NCT06910683

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
24mo left

Started Mar 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 18, 2025

Last Update Submit

March 20, 2026

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

TREE-Connect + Clinician-delivered psychotherapy

EXPERIMENTAL

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

Behavioral: TREE-ConnectBehavioral: Clinician-delivered psychotherapy

Clinician-delivered psychotherapy

ACTIVE COMPARATOR

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

Behavioral: Clinician-delivered psychotherapy

Interventions

TREE-ConnectBEHAVIORAL

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

TREE-Connect + Clinician-delivered psychotherapy
Clinician-delivered psychotherapyBEHAVIORAL

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

Clinician-delivered psychotherapyTREE-Connect + Clinician-delivered psychotherapy

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Nili Solomonov, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Samprit Banerjee, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Delaney Callaghan, BA

CONTACT

1-781-999-3731dec4018@med.cornell.edu

Maddy Schier, BA

CONTACT

1-484-354-1131mas4019@med.cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

April 4, 2025

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Relevant de-identified data as well as study protocol, treatment manuals, statistical analysis plan and informed consent.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Available to researchers upon reasonable request
Access Criteria
Available to researchers upon reasonable request

Locations

US(1)