Social Interaction Perceptions for Mental Illness

Overseen By Daphne J Holt, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Neurological disorder, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

Research Team

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)

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 Overview The 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

Group I: Ecological Momentary Assessment Experimental Treatment 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ecological momentary assessment of everyday social experiences of people with schizophrenia: A systematic review. Mote, J., Fulford, D.[2021]

Nurse-facilitated support groups for patients with serious mental illness (SMI) effectively promote social connectedness, with participation increasing over time and two-thirds of participants reporting satisfaction with the groups.

The intervention significantly reduced the perception of unmet needs for friendship among participants, highlighting its potential as a low-cost psychosocial strategy to aid recovery in individuals with SMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Group Process in Nurse-Facilitated Support Groups for Psychosocial Club Members. Getty, C., Perese, EF., Wooldridge, P.[2020]

The Social Occupational Functioning Scale (SOFS) was developed as a quick and effective tool to measure social functioning in individuals with schizophrenia, which is crucial for their community living and overall outcomes.

The SOFS demonstrated strong reliability and validity, with a three-factor structure that includes adaptive living skills, social appropriateness, and interpersonal skills, explaining 59% of the variance in scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Social Occupational Functioning Scale (SOFS): a brief measure of functional status in persons with schizophrenia. Saraswat, N., Rao, K., Subbakrishna, DK., et al.[2022]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

The Enhancing Quality Use of Medication Self-Reported Questionnaire (EQUIM-SRQ) was found to be applicable and interpretable in an Australian mental health outpatient population, despite a low response rate of only 18% from 160 distributed questionnaires.

The study suggests that the EQUIM-SRQ could be useful for future research and clinical practice, as it was acceptable to participants, with some needing assistance to complete it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of Enhancing Quality Use of Medication Self-Reported Questionniare (EQUIM-SRQ) among mental health consumers: a pilot study. Ashoorian, D., Salter, S., Denton, T., et al.[2015]

A total of 75 prescribing safety indicators related to mental health medications were developed, with 42 of them identified as high or extreme risk for patient care, highlighting significant safety concerns in prescribing practices.

The identified indicators include various hazardous prescribing types, such as drug-disease interactions and inadequate monitoring, covering multiple classes of mental health medications, which can guide future safety improvement initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of prescribing safety indicators related to mental health disorders and medications: Modified e-Delphi study. Khawagi, WY., Steinke, DT., Nguyen, J., et al.[2021]

A qualitative study involving 42 patients (25 with major depressive disorder and 17 with schizophrenia) and 4 psychiatrists identified common treatment-emergent adverse events (TEAEs) associated with atypical antipsychotics, including cognitive issues, weight gain, and extrapyramidal symptoms, which were reported as bothersome by patients.

The study revealed that the perception of TEAEs varies between patients and physicians, emphasizing the need for a personalized approach to managing these side effects when prescribing atypical antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the burden of treatment-emergent adverse events associated with atypical antipsychotic medications. Llorca, PM., Lançon, C., Hartry, A., et al.[2018]

Over 90% of individuals with severe mental illness reported experiencing at least one side effect from psychotropic medications, with nearly two-thirds feeling a high level of distress from these effects.

The most distressing side effects included weight gain, dry mouth, and sedation, and the likelihood of experiencing distress from these side effects varied based on gender and race.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distress with medication side effects among persons with severe mental illness. Covell, NH., Weissman, EM., Schell, B., et al.[2007]

The study with 64 healthy participants found that social exclusion towards individuals with schizophrenia is influenced by both the presence of negative symptoms and awareness of the diagnosis, indicating that stigma can vary based on these factors.

Participants preferred to engage in activities with individuals not displaying negative symptoms, regardless of whether they were labeled as having schizophrenia, suggesting that public mental health campaigns should focus on increasing acceptance of specific symptoms to reduce social exclusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stigma towards individuals with schizophrenia: Examining the effects of negative symptoms and diagnosis awareness on preference for social distance. Zahid, A., Best, MW.[2021]

The study used exploratory structural equation modeling to analyze stigma towards mental illness in two Australian national surveys, revealing that stigma has distinct dimensions, including 'Weak-not-sick' and 'Dangerous/unpredictable' components.

Stigma levels varied by age, gender, and the type of mental disorder depicted, indicating that perceptions of stigma are complex and influenced by demographic factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The measurement properties of stigmatizing attitudes towards mental disorders: results from two community surveys. Yap, MB., Mackinnon, A., Reavley, N., et al.[2022]

Patients with chronic schizophrenia experience a range of feelings during interpersonal interactions, which can be both pleasant and unpleasant, highlighting the emotional complexity of their social experiences.

The study identified that interpersonal interactions for these patients are dynamic and influenced by their ability to select interaction targets, suggesting that understanding these dynamics can help healthcare professionals improve their social relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of interpersonal interaction among patients with chronic schizophrenia: A phenomenological study. Chen, SH., Huang, XY., Cheng, JF.[2021]

A study conducted in Pulau-Pinang, Malaysia, with 100 respondents, found that the public has a higher recognition of depression compared to schizophrenia, and many attribute mental disorders to supernatural factors and chemical imbalances in the brain.

The study revealed significant stigma towards individuals with mental disorders, with 55% of respondents perceiving them as unfriendly and one-third believing they are moody, dangerous, and unpredictable, indicating a need for better public education on mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study Evaluating the Stigma and Public Perception about the Causes of Depression and Schizophrenia. Khan, T., Hassali, M., Tahir, H., et al.[2021]

A survey of 180 university students revealed that people tend to feel more social distance from individuals with severe mental illnesses, like schizophrenia, compared to those with less severe mental or physical illnesses.

The desire for social distance appears to be linked to a lack of familiarity with severe mental illness, suggesting that increasing public understanding could help reduce stigma and improve community integration for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in attributions of mental illness and social distance for portrayals of four mental disorders. Kasow, ZM., Weisskirch, RS.[2020]

References

1. China pubmed.ncbi.nlm.nih.gov

[Negative symptoms predict the improvement of social functioning of patients with schizophrenia]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Unmet Needs of People with Serious Mental Illness: Perspectives from Certified Peer Specialists. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Ecological momentary assessment of everyday social experiences of people with schizophrenia: A systematic review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Measuring Group Process in Nurse-Facilitated Support Groups for Psychosocial Club Members. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The Social Occupational Functioning Scale (SOFS): a brief measure of functional status in persons with schizophrenia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

7. England pubmed.ncbi.nlm.nih.gov

The use of Enhancing Quality Use of Medication Self-Reported Questionniare (EQUIM-SRQ) among mental health consumers: a pilot study. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Development of prescribing safety indicators related to mental health disorders and medications: Modified e-Delphi study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Assessing the burden of treatment-emergent adverse events associated with atypical antipsychotic medications. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Distress with medication side effects among persons with severe mental illness. [2007]

11. Ireland pubmed.ncbi.nlm.nih.gov

Stigma towards individuals with schizophrenia: Examining the effects of negative symptoms and diagnosis awareness on preference for social distance. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

The measurement properties of stigmatizing attitudes towards mental disorders: results from two community surveys. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Experiences of interpersonal interaction among patients with chronic schizophrenia: A phenomenological study. [2021]

14. Iran pubmed.ncbi.nlm.nih.gov

A Pilot Study Evaluating the Stigma and Public Perception about the Causes of Depression and Schizophrenia. [2021]

15. United States pubmed.ncbi.nlm.nih.gov

Differences in attributions of mental illness and social distance for portrayals of four mental disorders. [2020]