Structured Treatment of Pain (STOP) Study
NCT01768650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 231
Last updated 2019-09-09
Summary
This study seeks to compare two different behavioral treatments for pain in Veterans with a history of TBI. Both treatments involve educating the Veteran about pain, discussing the impact of pain, and different ways to manage it in hopes of decreasing pain and its impact on life. These approaches are called "self-management" approaches to pain. Both of these treatments are commonly used in pain clinics to treat pain in persons with back pain, headaches, and other types of chronic pain. The investigators will be delivering both treatments over the telephone to make the treatments accessible to Veterans wherever they live.
Conditions
Interventions
- BEHAVIORAL
-
Self-Management #1
Self-Management #1 will consist of eight 60-minute sessions conducted by phone over eight weeks. Sessions will include: (1) education about the role of cognitions and pain beliefs (including control) in chronic pain and adjustment; (2) instruction in how to identify negative thinking and cognitive distortions about pain; (3) instruction in thought-stopping and cognitive-restructuring techniques, including challenging negative thoughts and core beliefs about pain; (4) instruction in utilization of positive coping self-statements; (5) relaxation techniques; (6) activity pacing and scheduling; (7) coping with pain flare-ups; and (8) relapse prevention/maintenance of gains. Most sessions will include a brief relaxation exercise introduced over the phone.
- BEHAVIORAL
-
Self-Management #2
Self-Management #2 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average). The sessions will cover a variety of topics, including: (1) the definition of chronic pain, (2) the physiological processes underlying chronic pain, (3) common pain-related conditions such as sleep and mood disturbance (including posttraumatic stress disorder, due to its prevalence among Veterans), (4) the potential effects of chronic pain on activity level, (5) communication (including communication with healthcare providers), and (6) the role of social support in managing pain.
Sponsors & Collaborators
-
U.S. Army Medical Research and Development Command
collaborator FED -
VA Puget Sound Health Care System
collaborator FED - lead OTHER
Principal Investigators
-
Jeanne M Hoffman, PhD · University of Washington
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-30
- Primary Completion
- 2017-07-31
- Completion
- 2017-09-30
Countries
- United States
Study Locations
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