120 Participants Needed

Social Interaction Perceptions for Mental Illness

DJ
Overseen ByDaphne J Holt, MD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've had a recent change in medication.

What data supports the effectiveness of the treatment EMA for improving social interaction perceptions in mental illness?

The research suggests that addressing social isolation and loneliness is crucial for people with serious mental illness, and treatments like support groups have been effective in reducing the unmet need for friendship and social connectedness, which are important for recovery.12345

Is the treatment generally safe for humans?

Research on medications for mental health shows that while newer treatments may have fewer side effects than older ones, there are still risks of side effects like weight gain, dry mouth, and sedation. Most people report experiencing at least one side effect, and many find them distressing.678910

How does this treatment for mental illness differ from other treatments?

This treatment focuses on changing social perceptions and reducing stigma associated with mental illness, which is different from traditional treatments that often focus on managing symptoms through medication or therapy. By addressing social exclusion and stigma, it aims to improve social interactions and acceptance for individuals with mental illness.1112131415

Research Team

DJ

Daphne J Holt, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals aged 18-55 who have experienced serious mental illnesses like psychosis, schizophrenia, or mood disorders. Participants must speak English fluently and not have had any recent medication changes or acute symptoms. They can't join if they've used substances in the past 6 months, have neurological issues, MRI scan exclusions like metal implants, or severe claustrophobia.

Inclusion Criteria

I have had a psychotic or mood disorder.
I am between 18 and 55 years old.

Exclusion Criteria

I am not fluent in English.
I recently changed my medication or started having new symptoms.
Standard exclusion criteria for participation in an MRI scan (e.g., presence of metal in the body, claustrophobia, history of head trauma)
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ecological Momentary Assessment

EMA collected daily (4x/day) for two weeks to measure transient changes in social isolation and loneliness

2 weeks
Daily assessments (remote)

Longitudinal Assessment

Measure stable neural and behavioral predictors of social isolation and loneliness, and their impact on real-world functioning

6 months

Follow-up

Participants are monitored for safety and effectiveness after the main assessments

4 weeks

Treatment Details

Interventions

  • EMA
Trial OverviewThe study examines how social isolation and loneliness affect brain behavior related to social perception and motivation in people with serious mental illness. It uses EMA (Ecological Momentary Assessment) to track these experiences in real-time and their impact on daily functioning.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Ecological Momentary AssessmentExperimental Treatment1 Intervention
EMA collected daily (4x/day) for two weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Boston University

Collaborator

Trials
494
Recruited
9,998,000+

Findings from Research

In a study of 101 schizophrenia patients undergoing community rehabilitation, improvements in social functioning were significantly associated with reductions in negative symptoms as measured by the PANSS scale.
Younger age at onset of schizophrenia and improvements in overall disability (WHODAS-II score) also contributed to better social functioning, highlighting the importance of addressing negative symptoms in treatment plans.
[Negative symptoms predict the improvement of social functioning of patients with schizophrenia].He, Q., Chen, Y., Chow, SL., et al.[2018]
A survey of 267 certified peer specialists revealed that social isolation and feelings of loneliness are the most significant unmet needs for individuals with serious mental illness (SMI), affecting nearly 60% of respondents.
The study highlights the importance of addressing co-morbid health conditions and fostering hope as key intervention targets, suggesting that tackling loneliness could also help improve overall mental health outcomes.
Unmet Needs of People with Serious Mental Illness: Perspectives from Certified Peer Specialists.Fortuna, KL., Ferron, J., Pratt, SI., et al.[2020]
Ecological momentary assessment (EMA) reveals that individuals with schizophrenia often experience higher social stress and a preference for solitude, indicating unique social challenges compared to healthy individuals.
Despite reporting more positive feelings when interacting with others, the coherence between traditional assessments of social functioning and EMA-reported experiences is mixed, suggesting that EMA may provide deeper insights into the social lives of people with schizophrenia.
Ecological momentary assessment of everyday social experiences of people with schizophrenia: A systematic review.Mote, J., Fulford, D.[2021]

References

[Negative symptoms predict the improvement of social functioning of patients with schizophrenia]. [2018]
Unmet Needs of People with Serious Mental Illness: Perspectives from Certified Peer Specialists. [2020]
Ecological momentary assessment of everyday social experiences of people with schizophrenia: A systematic review. [2021]
Measuring Group Process in Nurse-Facilitated Support Groups for Psychosocial Club Members. [2020]
The Social Occupational Functioning Scale (SOFS): a brief measure of functional status in persons with schizophrenia. [2022]
Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]
The use of Enhancing Quality Use of Medication Self-Reported Questionniare (EQUIM-SRQ) among mental health consumers: a pilot study. [2015]
Development of prescribing safety indicators related to mental health disorders and medications: Modified e-Delphi study. [2021]
Assessing the burden of treatment-emergent adverse events associated with atypical antipsychotic medications. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Distress with medication side effects among persons with severe mental illness. [2007]
Stigma towards individuals with schizophrenia: Examining the effects of negative symptoms and diagnosis awareness on preference for social distance. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
The measurement properties of stigmatizing attitudes towards mental disorders: results from two community surveys. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Experiences of interpersonal interaction among patients with chronic schizophrenia: A phenomenological study. [2021]
A Pilot Study Evaluating the Stigma and Public Perception about the Causes of Depression and Schizophrenia. [2021]
15.United Statespubmed.ncbi.nlm.nih.gov
Differences in attributions of mental illness and social distance for portrayals of four mental disorders. [2020]