ACTIVE_NOT_RECRUITING

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

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Conditions

Post-Traumatic Headache

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-03
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06669780

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be aged ≥ 18 to ≤ 70 years
  2. * Have a history of concussive TBI ≥ 3 months prior to enrollment:
  3. * 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):
  4. * Loss of consciousness of approximately 30 minutes or less;
  5. * After 30 minutes an initial GCS score of 13-15; and
  6. * PTA not greater than 24 hours
  7. * Head trauma resulting in concussive TBI can be due to blast or non-blast mechanisms
  8. * 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
  9. * Have a history of chronic PTH defined as:
  10. * The injury to the head;
  11. * Regaining of consciousness following the injury to the head; or
  12. * Discontinuation of medication(s) impairing ability to sense or report headache following the injury to the head
  13. * Not better accounted for by another ICHD-3 diagnosis\*\*
  14. * 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)
  15. * Be able to provide written, informed consent in English and follow study-related instructions
  16. * Have ownership of or reliable access to a smartphone with a data plan or internet connecting capabilities
  17. * Be aged ≥ 18 to ≤ 70 years
  18. * Have a history of concussive TBI ≥ 3 months prior to enrollment:
  19. * A concussive TBI is defined by having at least one of the following after a head trauma (ACRM, 1993):
  20. * Any period of loss of consciousness;
  21. * Any loss of memory for events immediately before or after the accident;
  22. * Any alteration in mental state at the time of the accident (e.g., feeling dazed, disoriented, or confused); and
  23. * Focal neurological deficit(s) that may or may not be transient
  24. * The injury must not exceed any of the following (ACRM, 1993):
  25. * Loss of consciousness of approximately 30 minutes or less;
  26. * After 30 minutes an initial GCS score of 13-15; and
  27. * PTA not greater than 24 hours
  28. * Head trauma resulting in concussive TBI can be due to blast or non-blast mechanisms
  29. * 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
  30. * Have a history of chronic PTH defined as:
  31. * The injury to the head;
  32. * Regaining of consciousness following the injury to the head; or
  33. * Discontinuation of medication(s) impairing ability to sense or report headache following the injury to the head
  34. * Not better accounted for by another ICHD-3 diagnosis\*\*
  35. * 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)
  36. * Be able to provide written, informed consent in English and follow study-related instructions
  37. * Have ownership of or reliable access to a smartphone with a data plan or internet connecting capabilities
  1. * They experienced a moderate or severe TBI
  2. * 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)
  3. * 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')
  4. * They report change or discontinuation of headache prophylaxis in the past 4 weeks
  5. * They report active psychotic or bipolar symptoms
  6. * 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)

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-03
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-01-03
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Post-Traumatic Headache