NCT05147506

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Depressive Symptoms
• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	CNRM DTx	A mobile application intervention adapted from the CBT for Depression and CBT for TBI manuals.
OTHER	Psychoeducation Comparison	A mobile application that consists of psychoeducational material regarding depression and brain injury.

Timeline

• Start date: 2022-06-22
• Primary completion: 2024-10-30
• Completion: 2025-01-01
• First posted: 2021-12-07
• Last updated: 2024-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study