Social Isolation and Aging in Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Schizophrenia and Related Disorders. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Netherlands, Spain, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Social Isolation on Aging Health in Schizophrenia
Overview
Individuals diagnosed with schizophrenia and related psychotic disorders (SZ) exhibit a markedly elevated risk of premature mortality, with a 10-20-year shorter lifespan relative to the general population. Increased mortality rates in SZ are largely attributable to the early manifestation of medical conditions that normally occur later in life, a process known as 'accelerated aging'. While unhealthy lifestyle behaviors, such as smoking and unhealthy diet, account, in part, for accelerated aging in SZ, the excess of physical comorbidities cannot be solely attributed to these factors. Remarkably, the direct adverse health effects of key clinical characteristics of SZ have rarely been considered. In the general population, the absence of social contact is known to pose enormous challenges for physical health, especially at older ages. Given that social isolation is a persistent and disabling feature of SZ, it is possible that this behavior may contribute to the premature manifestation of health conditions in SZ. Building on rich pilot data pointing to significant associations between social isolation and long-term perceived health in SZ, the overarching goal is to test whether and how social isolation contributes to the health challenges of individuals with SZ as they age. With participants from Europe (EU-GEI) and the US (Olin Neuropsychiatry Research Center), the researchers will create a longitudinal database of 650 participants, including 500 individuals with SZ, and 150 of their unaffected siblings. The researchers will apply an accelerated longitudinal design by reassessing and by examining medical records of research participants who were first evaluated between the ages of 20-55 and are now 40-70 years of age, a period when many medical conditions and health problems tend to manifest. The researchers will determine the age-related association between social isolation and adverse health outcomes in SZ, test for familiality, directionality, and factors moderating this association, and determine the extent to which the COVID-19 pandemic and the resulting imposed lockdowns impacted health in SZ. The researchers will consider generalizability across countries, sexes, and race/ethnicities. The rationale for the proposed research is that in order to facilitate much-needed targeted therapies to prevent early mortality in SZ, the researchers need to better understand factors that contribute to the excess of medical comorbidities in SZ. The central hypothesis is that social isolation, a common and persistent characteristic of SZ, contributes to the excess of physical comorbidities in SZ. To meet the overall goal, the following aims are: (1) Determine the association between social isolation and adverse health outcomes in SZ; (2) Test for the directionality, and moderating factors, of the association between social isolation and health outcomes in SZ, and; (3) Examine whether the COVID-19 pandemic modified associations between social isolation and health outcome in SZ. This study will be the first to comprehensively examine the health impact of social isolation in SZ. The project may show that in SZ socialization in midlife can reduce the risk for poor health outcomes and ultimately facilitate much-needed preventive targeted therapies to reduce early-age mortality in SZ
Detailed description
An accelerated longitudinal design is employed, combining prior research data collected when participants were aged 20-55 with new follow-up assessments now that they are aged 40-70.
Primary outcome measures
- Occurrence of newly diagnosed conditions [Time frame: Day 1]
- Short Form Health Survey (SF-36), [Time frame: Day 1]
- Number of Participants with High Cholesterol [Time frame: Day 1]
- Number of participants with High Blood Pressure [Time frame: Day 1]
- Schedule for Deficit Syndrome (SDS) [Time frame: Chart Review for the legacy data from when participants were first assessed between 2004 and 2015]
- The Birchwood social functioning scale (SFS) [Time frame: Chart review for the legacy data from when participants were first assessed between 2004 and 2015; and Three times daily for 14 days]
- 'Social Isolation' subscale of the Structured Interview for Schizotypy-Revised (SIS-R) [Time frame: Chart review for the legacy data from when participants were first assessed between 2004 and 2015; and Three times daily for 14 days]
Secondary outcome measures (3)
- The Revised UCLA Loneliness Scale (R-UCLA) [Time frame: Day 1]
- Ecological Momentary Assessment (EMA) [Time frame: Chart review legacy data; and 3 times daily for 14 days]
- Barriers to Access to Care Evaluation scale (BACE) [Time frame: Day 1]
Eligibility criteria
Inclusion and exclusion criteria for participants with SZ:
- DSM-IV or V diagnosis of a SZ related disorder (295.x, 297.1, 298.8, or 298.9; e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, but not psychotic disorder that is solely substance induced) based on clinical interview;
- Between 40 and 70 years of age at time of study recruitment;
- Participant was enrolled in a previous research study between the ages of 20-55, and this study took place at least 5 years ago;
- Able to understand the spoken language of the participating country sufficiently to comprehend testing procedures;
- No history of serious head injury (i.e., loss of consciousness longer than 1 hour, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury);
- No history of IQ < 70, or developmental disability based on chart review;
- Clinically stable (i.e., no inpatient hospitalizations for three months prior to enrollment, no changes in medication in the four weeks prior to enrollment;
The inclusion and exclusion criteria for sibling participants in this study will be:
- No history of any DSM IV/V Axis I or axis II diagnosis that is known to be associated with social functioning (e.g. severe mood disorder, schizoaffective personality disorder, autism spectrum disorder);
- Between 40 and 70 years of age at time of study recruitment;;
- Participant was enrolled in a previous research study between the ages of 20-55, and this study took place at least 5 years ago;
- Able to understand the spoken language of the participating country sufficiently to comprehend testing procedures;
- No history of serious head injury (i.e., loss of consciousness longer than 1 hour, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury);
- No history of IQ < 70, or developmental disability based on chart review;
- Clinically stable (i.e., no inpatient hospitalizations for three months prior to enrollment, no changes in medication in the four weeks prior to enrollment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Olin Neuropsychiatry Research Center, Hartfort — Hartford
Netherlands · 1 center
- AUMC, University Hospital — Amsterdam
Spain · 1 center
- Hospital General Universitario Gregorio Marañon — Madrid
United Kingdom · 1 center
- King's College London — London
Publications
- Koster M, van der Pluijm M, Baldwin H, Greenburgh A, King D, Arnold C, Lopez-Morinigo JD, Underwood S, Larrauri CA, Racher M, Glahn DC, Harvey PD, Sandin S, Stevens M, Pearlson G, Arango C, Dazzan P, Morgan C, de Haan L, Reichenberg A, Velthorst E. Social Isolation and Aging health in Schizophrenia spectrum disorders (SIAS): study protocol for a multinational longitudinal study. BMC Psychiatry. 20 PMID 41808086
Identifiers
NCT: NCT07419321 · STUDY-22-00730 · 1R01MH128971-01A1