Neurobehavioral Mechanisms of Social Isolation and Loneliness in Serious Mental Illness
1 other identifier
interventional
120
1 country
1
Brief Summary
The proposed research will test the hypothesis that objective social isolation and loneliness are linked to neurobehavioral mechanisms involved in social perception and motivation in individuals with and without serious mental illness. Moreover, it will investigate the specific dynamic interactions among these experiences in daily life and how they, and their neurobehavioral predictors, are linked to day-to-day functioning. The findings of this project could provide novel targets for therapeutics aimed at improving functioning and overall quality of life in individuals with serious mental illnesses, as well as quantitative phenotypes for use in early detection efforts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedStudy Start
First participant enrolled
July 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
October 19, 2023
October 1, 2023
3.9 years
June 18, 2021
October 17, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Trait level social isolation and loneliness
UCLA Loneliness Scale(20 and 4 item), Social Network Index, Social Anhedonia Scale, Penn facial affect recognition Task, Social Disconnectedness Scale, Social Provisions Scale
6 months
Characterize within-person, dynamic changes in objective isolation and loneliness
EMA questions derived from the UCLA Loneliness Scales, perceived discrimination scale
6 months
Psychosocial functioning
Quality of Life Scale, Cornblatt Global Functioning - Social and Role Scales
6 months
Physical health and cardiometabolic/immunological panel
Height, weight, waist circumference, systolic and diastolic blood pressure, blood oxygen level, heart rate, interleukin-6, TNF-alpha, Complete metabolic panel, lipid panel, C-reactive protein, Cortisol, CBC, HbA1c
6 months
Study Arms (1)
Ecological Momentary Assessment
OTHEREMA collected daily (4x/day) for two weeks
Interventions
Participants will complete surveys about their feelings and social habits through a smartphone app (EMA)
Eligibility Criteria
You may qualify if:
- years old
- Experienced a psychotic disorder or mood disorder
You may not qualify if:
- Any neurological disorder or current substance use disorder (during the past 6 months)
- Not proficient in English
- A recent change in medication, or an acute symptom presentation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Boston Universitycollaborator
Study Sites (1)
Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daphne J Holt, MD, PhD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
June 18, 2021
First Posted
June 25, 2021
Study Start
July 13, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
October 19, 2023
Record last verified: 2023-10