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

NCT05147506 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2024-06-13

No results posted yet for this study

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.

Conditions

  • Depressive Symptoms
  • Mild Traumatic Brain Injury

Interventions

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.

Sponsors & Collaborators

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Principal Investigators

  • David Brody, MD · Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2024-10-30
Completion
2025-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05147506 on ClinicalTrials.gov