Digital Therapeutic for Depression After Head Injury in Current and Former US Military Personnel

A Single-Blind, Randomized, Controlled Trial of a Cognitive-Behavioral Therapy Digital Therapeutic to Combat Symptoms of Depression in Service Members and Adults With a History of MildTraumatic Brain Injury

The Center for Neuroscience and Regenerative Medicine (CNRM) Clinical Trials Unit has developed the first cognitive-behavioral therapy (CBT) digital therapeutic (DTx) mobile application to counteract depressive symptoms in military service members and veterans with a history of mild traumatic brain injury (mTBI). This trial will assess the efficacy of the novel CBT-DTx for depression following mTBI compared to an educational comparison DTx.

This trial is a single-blind, randomized, controlled interventional trial of current and former military personnel with symptoms of depression and a history of mTBI. The study will be conducted remotely.

Participants randomized to active intervention will access a structured, cognitive behavioral therapy (CBT) intervention.

A mobile application that consists of psychoeducational material regarding depression and brain injury.

Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity

Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who complete all treatment modules compared to those who do not

Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity

Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who report history of depression prior to mTBI compared to those who do not

Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity

Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who report family history of depression compared to those who do no

Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity

Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores, comparison between depression severity group

Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity

Computerized adaptive test that measures post-concussive symptoms and quality of life across multiple domains

Self-report measure that assess user opinion in 4 objective quality subscales: engagement, functionality, aesthetics, information quality; 1 subjective quality subscale; and 1 scale that measures the perceived impact of the app being evaluated

Self-report personality inventory that measures 6 dimensions of personality: honesty-humility, emotionality, eXtraversion, agreeableness (versus anger), conscientiousness, openness to experience

Inclusion Criteria: Be aged ≥ 18 to ≤ 65 years Be able to provide informed consent Diagnosed with mild TBI as defined by the Department of Veteran's Affairs and Department of Defense Clinical Practice Have a PHQ-9 score of ≥ 5 to 27, indicative of mild or greater depressive symptoms Have ownership of or reliable access to a smartphone with a data plan or internet connecting capabilities While participating in this study, be able to ensure that you have access to regular care for mental health and to speak with your provider as necessary Exclusion Criteria: Report of starting pharmacological or non-pharmacological treatment for depression within the 3 months prior to trial enrollment Report a recent change in type or dose of antidepressant medications within 12 weeks prior to trial enrollment Report active psychotic or bipolar symptoms Active plan and/or intent of suicide or homicide 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

Identifier-free participant data sets will be shared with the Uniformed Services University Center for Neuroscience and Regenerative Medicine Data Repository. Identifier-free data sets may also be shared with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Repository.

After study completion, data sets will be de-identified and shared with the repositories. De-identified data sets will be stored in the repositories indefinitely.

Access to the CNRM Data Repository will be determined b the CNRM Data Quality, Access, and Publication Committee. Investigators requesting access to the data will provide a list of investigators and collaborators who will have access to the data, documentation of Ethical Conduct of Research and Human Participants Protection Training, and documentation of Institutional Review Board Approval of the research project. Access to FITBIR will follow FITBIR Access Criteria