Clinical trial NCT05147506: Digital Therapeutic for Depression After Head Injury in Current and Former US Military Personnel
Official title: A Single-Blind, Randomized, Controlled Trial of a Cognitive-Behavioral Therapy Digital Therapeutic to Combat Symptoms of Depression in Service Members and Adults With a History of MildTraumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Mild Traumatic Brain Injury
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of the mean difference in Patient Health Questionnaire (PHQ-9) total score
timeFrame: Week 12 and Week 16 compared to Baseline
measure: 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
timeFrame: Week 12 compared to Baseline
measure: 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
timeFrame: Week 12 compared to Baseline
measure: 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
timeFrame: Week 12 compared to Baseline
measure: Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores, comparison between depression severity group
timeFrame: Week 12 compared to Baseline
Secondary outcomes:
measure: Change of the mean difference in Traumatic Brain Injury-Quality of Life (TBI-QOL) total score
timeFrame: Week 12 and Week 16, compared to Baseline
measure: Change of the mean difference in Posttraumatic Stress Disorder Checklist (PCL-5) total score
timeFrame: Week 12 and Week 16, compared to Baseline
measure: Change of the mean difference in Insomnia Severity Index (ISI) total score
timeFrame: Week 12 and Week 16, compared to Baseline
measure: Change in Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Week 12 and Week 16, compared to Baseline
measure: Blinding Efficacy
timeFrame: Week 12 and Week 16, compared to Baseline
Other outcomes:
measure: User Version of the Mobile Application Rating Scale (uMARS)
timeFrame: Week 12
measure: Mobile Agnew Relationship Measure (mARM) Questionnaire
timeFrame: Week 12
measure: HEXACO Personality Inventory-Revised (HEXACO-PI-R)
timeFrame: Baseline
Locations:
city: Bethesda
country: United States
facility: Remote Recruitment: Center for Neuroscience and Regenerative Medicine
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: David Brody, MD
role: PRINCIPAL_INVESTIGATOR
References: