Technology dRiven Enhancement to Engage & Connect (TREE-Connect)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: TREE-Connect; Behavioral: Clinician-delivered psychotherapy

Detailed Description

Depression in mid- and late-life is characterized with reduced functions of the reward system. The investigators designed a psychotherapy that aims to improve reward functions through engagement in pleasurable activities and in turn reduce depression. Prior work has shown that this therapy is acceptable and reduces depression. This study examines whether a hybrid intervention that combines clinician remotely-delivered psychotherapy, and a novel app named TREE-Connect, reduces late life depression. This TREE-Connect app uses a machine learning algorithm to promote adherence to therapy (completion of therapeutic homework) in late-life depression and increase cost-effectiveness and reach of treatment to older adults. This randomized controlled trials will test whether the hybrid intervention (clinician-delivered psychotherapy + app), compared to a condition that includes solely clinician-delivered therapy is acceptable and reduces late-life depression.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Delaney Callaghan, BA; Phone Number: 1-781-999-3731; Email: dec4018@med.cornell.edu
• Study Contact Backup: Name: Maddy Schier, BA; Phone Number: 1-484-354-1131; Email: mas4019@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
      • Contact: Nili Solomonov, PhD; Phone Number: 212-746-5886; Email: nis2051@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 50-80
• Capacity to provide consent for research assessment and treatment.
• Significant depression, i.e., PHQ-9 ≥ 7 (mild-moderate severity of symptoms)
• Mini Mental Status Exam (MMSE) equal or greater than a score of 23.
• Off antidepressants or on stable dose for 8 weeks and do not intend to change the dose in the next 10 weeks, without individual psychotherapy services during the study period.

Exclusion Criteria:

• Intent or plan to commit suicide in the near future.
• Inability to communicate in English.
• 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.
• Neurological disorders (dementias, amnestic and multidomain Mild Cognitive Impairment, Parkinson's disease, epilepsy, etc.).
• Acute or severe medical illness in the past 3 months (metastatic cancer, multiple sclerosis, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction, cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease, etc.) that may be the primary cause depressive symptoms, influence brain systems of interest, or impact ability to participate in the study.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TREE-Connect + Clinician-delivered psychotherapy; Participants will receive a hybrid intervention that includes clinician-delivered psychotherapy and a TREE-Connect app	Behavioral: TREE-Connect; TREE-Connect is a mental health app that aims to increase engagement in rewarding activities; Behavioral: Clinician-delivered psychotherapy; Clinician-delivered psychotherapy is delivered remotely and aimed to increase engagement in rewarding activities
Active Comparator: Clinician-delivered psychotherapy; Participants will receive clinician-delivered psychotherapy without the TREE-Connect app	Behavioral: Clinician-delivered psychotherapy; Clinician-delivered psychotherapy is delivered remotely and aimed to increase engagement in rewarding activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability (Client Satisfaction Questionnaire; CSQ)	Acceptability will measured using the Client Satisfaction Questionnaire (CSQ) with a benchmar score of >=3 (out of 4; average score); Range: 0 to 4, with higher scores indicating greater acceptability	9 Weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Nili Solomonov, PhD, Weill Medical College of Cornell University; Principal Investigator: Samprit Banerjee, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: 24-04027370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Relevant de-identified data as well as study protocol, treatment manuals, statistical analysis plan and informed consent.
• IPD Sharing Time Frame: Available to researchers upon reasonable request
• IPD Sharing Access Criteria: Available to researchers upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No