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Behavioral Intervention
Social Reward Psychotherapy for Suicidal Thoughts
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, midtreatment (week 6) and post treatment (week 9)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new talk therapy called Engage & Connect, aimed at middle-aged and older adults who feel socially isolated. The therapy encourages enjoyable social activities to help improve mood and reduce suicidal thoughts by making people feel happier and more connected.
Who is the study for?
This trial is for individuals aged 50-80 with Major Depressive Disorder and suicidal thoughts, who have a certain level of cognitive function (MMSE score within normal range) and are either off antidepressants or on a stable dose. They must not be receiving other psychotherapy, have no plans to change medication doses, and cannot have severe medical conditions or other psychiatric diagnoses that could interfere with the study.
What is being tested?
'Engage & Connect' Psychotherapy is being tested against Symptom Review and Psychoeducation (SRP) over a 9-week period to see if it improves brain functions related to positive emotions and reduces suicidality in older adults suffering from depression.
What are the potential side effects?
Since this trial involves psychotherapy interventions rather than medications, typical drug side effects are not expected. However, participants may experience emotional discomfort discussing personal issues during therapy sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, midtreatment (week 6) and post treatment (week 9)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, midtreatment (week 6) and post treatment (week 9)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in STAR task reaction time following social feedback
Change in resting state functional connectivity of the Positive Valence System
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: "Engage & Connect" PsychotherapyExperimental Treatment1 Intervention
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.
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 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.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,913 Previous Clinical Trials
2,738,407 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,084 Previous Clinical Trials
1,138,771 Total Patients Enrolled
Nili Solomonov, PhDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
120 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been on a stable dose of antidepressants for 8 weeks and won't change it.I have a neurological disorder like dementia or Parkinson's.I am able to understand and agree to the research and treatment plan.I take 0.5 mg or less of lorazepam daily, but no other psychotropic drugs.I haven't had a severe illness or major surgery that could affect my participation in the last 3 months.I have been diagnosed with Major Depressive Disorder.My mental function test score is within the normal range for my age and education.I am between 50 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Symptom Review and Psychoeducation (SRP)
- Group 2: "Engage & Connect" Psychotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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