Cognitive Behavioral Therapy for Post-Traumatic Headache

Recruiting at 6 trial locations

Overseen By Fermin A Carrizales

Age: 18+

Sex: Any

Trial Phase: Academic

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

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

525 Participants Needed

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

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
• 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.

Cognitive Behavioral Therapy for Posttraumatic Headache is already approved in United States for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Posttraumatic Headache for:

• Posttraumatic headache
• Posttraumatic stress disorder (PTSD)

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

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+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Findings from Research

A systematic review of 7 studies involving 1108 adult participants found that behavioral interventions, such as cognitive behavioral therapy (CBT), show potential for treating posttraumatic headache (PTH) and post-concussive symptoms (PCS), but results were inconclusive due to significant variability in study designs and participant characteristics.

The heterogeneity in timing of interventions, types of therapies used, and patient populations suggests that future research needs to standardize these factors to better assess the efficacy of mind-body interventions and behavioral therapies for PTH and PCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Therapies and Mind-Body Interventions for Posttraumatic Headache and Post-Concussive Symptoms: A Systematic Review. Minen, M., Jinich, S., Vallespir Ellett, G.[2020]

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]

Posttraumatic headache (PTH) is very common in children and adolescents following mild traumatic brain injury, affecting over 80% of this population, but there is limited evidence on the best treatment approaches.

The review identified 27 studies on various treatment modalities for PTH, including pharmacologic therapies and physical therapy, but highlighted a lack of clarity on how to tailor treatments based on headache characteristics or timing, indicating a need for more targeted research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and chronic management of posttraumatic headache in children: A systematic review. Patterson Gentile, C., Shah, R., Irwin, SL., et al.[2022]

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]