Yekrang Safakar Mojtaba, Hrabok Marianne, Urichuk Liana, Juhas Michal, Shalaby Reham, Parmar Devashree, Chue Pierre, Snaterse Mark, Mason Judith, Tchida Donna, Kelland Jill, Coulson Pamela, Sosdjan Daniella, Brown Jason, Hay Katherine, Lesage Deanna, Paulsen Lacey, Delday Amy, Duiker Sherianna, Surood Shireen, Abba-Aji Adam, Agyapong Vincent Israel Opoku
Department of Psychiatry, University of Alberta, Edmonton, AB, Canada.
Addiction and Mental Health, Alberta Health Services, Edmonton, AB, Canada.
JMIR Res Protoc. 2020 May 25;9(5):e14309. doi: 10.2196/14309.
Despite evidence in scientific literature indicating the effectiveness of both cognitive behavioral therapy (CBT) and physical exercise in the management of major depressive disorder (MDD), few studies have directly compared them.
This study aims to evaluate and compare the effectiveness of group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU) in the management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or exercise arms of the study will achieve superior outcomes compared with participants wait-listed to receive TAU only.
This prospective rater-blinded randomized controlled trial assesses the benefits of group CBT and exercise for participants with MDD. A total of 120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada, will be randomly assigned to one of the three equal-sized arms of the study to receive either weekly sessions of group CBT plus TAU, group exercise three times a week plus TAU, or only TAU for 14 weeks. Participants will be assessed at enrollment, 3 and 6 months post enrollment, midtreatment, and upon treatment completion for primary (functional and symptom variables) and secondary outcomes (service variables and health care utilization). In addition, participants in the intervention groups would be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point.
The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines). Written informed consent will be obtained from each subject. The study received ethical clearance from the Health Ethics Research Board of the University of Alberta on September 7, 2018 (Pro 00080975) and operational approval from the provincial health authority (Alberta Health Services 43638). As of October 13, 2019, we have enrolled 32 participants. The results will be disseminated at several levels, including patients, practitioners, academics, researchers, and health care organizations.
The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care.
ClinicalTrials.gov NCT03731728; https://clinicaltrials.gov/ct2/show/NCT03731728.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/14309.
尽管科学文献中的证据表明认知行为疗法（CBT）和体育锻炼在重度抑郁症（MDD）管理中均有效，但很少有研究直接对它们进行比较。
本研究旨在评估和比较团体CBT、体育锻炼以及仅等待接受常规治疗（TAU）在MDD管理中的有效性。研究人员假设，与仅等待接受TAU的参与者相比，被分配到研究中团体CBT或运动组的MDD参与者将获得更好的结果。
这项前瞻性评分者盲法随机对照试验评估团体CBT和运动对MDD参与者的益处。总共120名转诊至加拿大埃德蒙顿成瘾与心理健康诊所的MDD患者将被随机分配到研究的三个同等规模的组之一，接受每周一次的团体CBT加TAU、每周三次的团体运动加TAU，或仅接受TAU治疗14周。参与者将在入组时、入组后3个月和6个月、治疗中期以及治疗完成时接受主要（功能和症状变量）和次要结局（服务变量和医疗保健利用）的评估。此外，干预组的参与者将每周用一种功能测量方法进行评估。数据将使用重复测量和效应量分析进行分析，并且将在每个时间点的测量之间完成相关性分析。
该研究将按照《赫尔辛基宣言》（香港修订版）和《良好临床实践》（加拿大指南）进行。将从每个受试者获得书面知情同意书。该研究于2018年9月7日获得阿尔伯塔大学健康伦理研究委员会的伦理批准（Pro 00080975），并获得省级卫生当局（阿尔伯塔卫生服务局43638）的操作批准。截至2019年10月13日，我们已招募了32名参与者。研究结果将在多个层面进行传播，包括患者、从业者、学者、研究人员和医疗保健组织。
初步试验的结果可能为多中心临床试验的实施提供信息，并为有兴趣将团体CBT和团体运动干预纳入现有护理的管理人员和临床医生提供有用信息。
ClinicalTrials.gov NCT03731728；https://clinicaltrials.gov/ct2/show/NCT03731728。
国际注册报告识别码（IRRID）：PRR1-10.2196/14309。
