Lisham Ashrafioun , Anna Stephens , Hugh F. Crean , Autumn M. Gallegos , Kyle Possemato , Wilfred R. Pigeon
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引用次数: 0
Abstract
Introduction
Suicide risk and chronic pain are significant public health problems affecting veterans at a disproportionally high rate. There is a dearth of interventions directly targeting both chronic pain and suicide risk. Mindfulness-Based Cognitive Therapy for Pain and Suicide (MBCT-P/S) integrates components from MBCT-Pain and MBCT-Suicide, both of which demonstrate promising effects on their respective targets. We provide an overview of the rationale, design, and baseline characteristics of a randomized clinical trial of MBCT-P/S to assess feasibility and treatment acceptability.
Methods
We refined a version of the MBCT-P/S drafted by the researchers through an evidence-based consensus method, integrating feedback from relevant subject matter experts. Veterans (n = 76) reporting death or suicidal ideation and functional impairment from chronic pain were recruited using Veterans Health Administration electronic medical record data. After consent, participants completed a baseline assessment and randomized to MBCT-P/S or Health Education.
Results
Baseline data revealed a diverse sample of veterans with a clinically severe profile that differed by condition on key suicide risk variables. Recruitment was completed faster than anticipated, supporting recruitment feasibility. Upcoming milestones include the completion of interventions and 1-, 3-, and 6-month follow-up assessments evaluating pain, suicide risk, and other key clinical indicators. Feasibility assessment will also include study retention by condition and therapist fidelity to the MBCT-P/S. Treatment acceptability will be assessed at the 1-month follow-up.
Conclusions
Data generated from this study will provide critical insights into conducting a fully-powered efficacy trial evaluating the impact of MBCT-P/S on pain and suicide risk outcomes.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.