Digital Therapeutic for Depression After Traumatic Brain Injury

Overseen By Olivia Shaw

Age: 18+

Sex: Any

Trial Phase: Academic

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

Must not be taking: Antidepressants

Disqualifiers: Psychotic, Bipolar, Suicide, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new mobile app, CNRM DTx, designed to ease depression symptoms using cognitive-behavioral therapy (CBT) for military service members and veterans who have experienced a mild traumatic brain injury (mTBI). The trial will compare this CBT-based app with another app that offers educational content. Ideal participants are those diagnosed with mild TBI, who have experienced depressive symptoms like sadness or lack of interest, and can regularly use a smartphone. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mental health support for others in similar situations.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you should not have started new treatments for depression or changed your antidepressant dose in the 3 months before joining. It's best to discuss your current medications with the trial team.

What prior data suggests that this digital therapeutic is safe for treating depression after traumatic brain injury?

Research shows that digital tools for mental health, such as the CBT-DTx being studied, can assist individuals with traumatic brain injuries (TBI). A review of studies supports that these digital tools can enhance thinking skills in TBI patients, indicating they are generally safe and well-tolerated.

Other research has successfully used digital therapy programs for similar conditions, like post-trauma headaches, without major safety issues. Although this specific digital therapy is new for treating depression after a mild TBI, similar therapies have shown positive results without serious side effects.

As this is an early-stage trial, detailed safety information might not yet be available. However, the absence of major negative reports from similar treatments suggests this digital therapy is expected to be safe. For those considering joining the trial, existing research indicates a good safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CNRM DTx for treating depression after a traumatic brain injury because it offers a digital approach to cognitive behavioral therapy (CBT), which is structured and easily accessible. Unlike standard medications and traditional in-person therapy sessions, this digital therapeutic provides flexibility and convenience, allowing users to engage with the treatment at their own pace and from any location. Additionally, the Psychoeducation DTx arm offers a unique, unstructured educational experience that serves as an active comparator, helping to determine the effectiveness of digital CBT. This innovative approach could potentially broaden access to effective mental health care and personalize treatment for individuals with specific needs.

What evidence suggests that this trial's digital therapeutics could be effective for depression after traumatic brain injury?

Research has shown that digital tools can enhance thinking and memory in people with traumatic brain injury (TBI). A study that combined results from multiple research papers supports using these digital tools to boost mental function in TBI patients. Participants in this trial may receive the CNRM digital therapy, which is based on cognitive-behavioral therapy (CBT) and has been successfully adapted to help people with TBI manage depression. Case studies indicate that CBT can reduce depression symptoms in those with a history of TBI. This evidence suggests that the CNRM digital therapy might effectively manage depression after a mild traumatic brain injury. ^{1 2 3 4 6}

Who Is on the Research Team?

David Brody, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

You have a score of 5 or higher on the PHQ-9 test, which shows that you have mild or more severe signs of depression.

Be able to provide informed consent

Exclusion Criteria

I started treatment for depression in the last 3 months.

I have changed my antidepressant type or dose in the last 12 weeks.

I am experiencing symptoms of psychosis or bipolar disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a cognitive-behavioral therapy digital therapeutic or an educational digital therapeutic

12 weeks

Remote participation

Follow-up

Participants are monitored for changes in depression severity and other outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CNRM DTx
• Psychoeducation Comparison

Trial Overview 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.

How Is the Trial Designed?

Group I: CBT DTx Experimental Treatment 1 Intervention

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

Group II: Psychoeducations DTx Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05147506

Digital Therapeutic for Depression After Head Injury in ... This trial will assess the efficacy of the novel CBT-DTx for depression following mTBI compared to an educational comparison DTx. Detailed Description. This ...

2. my.nami.org my.nami.org/NAMI/media/NAMI-Media/Research/mtbi2acdc_flyer1.pdf

Updated DTx Flyers (MTBI2 and CNRM) A possible benefit is reduced depressive symptoms, but there is no guarantee you will benefit from this study. Time Commitment: 30 min - 1 hr per week for 16 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12537419/

The effectiveness of digital cognitive intervention in patients ... This meta-analysis supports the efficacy of digital cognitive intervention in improving cognitive function in TBI patients. We recommend ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06669780?term=AREA%5BConditionSearch%5D(%22Post-Traumatic%20Headache%22)&rank=2

e-CBT DTx for Post Traumatic Headaches in Adults With ... The AMMO digital therapeutic (DTx) study will provide an online based program for participants with migraines after head injury to follow for 12 weeks.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12331015/

Adapting Cognitive Behavioral Therapy for Depression ... This case study describes a cognitive-behavioral treatment for depression adapted for individuals with traumatic brain injury (CBT-TBI) and provides a case ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32394786/

Treatment of Depression after Traumatic Brain Injury ... These results provide evidence of a beneficial effect of antidepressant use on incidence of outcomes associated with poorer recovery from TBI.