E-CBT DTx for Post Traumatic Headaches in Adults with History of TBI

Description

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.

Conditions

Post-Traumatic Headache

Study Overview

Study Details

Study overview

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.

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

E-CBT DTx for Post Traumatic Headaches in Adults with History of TBI

Condition
Post-Traumatic Headache
Intervention / Treatment

-

Contacts and Locations

Bethesda

100% Remote Recruitment: Center for Neurscience and Regenerative Medicine, Bethesda, Maryland, United States, 20817

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * 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\*\*
  • * 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:
  • * 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\*\*
  • * 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
  • * 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)

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Henry M. Jackson Foundation for the Advancement of Military Medicine,

Study Record Dates

2026-06-30