Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality

NCT05925322 | Recruiting DMC

• 2 other identifiers: 23-05026093R01MH133953
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Suicidal Ideation; Major Depressive Disorder; Depressive Disorder; Depression

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in resting state functional connectivity of the Positive Valence System

  Change in resting state fMRI connectivity of functional networks representing structures previously associated with the Positive Valence System (Dorsal anterior cingulate cortex \[dACC\], the Subgenual Anterior Cingulate Cortex \[sgACC\], and the basal forebrain/nucleus accumbens \[NAcc\]). The investigators will also test between-network connectivity between the positive valence system and the default mode-, salience-, and fronto-parietal networks. Functional connectivity within- and between-network will be measured with a correlational score of 0 to 1, with 0 being the lowest and 1 being the highest.

  Baseline, midtreatment (week 6) and post treatment (week 9)

• Change in STAR task reaction time following social feedback

  "The Social Task for Assessment of Reward" is a computerized task that measures response to social rewards. Reaction time will be measures in milliseconds.

  Baseline, midtreatment (week 6), and post treatment (week 9)

Study Arms (2)

"Engage & Connect" Psychotherapy

EXPERIMENTAL

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.

Behavioral: "Engage & Connect" Psychotherapy

Symptom Review and Psychoeducation (SRP)

ACTIVE COMPARATOR

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.

Behavioral: Symptom Review and Psychoeducation (SRP)

Interventions

Symptom Review and Psychoeducation (SRP) BEHAVIORAL

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

Symptom Review and Psychoeducation (SRP)

"Engage & Connect" Psychotherapy BEHAVIORAL

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

"Engage & Connect" Psychotherapy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Depression; Suicidal Ideation; Depressive Disorder, Major; Depressive Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior; Mood Disorders; Mental Disorders

Study Officials

• Nili Solomonov, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nili Solomonov, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 29, 2023
• Study Start: September 18, 2023
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After the investigators publish the main results, they will make de-identified data available to other researchers, under a data-sharing agreement overseen by the DSMB, and in compliance with policy of the IRB and NIMH.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. All researchers requesting data will commit to using the data solely for research purpose; secure the data; return or destroy it once analyses are completed; do not share it with other researchers.

Locations

US (1)