Recruiting

Social Reward Psychotherapy

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05925322

Conditions

Depression

Suicidal Ideation

Major Depressive Disorder

Depressive Disorder

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

"Engage & Connect" Psychotherapy

Symptom Review and Psychoeducation (SRP)

Study Details

Brief summary:

The investigators hypothesized that during the 9-week course of Engage \& Connect treatment there will be an increase in brain functions of the Positive Valence System which in turn will lead to reduction in suicidality.

Conditions

Depression

Suicidal Ideation

Major Depressive Disorder

Depressive Disorder

Study ID

NCT05925322

Start date

Sep 18, 2023

Status verified date

Mar, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages aged 50-80 \[stratified so that 50% are older than 65\]
  • Endorsement of Suicidal Ideation \[Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID-5) Suicide Item (Item 9) with a score of 2
  • Major Depressive Disorder as determined by the SCID-5
  • Depression Rating Scale \[Montgomery-Åsberg Depression Rating Scale (MADRS)\] score of 16 or greater.
  • Mini Mental Status Exam (MMSE) equal or greater than a score of 23
  • Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks, without individual psychotherapy services during the study period.
  • Capacity to provide consent for research assessment and treatment.

Exclusion Criteria:

  • Intent or plan to attempt suicide in the near future.
  • History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.
  • Use of psychotropic drugs or cholinesterase inhibitors other than use of 0.5 mg or less of lorazepam daily up to seven times per week.
  • 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.
  • 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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: "Engage & Connect" Psychotherapy

Engage \& Connect is a remotely-delivered psychotherapy, aimed to increase engagement in rewarding social activities and in turn, reduce suicidality. In Engage \& Connect, depressed middle-aged and older adults with suicidal ideation work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.

active comparator: Symptom Review and Psychoeducation (SRP)

In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression and aging processes. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.

Interventions

"Engage & Connect" Psychotherapy

9-weeks of weekly psychotherapy sessions focused on social reward exposure

Symptom Review and Psychoeducation (SRP)

9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging

Primary outcome measure

  • Change in resting state functional connectivity of the Positive Valence System [ Time Frame: Baseline, midtreatment (week 6) and post treatment (week 9) ]
  • Change in STAR task reaction time following social feedback [ Time Frame: Baseline, midtreatment (week 6), and post treatment (week 9) ]

Central Contacts and Locations

Central contacts

Nili Solomonov, PhD

(914) 682-9100nis2051@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Nili Solomonov, PhD

844-999-8746nis2051@med.cornell.edu

Principal Investigator:

Nili Solomonov, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Late Life Depression
  • Psychotherapy
  • Mechanisms of Action
  • Positive Valence System
  • Social Reward

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-03-27.