Social Isolation and Loneliness in Older People (NCT03201731) | Clinical Trial Compass
UnknownNot Applicable
Social Isolation and Loneliness in Older People
66 participantsStarted 2017-10
Plain-language summary
Although psychotic disorders such as schizophrenia usually present in late adolescence or early adulthood, research suggests that a substantial subset of people are diagnosed for the first time after the age of 60. This condition is referred to as 'very late-onset schizophrenia-like psychosis' (VLOSLP). People with VLOSLP are thought to experience high levels of social isolation, yet there has been little research systematically examining this. Additionally, little is known about how lonely people with VLOSLP feel, or how this group relate to and perceive other people.
This study aims to examine levels of social isolation and loneliness in patients with VLOSLP. The investigators also aim to explore aspects of social cognition in relation to VLOSLP.
A case-control study design will be used to examine the relationship between VLOSLP, loneliness, social isolation and social cognition. The case group will be people diagnosed with a non-organic psychotic disorder after age 60. The comparison group will be those aged 60 and above in contact with mental health services for a mental health difficulty, except from a psychotic disorder or dementia.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Cases
Inclusion criteria:
* Aged 60 and above.
* Diagnosed with a psychotic disorder after age 60.
Exclusion criteria:
* Diagnosed with a psychotic disorder before age 60.
* Dementia diagnosis.
* Mild cognitive impairment diagnosis.
* Clear organic cause for psychosis.
* Does not speak English to the degree needed to engage with study materials.
* Mental health problems too severe to fully engage with the study.
* Other medical or psychosocial factor that could limit ability to fully engage with study materials, such as severe intellectual disability or imminently life-limiting illness.
Controls
Inclusion criteria:
* Aged 60 and above.
* Diagnosed with any mental health disorder except from a psychotic disorder, dementia, or severe depression.
Exclusion criteria:
* Diagnosed psychotic disorder, drug-induced psychosis or organic psychosis.
* Dementia diagnosis.
* Mental health problems too severe to fully engage with the study.
* Does not speak English to the degree needed to engage with study materials.
* Other medical or psychosocial factor that could limit ability to fully engage with study materials, such as severe intellectual disability or imminently life-limiting illness.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
UCLA loneliness Scale (version 3) (Russel, 1996)
Timeframe: Total assessment time: two hours
2
Lubben Social Network Scale - 6 (LSNS-6) (Lubben et al., 2006)