Online Cognitive Behavioral Therapy for Post-Traumatic Headache

(AMMO Trial)

Overseen By Noushin Mannan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Must not be taking: Headache medications

Disqualifiers: Moderate/severe TBI, Psychotherapy, Bipolar, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program using cognitive behavioral therapy to reduce migraines after a head injury. Specifically designed for military service members, it aims to determine if this self-administered therapy, called AMMO PTH DTx, can effectively relieve headaches. The trial includes two groups: one using the therapy and another using a different online program without therapy. Individuals who have experienced a mild traumatic brain injury (such as feeling dazed or losing memory after head trauma) and suffer frequent headaches for more than three months may be suitable candidates. Participants need reliable access to a smartphone or internet. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance headache management for military personnel.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have changed or stopped headache prevention medications in the past 4 weeks, you may not be eligible to participate.

What prior data suggests that this online cognitive behavioral therapy is safe for treating post-traumatic headache?

Research has shown that cognitive behavioral therapy (CBT) is generally safe and easy to manage. Many studies have found that online CBT programs, such as the AMMO digital therapeutic (DTx), are effective for various conditions. Typically, there are few, if any, side effects. In similar trials, participants rarely reported negative effects, suggesting that this online program could be a safe option for managing post-traumatic headaches. However, as with any treatment, individual experiences can vary. Consulting a healthcare provider about any possible risks is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AMMO PTH DTx because it offers a new digital approach for managing post-traumatic headaches through online cognitive behavioral therapy (CBT). Unlike traditional treatments that often rely on medications to relieve symptoms, this therapy focuses on addressing the psychological components of headaches, potentially reducing their frequency and severity. The online delivery method makes it accessible from anywhere, providing a convenient option for patients who may have difficulty accessing in-person therapy. This innovative approach could offer a non-pharmacological alternative that empowers patients to take control of their headache management.

What evidence suggests that this online cognitive behavioral therapy is effective for post-traumatic headache?

Research has shown that Cognitive Behavioral Therapy (CBT), a key component of the AMMO PTH digital treatment, can alleviate symptoms and enhance the quality of life for individuals with post-traumatic headaches. In this trial, participants in the active arm will access an online program that guides them through a CBT course. Studies have demonstrated that CBT can alter patients' perceptions of pain and improve headache management. For veterans with post-traumatic headaches and stress, CBT has reduced headache severity. This therapy is particularly beneficial as it imparts skills for more effective pain management. Early findings suggest that delivering CBT online could improve accessibility while remaining effective for those experiencing migraines after a head injury. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults who have had a traumatic brain injury (TBI) and are now experiencing post-traumatic headaches. Participants should be comfortable using an online platform for therapy.

Inclusion Criteria

Be able to provide written, informed consent in English and follow study-related instructions

I had a concussion more than 3 months ago.

Have a HIT-6™ score of ≥ 56 to 78 indicative of substantial or severe impact on functioning

Exclusion Criteria

Reported active psychotic or bipolar symptoms

Investigator's opinion of other considerations that may adversely affect patient safety, participation, or scientific validity of the data being collected

I have changed or stopped my headache prevention medication in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow an online cognitive behavioral therapy program for 12 weeks

12 weeks

Remote interaction via online portal

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants in the comparison group are provided access to the active intervention after the follow-up period

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AMMO PTH DTx

Trial Overview The study tests an online program called AMMO DTx, which uses cognitive behavioral therapy tailored to military service members, against a sham version of the program. It's designed to see if it can help relieve migraines caused by head injuries over 12 weeks.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

This arm will receive access to an online program that will guide them through cognitive behavioral therapy program.

Group II: Sham comparator Placebo Group 1 Intervention

Participants will obtain access to an online program with activities not including the cognitive behavioral therapy

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

Military Traumatic Brain Injury Initiative

Collaborator

Trials

1

Recruited

100+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

Published Research Related to This Trial

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]

Recent research highlights the role of inflammatory neuropeptides, particularly calcitonin gene-related peptide (CGRP), in the development and persistence of post-traumatic headache (PTH), suggesting that targeting these pathways could improve treatment outcomes.

There is a need for high-powered clinical trials to test early, targeted therapies for patients at risk of persistent PTH, as well as a multi-disciplinary approach to address the complex interactions between headaches and other post-concussion symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models for Treating Post-traumatic Headache. Kamins, J.[2023]

Military personnel are increasingly affected by traumatic brain injuries (TBI) and chronic post-traumatic headaches (PTH), particularly due to blast-related injuries from improvised explosive devices, with over 350,000 diagnoses reported from 2000 to 2016.

The report highlights the potential effectiveness of greater occipital and auriculotemporal nerve blocks in treating chronic PTH in a patient with a mild TBI, suggesting a need for more high-quality studies on treatment options for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventional pain management for a patient with chronic post-traumatic headaches after a traumatic brain injury. Hasoon, J., Urits, I., Berger, AA., et al.[2023]

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]

Post-traumatic headache (PTH) is often accompanied by significant comorbid conditions, with up to one third of patients experiencing depression and about a quarter suffering from insomnia, highlighting the need for comprehensive treatment approaches.

Recent studies suggest that topiramate may be a more effective preventive medication for PTH compared to other oral options, while additional treatments like nerve blocks and behavioral therapy are also being explored, indicating a growing understanding of PTH management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-Concussive Syndrome: a Focus on Post-Traumatic Headache and Related Cognitive, Psychiatric, and Sleep Issues. Minen, MT., Boubour, A., Walia, H., et al.[2018]

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]

Headaches, especially migraines, are prevalent among US servicemembers returning from combat, often linked to concussions from explosive blasts, with about 20% of deployed servicemembers experiencing concussions.

While no randomized controlled trials have been conducted on treatments for posttraumatic headaches (PTHAs), individualized management strategies using medications like triptans and topiramate show promise, and a multidisciplinary approach is recommended for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic headache in military personnel and veterans of the iraq and afghanistan conflicts. Theeler, BJ., Erickson, JC.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06669780?term=AREA%5BConditionSearch%5D(%22Post-Traumatic%20Headache%22)&rank=2

e-CBT DTx for Post Traumatic Headaches in Adults With ... The AMMO digital therapeutic (DTx) study will provide an online based program for participants with migraines after head injury to follow for 12 weeks.

2. withpower.com withpower.com/trial/online-cognitive-behavioral-therapy-for-post-traumatic-headache-23253

Online Cognitive Behavioral Therapy for Post-Traumatic ... Research shows that Cognitive Behavioral Therapy (CBT), a component of AMMO PTH DTx, can help improve headache symptoms, pain perception, and quality of life in ...

3. headaches.org headaches.org/new-mtbi-study-looking-for-participants/

Clinical Trial for Post Traumatic Headaches in Adults with ... The AMMO digital therapeutic (DTx) study will provide an online based program for participants with migraines after head injury to follow for 12 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06669780/e-cbt-dtx-for-post-traumatic-headaches-in-adults-with-history-of-tbi

E-CBT DTx for Post Traumatic Headaches in Adults ... The AMMO digital therapeutic (DTx) study will provide an online based program for participants with migraines after head injury to follow ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9237802/

Cognitive Behavioral Therapy for Veterans With Comorbid ... Cognitive behavioral therapy for veterans with comorbid posttraumatic headache and posttraumatic stress disorder symptoms: a randomized clinical trial.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7806520/

Study design for a randomized clinical trial of cognitive- ... This manuscript describes the design of a randomized clinical trial of two nonpharmacological (ie, behavioral) interventions for posttraumatic headache.