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Clinical Trials/NCT04940663
NCT04940663
Recruiting
Not Applicable

Neurobehavioral Mechanisms of Social Isolation and Loneliness in Serious Mental Illness

Massachusetts General Hospital1 site in 1 country120 target enrollmentJuly 13, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychosis
Sponsor
Massachusetts General Hospital
Enrollment
120
Locations
1
Primary Endpoint
Psychosocial functioning
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Detailed Description

Some of the most debilitating and harmful aspects of serious mental illnesses (SMI) are the 1) social isolation (low numbers of social contacts) and 2) the subjective experiences of social disconnection (loneliness) that frequently accompany these conditions. Social isolation and loneliness greatly impact day-to-day functioning and are associated with poor cardiometabolic health and early mortality in SMI, and currently there are no available treatments that can prevent or reverse these devastating consequences of having these illnesses. This may be in part because the neural and psychological mechanisms underlying social isolation and loneliness in SMI, and how they impact functioning and health outcomes, are poorly understood. However, recent clues from studies employing advanced neuroimaging and digital assessments have formed the basis of a novel approach to investigating such mechanisms, outlined in this proposal. Prior work has indicated that objective isolation and loneliness are correlated but also somewhat independent. Recent neuroimaging findings support this model, revealing that social isolation and loneliness have both shared and distinct neural correlates. However, it is also clear that these are not static phenomena; smartphone-based assessments have revealed transient, dynamic changes in social isolation and loneliness. Individual differences in the anticipation of rejection are associated with momentary experiences of loneliness, greater avoidance and subsequent increases in social isolation. Thus, in the current application, we propose to comprehensively measure both the relatively stable neural and behavioral predictors of social isolation and loneliness, as well as the moment-to-moment changes in these experiences, in 60 individuals with SMI and 60 control subjects. In Aim 1 of the proposed project, we will show that the higher levels of social isolation and loneliness in SMI are linked to shared and distinct neural responses to social stimuli, with deficient responses of social perception-related circuitry (medial temporal lobe regions) linked to social isolation, and deficient responses of reward-related circuitry (basal ganglia regions) linked to loneliness. In Aim 2, we will measure transient changes in social isolation and loneliness with smartphone assessments using a longitudinal "burst" design. Lastly, in Aim 3, we will determine how the quantitative markers of social isolation and loneliness identified in Aims 1 and 2 predict indices of real-world functioning, measuring the stability of these associations over time. Thus, in this project, we will show that fundamental neural and behavioral processes drive momentary variation in the experience of social isolation and loneliness, and directly impact functioning in SMI. In follow-up work, these findings can be used as objective targets in studies of novel interventions which aim to address these major causes of disability.

Registry
clinicaltrials.gov
Start Date
July 13, 2022
End Date
June 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daphne Holt

Associate Professor of Psychiatry

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • 18-55 years old
  • Experienced a psychotic disorder or mood disorder

Exclusion Criteria

  • 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
  • Standard exclusion criteria for participation in an MRI scan (e.g., presence of metal in the body, claustrophobia, a history of head trauma).

Outcomes

Primary Outcomes

Psychosocial functioning

Time Frame: 6 months

Quality of Life Scale, Cornblatt Global Functioning - Social and Role Scales

Trait level social isolation and loneliness

Time Frame: 6 months

UCLA Loneliness Scale(20 and 4 item), Social Network Index, Social Anhedonia Scale, Penn facial affect recognition Task, Social Disconnectedness Scale, Social Provisions Scale

Characterize within-person, dynamic changes in objective isolation and loneliness

Time Frame: 6 months

EMA questions derived from the UCLA Loneliness Scales, perceived discrimination scale

Physical health and cardiometabolic/immunological panel

Time Frame: 6 months

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

Study Sites (1)

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