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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