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

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status: Active, not recruiting

Conditions: Depressive Symptoms; Mild Traumatic Brain Injury

Treatments: Other: Psychoeducation Comparison; Device: CNRM DTx

Study type: Interventional

Funder types: Other

Identifiers

NCT05147506

CNRM-92-10531

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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113 participants in 2 patient groups

CBT DTx

Experimental group

Description:

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

Treatment:

Device: CNRM DTx

Psychoeducations DTx

Active Comparator group

Description:

Participants randomized to the comparison group will access an unstructured educational DTx.

Treatment:

Other: Psychoeducation Comparison