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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
An online cognitive behavioral therapy program accessed through a online program.
Online activities not including CBT in the AMMO online program.
100% Remote Recruitment: Center for Neurscience and Regenerative Medicine
Bethesda, Maryland, United States
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).
Time frame: 16 weeks
Determine the appropriate sample size for a future full clinical trial based on preliminary estimates of effect size for outcome measures
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.
Time frame: 12 weeks
Post Traumatic Stress Disorder Checklist (DSM-5)
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.
Time frame: 16 weeks
Traumatic Brain Injury Quality of Life Scale (TBI-QOL)
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.
Time frame: 16 weeks
Patient Health Questionnaire-9
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.
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Time frame: 16 weeks
Insomnia Severity Index (ISI)
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).
Time frame: 16 weeks
User Version of the Mobile Application Rating Scale
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.
Time frame: 12 weeks
Mobile Agnew Relationship Measure
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.
Time frame: 12 weeks
User Program Feedback Questionnaire
Brief questionnaire utilizing Likert Scales related to gathering user feedback on personal experience with ease and accessibility of app utilization.
Time frame: 12 weeks