Online Cognitive Behavioral Therapy for Post-Traumatic Headache
(AMMO Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Trial Summary
What is the purpose of this trial?The AMMO digital therapeutic (DTx) study will provide an online based program for participants with migraines after head injury to follow for 12 weeks. This study aims to see if using cognitive behavioral therapy aimed at military service members in an online self administered platform is effective therapy in the relief of migraines compared. The study will use a single blind online comparative program to test the effect.
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 data supports the effectiveness of the treatment AMMO PTH DTx for post-traumatic headache?
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 patients with chronic post-traumatic headache.
12345How does the treatment AMMO PTH DTx differ from other treatments for post-traumatic headache?
AMMO PTH DTx is unique because it uses online cognitive behavioral therapy (CBT), which is a non-drug approach focusing on changing thought patterns to manage headaches. This is different from traditional treatments that often rely on medications, which can have side effects.
34678Eligibility Criteria
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
I am between 18 and 70 years old.
I had a concussion more than 3 months ago.
Be able to provide written, informed consent in English and follow study-related instructions
+6 more
Exclusion Criteria
Reported active psychotic or bipolar symptoms
I have changed or stopped my headache prevention medication in the last 4 weeks.
Investigator's opinion of other considerations that may adversely affect patient safety, participation, or scientific validity of the data being collected
+3 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
This arm will receive access to an online program that will guide them through cognitive behavioral therapy program.
Group II: Sham comparatorPlacebo Group1 Intervention
Participants will obtain access to an online program with activities not including the cognitive behavioral therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
100% Remote Recruitment: Center for Neurscience and Regenerative MedicineBethesda, MD
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Who Is Running the Clinical Trial?
Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
Military Traumatic Brain Injury InitiativeCollaborator
Uniformed Services University of the Health SciencesCollaborator
References
Cognitive behavioural treatment for the chronic post-traumatic headache patient: a randomized controlled trial. [2018]Chronic post-traumatic headache (CPTH) after mild head injury can be difficult to manage. Research is scarce and successful interventions are lacking.To evaluate the effect of a group-based Cognitive Behavioural Therapy (CBT) intervention in relation to headache, pain perception, psychological symptoms and quality of life in patients with CPTH.
Post-Concussive Syndrome: a Focus on Post-Traumatic Headache and Related Cognitive, Psychiatric, and Sleep Issues. [2018]Post-traumatic headache (PTH) is a secondary headache disorder following traumatic brain injury. We sought to examine the recent literature on PTH and associated cognitive, psychiatric, and sleep conditions to understand the latest findings about the associated conditions and available screening tools, and to understand the available treatment options for PTH.
Onabotulinum toxin a for the treatment of headache in service members with a history of mild traumatic brain injury: a cohort study. [2018]Post-traumatic headache (PTH) of the migraine type is a common complication of mild traumatic brain injury (including blast injuries) in active duty service members. Persistent and near-daily headache occur. Usual preventive medications may have unacceptable side effects. Anecdotal reports suggest that onabotulinum toxin A (OBA) might be an effective treatment in these patients.
Models for Treating Post-traumatic Headache. [2023]To discuss the treatment of post-traumatic headache (PTH) and how to choose pharmacotherapy based upon known pathophysiology.
Acute and chronic management of posttraumatic headache in children: A systematic review. [2022]The goal of this paper is to provide a compilation of the evidence for the treatment of posttraumatic headache (PTH) in the pediatric population. Headache features and timing of therapy were considered.
Behavioral Therapies and Mind-Body Interventions for Posttraumatic Headache and Post-Concussive Symptoms: A Systematic Review. [2020]There are no clear guidelines on how to treat posttraumatic headache (PTH) or post-concussive symptoms (PCS). However, behavioral interventions such as cognitive behavioral therapy, biofeedback, and relaxation are Level-A evidence-based treatments for headache prevention. To understand how to develop and study further mind-body interventions (MBIs) and behavioral therapies for PTH and PCS, we developed the following question using the PICO framework: Are behavioral therapies and MBIs effective for treating PTH and PCS?
Posttraumatic headache in military personnel and veterans of the iraq and afghanistan conflicts. [2021]Headaches, particularly migraine, are common in US servicemembers (SMs) who are deployed to or have returned from theaters of combat operations in Iraq and Afghanistan. Concussions and exposure to explosive blasts may be a significant contributor to the increased prevalence of headaches in military veterans. Concussions, usually due to blast exposure, occur in approximately 20% of deployed SMs, and headaches are a common symptom after a deployment-related concussion. Posttraumatic headaches (PTHAs) in US SMs usually resemble migraines, and posttraumatic stress disorder (PTSD) and depression are common comorbidities. Treatment of PTHAs in SMs is based upon the treatment setting, whether the headaches are acute or chronic, the headache phenotype, and associated comorbidities. No randomized, controlled clinical trials evaluating the efficacy of therapies for PTHAs have been completed. Pharmacologic and nonpharmacologic management strategies should be selected on an individual basis. Acute therapy with NSAIDs or triptans and prophylactic therapy in acute and chronic settings using valproate, nortriptyline, amitriptyline, propranolol, topiramate, or botulinum toxin are discussed. Triptans and topiramate may be particularly effective in SMs with PTHA. Management of PTHA and other features of the posttraumatic syndrome should be multidisciplinary whenever possible.
Interventional pain management for a patient with chronic post-traumatic headaches after a traumatic brain injury. [2023]Traumatic brain injuries (TBI) and chronic post-traumatic headaches (PTH) have affected many military personnel. The increasing use of improvised explosive devices have made blast- and explosive-related head injuries more common than in previous wars [1, 2]. Data from Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn demonstrate that a significant portion of military TBIs are caused by blast-related injuries [3, 4]. From 2000 to 2016 more than 350,000 military service members were diagnosed with a TBI [4]. Military troops are at greater risk of developing PTH from head injuries that arise during deployment to combat zones. These patients can be extremely challenging because they often suffer from comorbid conditions including depression and post-traumatic stress disorder (PTSD). Additionally, there is a lack of high-quality studies on the treatment of PTH [5]. This brief report describes a patient who suffered from chronic PTH after sustaining a mild TBI, and our results with greater occipital and auriculotemporal nerve blocks.