Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression

NCT04487730 | Completed Results DMC

• 2 other identifiers: 20-04021860K23MH123864-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Abnormalities in the Positive Valence System (PVS) are associated with depressive symptoms and reduced behavioral activation in mid- and late-life. This study will investigate the engagement of the PVS during exposure to social rewards, part of a novel streamlined psychotherapy for mid- and late-life depression. Use of computational modeling will enable identification of neuroimaging and behavioral profiles associated with greater treatment response, and may guide future personalization of psychotherapy.

Conditions

Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Resting State fMRI Connectivity of the Positive Valence System

  Calculated from fMRI scan. Validation of target engagement (resting state functional connectivity (rsFC) within the right hemisphere orbital prefrontal cortex (OFC), specifically between the lateral and medial regions of the OFC).

  Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)

Secondary Outcomes (2)

• Change in Montgomery Asberg Depression Rating Scale (MADRS)

  Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)

• Change in Behavioral Activation for Depression Scale (BADS)

  Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)

Study Arms (2)

"Engage & Connect" Psychotherapy

EXPERIMENTAL

"Engage \& Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression 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. 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

"Engage & Connect" Psychotherapy BEHAVIORAL

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

"Engage & Connect" Psychotherapy

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)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages aged 50-85 \[stratified so that 50% are older than 65\]
• Diagnosis of unipolar major depressive disorder without psychotic features, determined by the SCID
• Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 20.
• Mini Mental Status Exam (MMSE) ≤ 1 SD below the mean score for patient's age and education
• 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.
• Capacity to provide written 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 of lorazepam daily up to seven times per week.
• Neurological disorders (dementias, history of stroke, multiple sclerosis, Parkinson's disease, epilepsy, etc.); cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses that may either influence brain systems of interest or ability to participate in the study. Dr. Alexopoulos or another research psychiatrist will review any medical illnesses that does not appear in the list above and determine whether it interferes with the study of positive valence system functions in depression.
• 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

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Nili Solomonov
• Organization: Weill Cornell Medicine

nis2051@med.cornell.edu

212-746-5886

Study Officials

• Nili Solomonov, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: This is a randomized controlled trial. Participants will be randomly assigned to 9-weeks of either "Engage-S" Psychotherapy or "Symptom Review and Psychoeducation" (SRP) Psychotherapy

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 27, 2020
• Study Start: October 15, 2020
• Primary Completion: August 13, 2024
• Study Completion: August 19, 2024
• Last Updated: June 3, 2025
• Results First Posted: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After we publish the main results, we will make de-identified data available to other researchers, under a data-sharing agreement overseen by the Weill Cornell ALACRITY Center's Executive Committee.
• 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)