Vogt Rabea, Haas Julia, Baumann Lukas, Sander Anja, Klose Christina, Riecke Jenny, Rief Winfried, Bingel Ulrike, Maser Dustin, Witthöft Michael, Keßler Jens, Zugaj Marco Richard, Ditzen Beate, Glombiewski Julia Anna
Department of Psychology, University of Kaiserslautern-Landau (RPTU), Kaiserslautern, Germany.
Institute of Medical Biometry (IMBI), University of Heidelberg, Heidelberg, Germany.
Trials. 2024 Mar 11;25(1):176. doi: 10.1186/s13063-024-08017-9.
Chronic back pain is a widespread medical condition associated with high socioeconomic costs and increasing prevalence. Despite the advanced implementation of multidisciplinary approaches, providing a satisfactory treatment offer for those affected is often not possible. Exposure therapy (EXP) promises to be an effective and economical form of treatment and in a previous pilot study showed to be superior to cognitive behavioral therapy (CBT) in reducing perceived limitations of movement. The current study aims to further compare the efficacy of both treatment methods and identify those patient groups that particularly benefit from EXP.
The general objective of this randomized multicenter clinical trial (targeted N = 380) is to improve and expand the range of treatments available to patients with chronic back pain. As the primary objective of the study, two different psychological treatments (EXP and CBT) will be compared. The primary outcome measure is a clinically significant improvement in pain-related impairment, measured by the QPBDS, from baseline to 6-month follow-up. Secondary outcome measures are absolute changes and clinically significant improvements in variables coping, psychological flexibility, depressiveness, catastrophizing, exercise avoidance and fear of exercise, and intensity of pain. Participants are recruited in five psychological and medical centers in Germany and receive ten sessions of manualized therapy by trained licensed CBT therapists or clinical psychologists, who are currently in their post-gradual CBT training. Potential predictors of each treatment's efficacy will be explored with a focus on avoidance and coping behavior.
This study will be the first RCT to compare CBT and EXP in chronic back pain in a large sample, including patients from different care structures due to psychological and medical recruitment centers. By identifying and exploring potential predictors of symptom improvement in each treatment group, this study will contribute to enable a more individualized assignment to treatment modalities and thus improves the care situation for chronic back pain and helps to create a customized treatment program for subgroups of pain patients. If our findings confirm EXP to be an efficacious and efficient treatment concept, it should gain more attention and be further disseminated.
ClinicalTrials.gov NCT05294081. Registered on 02 March 2022.
慢性背痛是一种普遍存在的病症，会带来高昂的社会经济成本且患病率不断上升。尽管多学科方法已得到广泛应用，但往往无法为患者提供令人满意的治疗方案。暴露疗法（EXP）有望成为一种有效且经济的治疗方式，在之前的一项试点研究中，它在减轻运动感知限制方面优于认知行为疗法（CBT）。本研究旨在进一步比较这两种治疗方法的疗效，并确定那些特别受益于暴露疗法的患者群体。
这项随机多中心临床试验（目标样本量N = 380）的总体目标是改善和扩大慢性背痛患者可获得的治疗范围。作为该研究的主要目标，将比较两种不同的心理治疗方法（暴露疗法和认知行为疗法）。主要结局指标是通过疼痛相关障碍问卷简表（QPBDS）测量的，从基线到6个月随访时疼痛相关损伤的临床显著改善。次要结局指标是应对、心理灵活性、抑郁、灾难化、运动回避和运动恐惧以及疼痛强度等变量的绝对变化和临床显著改善。参与者在德国的五个心理和医疗中心招募，并由经过培训的有执照的认知行为疗法治疗师或临床心理学家进行十次标准化治疗，这些治疗师目前正在接受毕业后的认知行为疗法培训。将重点探索回避和应对行为，以研究每种治疗方法疗效的潜在预测因素。
本研究将是第一项在大样本中比较认知行为疗法和暴露疗法治疗慢性背痛的随机对照试验，纳入了来自不同护理结构的患者，这是由于心理和医疗招募中心的原因。通过识别和探索每个治疗组症状改善的潜在预测因素，本研究将有助于实现更个性化的治疗方式分配，从而改善慢性背痛的护理状况，并有助于为疼痛患者亚组制定定制化治疗方案。如果我们的研究结果证实暴露疗法是一种有效且高效的治疗理念，它应会得到更多关注并得到进一步推广。
ClinicalTrials.gov NCT05294081。于2022年3月2日注册。
