Overview
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.
Description
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.
Eligibility
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