Online cognitive behavioral therapy for post-traumatic headaches in adults with a history of brain injury

Single-Blind, Randomized, Controlled Pilot Trial of a Cognitive-Behavioral Therapy Digital Therapeutic Delivered Online for Post-Traumatic Headaches in Adults with History of Concussive Traumatic Brain Injury

This study is testing an online therapy program to see if it can help adults with post-traumatic headaches after a brain injury feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine (other)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT06669780 on ClinicalTrials.gov

What this trial studies

This pilot trial evaluates the effectiveness of an online cognitive behavioral therapy program, known as AMMO DTx, for adults experiencing post-traumatic headaches following a history of concussive traumatic brain injury (TBI). Participants, including military personnel and civilians, will engage in a 12-week intervention delivered through a digital platform accessible via smartphones, tablets, or computers. The study employs a single-blind, randomized, controlled design, comparing the active intervention to a sham condition. Following the intervention, participants will undergo a follow-up assessment four weeks later to evaluate the outcomes. Feedback from this pilot will inform improvements to the digital therapeutic for future larger trials.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a history of concussive TBI and current post-traumatic headaches.

Not a fit: Patients without a history of concussive TBI or those with headaches not related to trauma may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the frequency and severity of migraines in individuals with post-traumatic headaches.

How similar studies have performed: While this approach is novel in its specific application to post-traumatic headaches, similar digital therapeutic interventions have shown promise in treating other conditions.

Eligibility criteria

Inclusion Criteria:

* 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
  * The 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

Exclusion Criteria:

* 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 this trial is running

Bethesda, Maryland

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

Study contacts

• Study coordinator: Noushin Mannan

Conditions: Post-Traumatic Headache