Social Isolation and Aging in Schizophrenia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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;

Trial population

500 clinically stable schizophrenia participants, and 150 of their unaffected siblings from a list of eligible participants of large existing studies of schizophrenia: e.g. EUropean network of national schizophrenia networks studying Gene-Environment Interactions (EU-GEI) and large scale research studies that took place at the Olin Neuropsychiatry Research Center, Institute of Living, Hartford, CT. All participants consented to be recruited for future studies.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

650 Participants
are grouped into 2 trial groups
Group A: Individuals with SZ
Group B: Unaffected first-degree relatives

Trial outcomes

Primary outcomes

1

Occurrence of newly diagnosed conditions

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).

Time frame
Day 1
2

Short Form Health Survey (SF-36),

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.

Time frame
Day 1
3

Number of Participants with High Cholesterol

High cholesterol (defined as low-density lipoprotein ≥160 mg/dL or total cholesterol ≥240 mg/dL)

Time frame
Day 1
4

Number of participants with High Blood Pressure

High blood pressure (defined as systolic ≥130 mm Hg or diastolic ≥80 mm Hg).

Time frame
Day 1

Secondary outcomes

1

The Revised UCLA Loneliness Scale (R-UCLA)

The Revised UCLA Loneliness Scale (R-UCLA) is a 20-item questionnaire. Every item is scored with a number that indicates how often each question is applicable (1 = Never, 2 = Rarely, 3 = Sometimes, and 4 = Always). To calculate the total score for each participant, all responses are summed to create a total score ranging from 20 to 80. Higher score indicates more loneliness. Total score \<28 = no/low loneliness Total score 28-43 = moderate loneliness Total score \>43 = a high degree of loneliness.

Time frame
Day 1
2

Ecological Momentary Assessment (EMA)

Severity of psychotic symptoms and functional impairments related to SZ of the EMA questions using "EMA-wellness". Scored from 0-12, with higher score indicating poorer health outcomes

Time frame
Chart review legacy data; and 3 times daily for 14 days
3

Barriers to Access to Care Evaluation scale (BACE)

The Barriers to Access to Care Evaluation scale (BACE) questionnaire will be used to establish any problems related to access to healthcare over the years. The BACE is designed to assess barriers to mental health care for people with mental health problems. It includes barriers related to, and unrelated to, stigma and discrimination. It has 30 items, and is scored by summing responses to these items, where each item uses a 0 (not at all) to 3 (a lot) scale, full scale scored from 0-90, with higher scores indicating greater perceived barriers.

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Yale University

Collaborator

Hartford Hospital

Collaborator

Hospital General Universitario Gregorio Marañon

Collaborator

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Collaborator

King's College London

Collaborator

University of Miami

Collaborator

Boston Children's Hospital

Collaborator

GGZ Noord-Holland-Noord

Collaborator

Karolinska Institutet

Collaborator