Influence of childhood trauma on the treatment outcomes of pharmacological and/or psychological interventions for adolescents and adults with bipolar disorder: protocol for a systematic review and meta-analysis.

Introduction Despite available pharmacological and psychological treatments, remission rates for bipolar disorder remain relatively low. Current research implicates the experience of childhood trauma as a potential moderator of poor treatment outcomes among individuals with bipolar disorder. To date, the evidence reporting the influence of childhood trauma on the treatment outcomes of pharmacological and/or psychological interventions for adolescents and adults with bipolar disorder has not been systematically reviewed. Method and analysis MEDLINE Complete, Embase, PsycINFO and the Cochrane Central Register of Controlled Trials will be searched to identify randomised and nonrandomised studies of pharmacological and/or psychological interventions for bipolar disorder, which also assessed childhood trauma. To be eligible for inclusion, studies must have been conducted with adolescents or adults (≥10 years). Data will be screened and extracted by two independent reviewers. The methodological quality of the included studies will be assessed with the Cochrane Collaboration’s Risk of Bias tool and the Newcastle-Ottawa Scale. If deemed viable, a meta-analysis will be conducted using a random effects model. Heterogeneity of evidence will be estimated with the I² statistics. Ethics and dissemination This systematic review will use only previously published data. Therefore, ethical approval is not required. The results will be written in concordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines, published in peer-reviewed journals and presented at relevant conferences. PROSPERO registration number CRD42020201891.