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Table 2 Summary of the study objectives, outcomes and analysis plans

From: A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol

Aim Objectives Outcome Hypothesis Statistical analysis
Primary Assess feasibility of recruitment, retention, group size and data completion Recruitment and retention rates, data missingness BA is feasible and acceptable Descriptive statistics: mean and SD for continuous variables and proportions for dichotomous variables
  Assess resources needed Group and interview rooms needed, number of clinicians to deliver groups, average length of group session (time needed per session)   Descriptive statistics: mean and SD for continuous variables and proportions for dichotomous variables
  Participants’ feedback and personal experiences Qualitative study feedback   Qualitative study results based on grounded theory
Secondary Clinical outcomes: BDI-II and quality of life Rate of completion of the scales The intervention group will show improvement in these scales Between and within group comparisons of the BDI-II and quality of life scales