Psychology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
Student Wellness & Counselling Centre, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
BMJ Open. 2020 Feb 28;10(2):e033350. doi: 10.1136/bmjopen-2019-033350.
Approximately one-third of adults with chronic pain also report clinically relevant levels of depression. Internet-delivered psychological therapies such as Cognitive Behavioural Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) have been developed to overcome barriers of access to services and ensure the timely delivery of care. The objective of this trial is to collect data on feasibility, acceptability and range of probable effect sizes for iCBT and iACT interventions tailored towards the treatment of depression and chronic pain using a randomised controlled patient-preference design.
Community dwelling adults with chronic non-cancer pain (CNCP) and major depression will be recruited from pain clinics and primary care providers in Newfoundland and Labrador, Canada. The study is a randomised controlled patient-preference trial. Eligible patients will be randomly assigned to a 'preference' or 'no-preference' arm during the first step of randomisation and to intervention or control in the second step of randomisation. Two interventions (ie, iCBT or iACT) will be evaluated relative to attention control. iCBT and iACT involve the completion of 7-weekly online modules augmented with one session of motivational enhancement and weekly therapy sessions. Primary outcomes include (1) feasibility and acceptability parameters and (2) change in symptoms of depression. Secondary outcomes include pain, physical function, emotional function and quality of life. We will recruit 60 participants and examine the range of effect sizes obtained from the trial but will not conduct significance testing as per recommendations for behavioural trial development.
Ethics was approved by the provincial Health Research Ethics Board. Dissemination of results will be published in a peer-reviewed academic journal and presented at scientific conferences.
NCT04009135.
约三分之一患有慢性疼痛的成年人也报告存在临床相关水平的抑郁。为了克服获得服务的障碍并确保及时提供护理，已经开发了互联网提供的心理疗法，如认知行为疗法（iCBT）和接纳与承诺疗法（iACT）。本试验的目的是收集针对使用随机对照患者偏好设计的抑郁和慢性疼痛治疗量身定制的 iCBT 和 iACT 干预措施的可行性、可接受性和可能的效应大小范围的数据。
将从加拿大纽芬兰和拉布拉多的疼痛诊所和初级保健提供者招募患有慢性非癌性疼痛（CNCP）和重度抑郁症的社区居民成年人。该研究是一项随机对照患者偏好试验。符合条件的患者将在第一次随机分组时被随机分配到“偏好”或“非偏好”臂，然后在第二次随机分组时被分配到干预或对照组。将评估两种干预措施（即 iCBT 或 iACT）相对于注意力对照组。iCBT 和 iACT 涉及完成 7 周的在线模块，辅以一次动机增强和每周治疗会议。主要结果包括：（1）可行性和可接受性参数；（2）抑郁症状的变化。次要结果包括疼痛、身体功能、情绪功能和生活质量。我们将招募 60 名参与者，并检查从试验中获得的效应大小范围，但根据行为试验开发的建议，不会进行显著性检验。
该伦理已获得省级卫生研究伦理委员会的批准。结果的传播将发表在同行评议的学术期刊上，并在科学会议上展示。
NCT04009135。
