Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT04940663

Conditions

Psychosis

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

EMA

Study Details

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.

Conditions

Psychosis

Schizophrenia

Study ID

NCT04940663

Start date

Jul 13, 2022

Status verified date

Jul, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 18-55 years old
2. Experienced a psychotic disorder or mood disorder

Exclusion Criteria:

1. Any neurological disorder or current substance use disorder (during the past 6 months)
2. Not proficient in English
3. A recent change in medication, or an acute symptom presentation
4. Standard exclusion criteria for participation in an MRI scan (e.g., presence of metal in the body, claustrophobia, a history of head trauma).

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Ecological Momentary Assessment

EMA collected daily (4x/day) for two weeks

Interventions

EMA

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

Primary outcome measure

  • Trait level social isolation and loneliness [ Time Frame: 6 months ]
  • Characterize within-person, dynamic changes in objective isolation and loneliness [ Time Frame: 6 months ]
  • Psychosocial functioning [ Time Frame: 6 months ]
  • Physical health and cardiometabolic/immunological panel [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Daphne J Holt, MD, PhD

617-726-7618dholt@partners.org

Locations

Massachusetts General Hospital

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Daphne J Holt, MD, PhD

617-726-7618dholt@mgh.harvard.edu

Nicole DeTore, PhD

617-726-2065ndetore@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-16.