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

Primary Purpose

Depression, Suicidal Ideation, Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"Engage & Connect" Psychotherapy
Symptom Review and Psychoeducation (SRP)
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 1 standard deviation 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, 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.

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 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2023
Last Updated
September 19, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05925322
Brief Title
Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality
Official Title
Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality: A Precision Imaging Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
September 30, 2028 (Anticipated)
Study Completion Date
September 30, 2028 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Social disconnection peaks in middle and late life and leads to an increased risk of suicide, persistent depression, and poor response to psychosocial interventions. There is a critical need to develop a mechanistic understanding of the link between social disconnection and suicidality, identify biological targets, and address targets with scalable interventions. The investigators developed a novel psychotherapy, Engage & Connect, aimed to improve functions of the Positive Valence System (PVS) that are impaired in suicidality through increased engagement in rewarding social activities. This study will use state-of-the-art precision imaging methods and clinical measures to evaluate brain- and behavioral changes in the PVS during psychotherapy. Participants will: Be randomly assigned to 9-weekly sessions of either Engage & Connect therapy or Symptom Review and Psychoeducation Complete 4 research assessments Complete 3 MRI scans

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicidal Ideation, Major Depressive Disorder, 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
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"Engage & Connect" Psychotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Symptom Review and Psychoeducation (SRP)
Arm Type
Active Comparator
Arm Description
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.
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 functional connectivity of the Positive Valence System
Description
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.
Time Frame
Baseline, midtreatment (week 6) and post treatment (week 9)
Title
Change in STAR task reaction time following social feedback
Description
"The Social Task for Assessment of Reward" is a computerized task that measures response to social rewards. Reaction time will be measures in milliseconds.
Time Frame
Baseline, midtreatment (week 6), and post treatment (week 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 1 standard deviation 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, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nili Solomonov, PhD
Phone
(914) 682-9100
Ext
1012497
Email
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
844-999-8746
Ext
718
Email
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. The investigators will also share the fMRI tasks and analytic code by request with all interested researchers.
IPD Sharing 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.
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

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

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