Technology dRiven Enhancement to Engage & Connect

NCT06910683 — Not applicable, Not yet recruiting, 60 participants, Weill Medical College of Cornell University

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RegistryNCT06910683, acronym TREE-Connect
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment60 (Estimated)
SponsorWeill Medical College of Cornell University (Other)
ConditionsDepression
InterventionsTREE-Connect, Clinician-delivered psychotherapy (Behavioral)
Datesstart 2027-03-01 (estimated), primary completion 2029-03-01 (estimated), completion 2029-03-01 (estimated), first posted 2025-04-04, last updated 2026-03-24
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Depression All trials of TREE-Connect All trials of Clinician-delivered psychotherapy

-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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
TREE-Connect + Clinician-delivered psychotherapyExperimentalBehavioral: TREE-Connect; Behavioral: Clinician-delivered psychotherapyParticipants will receive a hybrid intervention that includes clinician-delivered psychotherapy and a TREE-Connect app
Clinician-delivered psychotherapyActive comparatorBehavioral: Clinician-delivered psychotherapyParticipants will receive clinician-delivered psychotherapy without the TREE-Connect app
  • 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

+Outcome measures

Primary outcomes

  • Acceptability (Client Satisfaction Questionnaire; CSQ) [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

+Eligibility

Sex: All, ages: 50 Years to 80 Years

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.

+Locations (1)

FacilityCityCountryStatus
Weill Cornell MedicineNew York, New YorkUnited States

+Investigators