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NCT Number: NCT06910683

Technology dRiven Enhancement to Engage & 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

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TREE-Connect

Behavioral

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

Clinician-delivered psychotherapy

Behavioral

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

Primary outcomes

  1. Acceptability (Client Satisfaction Questionnaire; CSQ)

    Time frame: 9 Weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Delaney Callaghan, BA

CONTACT

[email protected]

1-781-999-3731

Maddy Schier, BA

CONTACT

[email protected]

1-484-354-1131

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Acronym: TREE-Connect

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Apr 4, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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