Digital App Therapy for Depression

Overseen By Aarthi Padmanabhan, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Big Health Inc.

Disqualifiers: Psychotherapy, Psychotropic changes, Suicide, Bipolar, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital therapeutic app designed to help manage Major Depressive Disorder (MDD) in teens and adults. Researchers aim to determine if this app is effective and safe compared to a regular app. Suitable participants have a primary diagnosis of MDD, access to a smartphone, and regular internet access. They must also be under the care of a licensed healthcare provider in the U.S. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mental health care.

Do I have to stop taking my current medications for the trial?

The trial does not specify that you must stop taking your current medications, but you cannot change your prescribed psychotropic medication or its dose within 30 days before the trial or during the study period.

What prior data suggests that this digital app therapy is safe for treating depression?

Research has shown that digital mental health apps can help manage depression, but their safety varies. One study found that these apps reduced symptoms in people with moderate to severe depression. However, another study noted that some apps might increase the risk of depression for certain users. A review of various mobile health tools suggests they generally help reduce depression symptoms.

While these findings are encouraging, the safety of digital treatments can differ from person to person. It is important to consult a healthcare provider before starting any new treatment, even if it is digital. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this digital app therapy for depression because it offers a new way to deliver treatment directly through a mobile app. Unlike traditional treatments like medication or face-to-face therapy sessions, this app provides a self-guided, accessible option that people can use anytime and anywhere. This could be a game-changer for individuals who find it challenging to access in-person therapy due to time, cost, or geographical barriers. Additionally, the intervention app promises a more personalized approach to managing depression, potentially increasing engagement and effectiveness.

What evidence suggests that this trial's digital apps could be effective for depression?

Research has shown that digital apps can help treat major depressive disorder. A review of 13 studies with 1,470 participants found that app-based treatments noticeably improve depression symptoms. This trial will compare two different apps: the Intervention app, a digitally-delivered self-guided intervention for depression, and the Control app, which serves as an app-based control condition. These apps are designed to be self-guided, making them easy for many people to use. Early findings suggest that using such an app can reduce depression symptoms over time. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adolescents and adults with Major Depressive Disorder who are fluent in English, have access to a compatible device with internet, and are under the care of a U.S.-based healthcare provider. It's not for those with bipolar disorder, severe substance use disorder in the past year, recent changes in psychotropic meds or psychotherapy, or suicidal behavior recently.

Inclusion Criteria

Under the care of a United States (U.S.)-based licensed healthcare provider and willing and able to provide contact information for the provider and sign a HIPAA release that allows investigator to contact provider

I have been diagnosed with Major Depressive Disorder.

I am 13 years old or older.

Exclusion Criteria

I have not changed my mental health medication or its dose in the last 30 days.

You have had thoughts or actions of hurting yourself in the past year.

Previously participated in user testing or a clinical study at Limbix Health Inc. or Big Health Inc. (such as the STAND study or Rise study), or have used a Limbix app

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a self-guided digital therapeutic app for depression for 5 weeks

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Control app
• Intervention app

Trial Overview The study tests a self-guided digital therapeutic app designed to help manage depression against a control app. Participants will use their own devices to interact with the apps while researchers monitor safety and effectiveness.

How Is the Trial Designed?

Group I: Intervention app Experimental Treatment 1 Intervention

Digitally-delivered self-guided intervention for depression accessed via mobile app

Group II: Control app Active Control 1 Intervention

An app based control condition

Who Is Running the Clinical Trial?

Big Health Inc.

Lead Sponsor

Trials

12

Recruited

139,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A systematic review of mobile health apps for depression found that 74% of the evaluated apps had acceptable quality, with 32% scoring 4.0 or higher on the Mobile Application Rating Scale (MARS), indicating their potential effectiveness.

These high-quality apps can enhance patient self-management and treatment engagement, suggesting they may be valuable tools for individuals with depression who face barriers to traditional treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Commercially Available Mobile Apps for Depression Self-Management. Myers, A., Chesebrough, L., Hu, R., et al.[2022]

In a study involving 301 participants, digital mental health interventions (DMHIs) for depression were found to be safe for individuals with suicidal ideation, as their suicidal thoughts decreased over the 8-week intervention period.

Importantly, the presence of suicidal ideation at the start of the study did not reduce the effectiveness of the depression treatment, indicating that DMHIs can perform well in high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Safety of a General Digital Mental Health Intervention to Effect Symptom Reduction among Individuals with and without Suicidal Ideation: A Secondary Analysis. Meyerhoff, J., Kruzan, KP., Kim, KA., et al.[2023]

The prevalence of depression is high, affecting about 20% of Americans, and access to effective treatments like cognitive behavioral therapy (CBT) is limited, especially for underrepresented groups.

The Entertain Me Well (EMW) platform offers an innovative, engaging online CBT program that tailors content to specific populations, such as rural church members and dialysis patients, aiming to improve treatment accessibility and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Entertain Me Well: An Entertaining, Tailorable, Online Platform Delivering CBT for Depression. Weaver, A., Zhang, A., Xiang, X., et al.[2023]

Digital interventions for depression have a significant medium effect size (g = .52) compared to control conditions, based on a systematic review of 83 studies involving 15,530 participants.

Interventions with human therapeutic guidance are more effective (g = .63) than self-help interventions (g = .34), and there is no significant difference in outcomes between digital interventions and traditional face-to-face therapy, suggesting that digital options can be a viable alternative for treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital interventions for the treatment of depression: A meta-analytic review. Moshe, I., Terhorst, Y., Philippi, P., et al.[2021]

A study involving 235 participants showed that the app-based intervention ImproveYourMood+ significantly reduced depressive symptoms and negative automatic thoughts over a 3-week period, with effects lasting up to one month after the intervention.

The most effective features of the app included mood monitoring, content delivery, and just-in-time prompts, indicating that comprehensive, multi-modal approaches may enhance user experience and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the features of an app-based just-in-time intervention for depression. Everitt, N., Broadbent, J., Richardson, B., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12079407/

The evolving field of digital mental health: current evidence ... New meta‐analytic evidence suggests that apps may enhance the efficacy of conventional treatments for major depressive disorder. A systematic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10660171/

App-Based Interventions for Moderate to Severe Depression This systematic review and meta-analysis of 13 randomized clinical trials of app interventions with 1470 participants found a significant medium effect size ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165032724016793

Digital mental health interventions for the treatment of ... Our study provides robust evidence for the effectiveness of digital interventions for depression while highlighting important factors associated with treatment ...

4. mhealth.jmir.org mhealth.jmir.org/2020/7/e15418/

Effectiveness of a Mobile App Intervention for Anxiety and ... We found preliminary evidence that the Feel Stress Free app reduced depression and anxiety symptoms after 6 weeks. At secondary time points, we ...

5. nature.com nature.com/articles/s44184-024-00086-7

Evaluating a mobile app's effects on depression and ... This study evaluated the feasibility, acceptability, and preliminary effectiveness of a mobile application designed to address these symptoms in individuals ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8075488/

Evaluating Commercially Available Mobile Apps for ... In one study of 96 individuals with severe symptoms of depression and anxiety, participants reported a reduction in depressive symptoms by 50% after the mHealth ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725005373

Exploring digital health tools for depression management ... The aim of this study is to assess the efficacy of digital health tools for the management of depression within primary care.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2812076

App-Based Interventions for Moderate to Severe Depression A fixed-effects meta-analysis showed that mobile app interventions were associated with significantly reduced depressive symptoms, with a medium ...

9. mental.jmir.org mental.jmir.org/2023/1/e46877

Efficacy, Safety, and Evaluation Criteria of mHealth ... This review suggests that mHealth interventions can be effective in reducing depressive symptoms, with hybrid interventions achieving the best results.