Clinical trial NCT06910683: Technology dRiven Enhancement to Engage & Connect
Official title: Technology dRiven Enhancement to Engage & Connect
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability (Client Satisfaction Questionnaire; CSQ)
timeFrame: 9 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nili Solomonov, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Samprit Banerjee, PhD
role: PRINCIPAL_INVESTIGATOR
References: