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Table 1 Details of the trials and the nested qualitative studies

From: Exploring patients’ treatment journeys following randomisation in mental health trials to improve future trial conduct: a synthesis of multiple qualitative data sets

Trial Trial aim Trial design Intervention treatment Patients intervieweda
1 Assess the clinical effectiveness and cost-effectiveness of a facilitated physical activity intervention plus usual care, versus usual care alone, for patients with a new episode of depression Patients randomised to receive a physical activity intervention plus usual care or usual care alone The physical activity intervention was delivered by physical activity facilitators. It consisted of a maximum of 13 sessions; one 1-h face-to-face session, two 45-minute face-to-face sessions and ten 10- to 20-minute telephone sessions. Thirty-three trial participants interviewed at 4 months post-randomisation, having completed their primary outcome measures for the trial. Nineteen had been randomised to facilitated activity plus usual care, the rest to usual care only. Twenty-one of the 33 were interviewed again 9 months later.
2 Examine the clinical effectiveness and cost-effectiveness of CBT plus usual care, versus usual care alone, for patients with treatment-resistant depression Participants randomised to face-to-face CBT plus usual care or usual care only Face-to-Face CBT was delivered by CBT therapists. Patients were allowed up to eighteen 1-h sessions. Forty trial participants were interviewed 6 months post-randomisation, having completed their primary outcome measures for the trial. Twenty-six had been randomised to CBT plus usual care and 14 to usual care only.
3 Evaluate the clinical effectiveness of antidepressants compared with general supportive care, and to evaluate the clinical effectiveness and cost-effectiveness of antidepressants compared with listening visits as an initial treatment for post-natal depression Participants randomised to antidepressants or listening visits but could ‘cross’ treatment arms after 4 weeks post-randomisation Listening visits were delivered by research health visitors. The visits lasted 1-h each. Women were allowed up to eight visits in total. Twenty-seven trial participants were interviewed at 44 weeks post-randomisation, having received treatment in the trial. Seventeen had been randomised to initially receive listening visits, and ten had been allocated to initially receive antidepressants.
  1. CBT Cognitive behavioural therapy
  2. aTrial 1 interviews were held between March and November 2009 and between November 2009 and July 2010. Trial 2 interviews were held between April 2010 and February 2011. Trial 3 interviews were held between November 2006 and June 2007