NCT01768650

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

3.1 years

First QC Date

January 9, 2013

Last Update Submit

September 5, 2019

Conditions

Traumatic Brain InjuryChronic Pain

Keywords

traumatic brain injurychronic painheadacheVeteran

Outcome Measures

Primary Outcomes (1)

  • average pain intensity in the past week

    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.

    10-12 weeks following randomization (post-treatment)

Secondary Outcomes (1)

  • average pain intensity in the past week

    6 months following randomization

Study Arms (2)

Self-Management #2

EXPERIMENTAL

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 #1

EXPERIMENTAL

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

Interventions

Self-Management #1BEHAVIORAL

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.

Self-Management #1
Self-Management #2BEHAVIORAL

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.

Self-Management #2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Washington, Ninth and Jefferson Building

Seattle, Washington, 98104, United States

Location

Veteran Affairs Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

University of Washington, Health Sciences Building

Seattle, Washington, 98195, United States

Location

VA Puget Sound Health Care System, American Lake

Tacoma, Washington, 98493, United States

Location

Related Publications (2)

  • Miller M, Williams R, Pagulayan K, Barber J, Ehde DM, Hoffman J. Correlates of sleep disturbance in Veterans with traumatic brain injury and chronic pain: A cross-sectional study. Disabil Health J. 2022 Jan;15(1):101203. doi: 10.1016/j.dhjo.2021.101203. Epub 2021 Aug 27.

    PMID: 34479850DERIVED

  • Hoffman JM, Ehde DM, Dikmen S, Dillworth T, Gertz K, Kincaid C, Lucas S, Temkin N, Sawyer K, Williams R. Telephone-delivered cognitive behavioral therapy for veterans with chronic pain following traumatic brain injury: Rationale and study protocol for a randomized controlled trial study. Contemp Clin Trials. 2019 Jan;76:112-119. doi: 10.1016/j.cct.2018.12.004. Epub 2018 Dec 13.

    PMID: 30553077DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticChronic PainHeadache

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeanne M Hoffman, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Rehabilitation Medicine

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 15, 2013

Study Start

June 1, 2014

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

September 9, 2019

Record last verified: 2019-09

Locations

US(4)