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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how feelings of loneliness or isolation might affect the perceptions and interactions of people with mental illnesses. It aims to uncover how these feelings relate to everyday life and overall functioning, potentially guiding new treatments. The trial employs Ecological Momentary Assessment (EMA), which involves multiple daily check-ins. Individuals who have experienced a psychotic or mood disorder and do not have a neurological disorder or current substance use issues may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to understanding mental health and potentially improve future treatments.

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 prior data suggests that this Ecological Momentary Assessment is safe?

Research has shown that Ecological Momentary Assessment (EMA) is generally safe for participants. EMA involves collecting data in real time, often using smartphones or other devices. Researchers frequently use this method in mental health studies to understand daily feelings and behaviors.

Studies have found that while EMA can sometimes feel demanding due to frequent check-ins, it does not pose significant health risks. As a non-invasive method, it avoids physical procedures. Participants typically adapt to the process, allowing researchers to gather important information about mental states with minimal disruption to daily activities.

In summary, EMA is well-tolerated and safe, offering a unique way to study mental health without causing harm to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Ecological Momentary Assessment (EMA) for mental illness because it offers a real-time, personalized approach to understanding social interactions. Unlike traditional methods that rely on retrospective surveys or interviews, EMA collects data multiple times a day, capturing the nuances of daily life as they happen. This method allows for a more accurate and immediate understanding of how social interactions impact mental health, potentially leading to more tailored and effective interventions.

What evidence suggests that Ecological Momentary Assessment is effective for understanding social perceptions in mental illness?

Research has shown that Ecological Momentary Assessment (EMA), which participants in this trial will use, is a promising tool for mental health. EMA tracks changes in mental health by collecting data in real-time, several times a day. Studies have found that this method can uncover important psychological patterns related to mental health issues. Experts believe EMA adds value to mental health care by offering more personalized insights. This tool can help identify new ways to improve daily life and well-being for people with serious mental illnesses. ^{2 6 7 8 9}

Who Is on the Research Team?

Daphne J Holt, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I am not fluent in English.

I recently changed my medication or started having new symptoms.

History of any neurological disorder or current substance use disorder (within the past 6 months)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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 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]

Citations

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Ecological Momentary Assessment of Mental Health ... This study aims to evaluate the quality of EMA data in a large sample of university students by estimating participation rate and mean compliance, identifying ...

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Ecological Momentary Assessment as a Measure ... Beyond measuring change, EMA offers unique opportunities to examine psychological dynamics that may be markers of mental health and intervention ...

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Practitioner and researcher perspectives on the utility of ... This survey study demonstrated that practitioners and researchers expect EMA to have added value for mental health care.

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Mobile-based ecological momentary assessment and ... Our analysis indicates that EMA and EMI have great potential in health behaviors and mental health, but implementation should consider ...

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Applying continuous-time models to ecological momentary ... Ecological momentary assessment (EMA) is a frequently used approach among clinical researchers to collect naturalistic data in real time.

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Mental health and ecological momentary assessments ... This dataset enables researchers to examine how anxiety, depression, and quality-of-life indicators fluctuated in response to pandemic restrictions.

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Using Ecological Momentary Assessments to Study How ... In conclusion, EMA methods have the potential to reveal how dynamic fluctuations in psychological states impact stress, well-being, and health. In the present ...

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Associations between ecological momentary assessment and ... Ecological momentary assessment (EMA) increases ecological validity but can be burdensome. To reduce this burden and to better understand psychological ...