Efficacy and moderators of cognitive therapy versus behavioural activation for adults with depression: study protocol of a systematic review and meta-analysis of individual participant data

Background Cognitive therapy and behavioural activation are both widely applied and effective psychotherapies for depression, but it is unclear which works best for whom. Individual participant data (IPD) meta-analysis allows for examining moderators at the participant level and can provide more precise effect estimates than conventional meta-analysis, which is based on study-level data. Aims This article describes the protocol for a systematic review and IPD meta-analysis that aims to compare the efficacy of cognitive therapy and behavioural activation for adults with depression, and to explore moderators of treatment effect. (PROSPERO: CRD42022341602) Method Systematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library, to identify randomised clinical trials comparing cognitive therapy and behavioural activation for adult acute-phase depression. Investigators of these trials will be invited to share their participant-level data. One-stage IPD meta-analyses will be conducted with mixedeffects models to assess treatment effects and to examine various available demographic, clinical and psychological participant characteristics as potential moderators. The primary outcome measure will be depressive symptom level at treatment completion. Secondary outcomes will include post-treatment anxiety, interpersonal functioning and quality of life, as well as follow-up outcomes. Conclusions To the best of our knowledge, this will be the first IPD metaanalysis concerning cognitive therapy versus behavioural activation for adult depression. This study has the potential to enhance our knowledge of depression treatment by using stateof- the-art statistical techniques to compare the efficacy of two widely used psychotherapies, and by shedding more light on which of these treatments might work best for whomThis work was supported by the Netherlands Organization of Scientific Research (grant number 016.Veni.195.215 6806 to E.D.); the National Institutes of Health (grant number KL2TR002530 to L.L.-L., and Sheri Robb, Principal Investigator); National Center for Advancing Translational Sciences and Clinical and Translational Sciences Award (grant number UL1TR002529 to L.L.-L., Sharon Moe and Sarah Wiehe, co-Principal Investigators). The funders had no role in the development of this study protocol, nor was there editorial direction or censorship from the sponsors in this manuscriptS