RECRUITING

Multisite Advancement of Research on Chronic Posttraumatic Headache

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache

Quick Facts

Study Start:2023-08-24
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05620719

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Contacts and Locations

Study Contact

Nicole A Brackins, MS
CONTACT
210-450-8076
brackins@uthscsa.edu
Fermin A Carrizales
CONTACT
210-562-6724
carrizalesF@uthscsa.edu

Principal Investigator

Donald D McGeary, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
United States
VA Palo Alto Health Care System
Palo Alto, California, 94304
United States
Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)
Honolulu, Hawaii, 96819
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
United States
Carl R. Darnall Army Medical Center (Fort Cavazos)
Killeen, Texas, 76544
United States
South Texas Veterans Health Care System
San Antonio, Texas, 78229
United States
Brooke Army Medical Center
San Antonio, Texas, 78234
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Donald D McGeary, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-24
Study Completion Date2026-08

Study Record Updates

Study Start Date2023-08-24
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • Cognitive Behavioral Therapy
  • Telehealth
  • Veterans
  • Military Service Members
  • Chronic Pain
  • Headaches

Additional Relevant MeSH Terms

  • Posttraumatic Headache