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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to address depression by using a mental health app called TREE-Connect alongside remote therapy sessions. Researchers aim to determine if combining the app with therapy reduces depression in older adults more effectively than therapy alone. Individuals experiencing significant depression and maintaining a steady dose of antidepressants for at least eight weeks may qualify for this study. The trial seeks to discover if this new approach can significantly impact those struggling with late-life depression. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could improve treatment options for late-life depression.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that digital mental health apps, like TREE-Connect, can enhance the effectiveness of traditional treatments for major depressive disorder. In a small study with 12 participants, the TREE-Connect app achieved a 65% response rate to daily mood check-ins and received positive feedback, suggesting users generally find the app easy to use.

While specific data on negative effects from using the TREE-Connect app is lacking, the positive response rate and feedback suggest it may be safe. Additionally, since the trial is in a "not applicable" phase, it focuses more on treatment effectiveness rather than initial safety testing. This typically indicates that the treatment has already demonstrated some level of safety in earlier tests or similar applications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TREE-Connect treatment for depression because it uniquely combines a mental health app with remote therapy. Unlike traditional therapy options that often require in-person sessions, TREE-Connect offers a hybrid approach that includes both clinician-delivered psychotherapy and a supportive app, making it more accessible and flexible for users. This method could potentially enhance patient engagement and provide continuous support outside of therapy sessions, which is not typically available in standard care like cognitive-behavioral therapy (CBT) alone. By integrating technology with human interaction, TREE-Connect aims to offer a more comprehensive and adaptable treatment for those struggling with depression.

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

Research shows that app-based tools, like the TREE-Connect app, can help reduce depression symptoms. In this trial, some participants will receive a hybrid intervention that includes both the TREE-Connect app and clinician-delivered psychotherapy. Studies have found that these digital tools can improve mood and well-being, especially when used with regular therapy. Specifically, one study found that people using similar mental health apps experienced a noticeable drop in depression symptoms. By combining a mobile app with online therapy, TREE-Connect aims to increase support and involvement for those facing depression later in life. Overall, early results are promising for using digital tools to enhance traditional therapy. ^{6 7 8 9 10}

Who Is on the Research Team?

Samprit Banerjee, PhD

Principal Investigator

Weill Medical College of Cornell University

Nili Solomonov, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. jcto.weill.cornell.edu jcto.weill.cornell.edu/open_clinical_trials/technology-driven-enhancement-to-engage-connect-tree-connect

Technology dRiven Enhancement to Engage & Connect ... This study aims to develop a hybrid intervention that combines a remote psychotherapy with a novel mobile health app (TREE-Connect).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37983028/

App-Based Interventions for Moderate to Severe Depression Data were analyzed from February 16 to March 25, 2023. Main outcomes and measures: The main outcome was changes in depression symptom ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10337403/

Protocol for the Implementation of a Patient Care Platform The first iteration of the Pathway app included patient-reported outcomes (PROs) related to depression, well-being, cognitive symptom tracking, ...

4. psychiatry.weill.cornell.edu psychiatry.weill.cornell.edu/join-our-treatment-studies

Join Our Treatment Studies This study aims to develop a hybrid intervention that combines a remote psychotherapy with a novel mobile health app (TREE-Connect). Together, this combined ...

5. jmir.org jmir.org/2025/1/e56975

Effectiveness of Digital Lifestyle Interventions on ... The primary aim of this review was to comprehensively evaluate the effectiveness of digital lifestyle interventions for improving symptoms of depression, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11786461/

Using tree-based models to identify factors contributing to trait ... Individuals with high levels of negative affect (NA) are at an increased risk of experiencing distress and negative self-views.

7. withpower.com withpower.com/trial/phase-depression-2-2026-bae31

Mental Health App + Remote Therapy for Depression · Info ... 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, ...

8. psychiatry.weill.cornell.edu psychiatry.weill.cornell.edu/research/clinical-studies

Clinical Studies | Weill Cornell Medicine Psychiatry This study aims to develop a hybrid intervention that combines a remote psychotherapy with a novel mobile health app (TREE-Connect). Together, this combined ...

9. 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 ...

10. researchgate.net researchgate.net/publication/371464401_Using_Tree-Based_Models_to_Identify_Factors_Contributing_to_Trait_Negative_Affect_in_Adults_With_and_Without_Major_Depression/download

Using Tree-Based Models to Identify Factors Contributing ... Background Individuals with high levels of negative affect (NA) are at an increased risk of experiencing distress and negative self-views.