Structured Treatment of Pain (STOP) Study - Full Text View

Purpose

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.

Condition	Intervention
Traumatic Brain Injury Chronic Pain	Behavioral: Self-Management #1 Behavioral: Self-Management #2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain Following Traumatic Brain Injury

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain Headache Traumatic Brain Injury

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

average pain intensity in the past week [ Time Frame: 10-12 weeks following randomization (post-treatment) ] [ Designated as safety issue: No ]
Average pain intensity will be assessed using an 11-point numerical rating scale (NRS), where 0 means "no pain" and 10 means "pain as bad as you can imagine", accompanied by the following instructions: "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours".This NRS will be administered by research staff via telephone assessments four times within the week before treatment begins following enrollment into the study and before randomization (pre-treatment), approximately halfway (4 to 6 weeks following randomization) through treatment (mid-treatment), 10-12 weeks following randomization (post-treatment), and 6 months following randomization (6-month). The arithmetic mean of the four ratings at 10-12 weeks following randomization will be used as the primary outcome measure of average pain level.

Secondary Outcome Measures:

average pain intensity in the past week [ Time Frame: 6 months following randomization ] [ Designated as safety issue: No ]
Average pain intensity will be assessed using an 11-point numerical rating scale (NRS), where 0 means "no pain" and 10 means "pain as bad as you can imagine", accompanied by the following instructions: "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours".This NRS will be administered by research staff via telephone assessments four times within the week before treatment begins following enrollment into the study and before randomization (pre-treatment), approximately halfway (4 to 6 weeks following randomization) through treatment (mid-treatment), 10-12 weeks following randomization (post-treatment), and 6 months following randomization (6-month). The arithmetic mean of the four ratings at 6 months following randomization will be used as the secondary outcome measure of average pain level to determine whether treatment effects can be maintained over time.

Estimated Enrollment:	200
Study Start Date:	April 2013
Estimated Study Completion Date:	April 2016
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	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.
Experimental: 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 #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.

Arms

Assigned Interventions

Experimental: 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.

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.

Experimental: 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 #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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Veteran Status
Diagnosis of TBI of any severity verified in VA medical records (e.g., VA TBI Comprehensive Evaluation or other comparable neuropsychological or medical evaluation in the record)
Most recent TBI must have occurred after onset of OEF
Military Service in OEF, OIF, and/or OND
Average pain intensity in the past month of 4 or above on 0-10 numeric rating scale (moderate pain and above)
Pain of at least six months duration, with pain reportedly present greater than or equal to half of the days in the past six months
Able to read and speak English
Able to communicate over the phone (i.e., must be verbal)
Age 18 years or older

Exclusion Criteria:

Hospitalization for psychiatric reasons involving psychosis other than suicidal ideation, homicidal ideation, and/or PTSD
Communication limitations that would prevent ability to participate in the intervention or assessments
Cognitive impairment that interferes with ability to engage in the intervention despite modifications specifically for TBI. This will be defined as a score of 5/10 or less indicating moderate or severe cognitive impairment on the Short Portable Mental Status Questionnaire (SPMSQ)
Diagnosis of primary psychotic or major thought disorder as listed in participant's medical record or self-reported
Pain medication that has changed within the last 3 months or which is planned to change during the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768650

Contacts

Contact: Jeanne M Hoffman, PhD	206-221-6511	jeanneh@uw.edu
Contact: Kevin J Gertz, MPA	206-616-8630	kjgertz@uw.edu

Locations

United States, Washington
University of Washington, Health Sciences Building	Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Jeanne M Hoffman, PhD 206-221-6511 jeanneh@uw.edu
Sub-Investigator: Kathleen Bell, MD
Sub-Investigator: Sylvia Lucas, MD
University of Washington, Ninth and Jefferson Building	Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Kevin Gertz, MPA 206-616-8630 kjgertz@uw.edu
Sub-Investigator: Sureyya Dikmen, PhD
Sub-Investigator: Dawn Ehde, PhD
Sub-Investigator: Nancy Temkin, PhD
Veteran Affairs Puget Sound Health Care System, Seattle	Not yet recruiting
Seattle, Washington, United States, 98108
Contact: Rhonda Williams, PhD 206-277-6290 rhonda.williams1@va.gov
Contact: Julie Bondzie, MA 206-277-1845 Juliana.Bondzie@va.gov
Principal Investigator: Rhonda Williams, PhD
VA Puget Sound Health Care System, American Lake	Not yet recruiting
Tacoma, Washington, United States, 98493
Contact: Rhonda Williams, PhD 206-277-6290 Rhonda.Williams1@va.gov
Contact: Julie Bondzie, MA 206-277-1845 Juliana.Bondzie@va.gov

Sponsors and Collaborators

University of Washington

U.S. Army Medical Research and Materiel Command

VA Puget Sound Health Care System

Investigators

Principal Investigator:

Jeanne M Hoffman, PhD

University of Washington

More Information

No publications provided

Responsible Party:	Jeanne Hoffman, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier:	NCT01768650 History of Changes
Other Study ID Numbers:	43778-K
Study First Received:	January 9, 2013
Last Updated:	January 11, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

traumatic brain injury
chronic pain
headache
Veteran

Additional relevant MeSH terms:

Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013