e-CBT DTx for Post Traumatic Headaches in Adults With History of TBI

Completed · Not applicable · Has a placebo group

Conditions studied: Post-Traumatic Headache

In brief

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.

Key facts

Study ID: NCT06669780
Run by: Henry M. Jackson Foundation for the Advancement of Military Medicine
People needed: 83
Starts: 2024-01-03
Expected to finish: 2026-04-27
Last updated by the study team: 2026-05-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Be aged ≥ 18 to ≤ 70 years
Have a history of concussive TBI ≥ 3 months prior to enrollment:
A concussive TBI is defined by having at least one of the following after a head trauma (ACRM, 1993) oAny period of loss of consciousness; oAny loss of memory for events immediately before or after the accident; oAny alteration in mental state at the time of the accident (e.g., feeling dazed, disoriented, or confused); and oFocal neurological deficit(s) that may or may not be transient oThe injury must not exceed any of the following (ACRM, 1993):
Loss of consciousness of approximately 30 minutes or less;
After 30 minutes an initial GCS score of 13-15; and
PTA not greater than 24 hours
Head trauma resulting in concussive TBI can be due to blast or non-blast mechanisms
Head trauma resulting in concussive TBI can have occurred any time in the participant's life: prior to military service, during deployment, in garrison, or after leaving military service
Have a history of chronic PTH defined as:
o Headache is reported to have developed (or worsened) after one of the following*:
The injury to the head;
Regaining of consciousness following the injury to the head; or
Discontinuation of medication(s) impairing ability to sense or report headache following the injury to the head
Not better accounted for by another ICHD-3 diagnosis**
o The headache persists for >3 months after its onset (ICHD, 2013)
Have a HIT-6™ score of ≥ 56 to 78 indicative of substantial impact (56-59) or severe impact (60-78) on functioning (Yang, Rendas-Baum, Varon, \& Kosinski, 2011)
Be able to provide written, informed consent in English and follow study-related instructions
Have ownership of or reliable access to a smartphone with a data plan or internet connecting capabilities
Be aged ≥ 18 to ≤ 70 years
Have a history of concussive TBI ≥ 3 months prior to enrollment:
A concussive TBI is defined by having at least one of the following after a head trauma (ACRM, 1993):
Any period of loss of consciousness;
Any loss of memory for events immediately before or after the accident;
Any alteration in mental state at the time of the accident (e.g., feeling dazed, disoriented, or confused); and
Focal neurological deficit(s) that may or may not be transient

You may not qualify if…

They experienced a moderate or severe TBI
Their secondary headache is better accounted for by the ICHD-3 diagnosis of 8.2 medication-overuse headache; must meet diagnostic criteria for at least 1 medication-overuse headache diagnosis (8.2.1-8.2.8)
They are currently engaged in psychotherapeutic treatment or have engaged in psychotherapeutic treatment within 8 weeks prior to trial enrollment (for more information regarding recent treatment in potential participants, see section '3.2 Study Procedures,' sub-section 'Baseline Evaluation')
They report change or discontinuation of headache prophylaxis in the past 4 weeks
They report active psychotic or bipolar symptoms
In the opinion of the investigator, they have other considerations that may adversely affect patient safety, participation, or scientific validity of the data being collected (including, but not limited to, active plan or intent for suicide, visual impairment, hand dysfunction or amputation, substantial cognitive impairment, life expectancy of less than 6 months)

Where it is running

100% Remote Recruitment: Center for Neurscience and Regenerative Medicine — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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