Technology dRiven Enhancement to Engage & Connect

Last updated: March 20, 2026
Sponsor: Weill Medical College of Cornell University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Depression

Treatment

TREE-Connect

Clinician-delivered psychotherapy

Clinical Study ID

NCT06910683
24-04027370
  • Ages 50-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 thedose in the next 10 weeks, without individual psychotherapy services during thestudy period.

Exclusion

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 disorderwithout psychotic features, generalized anxiety disorder, specific phobia, orantisocial or borderline personality disorder.

  • Neurological disorders (dementias, amnestic and multidomain Mild CognitiveImpairment, Parkinson's disease, epilepsy, etc.).

  • Acute or severe medical illness in the past 3 months (metastatic cancer, multiplesclerosis, decompensated cardiac, liver or kidney failure, major surgery, stroke ormyocardial infarction, cardiac, renal, or respiratory failure; severe chronicobstructive pulmonary disease, etc.) that may be the primary cause depressivesymptoms, influence brain systems of interest, or impact ability to participate inthe study.

  • For MRI only: Contraindications to MRI scanning including cardiac pacemaker, heartvalve replacement, vascular stent, insulin pump, cochlear implant, any othermetallic biomedical implant contraindicating to MRI, and claustrophobia.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: TREE-Connect
Phase:
Study Start date:
March 01, 2027
Estimated Completion Date:
March 31, 2029

Study 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.

Connect with a study center

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

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