Technology dRiven Enhancement to Engage & Connect

NCT ID: NCT06910683

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2028-03-31

Brief Summary

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

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TREE-Connect + Clinician-delivered psychotherapy

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

Group Type: EXPERIMENTAL

TREE-Connect

Intervention Type: BEHAVIORAL

TREE-Connect is a mental health app that aims to increase engagement in rewarding activities

Clinician-delivered psychotherapy

Intervention Type: BEHAVIORAL

Clinician-delivered psychotherapy is delivered remotely and aimed to increase engagement in rewarding activities

Clinician-delivered psychotherapy

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

Group Type: ACTIVE_COMPARATOR

Clinician-delivered psychotherapy

Intervention Type: BEHAVIORAL

Clinician-delivered psychotherapy is delivered remotely and aimed to increase engagement in rewarding activities

Interventions

TREE-Connect

TREE-Connect is a mental health app that aims to increase engagement in rewarding activities

Intervention Type: BEHAVIORAL

Clinician-delivered psychotherapy

Clinician-delivered psychotherapy is delivered remotely and aimed to increase engagement in rewarding activities

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults aged 50-80
• Capacity to provide consent for research assessment and treatment.
• Significant depression, i.e., PHQ-9 ≥10 (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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nili Solomonov, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Samprit Banerjee, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Central Contacts

Delaney Callaghan, BA

Role: CONTACT

dec4018@med.cornell.edu

1-781-999-3731

Maddy Schier, BA

Role: CONTACT

mas4019@med.cornell.edu

1-484-354-1131

Facility Contacts

Nili Solomonov, PhD

Role: primary

nis2051@med.cornell.edu

212-746-5886

Other Identifiers

24-04027370

Identifier Type: -

Identifier Source: org_study_id