Acceptance and commitment therapy for people with depressive and anxiety symptoms following acquired brain injury: Results of the BrainACT randomized controlled trial

Objective: This study aimed to investigate the effectiveness of an adapted ACT intervention (BrainACT) in people who experience anxiety and/or depressive symptoms following acquired brain injury. Methods: The study is a multicentre randomized controlled two-arm parallel trial. In total, 72 people who survived a stroke or traumatic brain injury were randomized into an eight-session ACT or control (i.e. psychoeducation and relaxation) intervention. The primary outcome measures were the Hospital Anxiety and Depression Scale (HADS) and the Depression Anxiety and Stress Scale (DASS). Secondary outcomes were ACT process measures, participation, and quality of life. Outcome assessments were performed by trained assessors, blinded to treatment condition, pre-treatment, during treatment, post-treatment, and at 7 and 12 months followup. Results: There were no differences between groups on any outcome measure. Participants in both groups significantly improved on all outcome measures, except for participation frequency. More clinically relevant long-term improvements (i.e. recovered or reliable changes on the HADS) were found in favour of ACT for depressive and anxiety symptoms. Conclusion: The study was negative on the primary outcome measures. On an individual level, this study showed that especially on the long term ACT seems to show a more clinically relevant decrease in anxiety and depressive symptoms compared to an active control intervention. However, ACT was not superior in improving ACT-related processes such as psychological flexibility, cognitive defusion, and valued living nor in increasing participation or quality of life. Further large-scale group studies are warranted. Trial registration: The study was originally registered in the Dutch Trial Register (now Clinical Trial Registry Platform), NL-OMON50203. Registered on 18/07/2018 and now to be found under https://trialsearch.who.int/ Trial2.aspx?TrialID=NL-OMON50203.