Psychotherapy to improve brain function and reduce suicidality in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a novel psychotherapy called Engage & Connect on brain functions related to social rewards in older adults experiencing suicidal ideation and major depressive disorder. Over a 9-week period, participants will be randomly assigned to either the Engage & Connect therapy or a control group receiving symptom review and psychoeducation. The study aims to enhance the Positive Valence System through increased engagement in rewarding social activities, while utilizing advanced imaging techniques and clinical assessments to monitor changes in brain function and behavior. The goal is to better understand the relationship between social disconnection and suicidality in mid- and late-life individuals.

Why it matters

Who can join: the full rules

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.

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Nili Solomonov, PhD — Weill Medical College of Cornell University
• Study coordinator: Nili Solomonov, PhD
• Email: nis2051@med.cornell.edu
• Phone: (914) 682-9100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.