- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06465173
Self-compassion and Quality of Life After Dementia Diagnosis
Is Self-compassion Associated With Older Adults' Quality of Life After Dementia Diagnosis and Does Perceived Threat Posed by Dementia Mediate This Relationship?
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 7JX
- Oxford Health NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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'High self-compassion' group
Participants' total mean score on the Self-compassion Scale - Short Form will be used as the independent variable.
A median split (+/-1 standard error of the median) on the Self-compassion Scale - Short Form will be used to retrospectively allocate participants to groups, with participants scoring ≥ + 1 standard error of the median on the Self-compassion Scale - Short Form allocated to a 'High self-compassion' group.
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'Low self-compassion' group
Participants' total mean score on the Self-compassion Scale - Short Form will be used as the independent variable.
A median split (+/-1 standard error of the median) on the Self-compassion Scale - Short Form will be used to retrospectively allocate participants to groups, with participants scoring ≤ - 1 standard error of the median on the Self-compassion Scale - Short Form allocated to a 'Low self-compassion' group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of Life in Alzheimer's Disease
Time Frame: Through study completion, average 40-60 minutes
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The Quality of Life in Alzheimer's Disease 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.
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Through study completion, average 40-60 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Stress Appraisal Measure
Time Frame: Through study completion, average 40-60 minutes
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The Stress Appraisal Measure 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.
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Through study completion, average 40-60 minutes
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Geriatric Depression Scale - 10
Time Frame: Through study completion, average 40-60 minutes
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The Geriatric Depression Scale - 10, 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 (α = 0.75), sensitivity and specificity.
The Geriatric Depression Scale -10 is considered a reliable screening measure for major depression in older adults.
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Through study completion, average 40-60 minutes
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-compassion Scale - Short Form
Time Frame: Through study completion, average 40-60 minutes
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The Self-Compassion Scale - Short Form 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.
It is recommended 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.
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Through study completion, average 40-60 minutes
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Collaborators and Investigators
Publications and helpful links
General Publications
- Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- Neff, K. (2003). Development and validation of a scale to measure self-compassion. Self and identity(2), 223-250.
- Neff, K. (2022). Self-Compassion Scale - Short-Form (SCS-SF) Information. https://self-compassion.org/self-compassion-scales-for-researchers/
- van Marwijk HW, Wallace P, de Bock GH, Hermans J, Kaptein AA, Mulder JD. Evaluation of the feasibility, reliability and diagnostic value of shortened versions of the geriatric depression scale. Br J Gen Pract. 1995 Apr;45(393):195-9.
- Peacock, E. J., & Wong, P. T. (1990). The stress appraisal measure (SAM): A multidimensional approach to cognitive appraisal. Stress medicine, 6(3), 227-236.
- Logsdon, R. G., Gibbons, L. E., McCurry, S. M., & Teri, L. (1999). Quality of life in Alzheimer's disease: patient and caregiver reports. Journal of Mental health and Aging, 5, 21-32
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PID 17089
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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