E-CBT DTx for Post Traumatic Headaches in Adults with History of TBI
- Conditions
- Post-Traumatic Headache
- Registration Number
- NCT06669780
- Lead Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- 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.
- Detailed Description
The AMMO digital therapeutic (DTx) will be a novel intervention for PTH following concussive TBI, therefore this project is a pilot trial designed to test this new treatment. This pilot is a single-blind, randomized, controlled, interventional trial of current and former military personnel along with civilians with a history of concussive TBI and current PTH. The pilot trial will be conducted via online portal accessible by smartphone, tablet, or computer with remote interaction between participants and study staff. The pilot trial will include up to 100 participants randomized to either the active intervention or a comparison condition at a 1:1 ratio, and will provide preliminary data to determine the sample size of a future full clinical trial. Participants will complete a 12 week intervention period followed by a follow-up assessment 4 weeks after intervention is complete. Participants randomized to the comparison group will be provided access to the open label after end of 16 week follow-up.
In addition, updates to the DTx to improve usability and acceptability will be made if necessary based on feedback from the pilot trial, then applied to the final DTx used in a future, larger, clinical trial.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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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;
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After 30 minutes an initial GCS score of 13-15; and
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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;
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Regaining of consciousness following the injury to the head; or
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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)
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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)
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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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 6-Item Headache Impact Test™ (HIT-6™) 16 weeks 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).
- Secondary Outcome Measures
Name Time Method Determine the appropriate sample size for a future full clinical trial based on preliminary estimates of effect size for outcome measures 12 weeks Use of Headache Impact Test and number of headache days per month to compare arms. This data will identify any changes to sample size in future studies.
Post Traumatic Stress Disorder Checklist (DSM-5) 16 weeks The PCL-5 is a self-report questionnaire designed to assess symptoms of PTSD (Blevins, Weathers, Davis, Witte, \& Domino, 2015). The PCL-5 takes approximately 5-10 minutes to complete.
Traumatic Brain Injury Quality of Life Scale (TBI-QOL) 16 weeks The TBI-QOL is a self-report questionnaire composed of 22 item banks (Tulsky et al., 2016). It was developed to measure multiple domains of life for patients living with TBI, including physical, mental, cognitive, and social. The TBI-QOL takes approximately 30 minutes to complete.
Patient Health Questionnaire-9 16 weeks The PHQ-9 is a self-report assessment for depressive symptoms (Kroenke, Spitzer, \& Williams, 2001). Each item is scored on a scale of 0 to 3 providing a summary score that ranges from 0 to 27, with higher scores representing more severe depression. On the PHQ-9 a total score \<5 is considered minimal depression, and scores of 5 to 9, 10 to 14, 15 to 19, and 20 to 27 are considered mild, moderate, moderately severe, and severe depression, respectively.
Insomnia Severity Index (ISI) 16 weeks The ISI is a self-report questionnaire designed to assess the presence and severity of primary insomnia sleep disorder and is empirically-validated in general and military populations (Bastien et al., 2001; Jenkins et al., 2015; Morin, Belleville, Belanger, \& Ivers, 2011).
User Version of the Mobile Application Rating Scale 12 weeks Adapted from the Mobile Application Rating Scale (MARS), the uMARS is a 26-item self-report questionnaire designed to assess the quality, functionality, and aesthetics of a mobile application and its information (Stoyanov, Hides, Kavanagh, \& Wilson, 2016). There is an additional open-text question for further comments on the users' opinions of the application. The uMARS takes approximately 15 minutes to complete. This measure will be optional for participants to complete.
Mobile Agnew Relationship Measure 12 weeks The mARM is an adaptation of a valid and reliable assessment of therapeutic alliance in face-to-face therapy (Berry, Salter, Morris, James, \& Bucci, 2018). The 25-item questionnaire has been adjusted for use with digital health interventions, specifically for mental health. The mARM takes approximately 5 minutes to complete.
User Program Feedback Questionnaire 12 weeks Brief questionnaire utilizing Likert Scales related to gathering user feedback on personal experience with ease and accessibility of app utilization.
Trial Locations
- Locations (1)
100% Remote Recruitment: Center for Neurscience and Regenerative Medicine
🇺🇸Bethesda, Maryland, United States