What side effects are associated with this type of intervention?

Common treatments for concussion include cognitive and physical rest, symptom management, and cognitive-behavioral therapy (CBT). CBT, particularly when delivered via digital therapeutics (DTx), is generally well-tolerated but may cause mild side effects such as increased anxiety or emotional discomfort during therapy sessions. Other treatments like medications for symptom relief (e.g., acetaminophen or ibuprofen) can have side effects such as gastrointestinal issues or allergic reactions. Prolonged use of medications to mask symptoms is discouraged due to potential dependency and masking of underlying issues.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of concussion. The management of concussion primarily involves physical and cognitive rest, followed by a gradual return to activity. However, there has been progress in the development of digital therapeutics for related conditions. For instance, the FDA has permitted the marketing of a game-based digital therapeutic to improve attention function in children with ADHD, which is somewhat analogous to the CBT-DTx being studied for depression following mild traumatic brain injury. This indicates a growing interest in digital therapeutic approaches for cognitive and neuropsychiatric symptoms post-injury.

What other types of research exist?

Promising novel alternatives to CBT-DTx for concussion patients in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing depressive relapses and improving mood. 2) Transcranial Direct Current Stimulation (tDCS), which has been effective in enhancing neurocognition and treating depression. 3) Cranial Electrotherapy Stimulation (CES), which has demonstrated safety and efficacy in treating depression. These neuromodulation techniques offer non-invasive options that could complement or serve as alternatives to digital CBT for managing concussion symptoms.

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Behavioural Intervention

Digital Therapeutic for Depression After Traumatic Brain Injury

N/A

Waitlist Available

Led By David Brody, MD

Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be aged ≥ 18 to ≤ 65 years

Diagnosed with mild TBI as defined by the Department of Veteran's Affairs and Department of Defense Clinical Practice

Must not have

Report active psychotic or bipolar symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 and week 16 compared to baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a mobile app designed to help military service members and veterans with mild traumatic brain injury reduce their depression. The app helps users change negative thoughts and behaviors to improve their mood. This type of therapy has been shown to be effective for various mental health issues, including depression, and can be delivered through different methods such as mobile apps.

Who is the study for?

This trial is for current and former US military personnel aged 18-65 who have had a mild traumatic brain injury (mTBI) and are experiencing mild to moderate depression. Participants must own or have access to a smartphone with internet, be able to consent, and maintain regular mental health care. Those on new depression treatments or with recent medication changes, psychotic/bipolar symptoms, safety concerns, or active suicidal/homicidal plans cannot join.

What is being tested?

The study is testing a mobile app that uses cognitive-behavioral therapy (CBT) designed for those with mTBI-related depression against an educational app. The goal is to see if the CBT-based digital therapeutic can help reduce depressive symptoms more effectively than just receiving psychoeducational content.

What are the potential side effects?

Since this trial involves digital therapeutics via an app rather than medication, traditional side effects like you'd expect from drugs aren't applicable. However, users may experience discomfort or emotional distress when engaging in psychological therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Select...

I have been diagnosed with a mild traumatic brain injury according to VA and DoD standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am experiencing symptoms of psychosis or bipolar disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of the mean difference in Patient Health Questionnaire (PHQ-9) total score

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

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

+2 more

Secondary study objectives

Blinding Efficacy

Change in Credibility and Expectancy Questionnaire (CEQ)

Change of the mean difference in Insomnia Severity Index (ISI) total score

+2 more

Other study objectives

HEXACO Personality Inventory-Revised (HEXACO-PI-R)

Mobile Agnew Relationship Measure (mARM) Questionnaire

User Version of the Mobile Application Rating Scale (uMARS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CBT DTxExperimental Treatment1 Intervention

Participants randomized to active intervention will access a structured, cognitive behavioral therapy (CBT) intervention.

Group II: Psychoeducations DTxActive Control1 Intervention

Participants randomized to the comparison group will access an unstructured educational DTx.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for concussion include cognitive and physical rest, which help reduce metabolic demands on the brain, allowing it to heal. Cognitive-behavioral therapy (CBT), particularly when delivered via digital therapeutics (CBT-DTx), targets maladaptive thoughts and behaviors that can exacerbate post-concussion symptoms such as depression and anxiety. By providing structured, accessible mental health support, CBT-DTx can help patients manage their symptoms more effectively, promoting better overall recovery. This approach is crucial as it addresses both the psychological and physiological aspects of concussion, facilitating a more comprehensive healing process.

Multi-Disciplinary Management of Athletes with Post-Concussion Syndrome: An Evolving Pathophysiological Approach.Treatment Perspectives Based on Our Current Understanding of Concussion.In search of evidence-based treatment for concussion: characteristics of current clinical trials.