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

NCT05147506 | Active Not Recruiting FDA Device

• 1 other identifier: CNRM-92-10531
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Change of the mean difference in Traumatic Brain Injury-Quality of Life (TBI-QOL) total score

  Week 12 and Week 16, compared to Baseline

• Change of the mean difference in Posttraumatic Stress Disorder Checklist (PCL-5) total score

  Week 12 and Week 16, compared to Baseline

• Change of the mean difference in Insomnia Severity Index (ISI) total score

  Week 12 and Week 16, compared to Baseline

• Change in Credibility and Expectancy Questionnaire (CEQ)

  Week 12 and Week 16, compared to Baseline

• Blinding Efficacy

  Week 12 and Week 16, compared to Baseline

Other Outcomes (3)

• User Version of the Mobile Application Rating Scale (uMARS)

  Week 12

• Mobile Agnew Relationship Measure (mARM) Questionnaire

  Week 12

• HEXACO Personality Inventory-Revised (HEXACO-PI-R)

  Baseline

Study Arms (2)

CBT DTx

EXPERIMENTAL

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

Device: CNRM DTx

Psychoeducations DTx

ACTIVE COMPARATOR

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

Other: Psychoeducation Comparison

Interventions

CNRM DTx DEVICE

A mobile application intervention adapted from the CBT for Depression and CBT for TBI manuals.

CBT DTx

Psychoeducation Comparison OTHER

A mobile application that consists of psychoeducational material regarding depression and brain injury.

Psychoeducations DTx

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead

Study Sites (1)

Remote Recruitment: Center for Neuroscience and Regenerative Medicine

Bethesda, Maryland, 20851, United States

Location

MeSH Terms

Conditions

Depression; Brain Concussion

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• David Brody, MD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: December 7, 2021
• Study Start: June 22, 2022
• Primary Completion: October 30, 2024
• Study Completion: January 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• 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.
• 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

Locations

US (1)