Recruiting
Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality
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.
ClinicalTrials.gov IDNCT05925322
PhaseNA
Enrollment128
SponsorWeill Medical College of Cornell University
Age50 Years
SexALL
Conditions studied
Depression, Suicidal Ideation, Major Depressive Disorder, Depressive Disorder
About this study
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.
Interventions
- Behavioral: "Engage & Connect" Psychotherapy — 9-weeks of weekly psychotherapy sessions focused on social reward exposure
- Behavioral: Symptom Review and Psychoeducation (SRP) — 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
Primary outcomes
- Change in resting state functional connectivity of the Positive Valence System (Baseline, midtreatment (week 6) and post treatment (week 9))
- Change in STAR task reaction time following social feedback (Baseline, midtreatment (week 6), and post treatment (week 9))
Eligibility information
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 locations
- Weill Cornell Medicine, New York, New York 10065 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.