Very Late Onset SchizophreniaNCT03201731
Social Isolation and Loneliness in Older People
An observational study of Very Late Onset Schizophrenia, run by University College, London.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Very Late Onset Schizophrenia
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Study population: Cases and controls will be recruited from the same Community Mental Health Team.
Who may be able to join
- Aged 60 and above.
- Diagnosed with a psychotic disorder after age 60.
- Aged 60 and above.
- Diagnosed with any mental health disorder except from a psychotic disorder, dementia, or severe depression.
Who cannot join
- 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.
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- 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
- 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.
About this study
Official title: Social Isolation and Loneliness in Very Late-onset Schizophrenia-like Psychosis: A Case-control Study
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.
- Conditions
- Very Late Onset Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Those diagnosed with a non-organic, non-affective psychotic disorder for the first time after age 60, recruited from a Community Mental Health Team. | |
| Controls | Those aged 60 and above in contact with the same Community Mental Health Team for another mental health problem aside from a psychotic disorder or dementia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA loneliness Scale (version 3) (Russel, 1996)
The UCLA loneliness scale is a 20-item measure of subjective feelings of loneliness. The scale has been validated for use in the elderly. Each item is scored from 1 (never) to 4 (often). Items include 'I lack companionship' and 'People are around me but not with me'. The scale yields an overall loneliness score between 0-80.
Measured: Total assessment time: two hours
Lubben Social Network Scale - 6 (LSNS-6) (Lubben et al., 2006)
The LSNS-6 is a six-item self-report scale to assess social isolation in older adults by measuring perceived social support received from family and friends. The scale assesses the size, closeness and frequency of contacts within a respondent's social network, with a subscale for friends and another for family. Higher scores indicate larger social networks and lower scores indicate higher levels of social isolation. Questions include 'How many relatives do you see or hear from at least once a month?' and 'How many friends do you feel at ease with that you can talk about private matters?'.
Measured: Total assessment time: two hours
Secondary outcomes (2)
Ambiguous Intentions Attribution Questionnaire (Combs, Penn, Wicher & Waldheter, 2007)
This questionnaire is designed to examine attribution bias with a particular focus on hostile social-cognitive bias. The researcher will read participants each vignette and ask them to imagine that the scenario is happening to them. Participants rate whether the action was performed on purpose, with ratings from 1 (definitely no) to 6 (definitely yes), how angry it would make them feel from 1 (not at all angry) to 5 (very angry) and how much they would blame the other person from 1 (not at all) to 5 (very much). These are totaled to create an overall score. Responses to each item are averaged across scenarios and summed, with higher scores indicating greater blame.
Measured: Total assessment time: two hours
The Faux Pas test (Stone, Baron-Cohen & Knight, 1998)
The Faux Pas test is designed to measure theory of mind, or the ability to make inferences about the thoughts, beliefs and intentions of others and to understand the possible motivations underlying others' actions. In this test, theory of mind is measured using short vignettes followed by a series of questions. We shall use a short version of the test developed by Negrão et al., (2016). This test uses 5/10 faux pas stories and 5/10 control stories from the original Faux Pas Test. After each story is read, participants will be asked five questions for: detecting a faux pas, understanding the faux pas, understanding the mental state of the faux pas recipient, understanding the mental state of the person delivering the faux pas and understanding the details but without making inferences about the mental states of the characters in the story.
Measured: Total assessment time: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study startOct 2017 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Late Onset SchizophreniaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201731
- Sponsor's protocol ID
- 17/0347
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Isolation and Loneliness in Very Late-onset Schizophrenia-like Psychosis: A Case-control Study
- ClinicalTrials.gov ID
- NCT03201731
- Acronym / sponsor ID
- 17/0347
- Conditions
- Very Late Onset Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Those diagnosed with a non-organic, non-affective psychotic disorder for the first time after age 60, recruited from a Community Mental Health Team. |
| Controls | – | –Those aged 60 and above in contact with the same Community Mental Health Team for another mental health problem aside from a psychotic disorder or dementia. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cases and controls will be recruited from the same Community Mental Health Team.
Key inclusion criteria (4 listed)
- Aged 60 and above.
- Diagnosed with a psychotic disorder after age 60.
- Aged 60 and above.
- Diagnosed with any mental health disorder except from a psychotic disorder, dementia, or severe depression.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
UCLA loneliness Scale (version 3) (Russel, 1996)
Time frame: Total assessment time: two hours
The UCLA loneliness scale is a 20-item measure of subjective feelings of loneliness. The scale has been validated for use in the elderly. Each item is scored from 1 (never) to 4 (often). Items include 'I lack companionship' and 'People are around me but not with me'. The scale yields an overall loneliness score between 0-80.
Lubben Social Network Scale - 6 (LSNS-6) (Lubben et al., 2006)
Time frame: Total assessment time: two hours
The LSNS-6 is a six-item self-report scale to assess social isolation in older adults by measuring perceived social support received from family and friends. The scale assesses the size, closeness and frequency of contacts within a respondent's social network, with a subscale for friends and another for family. Higher scores indicate larger social networks and lower scores indicate higher levels of social isolation. Questions include 'How many relatives do you see or hear from at least once a month?' and 'How many friends do you feel at ease with that you can talk about private matters?'.
2 secondary outcomes
Ambiguous Intentions Attribution Questionnaire (Combs, Penn, Wicher & Waldheter, 2007)
Time frame: Total assessment time: two hours
The Faux Pas test (Stone, Baron-Cohen & Knight, 1998)
Time frame: Total assessment time: two hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Late Onset Schizophrenia, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA loneliness Scale (version 3) (Russel, 1996) (time frame: Total assessment time: two hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.