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

NCT ID: NCT04487730

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2024-08-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

"Engage & Connect" Psychotherapy

"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.

Group Type: EXPERIMENTAL

"Engage & Connect" Psychotherapy

Intervention Type: BEHAVIORAL

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

Symptom Review and Psychoeducation (SRP)

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.

Group Type: ACTIVE_COMPARATOR

Symptom Review and Psychoeducation (SRP)

Intervention Type: BEHAVIORAL

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

Interventions

"Engage & Connect" Psychotherapy

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

Intervention Type: BEHAVIORAL

Symptom Review and Psychoeducation (SRP)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Ages aged 50-85 [stratified so that 50% are older than 65]

2. Diagnosis of unipolar major depressive disorder without psychotic features, determined by the SCID

3. Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 20.

4. Mini Mental Status Exam (MMSE) ≤ 1 SD below the mean score for patient's age and education

5. 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.

6. Capacity to provide written consent for research assessment and treatment.

Exclusion Criteria

1. Intent or plan to attempt suicide in the near future.

2. History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.

3. Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.

4. 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.

5. 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nili Solomonov, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23MH123864-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-04021860

Identifier Type: -

Identifier Source: org_study_id