition to written information, participants receive email feedback from a clinical psychologist on a weekly basis. Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks). The primary outcome measure is the Premenstrual Syndrome Impairment Measure. Secondary outcomes include the Premenstrual Syndrome Coping Measure, the Short-Form Social Support Questionnaire, the Questionnaire for the Assessment of Relationship Quality, and the Perceived Stress Scale. Data is collected during the premenstrual (luteal) phase at pre-treatment, post-treatment, and 6-month follow-up.So far, there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome. The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.ClinicalTrials.gov: NCT01961479, 9 October 2013.

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Dataset Information

Guided self-help cognitive behavioural therapy for depression in primary care: a randomised controlled trial.

Background

Hypotheses

Methods and findings

Participants

Interventions

Primary outcome

Outcome

Limitations

Conclusions

Trial registration

Publications

Guided self-help cognitive behavioural therapy for depression in primary care: a randomised controlled trial.

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