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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depressive Symptoms; Mild Traumatic Brain Injury
• Intervention / Treatment: Device: CNRM DTx; Other: Psychoeducation Comparison

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 Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20851
      • Remote Recruitment: Center for Neuroscience and Regenerative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT DTx; Participants randomized to active intervention will access a structured, cognitive behavioral therapy (CBT) intervention.	Device: CNRM DTx; A mobile application intervention adapted from the CBT for Depression and CBT for TBI manuals.
Active Comparator: Psychoeducations DTx; Participants randomized to the comparison group will access an unstructured educational DTx.	Other: Psychoeducation Comparison; A mobile application that consists of psychoeducational material regarding depression and brain injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total score	Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity	Week 12 and Week 16 compared to Baseline
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	Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity	Week 12 compared to Baseline
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	Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity	Week 12 compared to Baseline
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	Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity	Week 12 compared to Baseline
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores, comparison between depression severity group	Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity	Week 12 compared to Baseline

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Version of the Mobile Application Rating Scale (uMARS)	Self-report measure that assess user opinion in 4 objective quality subscales: engagement, functionality, aesthetics, information quality; 1 subjective quality subscale; and 1 scale that measures the perceived impact of the app being evaluated	Week 12
Mobile Agnew Relationship Measure (mARM) Questionnaire	Self-report measure of therapeutic alliance with mobile health intervention	Week 12
HEXACO Personality Inventory-Revised (HEXACO-PI-R)	Self-report personality inventory that measures 6 dimensions of personality: honesty-humility, emotionality, eXtraversion, agreeableness (versus anger), conscientiousness, openness to experience	Baseline

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Investigators: Principal Investigator: David Brody, MD, Uniformed Services University of the Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Depression; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: CNRM-92-10531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Identifier-free participant data sets will be shared with the Uniformed Services University Center for Neuroscience and Regenerative Medicine Data Repository. Identifier-free data sets may also be shared with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Repository.
• IPD Sharing Time Frame: After study completion, data sets will be de-identified and shared with the repositories. De-identified data sets will be stored in the repositories indefinitely.

IPD Sharing Access Criteria

Access to the CNRM Data Repository will be determined b the CNRM Data Quality, Access, and Publication Committee. Investigators requesting access to the data will provide a list of investigators and collaborators who will have access to the data, documentation of Ethical Conduct of Research and Human Participants Protection Training, and documentation of Institutional Review Board Approval of the research project.

Access to FITBIR will follow FITBIR Access Criteria

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes