Rhonda M Williams1, Dawn M Ehde2, Melissa Day3, Aaron P Turner4, Shahin Hakimian5, Kevin Gertz2, Marcia Ciol2, Alisha McCall6, Carrie Kincaid6, Mark W Pettet7, David Patterson2, Pradeep Suri4, Mark P Jensen2. 1. VA Puget Sound Health Care System, 1660 S. Columbian Way, RCS-117, Seattle, WA 98108, United States of America; University of Washington School of Medicine, Department of Rehabilitation Medicine, Ninth & Jefferson Building, Box 359612, Seattle, WA 98104, United States of America. Electronic address: Rhonda.Williams1@va.gov. 2. University of Washington School of Medicine, Department of Rehabilitation Medicine, Ninth & Jefferson Building, Box 359612, Seattle, WA 98104, United States of America. 3. The University of Queensland, School of Psychology, Faculty of Health & Behavioral Sciences, St. Lucia Campus, Brisbane, QLD 4072, Australia. 4. VA Puget Sound Health Care System, 1660 S. Columbian Way, RCS-117, Seattle, WA 98108, United States of America; University of Washington School of Medicine, Department of Rehabilitation Medicine, Ninth & Jefferson Building, Box 359612, Seattle, WA 98104, United States of America. 5. University of Washington School of Medicine, Department of Neurology, Harborview Medical Center, 325 Ninth Ave, Box 359745, Seattle, WA 98104, United States of America. 6. VA Puget Sound Health Care System, 1660 S. Columbian Way, RCS-117, Seattle, WA 98108, United States of America. 7. University of Washington, Integrated Brain Imaging Center, Department of Radiology, 1959 NE Pacific St., Box 357115, Seattle, WA 98195, United States of America.
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. Published by Elsevier Inc.
RCT Entities:
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. Published by Elsevier Inc.
Entities:
Keywords:
Chronic pain; Complementary and integrative medicine; Hypnosis; Mindfulness meditation
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