Patients' experiences of participating in a large-scale trial of cognitive behavioural therapy for depression: a mixed methods study.

Abstract

BACKGROUND: Adequate recruitment and retention rates are vital to achieving a successful randomized controlled trial. Historically this has been particularly challenging in mental health research. Few researchers have explored patients' reasons for taking part and remaining in a depression trial. OBJECTIVE: To explore patients' reasons for taking part and remaining in a trial that aimed to assess the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care for primary care patients with treatment resistant depression. METHOD: (i) DESIGN: Patients completed a short exit questionnaire about their experiences of taking part in the CoBalT trial. In addition, 40 semi-structured telephone interviews were conducted with a purposive sample of these patients to further explore their experiences. (ii) SETTING: General practices, England and Scotland. RESULTS: Of 469 patients randomized into the trial, 302 (64.4%) completed an exit questionnaire. The most frequently rated reason for taking part in the study were 'I was willing to try anything that might help me feel better' (66%). Patients indicated in interviews why they preferred follow-up data to be collected on a face-to-face basis rather than over the telephone. Some patients reported that taking part in the trial gave them a sense of self-worth and accomplishment. CONCLUSION: Patients felt they benefited from being in the trial because it enabled them to reflect on their feelings. For some, taking part increased their feelings of self-worth. These findings may be applicable to trials where feelings of inclusion and being valued are likely to promote continued participation.