Structured Treatment of Pain (STOP) Study (STOP)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Jeanne Hoffman, University of Washington
ClinicalTrials.gov Identifier:
NCT01768650
First received: January 9, 2013
Last updated: April 11, 2016
Last verified: April 2016
  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:


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: June 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Washington
University of Washington, Ninth and Jefferson Building
Seattle, Washington, United States, 98104
Veteran Affairs Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
University of Washington, Health Sciences Building
Seattle, Washington, United States, 98195
VA Puget Sound Health Care System, American Lake
Tacoma, Washington, United States, 98493
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

Responsible Party: Jeanne Hoffman, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01768650     History of Changes
Other Study ID Numbers: 44437-G 
Study First Received: January 9, 2013
Last Updated: April 11, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
traumatic brain injury
chronic pain
headache
Veteran

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Chronic Pain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2016