Assessing the subjective experience of participating in a clinical trial (AVATAR)

Abstract

This study assessed the subjective experience of participating in a clinical trial, specifically positive and negative experiences and the experience of audio recording assessment sessions. The study was cross-sectional from a single blinded randomised controlled trial. Forty participants with a primary diagnosis of non-organic psychosis completed baseline and 12-week follow-up questionnaires assessing their experiences. Participants rated research interviews as moderately helpful in facilitating their therapy and talking to the interviewer as moderately helpful at baseline and 12-week follow-up. Self-report ratings of the degree of self-realisation promoted by the research questionnaires were significantly higher at 12-week follow-up compared to baseline. Participants adjusted quickly to being audio recorded and rated interviews as not at all disruptive and not at all to slightly intrusive. On average there were neutral emotional reactions, positive gains and minimal inconveniences as a result of participation. The main reasons for taking part were: 'To help myself', 'I was curious' and 'To help others'. The findings offer support to previous research reporting that individuals with mental health problems find participating in clinical trials a beneficial experience. This may alleviate concerns that participation in similar studies may be personally intrusive or harmful.

Keywords: Audio recording; Mental health; Negative; Participate; Positive; Research.