Health TrialsbyHealthPanel

Neurobehavioral Mechanisms of Social Isolation and Loneliness in Serious Mental Illness

ConditionsPsychosisSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-55 years old

Experienced a psychotic disorder or mood disorder

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • EMA

    Behavioral

    Participants will complete surveys about their feelings and social habits through a smartphone app (EMA)

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Ecological Momentary AssessmentOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 months
2

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

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

Time frame
6 months
3

Psychosocial functioning

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

Time frame
6 months
4

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Boston University

Collaborator

Source ClinicalTrials.gov
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