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Trial record 1 of 7 for:    David Brody
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Digital Therapeutic for Depression After Head Injury in Current and Former US Military Personnel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05147506
Recruitment Status : Recruiting
First Posted : December 7, 2021
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Mild Traumatic Brain Injury Device: CNRM DTx Other: Psychoeducation Comparison Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single-Blind, Randomized, Controlled Trial of a Cognitive-Behavioral Therapy Digital Therapeutic to Combat Symptoms of Depression in Service Members and Veterans With a History of Mild Traumatic Brain Injury
Actual Study Start Date : June 22, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change of the mean difference in Patient Health Questionnaire (PHQ-9) total score [ Time Frame: Week 12 and Week 16 compared to Baseline ]
    Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity

  2. 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 [ Time Frame: Week 12 compared to Baseline ]
    Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity

  3. 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 [ Time Frame: Week 12 compared to Baseline ]
    Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity

  4. 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 [ Time Frame: Week 12 compared to Baseline ]
    Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity

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


Secondary Outcome Measures :
  1. Change of the mean difference in Traumatic Brain Injury-Quality of Life (TBI-QOL) total score [ Time Frame: Week 12 and Week 16, compared to Baseline ]
    Computerized adaptive test that measures post-concussive symptoms and quality of life across multiple domains

  2. Change of the mean difference in Posttraumatic Stress Disorder Checklist (PCL-5) total score [ Time Frame: Week 12 and Week 16, compared to Baseline ]
    Self-report measure of PTSD severity; range 0-80; higher score indicates greater severity

  3. Change of the mean difference in Insomnia Severity Index (ISI) total score [ Time Frame: Week 12 and Week 16, compared to Baseline ]
    Self-report measure of insomnia severity; range 0-28; higher score indicates greater severity

  4. Change in Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: Week 12 and Week 16, compared to Baseline ]
    Self-report measure of participation expectation of benefit

  5. Blinding Efficacy [ Time Frame: Week 12 and Week 16, compared to Baseline ]
    Participant blinding questionnaire


Other Outcome Measures:
  1. User Version of the Mobile Application Rating Scale (uMARS) [ Time Frame: Week 12 ]
    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

  2. Mobile Agnew Relationship Measure (mARM) Questionnaire [ Time Frame: Week 12 ]
    Self-report measure of therapeutic alliance with mobile health intervention

  3. HEXACO Personality Inventory-Revised (HEXACO-PI-R) [ Time Frame: Baseline ]
    Self-report personality inventory that measures 6 dimensions of personality: honesty-humility, emotionality, eXtraversion, agreeableness (versus anger), conscientiousness, openness to experience


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be aged ≥ 18 to ≤ 65 years
  • Be able to provide informed consent
  • Be a current or former member of the US Military
  • 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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05147506


Contacts
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Contact: Olivia Shaw 301-461-4322 CNRM-D@usuhs.edu
Contact: Noushin Mannan 301-456-5474 CNRM-D@usuhs.edu

Locations
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United States, Maryland
Remote Recruitment: Center for Neuroscience and Regenerative Medicine Recruiting
Bethesda, Maryland, United States, 20851
Contact: Noushin Mannan    301-461-4322    CNRM-D@usuhs.edu   
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Investigators
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Principal Investigator: David Brody, MD Uniformed Services University of the Health Sciences
More Information
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Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT05147506    
Other Study ID Numbers: CNRM-92-10531
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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
URL: http://fitbir.nih.gov/content/access-data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Depression
Behavioral Symptoms
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating