比较互联网提供的接纳与承诺疗法（ACT）干预与等待名单对照对慢性疼痛成年人的临床疗效和成本效益：一项随机对照试验的研究方案。
Comparing the clinical-effectiveness and cost-effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: study protocol for a randomised controlled trial.
作者信息
Hayes Sara, Hogan Michael, Dowd Haulie, Doherty Edel, O'Higgins Siobhan, Nic Gabhainn Saoirse, MacNeela Padraig, Murphy Andrew W, Kropmans Thomas, O'Neill Ciaran, Newell John, McGuire Brian E
机构信息
Department of Clinical Therapies, Faculty of Education and Health Sciences, University of Limerick, Limerick, Ireland.
School of Psychology, National University of Ireland, Galway, Ireland.
出版信息
BMJ Open. 2014 Jul 2;4(7):e005092. doi: 10.1136/bmjopen-2014-005092.
INTRODUCTION
Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence-based psychological treatment in the Irish health service context. While the use of internet-delivered cognitive-behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain, there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) programme among people with chronic pain. The current study will compare the clinical-effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain.
METHODS AND ANALYSIS
Participants with non-malignant pain that persists for at least 3 months will be randomised to one of two study conditions. The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period. The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period. Participants will be assessed preintervention, postintervention and at a 3-month follow-up. The primary outcome will be pain-related functional interference. Secondary outcomes will include: pain intensity, depression, global impression of change, acceptance of chronic pain and quality of life. A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial.
ETHICS AND DISSEMINATION
The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee (12/05/05). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
ISRCTN18166896.
引言
在爱尔兰医疗服务背景下，为慢性疼痛患者提供的互联网心理干预有可能克服提供循证心理治疗的环境和经济障碍。虽然一直以来都表明，使用互联网认知行为治疗方案对慢性疼痛管理有小到中等程度的效果，但关于互联网接纳与承诺疗法（ACT）方案对慢性疼痛患者有效性的研究却很少。本研究将比较在线ACT干预与等待名单对照条件在慢性疼痛患者疼痛相关功能干扰管理方面的临床有效性和成本效益。
方法与分析
患有持续至少3个月的非恶性疼痛的参与者将被随机分配到两种研究条件之一。实验组将在8周内接受为期八节的互联网ACT方案。对照组为等待名单组，在3个月随访期后将接受ACT干预。参与者将在干预前、干预后和3个月随访时接受评估。主要结局将是疼痛相关功能干扰。次要结局将包括：疼痛强度、抑郁、总体变化印象、对慢性疼痛的接纳程度和生活质量。试验结束后将完成对参与者关于ACT干预观点的定性评估。
伦理与传播
本研究将按照《赫尔辛基宣言》进行，并获得爱尔兰国立高威大学研究伦理委员会批准（12/05/05）。试验结果将根据CONSORT声明发表，并将在会议上展示并在同行评审期刊上报告。
试验注册号
ISRCTN18166896。
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