Smartphone CBT for Depression

Overseen By Emma Wolfe, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Psychotropics

Disqualifiers: Severe substance use, Bipolar, Psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cognitive behavioral therapy (CBT), delivered through a smartphone app, can improve symptoms of major depressive disorder (MDD). Participants will either receive the app-based therapy immediately or begin after an 8-week wait. The trial targets individuals currently diagnosed with MDD who reside in the United States and have access to a mobile smartphone with a data plan. It may suit those seeking treatment options who haven't had recent medication changes or extensive prior CBT for depression. As an unphased trial, this study provides a unique opportunity for participants to explore innovative treatment options for MDD.

Will I have to stop taking my current medications?

You can continue taking your current medications as long as you have been on a stable dose for at least 2 months before joining the study and do not change your medication during the study period.

What prior data suggests that Smartphone-delivered CBT for MDD is safe?

Research has shown that using a smartphone app for cognitive behavioral therapy (CBT) to treat major depressive disorder (MDD) is generally safe and well-tolerated. In studies where participants used this app-based therapy, no serious safety issues emerged.

One study found that users could easily navigate the app and felt comfortable with it. Another study noted that while the app's full effectiveness remains somewhat unclear, it did not cause any major adverse side effects.

Overall, the research supports the safety of smartphone-delivered CBT, with no significant safety problems identified in the studies reviewed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Smartphone-delivered CBT for Major Depressive Disorder (MDD) is unique because it brings therapy right to your pocket, offering unprecedented accessibility and flexibility. Traditional treatments for depression often involve face-to-face cognitive behavioral therapy sessions or medication like SSRIs, which can require scheduling and travel. This smartphone-based approach allows users to engage in therapy at their own pace and convenience, breaking down barriers such as transportation or time constraints. Researchers are excited about this treatment because it has the potential to reach underserved populations and provide immediate support, which could significantly improve the accessibility and effectiveness of mental health care.

What evidence suggests that Smartphone-delivered CBT is effective for major depressive disorder?

Research has shown that using a smartphone app for cognitive behavioral therapy (CBT) can effectively treat major depressive disorder (MDD). Studies have found that these apps help improve symptoms of depression. In one study, 97% of participants continued using the app, and most found it easy to use. Another study demonstrated high adherence, with people regularly using the app as intended. This trial will evaluate the effectiveness of an 8-week smartphone-delivered CBT for MDD. These findings suggest that smartphone-based CBT could effectively help people with depression feel better. ^{3 4 6 7 8}

Who Is on the Research Team?

Sabine Wilhelm, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Major Depressive Disorder (MDD) who live in the US and haven't had much CBT before. They must be stable on any current meds, not have severe substance issues, or acute suicidal thoughts. Tech literacy and owning a smartphone with data are required.

Inclusion Criteria

Currently living in the United States

I have been diagnosed with major depression.

Exclusion Criteria

I have never been diagnosed with bipolar disorder or psychosis.

I am currently receiving psychological therapy.

I have attended at least 4 CBT sessions for depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weeks of Smartphone-delivered CBT for MDD

8 weeks

Waitlist Control

Participants are in a waitlist control group for 8 weeks before crossing over to treatment

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smartphone-delivered CBT for MDD

Trial Overview The study tests if using a smartphone app to do cognitive behavioral therapy (CBT) helps people with MDD feel better compared to those just waiting for treatment. It's measured by changes in depression scores after 8 weeks.

How Is the Trial Designed?

Group I: Smartphone-delivered CBT for MDD Experimental Treatment 1 Intervention

8-week Smartphone delivered CBT for MDD.

Group II: 8 Week Waitlist Control Experimental Treatment 1 Intervention

8-week waitlist control. (Note: participants will be crossed over to 8-week Smartphone-delivered CBT for MDD following the 8-week waitlist control).

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Koa Health B.V.

Industry Sponsor

Trials

6

Recruited

420+

Published Research Related to This Trial

A smartphone-based intervention (SBI) combining group psychoeducation and 14 days of app training showed high usability and engagement among participants, indicating it is user-friendly and well-received.

The pilot trial with 16 individuals suggested that the SBI effectively reduced depressive symptoms compared to a waitlist control, providing preliminary evidence for its efficacy in treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blending group-based psychoeducation with a smartphone intervention for the reduction of depressive symptoms: results of a randomized controlled pilot study. Lukas, CA., Berking, M.[2021]

The study evaluated the feasibility of two mental health apps, BackUp and mEMA, for treating depressed outpatients with suicidal ideation, involving 17 participants over a 3-month period.

Both apps were found to be usable and acceptable, scoring above the thresholds for usability and satisfaction, but the study did not meet the criteria for sufficient uptake, indicating that further exploration is needed for integrating these apps into routine mental healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of using smartphone apps as treatment components for depressed suicidal outpatients. Nuij, C., van Ballegooijen, W., de Beurs, D., et al.[2023]

A systematic review of seven studies on mobile health applications for depression found that while these apps are a promising new approach to mental health care, there is a critical need to focus on user acceptability and adherence rates to improve their effectiveness.

Most studies reviewed were conducted in developed countries, indicating a potential gap in understanding how these apps perform in diverse populations, and highlighting the need for innovative designs to enhance user engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability, Acceptability, and Adherence Rates of Mobile Application Interventions for Prevention or Treatment of Depression: A Systematic Review. Rismawan, W., Marchira, CR., Rahmat, I.[2021]

Mobile phone-based psychotherapies, including apps and text messages, are feasible and generally acceptable for treating various mental health disorders, as shown by a review of 24 studies with good retention rates.

While these interventions show potential benefits for mental health outcomes, the evidence on their effectiveness in real-world settings is still limited, particularly in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapeutic Applications of Mobile Phone-based Technologies: A Systematic Review of Current Research and Trends. Menon, V., Rajan, TM., Sarkar, S.[2022]

A review of 27 popular mental health apps for depression and anxiety revealed that while 23 apps included evidence-based therapeutic elements, many core components of effective psychotherapy, such as cognitive restructuring and problem solving, were significantly underrepresented.

Common elements like psychoeducation, relaxation, and mindfulness were present in many apps, but the lack of critical treatment strategies suggests a need for further research and randomized trials to evaluate the effectiveness of these apps in delivering comprehensive mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of popular smartphone apps for depression and anxiety: Assessing the inclusion of evidence-based content. Wasil, AR., Venturo-Conerly, KE., Shingleton, RM., et al.[2020]

A review of 55 studies on Internet and mobile-based psychoeducational interventions for depression found that most programs primarily used websites and emphasized communication tools, but less effective methods like interactive technologies were underutilized.

Higher clinician involvement in these interventions was associated with better treatment compliance, suggesting that optimizing technology features could enhance effectiveness while reducing clinician workload.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the information and communication technology features of web- and mobile-based psychoeducational interventions for depression. Zhao, D., Lustria, MLA., Hendrickse, J.[2018]

An automated text-messaging system was developed to support cognitive-behavioral therapy (CBT) for depression, focusing on enhancing homework adherence and tracking patient progress among low-income patients.

In a feasibility test with 12 participants in two CBT groups, the system achieved a 65% response rate to daily mood inquiries and received positive feedback, suggesting it could be a cost-effective tool to improve mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Messaging as an Adjunct to CBT in Low-Income Populations: A Usability and Feasibility Pilot Study. Aguilera, A., Muñoz, RF.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7904402/

Effectiveness of Smartphone-Based Cognitive Behavioral ... The objective of this review was to identify and summarize the existing evidence regarding smartphone-based cognitive behavioral therapy for patients with ...

2. nature.com nature.com/articles/s41591-025-03639-1

Cognitive behavioral therapy skills via a smartphone app ... Among those randomized, the follow-up rate was 97% at week 6 and adherence to the app was 84%. The study showed that all included CBT skills and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11808736/

Long-term outcomes of smartphone-delivered cognitive ... Research shows that smartphone-delivered cognitive behavior therapy (CBT) with coaching may be a scalable and effective treatment for BDD.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214782925000041

Long-term outcomes of smartphone-delivered cognitive ... Highlights · Efficacy of smartphone-based CBT for BDD was maintained at 1-year follow-up · 37 % of participants were in partial/full remission at 1-year follow-up.

5. mental.jmir.org mental.jmir.org/2024/1/e53998

Feasibility, Acceptability, and Preliminary Efficacy of a ... The purpose of this study was to conduct an open trial to test the feasibility, acceptability, and efficacy of the Mindset for Depression app (a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12176654/

Cognitive behavioral therapy skills via a smartphone app for ... We developed a self-help smartphone CBT app involving five representative cognitive or behavioral skills (BA, CR, PS, AT and BI) and conducted ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04594616

Waitlist-Control Trial of Smartphone CBT for Major ... 8-week Smartphone-delivered CBT for MDD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for MDD. The app-delivered CBT in ...

8. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04778-1

Treating depression with a smartphone-delivered self-help ... This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major ...