接受和承诺疗法对脑损伤后出现抑郁和焦虑症状人群的疗效：BrainACT 随机对照试验结果。
Acceptance and commitment therapy for people with depressive and anxiety symptoms following acquired brain injury: Results of the BrainACT randomized controlled trial.
机构信息
School for Mental Health and Neuroscience, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands; Limburg Brain Injury Centre, Maastricht, the Netherlands; Department of Psychology, Norwegian University of Science and Technology, Trondheim, Norway.
Department of Clinical and Medical Psychology, Zuyderland Medical Centre, Sittard-Geleen/Heerlen, the Netherlands.
出版信息
J Psychosom Res. 2024 Dec;187:111933. doi: 10.1016/j.jpsychores.2024.111933. Epub 2024 Sep 12.
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. psycho-education 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 follow-up.
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.
目的
本研究旨在探讨一种适应性接受与承诺疗法（BrainACT）对脑损伤后出现焦虑和/或抑郁症状的人群的有效性。
方法
该研究为多中心随机对照两臂平行试验。共有 72 名中风或创伤性脑损伤幸存者被随机分为八节 ACT 或对照组（即心理教育和放松）干预组。主要结局测量指标为医院焦虑抑郁量表（HADS）和抑郁焦虑应激量表（DASS）。次要结局为 ACT 过程测量指标、参与度和生活质量。由经过培训的评估人员进行结果评估，评估人员对治疗条件、治疗前、治疗中、治疗后以及 7 个月和 12 个月随访时均保持盲态。
结果
两组在任何结局测量指标上均无差异。两组参与者在所有结局测量指标上均显著改善，除了参与频率。在 HADS 上有更具临床意义的长期改善（即恢复或可靠变化），ACT 在抑郁和焦虑症状方面更具优势。
结论
本研究在主要结局测量指标上为阴性。在个体层面上，本研究表明，尤其是在长期来看，ACT 似乎在降低焦虑和抑郁症状方面比积极对照干预更具临床意义。然而，ACT 在改善与 ACT 相关的过程（如心理灵活性、认知解离和有价值的生活）以及增加参与度或生活质量方面并不优于积极对照干预。需要进一步开展大规模的群组研究。
试验注册
该研究最初在荷兰试验注册库（现为临床试验注册平台）中注册，注册号为 NL-OMON50203。于 2018 年 7 月 18 日注册，现可在 https://trialsearch.who.int/Trial2.aspx?TrialID=NL-OMON50203 找到。
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