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Engage & Connect Therapy for Depression

N/A
Recruiting
Led By Nili Solomonov, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of unipolar major depressive disorder without psychotic features, determined by the SCID
Mini Mental Status Exam (MMSE) ≤ 1 SD below the mean score for patient's age and education
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, mid-treatment (week 5) and post treatment (week 9)
Awards & highlights

Study Summary

This trial will use fMRI to study how people with depression react to social rewards, in order to help develop a more personalized form of treatment.

Who is the study for?
This trial is for individuals aged 50-85 with major depressive disorder, a MADRS score ≥ 20, and stable mental status. They must be on a steady antidepressant dose or off medication for 8 weeks and able to consent. Excluded are those with suicidal intent, other psychiatric/neurological disorders, certain medical conditions, or contraindications to MRI scanning.Check my eligibility
What is being tested?
'Engage & Connect' psychotherapy aims at activating the brain's reward system during social interactions in older adults with depression. The study will use neuroimaging and computational modeling to predict who benefits most from this therapy compared to standard Symptom Review and Psychoeducation (SRP).See study design
What are the potential side effects?
Since this trial involves psychotherapy rather than medication, side effects may include emotional discomfort or distress due to discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with major depression without psychosis.
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My mental function test score is slightly below average for my age and education.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, mid-treatment (week 5) and post treatment (week 9)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, mid-treatment (week 5) and post treatment (week 9) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Resting State fMRI Connectivity of the Positive Valence System
Secondary outcome measures
Change in Behavioral Activation for Depression Scale (BADS)
Change in Montgomery Asberg Depression Rating Scale (MADRS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: "Engage & Connect" PsychotherapyExperimental Treatment1 Intervention
"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 II: Symptom Review and Psychoeducation (SRP)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,492 Total Patients Enrolled
66 Trials studying Depression
16,338 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,067 Total Patients Enrolled
665 Trials studying Depression
251,374 Patients Enrolled for Depression
Nili Solomonov, PhDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
188 Total Patients Enrolled
2 Trials studying Depression
188 Patients Enrolled for Depression

Media Library

Engage & Connect Psychotherapy Clinical Trial Eligibility Overview. Trial Name: NCT04487730 — N/A
Depression Research Study Groups: "Engage & Connect" Psychotherapy, Symptom Review and Psychoeducation (SRP)
Depression Clinical Trial 2023: Engage & Connect Psychotherapy Highlights & Side Effects. Trial Name: NCT04487730 — N/A
Engage & Connect Psychotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04487730 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the eligibility criteria for joining this clinical experiment?

"This medical study requires sixty participants over the age of 50 and below 85 with a diagnosis of involutional psychosis. Furthermore, entrants must have an MADRS score no less than 20, be currently off antidepressants or on a stable dose for two months preceding participation and not intend to change it in the next 10 weeks, as well as present an MMSE result that falls within one standard deviation from average corresponding to their age and educational level."

Answered by AI

Are there presently any openings for volunteers to join this research project?

"According to the information on clinicaltrials.gov, this medical study is actively searching for participants with a start date of October 15th 2020 and last update occurring on May 23rd 2022."

Answered by AI

Does this research encompass participants aged 70 and above?

"This medical trial's inclusion guidelines are quite specific, requiring participants to be between the ages of 50 and 85. For those under 18 or over 65 there is an abundance of trials available with 193 and 968 trials respectively."

Answered by AI

How many individuals have registered for this research study?

"Affirmative. Clinicaltrials.gov, which was last updated on the 23rd of May 2022, indicates that this experiment is currently recruiting participants. The trial began recruitment efforts on October 15th 2020 and needs to acquire 60 volunteers from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Weill Cornell Medicine: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression
2020. "Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04487730.
All > Depression New York
~12 spots leftby Apr 2025
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