ABSTRACT
OBJECTIVES: To describe the protocol of a randomized controlled trial to evaluate the effectiveness and mechanisms of three behavioral interventions. METHODS: Participants will include up to 343 Veterans with chronic pain due to a broad range of etiologies, randomly assigned to one of three 8-week manualized in-person group treatments: (1) Hypnosis (HYP), (2) Mindfulness Meditation (MM), or (3) Education Control (EDU). PROJECTED OUTCOMES: The primary aim of the study is to compare the effectiveness of HYP and MM to EDU on average pain intensity measured pre- and post-treatment. Additional study aims will explore the effectiveness of HYP and MM compared to EDU on secondary outcomes (i.e., pain interference, sleep, depression, anxiety and PTSD), and the maintenance of effects at 3- and 6-months post-treatment. Participants will have electroencephalogram (EEG) assessments at pre- and post-treatment to determine if the power of specific brain oscillations moderate the effectiveness of HYP and MM (Study Aim 2) and examine brain oscillations as possible mediators of treatment effects (exploratory aim). Additional planned exploratory analyses will be performed to identify possible treatment mediators (i.e., pain acceptance, catastrophizing, mindfulness) and moderators (e.g., hypnotizability, treatment expectations, pain type, cognitive function). SETTING: The study treatments will be administered at a large Veterans Affairs Medical Center in the northwest United States. The treatments will be integrated within clinical infrastructure and delivered by licensed and credentialed health care professionals.
Subject(s)
Chronic Pain/therapy , Meditation/methods , Mindfulness/methods , Patient Education as Topic/methods , Veterans , Double-Blind Method , Electroencephalography , Female , Humans , Male , Research DesignABSTRACT
INTRODUCTION: The annual cost of treatment and lost productivity due to chronic pain is estimated to be $635 billion within the USA. Self-management treatments for chronic pain result in lower health care costs and lower utilization of provider-management treatments, such as hospitalization and medication use. The current study sought to identify and characterize patient factors and health conditions associated with chronic pain treatment utilization to inform ways to improve engagement in self-management pain treatment (e.g., applying heat or ice, exercising, or practicing relaxation). This study predicted (1) greater pain intensity and pain interference would be associated with greater utilization of self-management treatments and (2) this association would be moderated by patient factors (gender and age) and health comorbidities (anxiety, trauma, depression, and sleep disturbance). MATERIALS AND METHODS: Baseline data from a three-arm clinical trial were collected for 127 Veterans seeking treatment for chronic pain. Veterans were recruited via clinician referral and medical record review at the Veterans Affairs Puget Sound Health Care System, Washington, USA. RESULTS: Self-management treatments were more utilized than provider-management treatments. Pain intensity and pain interference were not uniquely associated with provider-management or self-management treatment utilization after controlling for demographics and mental health status. Sleep disturbance moderated the relationship between pain interference and provider-management treatment utilization. Depression moderated the relationship between pain intensity and provider-management treatment utilization. CONCLUSIONS: While study conclusions may not generalize to all Veteran populations, findings suggest that Veterans with chronic pain were more likely to seek provider-management treatments when experiencing high-pain interference and high-sleep disturbance. In addition, Veterans were more likely to seek provider-management treatments when experiencing low-pain intensity and high-depression symptoms.