← Back to Search

Cognitive Behavioral Therapy for Post-Traumatic Headache

N/A

Recruiting

Led By Donald D McGeary, PhD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare in-person CBT for PTH to delivered via telemedicine, to see if it helps reduce disability in military service members & veterans with chronic PTH. It will assess 525 participants at 3 VA centers & 4 military facilities across the US.

Who is the study for?

This trial is for U.S. military service members and veterans aged 18-70 with chronic posttraumatic headaches (PTH) that started after a mild traumatic brain injury (mTBI). Participants should have significant headache-related disability, stable headache medication use, and meet specific criteria for PTH. They must be able to speak English at a 6th grade level, not have certain psychiatric or cognitive impairments, or other conditions that could affect treatment.

What is being tested?

The study compares in-person Cognitive Behavioral Therapy (CCBT), Telemedicine-based CBT (TCBT), and usual care to see which is best for treating chronic PTH. It will involve assessments of headache-related disability, the experience of headaches, and any psychiatric issues across multiple time points among participants from VA medical centers and military facilities.

What are the potential side effects?

While the trial focuses on therapy rather than medication, potential side effects may include discomfort during therapy sessions such as emotional distress or fatigue. Since it's non-pharmacological treatment, traditional drug side effects are not expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Headache

Secondary study objectives

Anxiety Disorders

Change in PTSD Checklist-5

Change in Patient Health Questionnaire-9

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Clinic-based Cognitive Behavioral Therapy (CCBT)Active Control1 Intervention

CCBT provides CBT for posttraumatic headache through 8 face-to-face, in-clinic sessions.

Group II: Treatment As UsualActive Control1 Intervention

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.

Group III: Telemedicine-based Cognitive Behavioral Therapy (TCBT)Active Control2 Interventions

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.

Do I qualify?Apply below to find out