Stangier Ulrich, Kohl Viktoria, Görg Nora, Sendig Lucie, Hufschmidt Bettina, Bonarius Desiree, Nemani Arwin, Ebert Mareike, Hofmann Stefan G
Department of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, Frankfurt, 60486, Germany.
Department of Psychology, Philipps University Marburg, Schulstr. 12, 35037, Marburg/Lahn, Germany.
Trials. 2024 Dec 19;25(1):838. doi: 10.1186/s13063-024-08689-3.
Process-based therapy (PBT) is a new framework to intervention planning, based on the use of ecological momentary assessment (EMA) data and dynamic and idiographic network analyses. Support for its applicability has been reported from a single-case studies. Here, we examine the feasibility and effectiveness of PBT in a larger clinical sample. We have translated a training manual of PBT and modified for delivery of CBT in mental health service. The aim of this study is to test the relative efficacy of PBT compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat mood and anxiety disorders.
The study is a randomized controlled trial (RCT) of PBT vs r-CBT for difficult-to-treat unipolar depression and anxiety disorders. In total, 80 patients are recruited at an outpatient clinic and included in two intervention arms. Primary outcome is emotional distress; secondary outcomes include psychological well-being and quality of life, adaptive behavior, psychological flexibility, and reflective functioning. Assessments of outcome variables are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes are collected for every session to investigate process of change. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and adherence with manual will be monitored using self-report.
The current study will be the first RCT of PBT in a health care setting. The planned moderator and mediator analyses will clarify the mechanisms of change in psychotherapy and the association between personalized assessment based on dynamic network analysis and treatment effect.
ClinicalTrials.gov NCT06517589. Registered 24 July 2024.
基于过程的疗法（PBT）是一种干预计划的新框架，它基于生态瞬时评估（EMA）数据以及动态和个性化网络分析的运用。单病例研究报告了对其适用性的支持。在此，我们在一个更大的临床样本中检验PBT的可行性和有效性。我们翻译了一份PBT培训手册，并对其进行修改以用于心理健康服务中认知行为疗法（CBT）的实施。本研究的目的是测试与常规实践中提供的传统CBT（r-CBT）相比，PBT对难治性情绪和焦虑障碍的相对疗效。
该研究是一项针对难治性单相抑郁和焦虑障碍的PBT与r-CBT的随机对照试验（RCT）。总共在一家门诊诊所招募了80名患者，并将其纳入两个干预组。主要结局是情绪困扰；次要结局包括心理健康和生活质量、适应性行为、心理灵活性和反思功能。在治疗前后以及6个月随访时对结局变量进行评估。为每个疗程收集患者每周的自评结局，以调查变化过程。对治疗分配不知情的结局评估者将进行基于观察者的症状评分，并使用自我报告监测对手册的依从性。
本研究将是在医疗环境中进行的第一项PBT的RCT。计划中的调节因素和中介分析将阐明心理治疗中的变化机制以及基于动态网络分析的个性化评估与治疗效果之间的关联。
ClinicalTrials.gov NCT06517589。于2024年7月24日注册。
