RECRUITING

Social Disconnection Study

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Conditions

Social Disconnectionlonelinessisolation

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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 purpose of this research study is to examine the effect of social connectedness on the brain. Study procedures include one Magnetic Resonance Imaging (MRI) or functional Magnetic Resonance Imaging (fMRI) scan, one Positron Emission Tomography (PET) scan, one Magnetic Resonance Spectroscopy (MRS) scan, an electroencephalogram (EEG), and in-person and phone call follow-ups.

Official Title

Role of Synaptic Density in Mediating the Relation Between Social Disconnection and Late-life Suicide Risk

Quick Facts

Study Start:2023-05-08
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06705348

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:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * able to give written informed consent
  2. * age 55+
  3. * English speaking
  1. * contraindication to MRI scanning including claustrophobia, high girth, moderate to significant white matter atrophy, and presence of ferromagnetic material in the body, including orthodontic braces or other non MR-compatible foreign bodies. All participants will be screened for metal objects by the same methods used for routine clinical MRI scanning
  2. * for women: pregnancy or breastfeeding
  3. * serious medical or neurological illness that in the opinion of the PI would interfere with the scientific goals of the study or participant safety
  4. * pervasive developmental disorders (PDD) or primary psychotic disorders
  5. * meet DSM-5 criteria for current severe substance use disorder (except marijuana or nicotine)
  6. * head injury that led to significant long term decline in cognitive abilities as seen by decline in grades or work performance
  7. * current psychosis, active significant suicidal (score of 6 on MADRS suicide item) or homicidal ideation
  8. * lifetime history of neurologic abnormality including seizure disorder, cerebrovascular, or neoplastic lesion, neurodegenerative disorder, or significant head trauma resulting in post-traumatic amnesia \>24 hours
  9. * full scale IQ lower than 70
  10. * contraindications to PET (e.g. poor venous access for placement of venous lines)
  11. * history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year
  12. * history of a bleeding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto) \*for subjects obtaining arterial line.
  13. * blood donation within 8 weeks of the start of the study
  14. * REM sleep disorder
  15. * brain injury (TBI, seizure/epilepsy, stroke, TIA) in lifetime (self-report and medical chart review)
  16. * electroconvulsive or ketamine therapy, or similar therapies that have rapid effects on brain neurochemistry within the past 6 months
  17. * high risk for stroke (above first quartile on Framingham Stroke Risk Profile)
  18. * current cancer

Contacts and Locations

Study Contact

Sarah Boster, MA
CONTACT
203-737-7066
Sarah.debonee@yale.edu
Nicole DellaGioia, MA
CONTACT
203-737-6884
nicole.dellagioia@yale.edu

Principal Investigator

Irina Esterlis, Ph.D.
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale Translational Brain Imaging Program
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

  • Irina Esterlis, Ph.D., PRINCIPAL_INVESTIGATOR, Yale 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 Date2023-05-08
Study Completion Date2028-02

Study Record Updates

Study Start Date2023-05-08
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

  • loneliness
  • social disconnection
  • isolation

Additional Relevant MeSH Terms

  • Social Disconnection