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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Headache

Secondary outcome measures

Anxiety Disorders

Change in PTSD Checklist-5

Change in Patient Health Questionnaire-9

+1 more

Trial Design

3Treatment groups

Active Control

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

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

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

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

453 Previous Clinical Trials

90,905 Total Patients Enrolled

1 Trials studying Headache

192 Patients Enrolled for Headache

Brooke Army Medical CenterFED

119 Previous Clinical Trials

26,034 Total Patients Enrolled

2 Trials studying Headache

115 Patients Enrolled for Headache

C.R.Darnall Army Medical CenterFED

15 Previous Clinical Trials

5,161 Total Patients Enrolled

1 Trials studying Headache

56 Patients Enrolled for Headache

Media Library

Cognitive Behavioral Therapy for Posttraumatic Headache Clinical Trial Eligibility Overview. Trial Name: NCT05620719 — N/A

Headache Research Study Groups: Treatment As Usual, Clinic-based Cognitive Behavioral Therapy (CCBT), Telemedicine-based Cognitive Behavioral Therapy (TCBT)

Headache Clinical Trial 2023: Cognitive Behavioral Therapy for Posttraumatic Headache Highlights & Side Effects. Trial Name: NCT05620719 — N/A

Cognitive Behavioral Therapy for Posttraumatic Headache 2023 Treatment Timeline for Medical Study. Trial Name: NCT05620719 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the enrolling parameters for this experiment still open?

"Affirmative. According to clinicaltrials.gov, this venture is actively searching for 525 patients from a single location and was posted on July 20th of 2023 with its most recent update occurring that same day."

Answered by AI

Does this research permit the involvement of adults aged 18 and over?

"This study seeks to enroll patients who have attained the age of majority and are below 70 years old."

Answered by AI

To what extent has the general public participated in this clinical experiment?

"Affirmative, clinicaltrials.gov data indicates that this trial is actively recruiting patients. The study was initially made available on July 20th 2023 and has been edited since then to reflect the current protocol. 525 individuals are being sought from 1 research site."

Answered by AI

Who is eligible for this medical experiment?

"The current recruitment for this trial calls for 525 patients aged 18 to 70, who have experienced headaches in the 3 months following a head or neck injury. Additionally, participants must possess moderate-to-severe disability from headache based on HIT-6 scores and not be undergoing any changes in medication within 4 weeks of enrollment. Furthermore, applicants are required to possess access to high speed internet/4G/5G phone service and have compatible computer equipment that can run virtual video connect platform. If needed, study provided technology is available as well."

Answered by AI

Recent research and studies

Archives of Internal MedicineJournal

A Brief Measure for Assessing Generalized Anxiety Disorder

Spitzer, Robert L., Kurt Kroenke, Janet B. W. Williams, and Bernd Löwe. 2006. “A Brief Measure for Assessing Generalized Anxiety Disorder”. Archives of Internal Medicine. American Medical Association (AMA). doi:10.1001/archinte.166.10.1092.

Journal of General Internal MedicineJournal

The PHQ-9

Kroenke, Kurt, Robert L. Spitzer, and Janet B. W. Williams. 2001. “The PHQ-9”. Journal of General Internal Medicine. Springer Science and Business Media LLC. doi:10.1046/j.1525-1497.2001.016009606.x.

Quality of Life ResearchJournal

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Kosinski, M., M.S. Bayliss, J.B. Bjorner, J.E. Ware Jr., W.H. Garber, A. Batenhorst, R. Cady, C.G.H. Dahlöf, A. Dowson, and S. Tepper. 2003. “[]”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1023/a:1026119331193.

General Hospital PsychiatryJournal