PDF(Pubmed)
Abstract：
BACKGROUND: Emotion dysregulation is key to the development and maintenance of chronic pain, feeding into a cycle of worsening pain and disability. Dialectical behavioral therapy (DBT), an evidence-based treatment for complex transdiagnostic conditions presenting with high emotion dysregulation, may be beneficial to manage and mitigate the emotional and sensory aspects of chronic pain. Increasingly, DBT skills training as a key component of standard DBT is being delivered as a stand-alone intervention without concurrent therapy to help develop skills for effective emotion regulation. A previous repeated-measure single-case trial investigating a novel technologically driven DBT skills training, internet-delivered DBT skills training for chronic pain (iDBT-Pain), revealed promising findings to improve both emotion dysregulation and pain intensity.
OBJECTIVE: This randomized controlled trial aims to examine the efficacy of iDBT-Pain in comparison with treatment as usual to reduce emotion dysregulation (primary outcome) for individuals with chronic pain after 9 weeks and at the 21-week follow-up. The secondary outcomes include pain intensity, pain interference, anxiety symptoms, depressive symptoms, perceived stress, posttraumatic stress, harm avoidance, social cognition, sleep quality, life satisfaction, and well-being. The trial also examines the acceptability of the iDBT-Pain intervention for future development and testing.
METHODS: A total of 48 people with chronic pain will be randomly assigned to 1 of 2 conditions: treatment and treatment as usual. Participants in the treatment condition will receive iDBT-Pain, consisting of 6 live web-based group sessions led by a DBT skills trainer and supervised by a registered psychologist and the iDBT-Pain app. Participants in the treatment-as-usual condition will not receive iDBT-Pain but will still access their usual medication and health interventions. We predict that iDBT-Pain will improve the primary outcome of emotion dysregulation and the secondary outcomes of pain intensity, pain interference, anxiety symptoms, depressive symptoms, perceived stress, harm avoidance, social cognition, sleep quality, life satisfaction, and well-being. A linear mixed model with random effects of individuals will be conducted to investigate the differences between the baseline, 9-week (primary end point), and 21-week (follow-up) assessments as a function of experimental condition.
RESULTS: Recruitment started in February 2023, and the clinical trial started in March 2023. Data collection for the final assessment is planned to be completed by July 2024.
CONCLUSIONS: If our hypothesis is confirmed, our findings will contribute to the evidence for the efficacy and acceptability of a viable intervention that may be used by health care professionals for people with chronic pain. The results will add to the chronic pain literature to inform about the potential benefits of DBT skills training for chronic pain and will contribute evidence about technologically driven interventions.
BACKGROUND: Australian New Zealand Clinical Trials Registry ACTRN12622000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383208&isReview=true.
UNASSIGNED: PRR1-10.2196/41890.
OBJECTIVE: This randomized controlled trial aims to examine the efficacy of iDBT-Pain in comparison with treatment as usual to reduce emotion dysregulation (primary outcome) for individuals with chronic pain after 9 weeks and at the 21-week follow-up. The secondary outcomes include pain intensity, pain interference, anxiety symptoms, depressive symptoms, perceived stress, posttraumatic stress, harm avoidance, social cognition, sleep quality, life satisfaction, and well-being. The trial also examines the acceptability of the iDBT-Pain intervention for future development and testing.
METHODS: A total of 48 people with chronic pain will be randomly assigned to 1 of 2 conditions: treatment and treatment as usual. Participants in the treatment condition will receive iDBT-Pain, consisting of 6 live web-based group sessions led by a DBT skills trainer and supervised by a registered psychologist and the iDBT-Pain app. Participants in the treatment-as-usual condition will not receive iDBT-Pain but will still access their usual medication and health interventions. We predict that iDBT-Pain will improve the primary outcome of emotion dysregulation and the secondary outcomes of pain intensity, pain interference, anxiety symptoms, depressive symptoms, perceived stress, harm avoidance, social cognition, sleep quality, life satisfaction, and well-being. A linear mixed model with random effects of individuals will be conducted to investigate the differences between the baseline, 9-week (primary end point), and 21-week (follow-up) assessments as a function of experimental condition.
RESULTS: Recruitment started in February 2023, and the clinical trial started in March 2023. Data collection for the final assessment is planned to be completed by July 2024.
CONCLUSIONS: If our hypothesis is confirmed, our findings will contribute to the evidence for the efficacy and acceptability of a viable intervention that may be used by health care professionals for people with chronic pain. The results will add to the chronic pain literature to inform about the potential benefits of DBT skills training for chronic pain and will contribute evidence about technologically driven interventions.
BACKGROUND: Australian New Zealand Clinical Trials Registry ACTRN12622000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383208&isReview=true.
UNASSIGNED: PRR1-10.2196/41890.
摘要：
背景：情绪失调是慢性疼痛发展和维持的关键，导致疼痛和残疾恶化。辩证行为疗法（DBT），一种基于证据的治疗方法，用于表现出高度情绪失调的复杂诊断疾病，可能有利于管理和减轻慢性疼痛的情绪和感官方面。越来越多,DBT技能培训作为标准DBT的关键组成部分，正在作为独立干预措施提供，而无需同时进行治疗，以帮助开发有效的情绪调节技能。先前的重复测量单例试验调查了一种新颖的技术驱动的DBT技能培训，互联网提供的慢性疼痛DBT技能培训（iDBT-Pain），揭示了改善情绪失调和疼痛强度的有希望的发现。
目的：这项随机对照试验旨在研究iDBT-Pain与常规治疗相比的疗效，以减轻慢性疼痛患者9周后和21周后的情绪失调（主要结果）。次要结果包括疼痛强度，疼痛干扰，焦虑症状,抑郁症状,感知压力，创伤后应激,避免伤害，社会认知，睡眠质量,生活满意度,和幸福。该试验还检查了iDBT-Pain干预对未来开发和测试的可接受性。
方法：总共48名患有慢性疼痛的人将被随机分配到2种疾病中的1种：治疗和照常治疗。治疗条件的参与者将接受iDBT-Pain，由DBT技能培训师领导并由注册心理学家和iDBT-Pain应用程序监督的6个基于网络的实时小组会议组成。如往常一样治疗的参与者将不会接受iDBT-Pain，但仍将获得他们通常的药物和健康干预措施。我们预测iDBT-疼痛将改善情绪失调的主要结果和疼痛强度的次要结果，疼痛干扰，焦虑症状,抑郁症状,感知压力，避免伤害，社会认知，睡眠质量,生活满意度,和幸福。将进行具有个体随机效应的线性混合模型以调查基线之间的差异，9周（主要终点），和21周（随访）评估作为实验条件的函数。
结果：招募于2023年2月开始，临床试验于2023年3月开始。最终评估的数据收集计划于2024年7月完成。
结论：如果我们的假设得到证实，我们的研究结果将为卫生保健专业人员可能对慢性疼痛患者使用的可行干预措施的有效性和可接受性提供证据.结果将增加慢性疼痛文献，以告知DBT技能培训对慢性疼痛的潜在益处，并将提供有关技术驱动的干预措施的证据。
背景：澳大利亚新西兰临床试验注册ACTRN12622000113752;https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383208&isReview=true。
■PRR1-10.2196/41890。
目的：这项随机对照试验旨在研究iDBT-Pain与常规治疗相比的疗效，以减轻慢性疼痛患者9周后和21周后的情绪失调（主要结果）。次要结果包括疼痛强度，疼痛干扰，焦虑症状,抑郁症状,感知压力，创伤后应激,避免伤害，社会认知，睡眠质量,生活满意度,和幸福。该试验还检查了iDBT-Pain干预对未来开发和测试的可接受性。
方法：总共48名患有慢性疼痛的人将被随机分配到2种疾病中的1种：治疗和照常治疗。治疗条件的参与者将接受iDBT-Pain，由DBT技能培训师领导并由注册心理学家和iDBT-Pain应用程序监督的6个基于网络的实时小组会议组成。如往常一样治疗的参与者将不会接受iDBT-Pain，但仍将获得他们通常的药物和健康干预措施。我们预测iDBT-疼痛将改善情绪失调的主要结果和疼痛强度的次要结果，疼痛干扰，焦虑症状,抑郁症状,感知压力，避免伤害，社会认知，睡眠质量,生活满意度,和幸福。将进行具有个体随机效应的线性混合模型以调查基线之间的差异，9周（主要终点），和21周（随访）评估作为实验条件的函数。
结果：招募于2023年2月开始，临床试验于2023年3月开始。最终评估的数据收集计划于2024年7月完成。
结论：如果我们的假设得到证实，我们的研究结果将为卫生保健专业人员可能对慢性疼痛患者使用的可行干预措施的有效性和可接受性提供证据.结果将增加慢性疼痛文献，以告知DBT技能培训对慢性疼痛的潜在益处，并将提供有关技术驱动的干预措施的证据。
背景：澳大利亚新西兰临床试验注册ACTRN12622000113752;https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383208&isReview=true。
■PRR1-10.2196/41890。
