64 - Can A Cognitive-Behavioral Therapy Digital Therapeutic App Combat Symptoms of Depression in Service Members and Veterans with Mild Traumatic Brain Injury? A Methodological Approach.

Abstract Text: Background
Most traumatic brain injuries (TBI) are classified as mild TBI (mTBI). Between 2000 and Q1 of 2022, 377,425 mTBIs were reported (TBICoE, 2022). Although common, mTBI is difficult to detect, often undiagnosed and untreated. Besides physical symptoms like headaches, mTBI can cause sleep disturbances and depression. When left untreated symptoms can worsen overtime, disrupting the lives of service members (SMs) and veterans.

Since Cognitive Behavioral Therapy’s (CBT) inception, it has been utilized to treat depression. The VA developed the CBT-Depression manual, closely following original psychotherapy. Minor modifications make the manual specific to SMs.

Emerging technology allows CBT to be delivered without guidance from providers, leading to development of CBT smartphone applications made available to large populations. Generally, mobile interventions are well-accepted for mental health treatment (Aguilera & Muench, 2012). While findings from empirical studies are difficult to generalize due to small sample sizes, evidence gathered supports the need for larger randomized controlled trials (RCTs) (Donker et al., 2013). A systematic review found mobile applications based on CBT principles were effective in reducing depressive symptoms (Rathbone et al., 2017).

CBT is an effective treatment for post-concussive syndrome (Al Sayegh et al., 2010), and appears to have the best preliminary evidence for treating depressive symptoms following mTBI (Fann et al., 2009). A recent review noted out of 70 applications for TBI, none were based in CBT principles (Kwan et al., 2019).

Upon review, The Mobile Application to Combat Depression and Concussion (ACDC) is the first CBT mobile application being developed focused on depressive symptoms in SMs and veterans with a history of mTBI. This study aims to perform a large RCT in the field of DTx for depression post mTBI. The trial is currently IRB approved and open for enrollment, with n=14 randomized as of December 2022.

Trial Design
This is a smartphone app-based, single-blind, interventional RCT of SMs and Veterans with symptoms of depression and a history of mTBI. Unique proprietary, highly interactive, guided dissemination of CBT fundamentals will be utilized in the active app that has to date not been produced or replicated in other available applications on the market or published research.
Up to 200 participants will be randomized to the active CBT application or a comparison psychoeducational application (1:1 ratio), with an optional subsequent open-label intervention period. Participation will be completely remote. Our target population is SMs and veterans with mild, to severe depressive symptoms, as measured by the Patient Health Questionnaire – 9 (PHQ-9), and history of mTBI, confirmed by a TBI screener. A major depressive disorder diagnosis is not required.

Objectives
The primary outcome measure is the PHQ-9, to evaluate the intervention’s effectiveness. The PHQ-9 is a self-report assessment for depressive symptoms validated in military populations. Items are scored on a scale of 0 to 3, providing a summary score ranging from 0 to 27. Higher scores represent more severe depression. The PHQ-9 is also a gauge of minimal clinically significant changes for depressive symptoms (Löwe et al., 2004).

The following self-report questionnaires will be used to evaluate the intervention’s effectiveness:
The Traumatic Brain Injury Quality of Life Scale (TBI-QOL) measures multiple domains of life for those living with TBI, including physical, mental, cognitive, and social.

The PTSD Checklist for DSM-5 (PCL 5) assess symptoms of PTSD.

The Insomnia Severity Index (ISI) assesses presence and severity of primary insomnia sleep disorder and is empirically-validated in military populations.

Discussion
To our knowledge, this intervention has never been tested in SM populations. This study will enroll mTBI participants. While participants may not receive any benefits, results of the study could ensure new and adaptable future treatment modalities for SMs and veterans. RCTs with larger sample sizes will allow further development of effective interventions for SMs and veterans with depressive symptoms and a history of mTBIs and could influence future clinical standard of care.

Keywords: cognitive-behavioral therapy, digital therapeutics, depression, service members, veterans