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

NCT06669780 | Active Not Recruiting FDA Device

• 1 other identifier: AMMO-TBI-2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 6-Item Headache Impact Test™ (HIT-6™)

  The HIT-6™ is a brief standardized headache screening tool and questionnaire, derived from the original 54-item Headache Impact Test. It has been found to have good psychometric properties in assessing headache impact among patients in clinical practice and research (Bjorner, Kosinski, \& Ware, 2003; Kosinski et al., 2003).

  16 weeks

Secondary Outcomes (8)

• Determine the appropriate sample size for a future full clinical trial based on preliminary estimates of effect size for outcome measures

  12 weeks

• Post Traumatic Stress Disorder Checklist (DSM-5)

  16 weeks

• Traumatic Brain Injury Quality of Life Scale (TBI-QOL)

  16 weeks

• Patient Health Questionnaire-9

  16 weeks

• Insomnia Severity Index (ISI)

  16 weeks

Study Arms (2)

Active

EXPERIMENTAL

This arm will receive access to an online program that will guide them through cognitive behavioral therapy program.

Device: AMMO PTH DTx

Sham comparator

SHAM COMPARATOR

Participants will obtain access to an online program with activities not including the cognitive behavioral therapy

Device: AMMO SHAM

Interventions

AMMO PTH DTx DEVICE

An online cognitive behavioral therapy program accessed through a online program.

Active

AMMO SHAM DEVICE

Online activities not including CBT in the AMMO online program.

Sham comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

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)

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

100% Remote Recruitment: Center for Neurscience and Regenerative Medicine

Bethesda, Maryland, 20817, United States

Location

Related Publications (10)

• Berry K, Salter A, Morris R, James S, Bucci S. Assessing Therapeutic Alliance in the Context of mHealth Interventions for Mental Health Problems: Development of the Mobile Agnew Relationship Measure (mARM) Questionnaire. J Med Internet Res. 2018 Apr 19;20(4):e90. doi: 10.2196/jmir.8252.

  PMID: 29674307 BACKGROUND

• Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.

  PMID: 27287964 BACKGROUND

• Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

  PMID: 21532953 BACKGROUND

• Jenkins MM, Colvonen PJ, Norman SB, Afari N, Allard CB, Drummond SP. Prevalence and Mental Health Correlates of Insomnia in First-Encounter Veterans with and without Military Sexual Trauma. Sleep. 2015 Oct 1;38(10):1547-54. doi: 10.5665/sleep.5044.

  PMID: 26085301 BACKGROUND

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• Tulsky DS, Kisala PA, Victorson D, Carlozzi N, Bushnik T, Sherer M, Choi SW, Heinemann AW, Chiaravalloti N, Sander AM, Englander J, Hanks R, Kolakowsky-Hayner S, Roth E, Gershon R, Rosenthal M, Cella D. TBI-QOL: Development and Calibration of Item Banks to Measure Patient Reported Outcomes Following Traumatic Brain Injury. J Head Trauma Rehabil. 2016 Jan-Feb;31(1):40-51. doi: 10.1097/HTR.0000000000000131.

  PMID: 25931184 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

  PMID: 26606250 BACKGROUND

• Kosinski M, Bjorner JB, Ware JE Jr, Batenhorst A, Cady RK. The responsiveness of headache impact scales scored using 'classical' and 'modern' psychometric methods: a re-analysis of three clinical trials. Qual Life Res. 2003 Dec;12(8):903-12. doi: 10.1023/a:1026111029376.

  PMID: 14651411 BACKGROUND

• Bjorner JB, Kosinski M, Ware JE Jr. Using item response theory to calibrate the Headache Impact Test (HIT) to the metric of traditional headache scales. Qual Life Res. 2003 Dec;12(8):981-1002. doi: 10.1023/a:1026123400242.

  PMID: 14651417 BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: November 1, 2024
• Study Start: January 3, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-01

Locations

US (1)