Multisite Advancement of Research on Chronic Posttraumatic Headache

Not Applicable

Recruiting

• Conditions: Posttraumatic Headache

• Registration Number: NCT05620719
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-1
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Any veteran or active duty service member (DEERS-eligible; age 18 to 70 years) with<br> mild or moderate TBI whose headache began or exacerbated within 3 months of a head<br> or neck injury.<br><br> - Headache meets ICHD-3 A5.2 criterion for delayed-onset persistent headache<br> attributable to mild or moderate TBI and PTH is ongoing at enrollment (most recent<br> headache within the past 2 weeks).<br><br> - At least moderate to severe headache-related disability based on a HIT-6 score<br> greater than 50.<br><br> - Participant is stable on headache medication at baseline assessment (i.e., no<br> changes in medication prescriptions in the past 4 weeks; this includes botulinum<br> toxin injections and devices like Cefaly).<br><br> - Participant has a phone where they can receive reminders and complete the on-line<br> Headache Diaries.<br><br> - Participant speaks and reads/understands English well enough to fully participate in<br> the intervention and to reliably complete assessment measures.<br><br>Exclusion Criteria:<br><br> - Participant reports a significant change in headache symptoms within 4 weeks of<br> screening or has another secondary headache that may account for symptoms.<br><br> - Participant has medication overuse headache based on Structured Diagnostic Headache<br> Interview-Revised (Brief Version; SDIH-R) and clinical judgment.<br><br> - Participant has a psychiatric problem that warrants immediate treatment as indicated<br> in the electronic health record, flagged study during testing, or confirmed by a<br> clinician through screening or review of clinical notes.<br><br> - Participant demonstrates significant cognitive impairment that could impact<br> treatment adherence/benefit.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Headache Impact Test (HIT-6)

Secondary Outcome Measures

Name	Time	Method
Change in Standardized Headache Diary;Change in Patient Health Questionnaire-9;Change in Generalized Anxiety Disorder Screener-7;Change in PTSD Checklist-5