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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06465173
Other study ID # PID 17089
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 18, 2024
Est. completion date September 2024

Study information

Verified date May 2024
Source Oxford Health NHS Foundation Trust
Contact Trainee Clinical Psychologist
Phone 01865 901000
Email natasha.reed@hmc.ox.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to investigate whether self-compassion is associated with older adult's quality of life after a diagnosis of dementia, and whether perceived threat posed by dementia mediates this relationship. Self-compassion has been found to be positive in supporting individuals in times of difficulty, in adjustment processes and older adults' wellbeing. While different factors have begun to be identified which are associated with individuals' psychological wellbeing and adjustment following a dementia diagnosis, little is known about the influence of self-compassion. Participants will be recruited via NHS memory clinics, Join Dementia Research and from the community via third-sector organisations. Individuals will be invited to attend a Microsoft Teams/telephone appointment in which informed consent and cognitive screening processes will take place at the start. Eligible participants will then be invited to continue to complete measures administered by a researcher and an interview question. Participants will be offered the opportunity to complete the measures in a second session (within 8 weeks) or using the online survey software, Qualtrics, if preferred. A small pilot study (n = 5) will take place prior to the main study.


Recruitment information / eligibility

Status Recruiting
Enrollment 23
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - An older adult aged = 65 years - A confirmed diagnosis of dementia received within the past 12 months - They have knowledge of their diagnosis - They have English language proficiency - They have capacity to give informed consent to participation. Exclusion Criteria: - They are deemed to lack capacity to give informed consent to participate (as per the Mental Capacity Act, 2005). - They have a diagnosis of early-onset dementia, defined as individuals who are aged < 65 at diagnosis - A score on the MoCA Blind (Nasreddine, 2022b) screening measure of <7 out of 22, which is calculated as equivalent to <10 out of 30 on the MoCA (Nasreddine et al., 2005).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Oxford Health NHS Foundation Trust Oxford Oxfordshire

Sponsors (1)

Lead Sponsor Collaborator
Oxford Health NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Self-compassion Scale - Short Form (Raes, et al., 2011) The Self-Compassion Scale - Short Form (Self-Compassion Scale - Short Form; Raes et al., 2011) consists of 12 items relating to six subscales (self-judgement, self-kindness, common humanity, mindfulness, isolation and over-identification), with each item scored from 1 ('almost never') to 5 ('almost always') and three items reverse-scored. The Self-Compassion Scale - Short Form is a shortened version of the Self-Compassion Scale (Neff, 2003). Neff (2022) recommends utilising a total mean score calculated using the subscale mean scores, and this will be adopted in the current study to form the independent variable. Through study completion, average 40-60 minutes
Primary Quality of Life in Alzheimer's Disease (Logsdon et al., 1999) The Quality of Life in Alzheimer's Disease (Logsdon et al., 1999) consists of 13 items relating to different aspects of quality of life, such as mood, physical health, friends and ability to do things for fun. Each item is scored from 1 ('poor') to 4 ('excellent') to calculate a total score (Logsdon et al., 1999). Through study completion, average 40-60 minutes
Secondary Stress Appraisal Measure (Peacock and Wong, 1990) The Stress Appraisal Measure (Peacock & Wong, 1990) consists of 28 items pertaining to perceived future threat, measured across seven subscales; three referring to primary appraisals of threat, centrality and challenge, three relating to secondary appraisal - controllable by self, controllable by others and uncontrollable), and stressfulness. Only the threat and 'stressfulness' subscales, consisting of four items respectively, will be completed. Through study completion, average 40-60 minutes
Secondary Geriatric Depression Scale - 10 (van Marwijk et al., 1995) The Geriatric Depression Scale - 10 (Van Marwijk et al., 1995), consisting of 10 items relating to how the person has felt over the past week (e.g. 'do you feel happy most of the time?'), has good reliability (a = 0.75), sensitivity and specificity (Almeida & Almeida, 1999). The Geriatric Depression Scale -10 is considered a reliable screening measure for major depression in older adults (Almeida & Almeida, 1999). Through study completion, average 40-60 minutes
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