The Impact of Social Isolation on Aging Health in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 4
- 主要终点
- Occurrence of newly diagnosed conditions
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion and
排除标准
- •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
研究组 & 干预措施
Individuals with SZ
Individuals with a schizophrenia-related diagnosis
Unaffected first-degree relatives
Unaffected first-degree relatives of individuals with a schizophrenia-related diagnosis
结局指标
主要结局
Occurrence of newly diagnosed conditions
时间窗: Day 1
Physician diagnosed medical conditions - Medical records from hospitals and general practitioners will be reviewed to identify the occurrence and timing of any newly diagnosed conditions (e.g., cardiovascular disease, COPD, diabetes).
Short Form Health Survey (SF-36),
时间窗: Day 1
The 36-Item Short Form Health Survey (SF-36), which includes five physical domains: physical functioning, role limitations due to physical problems, bodily pain, general health, and vitality. The individuals item scores (scored between 1-60, according to the manual) are summed to scale scores and transformed to a 100-point scale, with higher scores indicating a better health status.
Number of Participants with High Cholesterol
时间窗: Day 1
High cholesterol (defined as low-density lipoprotein ≥160 mg/dL or total cholesterol ≥240 mg/dL)
Number of participants with High Blood Pressure
时间窗: Day 1
High blood pressure (defined as systolic ≥130 mm Hg or diastolic ≥80 mm Hg).
Schedule for Deficit Syndrome (SDS)
时间窗: Chart Review for the legacy data from when participants were first assessed between 2004 and 2015
Social isolation is measured with the Schedule for Deficit Syndrome (SDS) - each item scored from 0 (normal) to 4 (severely impaired). there is also a global severity score (0 to 4). Full scale scored from 0 to 20, with higher score representing greater severity of symptoms.
The Birchwood social functioning scale (SFS)
时间窗: 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 is measured with the Birchwood social functioning scale (SFS) - a 79 item instrument, and consists of seven subscales: (1) social engagement/withdrawal (amount of time to spend alone, the likelihood to initiate conversation); (2) interpersonal behaviour (number of friends, engagement in a romantic relationship); (3) prosocial activities (participation in social activities e.g. visit friends, play sports); (4) recreation (engagement in activities and hobbies); (5) independence-competence (ability to maintain independent living); (6) independence-performance (performance of the skills required for independent living); (7) employment/occupation (engagement in employment), The sum of each scale, and the full scale is standardized and normalized with a mean of 100 and standard deviation of 15. Higher scores represent better health outcomes.
'Social Isolation' subscale of the Structured Interview for Schizotypy-Revised (SIS-R)
时间窗: 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 is measured with the 'Social Isolation' subscale of the Structured Interview for Schizotypy-Revised (SIS-R). The subscale range from 0 (virtually no evidence of symptoms) to 6 (symptoms present and quite severe).
次要结局
- The Revised UCLA Loneliness Scale (R-UCLA)(Day 1)
- Ecological Momentary Assessment (EMA)(Chart review legacy data; and 3 times daily for 14 days)
- Barriers to Access to Care Evaluation scale (BACE)(Day 1)
研究者
Abraham Reichenberg
Professor
Icahn School of Medicine at Mount Sinai
