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

248 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will examine the efficacy and safety of a self-guided digital therapeutic app for the adjunct treatment of Major Depressive Disorder compared to a control app in adolescents and adults.

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 data supports the effectiveness of this treatment for depression?

Research shows that digital interventions, including smartphone apps, can effectively reduce depression symptoms. A large study found that digital treatments had a medium effect size in improving depression, especially when guided by a therapist. Additionally, app-based interventions with features like mood monitoring and just-in-time prompts have shown promise in decreasing depressive symptoms. ^{1 2 3 4 5}

Is the digital app therapy for depression safe for humans?

Research suggests that digital mental health interventions, including apps for depression, can be safe for users, even those with suicidal thoughts. A study found that these interventions did not worsen symptoms and were generally safe for people with depression. ^{2 5 6 7 8}

How does the digital app therapy for depression differ from other treatments?

This digital app therapy is unique because it delivers interventions 'just-in-time' through a smartphone app, responding to acute negative mood states with micro-interventions and mood monitoring. Unlike traditional therapies, it offers immediate, personalized support and can be accessed anytime, making it more flexible and accessible for users. ^{2 3 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Smartphone Apps in Patients With Depressive Disorders: A Systematic Review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Digital interventions for the treatment of depression: A meta-analytic review. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Exploring the features of an app-based just-in-time intervention for depression. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Behavioral and cognitive intervention strategies delivered via coached apps for depression: Pilot trial. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

Smartphone-assisted online brief cognitive behavioral therapy to treat maternal depression: findings of a randomized controlled trial. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of Treatment Descriptions and Alignment With Clinical Guidance of Apps for Depression on App Stores: Systematic Search and Content Analysis. [2023]

7. England 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. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Utilization of Patient-Generated Data Collected Through Mobile Devices: Insights From a Survey on Attitudes Toward Mobile Self-Monitoring and Self-Management Apps for Depression. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Entertain Me Well: An Entertaining, Tailorable, Online Platform Delivering CBT for Depression. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluating Commercially Available Mobile Apps for Depression Self-Management. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Participants' and Nurses' Experiences With a Digital Intervention for Patients With Depressive Symptoms and Comorbid Hypertension or Diabetes in Peru: Qualitative Post-Randomized Controlled Trial Study. [2022]