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NCT05620719 · ClinicalTrials.gov registry record · NA
Multisite Advancement of Research on Chronic Posttraumatic Headache
A NA study of Post-Traumatic Headache, sponsored by The University of Texas Health Science Center at San Antonio.
- Recruiting
- Registry status
- NA
- Development phase
- 525
- Enrollment target
- 8
- Study locations
NCT05620719: Recruiting NA study of Post-Traumatic Headache, sponsored by The University of Texas Health Science Center at San Antonio.
NCT05620719 is a NA study of Post-Traumatic Headache that is actively recruiting participants, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 525 participants, above the 126-participant average among 11 other Post-Traumatic Headache trials with a reported enrollment target (317% higher). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05620719, a NA study of Post-Traumatic Headache, is actively recruiting participants, sponsored by The University of Texas Health Science Center at San Antonio.
- RECRUITING
- Registry status
- NA
- Development phase
- 525 participants
- Enrollment target
- 8
- Study locations
Study Summary
Posttraumatic headache (PTH) is a common and highly disabling consequence of traumatic brain injury (TBI) in U.S. military service members and veterans. Cognitive Behavioral Therapy for PTH has been shown to significantly improve disability outcomes in veterans with persistent PTH when delivered in-person. Telemedicine platforms can dramatically increase access to evidence-based care. However, whether CBT for PTH retains its effectiveness when delivered through a telemedicine platform has yet to be established. The purpose of this 3-arm randomized clinical trial is to compare Clinic-based Cognitive-Behavioral Therapy (CCBT) to Telemedicine-based Cognitive Behavioral Therapy (TCBT) and to treatment as usual (TAU) in 525 service members and veterans with chronic posttraumatic headaches (PTH) at 4 VA medical centers\* and 3 military treatment facilities across the U.S. Participants will be assessed for headache-related disability, headache experience, and psychiatric comorbidities across multiple time points. \*VA Palo Alto Health Care System is temporarily randomizing into TAU and TCBT only.
Primary Outcome
Headache-disability as measured by the Headache Impact Test. The HIT-6 is a 6-item measure of headache-disability. The measure uses a 5-point Likert scale to rate the frequency that the respondent experiences headache-relate disability across six domains of functioning. Total scores range from 36 to 78 with higher scores representing a higher level of headache-relate disability.
Conditions Studied
Interventions
- OTHER Treatment as Usual
- BEHAVIORAL Cognitive Behavioral Therapy for Posttraumatic Headache
- OTHER Telemedicine-based Cognitive Behavioral Therapy (TCBT)
Study Locations (8)
Texas
- Carl R. Darnall Army Medical Center (Fort Cavazos) - Killeen
- South Texas Veterans Health Care System - San Antonio
- Brooke Army Medical Center - San Antonio
California
- VA Greater Los Angeles Healthcare System - Los Angeles
- VA Palo Alto Health Care System - Palo Alto
Hawaii
- Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks) - Honolulu
Maryland
- Walter Reed National Military Medical Center - Bethesda
Minnesota
- Minneapolis VA Health Care System - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 525 participants |
| Start Date | 2023-08-24 |
| Est. Completion | 2027-08 |
| Phase | NA |
What NCT05620719 shows while recruiting
NCT05620719 is an interventional study that assigns participants to a tested intervention. The registered 525 participants enrollment target is mid-sized for trials with a published cap, above the 126-participant average among 11 other Post-Traumatic Headache trials with a reported enrollment target (317% higher).
The record links to 1 condition, with Post-Traumatic Headache appearing as the primary indexed condition, and to 3 interventions - of which Treatment as Usual is the first listed.
NCT05620719 lists 8 locations in 5 states (Texas, California, Hawaii).
Frequently Asked Questions
What is clinical trial NCT05620719 about?
NCT05620719 is a clinical study titled "Multisite Advancement of Research on Chronic Posttraumatic Headache". Posttraumatic headache (PTH) is a common and highly disabling consequence of traumatic brain injury (TBI) in U.S. military service members and veterans. Cognitive Behavioral Therapy for PTH has been shown to significantly improve disability outcomes in veterans with persistent PTH when delivered in-...
What is the current status of trial NCT05620719?
This trial is currently recruiting. It is a NA study. The enrollment target is 525 participants. The study started on 2023-08-24. Estimated completion is 2027-08.
What conditions does trial NCT05620719 study?
This clinical trial studies the following conditions: Post-Traumatic Headache.
What interventions are being tested in trial NCT05620719?
The interventions under investigation include: Treatment as Usual (OTHER), Cognitive Behavioral Therapy for Posttraumatic Headache (BEHAVIORAL), Telemedicine-based Cognitive Behavioral Therapy (TCBT) (OTHER).
Who is sponsoring clinical trial NCT05620719?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05620719 being conducted?
This trial has 8 study locations across California, Hawaii, Maryland, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post-Traumatic Headache
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05620719's enrollment target sits among peer trials
525 1st of 11 higher than 11 of 11 other Post-Traumatic Headache trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post-Traumatic Headache trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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