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

Not Applicable

Active, not recruiting

• Conditions: Mild Traumatic Brain Injury; Depressive Symptoms
• Interventions: Device: CNRM DTx; Other: Psychoeducation Comparison

• Registration Number: NCT05147506
• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-07
• Study Start: 2022-06-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-10-30
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT DTx	CNRM DTx	Participants randomized to active intervention will access a structured, cognitive behavioral therapy (CBT) intervention.
Psychoeducations DTx	Psychoeducation Comparison	Participants randomized to the comparison group will access an unstructured educational DTx.

Primary Outcome Measures

Name	Time	Method
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	Week 12 compared to Baseline	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	Week 12 compared to Baseline	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 score	Week 12 and Week 16 compared to Baseline	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	Week 12 compared to Baseline	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	Week 12 compared to Baseline	Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity

Secondary Outcome Measures

Name	Time	Method
Change of the mean difference in Insomnia Severity Index (ISI) total score	Week 12 and Week 16, compared to Baseline	Self-report measure of insomnia severity; range 0-28; higher score indicates greater severity
Change in Credibility and Expectancy Questionnaire (CEQ)	Week 12 and Week 16, compared to Baseline	Self-report measure of participation expectation of benefit
Change of the mean difference in Posttraumatic Stress Disorder Checklist (PCL-5) total score	Week 12 and Week 16, compared to Baseline	Self-report measure of PTSD severity; range 0-80; higher score indicates greater severity
Blinding Efficacy	Week 12 and Week 16, compared to Baseline	Participant blinding questionnaire
Change of the mean difference in Traumatic Brain Injury-Quality of Life (TBI-QOL) total score	Week 12 and Week 16, compared to Baseline	Computerized adaptive test that measures post-concussive symptoms and quality of life across multiple domains

Trial Locations

Locations (1)

Remote Recruitment: Center for Neuroscience and Regenerative Medicine; 🇺🇸 Bethesda, Maryland, United States