Digital Therapeutic for Depression After Head Injury in Current and Former US Military Personnel

Depressive Symptoms Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05147506
• Other study ID #: CNRM-92-10531
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2024
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: January 1, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Depression
• Depressive Symptoms
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• CNRM DTx
A mobile application intervention adapted from the CBT for Depression and CBT for TBI manuals.

Other:
• Psychoeducation Comparison
A mobile application that consists of psychoeducational material regarding depression and brain injury.

Locations

Country	Name	City	State
United States	Remote Recruitment: Center for Neuroscience and Regenerative Medicine	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User Version of the Mobile Application Rating Scale (uMARS)	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	Week 12
Other	Mobile Agnew Relationship Measure (mARM) Questionnaire	Self-report measure of therapeutic alliance with mobile health intervention	Week 12
Other	HEXACO Personality Inventory-Revised (HEXACO-PI-R)	Self-report personality inventory that measures 6 dimensions of personality: honesty-humility, emotionality, eXtraversion, agreeableness (versus anger), conscientiousness, openness to experience	Baseline
Primary	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	Week 12 and Week 16 compared to Baseline
Primary	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	Week 12 compared to Baseline
Primary	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	Week 12 compared to Baseline
Primary	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	Week 12 compared to Baseline
Primary	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	Week 12 compared to Baseline
Secondary	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	Week 12 and Week 16, compared to Baseline
Secondary	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	Week 12 and Week 16, compared to Baseline
Secondary	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	Week 12 and Week 16, compared to Baseline
Secondary	Change in Credibility and Expectancy Questionnaire (CEQ)	Self-report measure of participation expectation of benefit	Week 12 and Week 16, compared to Baseline
Secondary	Blinding Efficacy	Participant blinding questionnaire	Week 12 and Week 16, compared to Baseline