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

Primary Purpose

Major Depressive Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

"Engage & Connect" Psychotherapy

Symptom Review and Psychoeducation (SRP)

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Late Life Depression, Psychotherapy, Mechanisms of Action, Positive Valence System, Social Reward

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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 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.

Sites / Locations

Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

"Engage & Connect" Psychotherapy

Symptom Review and Psychoeducation (SRP)

Arm Description

"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.

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.

Outcomes

Primary Outcome Measures

Change in Resting State fMRI Connectivity of the Positive Valence System

Calculated from fMRI scan. Validation of target engagement.

Secondary Outcome Measures

Change in Montgomery Asberg Depression Rating Scale (MADRS)

10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression).

Change in Behavioral Activation for Depression Scale (BADS)

25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).

Full Information

NCT ID

NCT04487730

First Posted

July 23, 2020

Last Updated

May 23, 2023

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT04487730

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 15, 2020 (Actual)

Primary Completion Date

April 1, 2025 (Anticipated)

Study Completion Date

April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

"Engage & Connect" Psychotherapy

Arm Type

Experimental

Arm Description

Arm Title

Symptom Review and Psychoeducation (SRP)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

"Engage & Connect" Psychotherapy

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Symptom Review and Psychoeducation (SRP)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Resting State fMRI Connectivity of the Positive Valence System

Description

Calculated from fMRI scan. Validation of target engagement.

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in Montgomery Asberg Depression Rating Scale (MADRS)

Description

10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression).

Time Frame

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

Title

Change in Behavioral Activation for Depression Scale (BADS)

Description

25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nili Solomonov, PhD

Phone

914-682-9100

Ext

1012497

nis2051@med.cornell.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nili Solomonov, PhD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nili Solomonov, PhD

Phone

914-682-9100

Ext

1012497

nis2051@med.cornell.edu

First Name & Middle Initial & Last Name & Degree

Nili Solomonov, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results reported in publications, after de-identification, as well as study protocol, treatment manuals, statistical analysis plan and informed consent. We will also share our fMRI tasks and analytic code by request with all interested researchers.

IPD Sharing 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.

IPD Sharing 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.

Learn more about this trial

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

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