Psychotherapy to improve brain function and reduce suicidality in older adults
Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality: A Precision Imaging Trial
This study is testing a new therapy called Engage & Connect to see if it can help older adults with depression and suicidal thoughts by improving their brain function and encouraging social connections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05925322 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50-80 with major depressive disorder and suicidal ideation.
Not a fit: Patients with an immediate intent or plan to attempt suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce suicidality and improve mental health outcomes for older adults.
How similar studies have performed: Other studies have shown promise in using psychotherapy to address suicidality, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.