Department of Applied Psychotherapy and Psychiatry, Christophsbad GmbH & Co Fachkrankenhaus KG, Goppingen, Germany
University of Ulm, Ulm, Germany.
BMJ Open. 2023 Feb 16;13(2):e069228. doi: 10.1136/bmjopen-2022-069228.
Previous studies indicate that computerised trainings implementing cognitive bias modification (CBM) for interpretation bias might be promising treatments for trauma-related cognitive distortions and symptoms. However, results are mixed, which might be related to the implemented task (sentence completion task), setting, or training duration. Within the present study, we aim to evaluate the efficacy and safety of an app-based intervention for interpretation bias using standardised imagery audio scripts, which is designed as a standalone treatment.
The study is a randomised controlled trial, implementing two parallel arms. 130 patients diagnosed with post-traumatic stress disorder (PTSD) will be allocated to either the intervention group or the waiting-list control group receiving treatment as usual. The intervention consists of 3 weeks of an app-based CBM training for interpretation bias using mental imagery, with three training sessions (20 min) per week. Two months after the last training session, 1 week of booster CBM treatment will be implemented, consisting of three additional training sessions. Outcome assessments will be conducted pretraining, 1 week post-training, 2 months post-training, as well as 1 week after the booster session (approximately 2.5 months after initial training termination). The primary outcome is interpretation bias. Secondary outcomes include PTSD-related cognitive distortions and symptom severity, as well as negative affectivity. Outcome assessment will be conducted by intention-to-treat analysis, as well as per-protocol analysis using linear mixed models.
The study was approved by the Ethics Committee of the State Chamber of Physicians in Baden-Wuerttemberg, Germany (number of approval: F-2022-080). Scientific findings will be published in peer-reviewed journals informing future clinical studies, which focus on the reduction of PTSD-related symptoms using CBM.
German Clinical Trials Register (DRKS00030285; https://drks.de/search/de/trial/DRKS00030285).
先前的研究表明，针对解释偏差实施计算机化认知偏差矫正（CBM）的训练可能是治疗创伤相关认知扭曲和症状的有前途的方法。然而，结果参差不齐，这可能与所实施的任务（句子完成任务）、环境或训练持续时间有关。在本研究中，我们旨在评估使用标准化意象音频脚本的基于应用程序的干预措施对解释偏差的疗效和安全性，该干预措施被设计为独立的治疗方法。
该研究为一项随机对照试验，实施两个平行臂。将 130 名被诊断患有创伤后应激障碍（PTSD）的患者分配到干预组或接受常规治疗的等待名单对照组。干预措施包括使用心理意象进行 3 周的基于应用程序的 CBM 训练，每周进行三次训练（每次 20 分钟）。最后一次训练结束后两个月，将进行为期一周的强化 CBM 治疗，包括另外三次训练。在训练前、训练后一周、训练后两个月以及强化治疗后一周（初始训练结束后约 2.5 个月）进行结果评估。主要结局是解释偏差。次要结局包括 PTSD 相关认知扭曲和症状严重程度以及负性情感。将通过意向治疗分析以及使用线性混合模型进行的方案分析进行结果评估。
该研究已获得德国巴登-符腾堡州医师州议会伦理委员会的批准（批准编号：F-2022-080）。科学发现将发表在同行评议的期刊上，为今后使用 CBM 降低 PTSD 相关症状的临床研究提供信息。
德国临床试验注册处（DRKS00030285；https://drks.de/search/de/trial/DRKS00030285）。
