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Behavioural Intervention

Online Cognitive Behavioral Therapy for Post-Traumatic Headache (AMMO Trial)

N/A
Waitlist Available
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be aged ≥ 18 to ≤ 70 years
Have a history of chronic PTH with specific criteria for onset and persistence
Must not have
Secondary headache better accounted for by ICHD-3 diagnosis of medication-overuse headache
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks

Summary

This trial aims to test an online program for people with migraines after head injury. The program uses cognitive behavioral therapy and is compared to standard migraine treatment. Participants will follow the program for 12 weeks

Who is the study for?
This trial is for adults who have had a traumatic brain injury (TBI) and are now experiencing post-traumatic headaches. Participants should be comfortable using an online platform for therapy.
What is being tested?
The study tests an online program called AMMO DTx, which uses cognitive behavioral therapy tailored to military service members, against a sham version of the program. It's designed to see if it can help relieve migraines caused by head injuries over 12 weeks.
What are the potential side effects?
Since this is a digital therapeutic based on cognitive behavioral therapy, there may not be direct side effects like with medication. However, participants might experience discomfort or emotional distress while engaging in the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I have a long-term history of chronic PTH.
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I have had a concussion with symptoms like memory loss or unconsciousness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My frequent headaches are due to overusing headache medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
6-Item Headache Impact Test™ (HIT-6™)
Secondary study objectives
Determine the appropriate sample size for a future full clinical trial based on preliminary estimates of effect size for outcome measures
Insomnia Severity Index (ISI)
Mobile Agnew Relationship Measure
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
This arm will receive access to an online program that will guide them through cognitive behavioral therapy program.
Group II: Sham comparatorPlacebo Group1 Intervention
Participants will obtain access to an online program with activities not including the cognitive behavioral therapy

Find a Location

Who is running the clinical trial?

Military Traumatic Brain Injury InitiativeUNKNOWN
Uniformed Services University of the Health SciencesFED
124 Previous Clinical Trials
90,653 Total Patients Enrolled
1 Trials studying Post-Traumatic Headache
300 Patients Enrolled for Post-Traumatic Headache
Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
98 Previous Clinical Trials
93,655 Total Patients Enrolled
2 Trials studying Post-Traumatic Headache
404 Patients Enrolled for Post-Traumatic Headache
~67 spots leftby Dec 2025
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