Depressive Symptoms, Mild Traumatic Brain Injury
Conditions
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.
Interventions
DEVICECNRM DTx
A mobile application intervention adapted from the CBT for Depression and CBT for TBI manuals.
OTHERPsychoeducation Comparison
A mobile application that consists of psychoeducational material regarding depression and brain injury.
Sponsors
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| Blinding Efficacy | Week 12 and Week 16, compared to Baseline | Participant blinding questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Mobile Agnew Relationship Measure (mARM) Questionnaire | Week 12 | Self-report measure of therapeutic alliance with mobile health intervention |
Countries
United States
Outcome results
None listed