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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
113
A mobile application intervention adapted from the CBT for Depression and CBT for TBI manuals.
A mobile application that consists of psychoeducational material regarding depression and brain injury.
Remote Recruitment: Center for Neuroscience and Regenerative Medicine
Bethesda, Maryland, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 12 compared to Baseline
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
Time frame: 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
Time frame: 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
Time frame: Week 12 and Week 16, compared to Baseline
Change in Credibility and Expectancy Questionnaire (CEQ)
Self-report measure of participation expectation of benefit
Time frame: Week 12 and Week 16, compared to Baseline
Blinding Efficacy
Participant blinding questionnaire
Time frame: Week 12 and Week 16, compared to Baseline
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