RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality: A Precision Imaging Trial

Quick Facts

Study Start:2023-09-18
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05925322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages aged 50-80 \[stratified so that 50% are older than 65\]
  2. * 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
  3. * Major Depressive Disorder as determined by the SCID-5
  4. * Depression Rating Scale \[Montgomery-Åsberg Depression Rating Scale (MADRS)\] score of 16 or greater.
  5. * Mini Mental Status Exam (MMSE) equal or greater than a score of 23
  6. * 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.
  7. * Capacity to provide consent for research assessment and treatment.
  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 or less of lorazepam daily up to seven times per week.
  4. * Neurological disorders (dementias, amnestic and multidomain Mild Cognitive Impairment, Parkinson's disease, epilepsy, etc.).
  5. * 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.
  6. * 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.

Contacts and Locations

Study Contact

Nili Solomonov, PhD
CONTACT
(914) 682-9100
nis2051@med.cornell.edu

Principal Investigator

Nili Solomonov, PhD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Nili Solomonov, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-18
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2023-09-18
Study Completion Date2028-09-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Depression
  • Suicidal Ideation
  • Major Depressive Disorder
  • Depressive Disorder