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

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ClinicalTrials.gov Identifier: NCT04487730
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : April 12, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: "Engage & Connect" Psychotherapy Behavioral: Symptom Review and Psychoeducation (SRP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: "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.
Behavioral: "Engage & Connect" Psychotherapy
9-weeks of weekly psychotherapy sessions focused on social reward exposure

Active Comparator: 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.
Behavioral: Symptom Review and Psychoeducation (SRP)
9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging




Primary Outcome Measures :
  1. Change in Resting State fMRI Connectivity of the Positive Valence System [ Time Frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) ]
    Calculated from fMRI scan. Validation of target engagement.


Secondary Outcome Measures :
  1. Change in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) ]
    10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression).

  2. Change in Behavioral Activation for Depression Scale (BADS) [ Time Frame: Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) ]
    25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487730


Contacts
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Contact: Nili Solomonov, PhD 914-682-9100 ext 1012497 nis2051@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Nili Solomonov, PhD    914-682-9100 ext 1012497    nis2051@med.cornell.edu   
Principal Investigator: Nili Solomonov, PhD         
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Nili Solomonov, PhD Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04487730    
Other Study ID Numbers: 20-04021860
K23MH123864-01 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Late Life Depression
Psychotherapy
Mechanisms of Action
Positive Valence System
Social Reward
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders