Not Yet RecruitingNot Applicable

Behavior Therapy vs Education for Persistent Headache After Mild TBI

United States60 participantsStarted 2027-10-01

Plain-language summary

This study will test a new treatment, called Headache reprocessing, for persistent post-traumatic headache. The new treatment will be compared to a headache education intervention. The main objectives of the study are to examine the feasibility, safety, and clinical appropriateness of the new treatment.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Enrolled in healthcare at VA San Diego Healthcare System;
✓. History of mild TBI (mTBI), or head injury that is below the diagnostic threshold for mTBI
✓. Headache that had its lifetime onset or significantly worsened within 90 days of a concussive event
✓. Headache has persisted for at least 90 days since its onset or worsening
✓. No changes in past 3 months to medical management of headache or comorbid psychiatric symptoms, and no anticipated changes during the study interval
✓. No current participation in psychological intervention for pain or headache

Exclusion criteria

✕. History of moderate or severe traumatic brain injury
✕. Uncontrolled bipolar, psychotic, or substance use disorder
✕. Acute suicidality as determined by screening as "high risk" or has a history of suicide attempt within the past 1 year;
✕. Other factors that would preclude participation in the study

What they're measuring

Enrollment rate

Timeframe: Typically up to 3 months, from initial referral to decision to enroll or not

Attrition

Timeframe: 12 weeks

Attendance

Timeframe: During the 8-week intervention

Homework completion

Timeframe: During the 8-week intervention

Credibility/Expectancy Questionnaire

Timeframe: Week 12

Client Satisfaction Questionnaire

Timeframe: Week 12

Adverse events rated to the intervention

Timeframe: Full study period (28 weeks)

Change in Headache Impact Test-6 score

Timeframe: Week 0 through Week 12

Trial details

NCT IDNCT07229391

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2030-01-01

Contact for this trial

Joel Fishbein

(858) 642-3870 joel.fishbein2@va.gov

View on ClinicalTrials.gov More Post-Traumatic Headache trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Enrolled in healthcare at VA San Diego Healthcare System;
✓. History of mild TBI (mTBI), or head injury that is below the diagnostic threshold for mTBI
✓. Headache that had its lifetime onset or significantly worsened within 90 days of a concussive event
✓. Headache has persisted for at least 90 days since its onset or worsening
✓. No changes in past 3 months to medical management of headache or comorbid psychiatric symptoms, and no anticipated changes during the study interval
✓. No current participation in psychological intervention for pain or headache

Exclusion criteria

✕. History of moderate or severe traumatic brain injury
✕. Uncontrolled bipolar, psychotic, or substance use disorder
✕. Acute suicidality as determined by screening as "high risk" or has a history of suicide attempt within the past 1 year;
✕. Other factors that would preclude participation in the study

What they're measuring

Enrollment rate

Timeframe: Typically up to 3 months, from initial referral to decision to enroll or not

Attrition

Timeframe: 12 weeks

Attendance

Timeframe: During the 8-week intervention

Homework completion

Timeframe: During the 8-week intervention

Credibility/Expectancy Questionnaire

Timeframe: Week 12

Client Satisfaction Questionnaire

Timeframe: Week 12

Adverse events rated to the intervention

Timeframe: Full study period (28 weeks)

Change in Headache Impact Test-6 score

Timeframe: Week 0 through Week 12