NCT07229391

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
30mo left

Started Oct 2027

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

November 12, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
1.9 years until next milestone

Study Start

First participant enrolled

October 1, 2027

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

November 12, 2025

Last Update Submit

December 18, 2025

Conditions

Post-Traumatic Headache

Keywords

HeadacheBehavior therapyBrain Injuries, Traumatic

Outcome Measures

Primary Outcomes (8)

  • Enrollment rate

    Number enrolled out of number approached

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

  • Attrition

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

    12 weeks

  • Attendance

    Percent of participants attending 80+% of sessions

    During the 8-week intervention

  • Homework completion

    Percent of participants completing 80+% of homework

    During the 8-week intervention

  • Credibility/Expectancy Questionnaire

    Scale measuring how credible the intervention seemed to participants

    Week 12

  • Client Satisfaction Questionnaire

    Scale measuring participant satisfaction with the intervention

    Week 12

  • Adverse events rated to the intervention

    Adverse events determined to be caused by the intervention

    Full study period (28 weeks)

  • Change in Headache Impact Test-6 score

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

    Week 0 through Week 12

Study Arms (2)

Headache reprocessing

EXPERIMENTAL

Behavior therapy focused on sensations and avoidance behaviors

Behavioral: Headache reprocessing

Headache education

ACTIVE COMPARATOR

Education about ways to limit and manage headaches

Behavioral: Headache education

Interventions

Headache reprocessingBEHAVIORAL

Behavior therapy focused on sensations and avoidance behaviors

Headache reprocessing
Headache educationBEHAVIORAL

Education about ways to limit and manage headaches

Headache education

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Post-Traumatic HeadacheHeadacheBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Joel Fishbein

    VA San Diego Healthcare System, San Diego, CA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel Fishbein

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2025

First Posted

November 17, 2025

Study Start (Estimated)

October 1, 2027

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

April 1, 2030

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Final datasets in machine-readable format will be shared via PubMed Central

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Available upon study completion, indefinite
Access Criteria
Public access
More information

Locations

US(1)