Digital Therapeutic for Depression After Head Injury in Current and Former US Military Personnel
Study Details
Study Description
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 |
|---|---|---|
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N/A |
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
Arms and Interventions
| 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.
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| 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
Primary Outcome Measures
- 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 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
- 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 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, 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
Secondary Outcome Measures
- 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
- 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
- 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
- Blinding Efficacy [Week 12 and Week 16, compared to Baseline]
Participant blinding questionnaire
Other Outcome Measures
- User Version of the Mobile Application Rating Scale (uMARS) [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
- Mobile Agnew Relationship Measure (mARM) Questionnaire [Week 12]
Self-report measure of therapeutic alliance with mobile health intervention
- HEXACO Personality Inventory-Revised (HEXACO-PI-R) [Baseline]
Self-report personality inventory that measures 6 dimensions of personality: honesty-humility, emotionality, eXtraversion, agreeableness (versus anger), conscientiousness, openness to experience
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be aged ≥ 18 to ≤ 65 years
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Be able to provide informed consent
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Be a current or former member of the US Military
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Diagnosed with mild TBI as defined by the Department of Veteran's Affairs and Department of Defense Clinical Practice
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Have a PHQ-9 score of ≥ 5 to 27, indicative of mild or greater depressive symptoms
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Have ownership of or reliable access to a smartphone with a data plan or internet connecting capabilities
Exclusion Criteria:
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Report of starting pharmacological or non-pharmacological treatment for depression within the 3 months prior to trial enrollment
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Report a recent change in type or dose of antidepressant medications within 12 weeks prior to trial enrollment
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Report active psychotic or bipolar symptoms
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Active plan and/or intent of suicide or homicide
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Remote Recruitment: Center for Neuroscience and Regenerative Medicine | Bethesda | Maryland | United States | 20851 |
Sponsors and Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
Investigators
- Principal Investigator: David Brody, MD, Uniformed Services University of the Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CNRM-92-10531