Behavior Therapy vs Education for Persistent Headache After Mild TBI

This study is testing a new treatment called Headache reprocessing for people who have persistent headaches after a mild traumatic brain injury (TBI). Headache reprocessing is a type of behavior therapy that focuses on sensations and avoiding certain behaviors. This new treatment will be compared to Headache education, which teaches ways to limit and manage headaches. The study wants to see if Headache reprocessing is practical, safe, and appropriate for patients. You might be able to join if you are 18 or older, receive healthcare at VA San Diego, and have had persistent headaches for at least 90 days after a head injury. The current recruitment status is unclear.

Study design
This is an interventional study comparing two behavioral therapies. It will involve 60 participants who will be randomly assigned to one of the two groups.
What's involved
Participants will attend 8 weekly group sessions for either Headache reprocessing or Headache education.
Compensation
Not stated in the trial record.
Follow-up
The study will track attendance during the 8-week intervention and attrition (people leaving the study) for 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07229391

Behavior Therapy vs Education for Persistent Headache After Mild TBI

Not Yet Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~60 participants
Updated 2025-12-26 on ClinicalTrials.gov
What's tested:Headache reprocessingHeadache education

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Enrollment rate
Measured over Typically up to 3 months, from initial referral to decision to enroll or not
+7 more outcomes measured
Post-Traumatic Headache
1 sites across 1 states
California1
  • Joel Fishbein · PRINCIPAL_INVESTIGATOR · VA San Diego Healthcare System, San Diego, CA

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  • Enrollment rateTypically up to 3 months, from initial referral to decision to enroll or not

    Number enrolled out of number approached

  • Attrition12 weeks

    % of randomized who are lost to follow-up before week 12

  • AttendanceDuring the 8-week intervention

    Percent of participants attending 80+% of sessions

  • Homework completionDuring the 8-week intervention

    Percent of participants completing 80+% of homework

  • Credibility/Expectancy QuestionnaireWeek 12

    Scale measuring how credible the intervention seemed to participants

  • Client Satisfaction QuestionnaireWeek 12

    Scale measuring participant satisfaction with the intervention

  • Adverse events rated to the interventionFull study period (28 weeks)

    Adverse events determined to be caused by the intervention

  • Change in Headache Impact Test-6 scoreWeek 0 through Week 12

    A widely-used scale measuring the impact that headaches have on daily life.