What this study is
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
What's being tested
- TREE-Connect
Intervention · BEHAVIORAL
TREE-Connect is a mental health app that aims to increase engagement in rewarding activities
- Clinician-delivered psychotherapy
Intervention · BEHAVIORAL
Clinician-delivered psychotherapy is delivered remotely and aimed to increase engagement in rewarding activities
Study details
- Sponsor
- Weill Medical College of Cornell University
- Conditions
- Depression
- Enrolling
- 60 people
- Starts
- 2027-03
- Est. completion
- 2029-03
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWeill Cornell Medicine
New York, New York, United States
- Nili Solomonov, PhD · Contact212-746-5886nis2051@med.cornell.edu
Study team
Sponsor
Weill Medical College of Cornell University
Study ID 24-04027370
Principal investigator
Nili Solomonov, PhD
Weill Medical College of Cornell University
Principal investigator
Samprit Banerjee, PhD
Weill Medical College of Cornell University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.