Mental Health App + Remote Therapy for Depression

(TREE-Connect Trial)

Overseen By Maddy Schier, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Suicidal intent, Neurological disorders, Acute illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you either be off antidepressants or on a stable dose for at least 8 weeks before joining, and you should not plan to change the dose during the study. If you meet these conditions, you can continue your current medication.

What data supports the effectiveness of the treatment Clinician-delivered psychotherapy, TREE-Connect for depression?

Research shows that mobile phone-based psychotherapies, including apps and text messaging, are feasible and acceptable for treating mental health disorders like depression. A study on guided Internet-delivered treatment for major depression found significant improvements in depressive symptoms, suggesting that digital and remote therapy approaches can be effective. ^{1 2 3 4 5}

Is the Mental Health App + Remote Therapy for Depression safe for humans?

Research shows that digital mental health interventions, including those using smartphone apps, are generally safe for people with depression, even those with suicidal thoughts. These interventions are feasible and acceptable, with good retention rates, indicating they are safe for use in humans. ^{1 2 6 7 8}

How is the TREE-Connect treatment for depression different from other treatments?

TREE-Connect is unique because it combines a mental health app with remote therapy, offering a digital and personalized approach to managing depression. This treatment leverages technology to improve access and engagement, which is particularly beneficial for those who may not have easy access to traditional therapy. ^{1 9 10 11 12}

What is the purpose of this trial?

This study will investigate whether an intervention that includes remotely delivered therapy sessions and a digital mental health app, compared to only remotely delivered therapy reduces late-life depression

Research Team

Nili Solomonov, PhD

Principal Investigator

Weill Medical College of Cornell University

Samprit Banerjee, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for adults aged 50-80 with moderate to severe depression (PHQ-9 ≥10), a clear mental state (MMSE ≥23), and stable on antidepressants or off them. They must not be receiving other psychotherapy, have no major psychiatric diagnoses besides specific ones allowed, no recent suicidal intent, and no severe medical conditions that could affect depression or participation.

Inclusion Criteria

Significant depression, i.e., PHQ-9 ≥10 (moderate severity of symptoms)

Mini Mental Status Exam (MMSE) score equal to or greater than 23

I am between 50 and 80 years old.

Exclusion Criteria

History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, specific phobia, or antisocial or borderline personality disorder

Intent or plan to commit suicide in the near future

For MRI only: Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, insulin pump, cochlear implant, any other metallic biomedical implant contraindicating to MRI, and claustrophobia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a hybrid intervention that includes clinician-delivered psychotherapy and the TREE-Connect app, or solely clinician-delivered psychotherapy

9 weeks

Remotely delivered therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Clinician-delivered psychotherapy
• TREE-Connect

Trial Overview The study compares two approaches to treating late-life depression: one group receives therapy sessions remotely plus a digital mental health app (TREE-Connect), while the other only gets remote therapy. The goal is to see if adding the app improves outcomes.

Participant Groups

Group I: TREE-Connect + Clinician-delivered psychotherapy Experimental Treatment 2 Interventions

Participants will receive a hybrid intervention that includes clinician-delivered psychotherapy and a TREE-Connect app

Group II: Clinician-delivered psychotherapy Active Control 1 Intervention

Participants will receive clinician-delivered psychotherapy without the TREE-Connect app

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

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 14-week therapist-guided Internet-delivered program for major depression showed significant improvements in depressive symptoms among 105 patients, with effect sizes of 0.96 post-treatment and 1.21 at a 6-month follow-up.

While 48% of participants reported clinically reliable improvement, there is still a need to enhance the treatment's usability, as a significant number of patients experienced no reliable change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of guided Internet-delivered treatment for major depression in routine mental healthcare - An open study. Nordgreen, T., Blom, K., Andersson, G., et al.[2020]

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]

Patients using the online telemental health platform (Brightside) showed a significantly higher rate of improvement in depression symptoms, with nearly 80% experiencing a reduction of 5 or more points on the PHQ-9 scale, compared to 52% in the treatment as usual (TAU) group.

The average reduction in PHQ-9 scores was greater for the Brightside group (-11.5) than for the TAU group (-10.1), indicating that the telemental health approach may be more effective in managing depression symptoms in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Evaluation of Measurement-Based Psychiatric Care Delivered via Specialized Telemental Health Platform Versus Treatment As Usual: A Retrospective Analysis. Chokshi, S., Senathirajah, Y., Yadav, V., 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]

In a study involving 218 patients with moderately severe to severe depression, participation in the therapist-supported Meru Health Program led to a significant reduction in depressive symptoms, with an average decrease of 8.30 points on the PHQ-9 scale, indicating strong efficacy.

Approximately 34% of patients with moderately severe symptoms and 29.9% of those with severe symptoms showed a response to the intervention, achieving at least a 50% reduction in their PHQ-9 scores, suggesting that the program may be effective for those with more severe depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant reduction in depressive symptoms among patients with moderately-severe to severe depressive symptoms after participation in a therapist-supported, evidence-based mobile health program delivered via a smartphone app. Forman-Hoffman, VL., Nelson, BW., Ranta, K., et al.[2021]

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]

The 16-week Feel Program, a digital mental health support initiative, showed a 65% retention rate among 48 adult participants, with high user satisfaction (65% reported very high satisfaction) and significant engagement in activities designed to manage depressive and anxiety symptoms.

Results indicated that 93.5% of participants experienced a decrease in depressive or anxiety symptoms, with 51.6% showing clinically significant improvement, suggesting that higher engagement in the program correlates with better mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, engagement, and preliminary clinical outcomes of a digital biodata-driven intervention for anxiety and depression. Tsirmpas, C., Andrikopoulos, D., Fatouros, P., et al.[2022]

Digital media and electronic health systems can effectively assess and monitor both somatic and psychiatric disorders by collecting real-world data on symptoms, wellbeing, and physiological indicators over time.

For online interventions to be successful, patients require motivation and support from therapists, highlighting the need for mental health professionals to become proficient in using digital tools to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[E-Health in diagnosis and therapy of mental disorders : Will therapists soon become superfluous?] Lüttke, S., Hautzinger, M., Fuhr, K.[2019]

References

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

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

2. Brazil pubmed.ncbi.nlm.nih.gov

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

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

A roadmap to computer-based psychotherapy in the United States. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of guided Internet-delivered treatment for major depression in routine mental healthcare - An open study. [2020]

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

A Comparative Evaluation of Measurement-Based Psychiatric Care Delivered via Specialized Telemental Health Platform Versus Treatment As Usual: A Retrospective Analysis. [2022]

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. Netherlands pubmed.ncbi.nlm.nih.gov

Significant reduction in depressive symptoms among patients with moderately-severe to severe depressive symptoms after participation in a therapist-supported, evidence-based mobile health program delivered via a smartphone app. [2021]

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

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

10. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility, engagement, and preliminary clinical outcomes of a digital biodata-driven intervention for anxiety and depression. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The first 30 months of the MindSpot Clinic: Evaluation of a national e-mental health service against project objectives. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

[E-Health in diagnosis and therapy of mental disorders : Will therapists soon become superfluous?] [2019]