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Social Isolation and Loneliness in Older People

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ClinicalTrials.gov Identifier: NCT03201731
Recruitment Status : Unknown
Verified June 2017 by University College, London.
Recruitment status was:  Not yet recruiting
First Posted : June 28, 2017
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date June 26, 2017
First Posted Date June 28, 2017
Last Update Posted Date July 5, 2017
Estimated Study Start Date October 2017
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2017)
  • 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?'.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 26, 2017)
  • Ambiguous Intentions Attribution Questionnaire (Combs, Penn, Wicher & Waldheter, 2007) [ Time Frame: Total assessment time: two hours ]
    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.
  • The Faux Pas test (Stone, Baron-Cohen & Knight, 1998) [ Time Frame: Total assessment time: two hours ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Social Isolation and Loneliness in Older People
Official Title Social Isolation and Loneliness in Very Late-onset Schizophrenia-like Psychosis: A Case-control Study
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cases and controls will be recruited from the same Community Mental Health Team.
Condition Very Late Onset Schizophrenia
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 26, 2017)
66
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03201731
Other Study ID Numbers 17/0347
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University College, London
Study Sponsor University College, London
Collaborators Not Provided
Investigators Not Provided
PRS Account University College, London
Verification Date June 2017