Department of Psychiatry and Psychotherapy, Centre for Health Services Research in Medicine, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.
Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.
BMC Psychiatry. 2019 May 17;19(1):154. doi: 10.1186/s12888-019-2140-5.
Besides classical approaches for treating depression, physical activity has been demonstrated to be an effective option. Bouldering psychotherapy (BPT) combines psychotherapeutic interventions with action-oriented elements from the field of climbing. The aim of this study is to investigate the effectiveness of BPT compared with a home-based exercise program (EP - active control group, superiority trial) and state-of-the-art cognitive behavioural therapy (CBT - non-inferiority trial).
The study is being conducted as a multicentre randomised controlled intervention trial at three locations in Germany. Participants are being randomised into three groups: BPT, CBT, or EP, each with a 10-week treatment phase. A power analysis indicated that about 240 people should initially be included. The primary outcome of the study is the Montgomery and Asberg Depression Rating Scale (MADRS) directly after the intervention. Additional measurement points are located three, six, and 12 months after the end of the intervention. The data are being collected via computer-assisted telephone interviews. Statistical analyses comprise regression analyses to test for the superiority of BPT over EP. To test for the non-inferiority of BPT and CBT, a non-inferiority margin of 1.9 points in the Patient Health Questionnaire (PHQ-9) and two non-inferiority margins for the MADRS (half of the two smallest Cohen's d values from the current meta-analyses) was predefined. The mean difference between CBT and EP is being used as a supplementary equivalence margin.
This is the first study to investigate the effect of a bouldering psychotherapy (BPT) on outpatients' depressive symptoms compared with mere physical activity (superiority analysis) and state-of-the-art cognitive behavioural therapy (CBT, non-inferiority analysis). Methodological strengths of the study are the elaborated, multicentred, randomised, controlled design. Assessors are blinded with regard to group allocation which leads to high objectivity. The study is conducted in a naturalistic setting, which leads to high external validity. Methodological limitations might be the clinical heterogeneity of the sample, which may dilute the intervention effects.
ISRCTN12457760 (Registration date: 26 July 2017, retrospectively registered).
除了经典的治疗抑郁症方法外，身体活动也被证明是一种有效的选择。攀岩心理治疗（Bouldering Psychotherapy，BPT）将心理治疗干预与攀岩领域的行动导向元素相结合。本研究旨在比较 BPT 与基于家庭的运动计划（EP-主动对照组，优势试验）和最先进的认知行为疗法（CBT-非劣效性试验）的有效性。
该研究在德国三个地点进行，是一项多中心随机对照干预试验。参与者被随机分为三组：BPT、CBT 或 EP，每组有 10 周的治疗阶段。一项功效分析表明，最初应纳入约 240 人。研究的主要结果是直接干预后蒙哥马利和阿斯伯格抑郁评定量表（MADRS）。额外的测量点位于干预结束后 3、6 和 12 个月。数据通过计算机辅助电话访谈收集。统计分析包括回归分析，以检验 BPT 优于 EP 的优越性。为了检验 BPT 和 CBT 的非劣效性，我们预设了患者健康问卷（PHQ-9）中的 1.9 点非劣效性边界和 MADRS 的两个非劣效性边界（当前荟萃分析中两个最小 Cohen's d 值的一半）。CBT 和 EP 之间的平均差异被用作补充等效性边界。
这是第一项研究，旨在调查与单纯身体活动（优势分析）和最先进的认知行为疗法（CBT，非劣效性分析）相比，攀岩心理治疗（BPT）对门诊患者抑郁症状的影响。该研究的方法学优势在于精心设计的、多中心的、随机的、对照设计。评估人员对分组分配保持盲法，从而具有高度客观性。该研究在自然环境中进行，具有较高的外部有效性。方法学上的局限性可能是样本的临床异质性，这可能会稀释干预效果。
ISRCTN8236166（注册日期：2017 年 7 月 26 日，回顾性注册）。
