Cognitive Behavioral Therapy for Post-Traumatic Headache

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Donald D McGeary, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Disqualifiers: Secondary headache, Medication overuse, Psychiatric problems, Cognitive impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, you must be stable on your headache medication, meaning no changes in prescriptions in the past 4 weeks.

What data supports the idea that Cognitive Behavioral Therapy for Post-Traumatic Headache is an effective treatment?

The available research shows that Cognitive Behavioral Therapy (CBT) is considered a strong treatment option for preventing headaches, including post-traumatic headaches. It is mentioned alongside other behavioral therapies like biofeedback and relaxation as effective methods. Although specific data on CBT for post-traumatic headaches is limited, its success in treating other types of headaches suggests it can be beneficial. Compared to acupuncture, which is also used for post-traumatic headaches but lacks thorough evaluation, CBT has more established evidence supporting its effectiveness. ^{1 2 3 4 5}

What safety data exists for Cognitive Behavioral Therapy for Post-Traumatic Headache?

The systematic review titled 'Behavioral Therapies and Mind-Body Interventions for Posttraumatic Headache and Post-Concussive Symptoms' suggests that cognitive behavioral therapy (CBT) is a Level-A evidence-based treatment for headache prevention, indicating its safety and efficacy. Additionally, the randomized controlled trial 'Cognitive behavioural treatment for the chronic post-traumatic headache patient' evaluates the effects of CBT on headache, pain perception, psychological symptoms, and quality of life, providing further safety data for this treatment. ^{1 2 3 6 7}

Is Cognitive Behavioral Therapy a promising treatment for post-traumatic headache?

Yes, Cognitive Behavioral Therapy (CBT) is a promising treatment for post-traumatic headache. Research shows that behavioral therapies like CBT are effective in preventing headaches and improving quality of life for those with chronic post-traumatic headache. These therapies help manage pain and psychological symptoms, making them a valuable option for treatment. ^{1 2 5 6 8}

Research Team

Donald D McGeary, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

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.

Inclusion Criteria

I am a veteran or active duty service member aged 18-70 with a recent TBI-related headache.

I have ongoing headaches due to a mild brain injury.

My headaches severely impact my daily life.

Exclusion Criteria

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

Participant has medication overuse headache based on Structured Diagnostic Headache Interview-Revised (Brief Version; SDIH-R) and clinical judgment

Participant demonstrates significant cognitive impairment that could impact treatment adherence/benefit

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Clinic-based CBT, Telemedicine-based CBT, or Treatment As Usual for posttraumatic headache over 8 sessions

8 weeks

8 visits (in-person for CCBT, virtual for TCBT)

Follow-up

Participants are monitored for headache-related disability, anxiety, PTSD, and depressive symptoms

3 months

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Posttraumatic Headache (Behavioral Intervention)
• Telemedicine-based Cognitive Behavioral Therapy (TCBT) ()
• Treatment as Usual ()

Trial Overview 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.

Participant Groups

Group I: Clinic-based Cognitive Behavioral Therapy (CCBT) Active Control 1 Intervention

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

Group II: Treatment As Usual Active Control 1 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 Control 2 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.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Dr. Andrew Masica

The University of Texas Health Science Center at San Antonio

Chief Medical Officer

MD from Indiana University School of Medicine

Dr. Taylor Eighmy

The University of Texas Health Science Center at San Antonio

Acting President

PhD in Civil Engineering from the University of New Hampshire

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Col. Mark Stackle

Brooke Army Medical Center

Chief Executive Officer since 2024

MD

Col. Sean Hipp

Brooke Army Medical Center

Chief Medical Officer since 2024

MD

C.R.Darnall Army Medical Center

Collaborator

Trials

17

Recruited

5,800+

Desmond Doss Health Clinic, Schofield Barracks

Collaborator

Trials

1

Recruited

530+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

South Texas Veterans Health Care System

Collaborator

Trials

19

Recruited

6,100+

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

Jean J. Gurga

VA Palo Alto Health Care System

Medical Center Director since 2023

Master's degree in Occupational Therapy from Tufts University, Bachelor's degree in Business Economics from Mills College

Rina N. Shah

VA Palo Alto Health Care System

Chief of Staff

MD, FACP

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

Melissa C. Austin

Walter Reed National Military Medical Center

Chief Executive Officer since 2020

MD from University of Colorado Health Sciences Center

Melissa C. Austin

Walter Reed National Military Medical Center

Chief Medical Officer since 2020

MD, Board Certified in Anatomic and Clinical Pathology

Harvard University

Collaborator

Trials

237

Recruited

588,000+

Dr. Christopher Anzalone

Harvard University

Chief Executive Officer since 2007

PhD in Biology from UCLA

Dr. Perry

Harvard University

Chief Medical Officer since 2011

MD from Albert Einstein College of Medicine, MPH from Harvard University

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

Findings from Research

A study involving 90 patients with chronic post-traumatic headache (CPTH) found that a nine-week group-based Cognitive Behavioural Therapy (CBT) intervention had no significant effect on headache severity or pain thresholds, and only a minor impact on quality of life and psychological symptoms.

The waiting-list group showed a significant decrease in somatic and cognitive symptoms over time, suggesting a possibility of spontaneous remission, which highlights the ongoing challenges in effectively managing CPTH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural treatment for the chronic post-traumatic headache patient: a randomized controlled trial. Kjeldgaard, D., Forchhammer, HB., Teasdale, TW., et al.[2018]

This systematic review aims to evaluate the effectiveness of acupuncture for treating posttraumatic headache (PTH) in patients with traumatic brain injury (TBI), addressing a common symptom that has not been methodically assessed before.

The review will include various study types, such as randomized controlled trials and cohort studies, and aims to provide substantial evidence for the clinical application of acupuncture in managing PTH after TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of acupuncture treatment on posttraumatic headache after traumatic brain injury in patients: A protocol for systematic review. Wen, X., Yang, Y., Li, Y., et al.[2023]

Behavioral treatments like relaxation, biofeedback, and cognitive behavior therapy have been proven effective for common types of headaches, such as migraines and tension-type headaches, over 30 years of research.

However, there is limited research on the effectiveness of these treatments for more complex headache conditions, such as chronic, refractory headaches and those associated with medication overuse or psychiatric issues, indicating a need for further studies in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatment approaches to chronic headache. Andrasik, F.[2022]

In a study of 64 active duty military patients with post-traumatic headaches, 64% reported improvement after treatment with onabotulinum toxin A (OBA), suggesting it may be an effective option for managing these headaches.

Most patients had persistent headaches, with many experiencing multiple headache types, indicating the complexity of post-traumatic headache conditions and the need for tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Onabotulinum toxin a for the treatment of headache in service members with a history of mild traumatic brain injury: a cohort study. Yerry, JA., Kuehn, D., Finkel, AG.[2018]

Post-traumatic headache (PTH) is a common and complex condition following mild traumatic brain injury (mTBI), with varying incidence and prevalence rates that highlight its chronic nature.

Recent neuroimaging studies suggest that analyzing changes in brain network connectivity could enhance our understanding of PTH, potentially leading to more effective treatment strategies for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-traumatic Headache and Mild Traumatic Brain Injury: Brain Networks and Connectivity. Maleki, N., Finkel, A., Cai, G., et al.[2021]

Post-traumatic headache typically begins within 7 days after a mild traumatic brain injury, and while many cases resolve quickly, 30-50% of individuals experience headaches that persist for at least 3 months.

Current understanding of the mechanisms behind post-traumatic headache is based largely on animal studies and imaging in humans, highlighting the need for more research to develop effective and safe treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-traumatic headache due to mild traumatic brain injury: Current knowledge and future directions. Schwedt, TJ.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Behavioral Therapies and Mind-Body Interventions for Posttraumatic Headache and Post-Concussive Symptoms: A Systematic Review. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural treatment for the chronic post-traumatic headache patient: a randomized controlled trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Acute and chronic management of posttraumatic headache in children: A systematic review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of acupuncture treatment on posttraumatic headache after traumatic brain injury in patients: A protocol for systematic review. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

Behavioral treatment approaches to chronic headache. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Onabotulinum toxin a for the treatment of headache in service members with a history of mild traumatic brain injury: a cohort study. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Post-traumatic Headache and Mild Traumatic Brain Injury: Brain Networks and Connectivity. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Post-traumatic headache due to mild traumatic brain injury: Current knowledge and future directions. [2021]