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

Trial Summary

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 data supports the effectiveness of the treatment Smartphone-delivered CBT for MDD?

Research shows that mobile phone-based psychotherapies, including smartphone apps, are feasible and acceptable for treating mental disorders like depression. Studies have reported benefits in mental health outcomes, indicating that these approaches can be effective, although more data is needed to confirm their effectiveness in real-world settings. ^{1 2 3 4 5}

Is smartphone-delivered CBT generally safe for treating depression?

Research shows that smartphone-based therapies for mental health, including depression, are generally safe and acceptable for users. Studies have reported good usability and acceptability, indicating that people find these treatments easy to use and satisfactory. ^{1 2 6 7 8}

How is smartphone-delivered CBT for depression different from other treatments?

Smartphone-delivered CBT (cognitive-behavioral therapy) for depression is unique because it uses mobile technology to provide therapy, making it more accessible and cost-effective for people who may not have access to traditional therapy. This approach allows individuals to receive evidence-based treatment through their smartphones, which can be particularly beneficial for those who have difficulty accessing conventional therapies. ^{3 9 10 11 12}

What is the purpose of this trial?

The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in SIGH-D scores than those in the waitlist condition at treatment endpoint (week 8).

Research Team

Sabine Wilhelm, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

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

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

Psychotherapeutic Applications of Mobile Phone-based Technologies: A Systematic Review of Current Research and Trends. [2022]

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

Use of Computer and Mobile Technologies in the Treatment of Depression. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Systematic review of the information and communication technology features of web- and mobile-based psychoeducational interventions for depression. [2018]

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

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

The feasibility of using smartphone apps as treatment components for depressed suicidal outpatients. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A review of popular smartphone apps for depression and anxiety: Assessing the inclusion of evidence-based content. [2020]

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

Practical application of digital therapeutics in people with mood disorders. [2023]

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

Smartphone applications for the treatment of depressive symptoms: A meta-analysis and qualitative review. [2020]

10. England 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. [2021]

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

Usability, Acceptability, and Adherence Rates of Mobile Application Interventions for Prevention or Treatment of Depression: A Systematic Review. [2021]

12. Italy pubmed.ncbi.nlm.nih.gov

The efficacy of smartphone-based mental health interventions for depressive symptoms: a meta-analysis of randomized controlled trials. [2022]