Multisite Advancement of Research on Chronic Posttraumatic Headache

Conditions

• Posttraumatic Headache

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Cognitive Behavioral Therapy for Posttraumatic Headache — BEHAVIORAL
  CBT for Posttraumatic Headaches consists of 8 sessions of cognitive behavioral therapy that focus on (1) discussions and exercises that increase awareness of what may be related to headaches, (2) relaxation techniques to manage physiological stress, and (3) problem-solving techniques to manage common stressors. Sessions are delivered weekly and can last between 45 to 75 minutes based on clinical content and patient response to the material.
• Treatment as Usual — OTHER
  Participants will continue to engage in medical care as usual for 8 weeks.
• Telemedicine-based Cognitive Behavioral Therapy (TCBT) — OTHER
  Participants assigned to TCBT will receive 8 sessions of cognitive behavioral therapy using telemedicine rather than face-to face office visits.

Study Details

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.

Key Dates

Start date

Aug 24, 2023

Status verified

Jan 2026

Primary completion

Sep 30, 2026

Completion

Aug 31, 2027

Study Design

Enrollment

525 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Clinic-based Cognitive Behavioral Therapy (CCBT)
  CCBT provides CBT for posttraumatic headache through 8 face-to-face, in-clinic sessions.
• Active Comparator: Telemedicine-based Cognitive Behavioral Therapy (TCBT)
  TCBT provides 8-sessions of CBT for posttraumatic headache using telemedicine technology rather than attending in-office sessions. Additionally, TCBT includes instructions for each session specific to the mechanics of a telehealth encounter (e.g., asking participant for name, location, and accessible phone number for location in case of technical failure or crisis). All TCBT participants must be enrolled at the MTF or VA from which they were recruited, and the treatment facility will be notified that they are receiving TCBT in case a crisis arises and needs to be managed by the site.
• Active Comparator: Treatment As Usual
  Participants will continue to engage in clinical care as usual for 8 weeks. Research staff will call the TAU participants weekly to assess for adverse events. Research staff at each site will be trained on standardized assessment of usual care activities using forms adapted from our single-site trial.

Primary Outcome Measure

Change in Headache Impact Test (HIT-6) [ Time Frame: Baseline to 3-month follow-up ]

Central Contacts

• Nicole A Brackins, MS
  210-450-8076
  [email protected]
• Fermin A Carrizales
  210-562-6724
  [email protected]

Locations (8)

Find similar trials in Los Angeles, CA

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