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

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.