Technology dRiven Enhancement to Engage & Connect (TREE-Connect)

Weill Cornell Medicine (WCM)

Status: Begins enrollment this month

Conditions: Depression

Treatments: Behavioral: Clinician-delivered psychotherapy; Behavioral: TREE-Connect

Study type: Interventional

Funder types: Other

Identifiers

NCT06910683

24-04027370

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

TREE-Connect + Clinician-delivered psychotherapy

Experimental group

Description:

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

Treatment:

Behavioral: TREE-Connect

Behavioral: Clinician-delivered psychotherapy

Clinician-delivered psychotherapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Clinician-delivered psychotherapy