NCT06465173

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2024

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

May 24, 2024

Last Update Submit

April 13, 2026

Conditions

Keywords

dementiaself-compassionquality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life in Alzheimer's Disease

    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.

    Through study completion, average 40-60 minutes

Secondary Outcomes (2)

  • Stress Appraisal Measure

    Through study completion, average 40-60 minutes

  • Geriatric Depression Scale - 10

    Through study completion, average 40-60 minutes

Other Outcomes (1)

  • Self-compassion Scale - Short Form

    Through study completion, average 40-60 minutes

Study Arms (2)

'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.

'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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participant sample is anticipated to comprise NHS patients who have been seen in memory clinic and individuals recruited from the community.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Health NHS Foundation Trust

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

Related Publications (6)

  • Neff, K. (2003). Development and validation of a scale to measure self-compassion. Self and identity(2), 223-250.

    BACKGROUND
  • Neff, K. (2022). Self-Compassion Scale - Short-Form (SCS-SF) Information. https://self-compassion.org/self-compassion-scales-for-researchers/

    BACKGROUND
  • 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.

    PMID: 7612321BACKGROUND
  • Peacock, E. J., & Wong, P. T. (1990). The stress appraisal measure (SAM): A multidimensional approach to cognitive appraisal. Stress medicine, 6(3), 227-236.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 21584907BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2024

First Posted

June 18, 2024

Study Start

February 2, 2024

Primary Completion

October 23, 2024

Study Completion

October 23, 2024

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations