NCT06507826

Brief Summary

The goal of this study was to test an online writing intervention to encourage a self-compassionate mindset in family caregivers of older adults. The main aims were to answer the questions:

  • Writing with self-compassion would increase self-compassion.
  • Writing with self-compassion would improve mood. Researchers compared self-compassion components (self-kindness, which involves a gentle and non-judgemental approach to oneself at times of difficulty; common humanity, which includes recognising one's difficulties as part of a shared human experience; mindfulness, which includes noticing difficult feelings without becoming overwhelmed by them) to see which combinations achieved the best outcomes. Participants wrote with different combinations of self-compassion components together, such as mindfulness and common humanity or mindfulness and self-kindness. Participants also wrote with self-kindness, common humanity, or mindfulness separately.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
652

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

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 18, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

July 5, 2024

Last Update Submit

July 12, 2024

Conditions

Keywords

MindfulnessSelf-kindnessCommon humanitySelf-compassion

Outcome Measures

Primary Outcomes (3)

  • Self-kindness measured with the State Self-Compassion Scale (Neff et al., 2021)

    Scores closer to 5 expected on a scale of 1 to 5

    State measured immediately after intervention

  • Common humanity measured with the State Self-Compassion Scale (Neff et al., 2021)

    Scores closer to 5 expected on a scale of 1 to 5

    State measured immediately after intervention

  • Mindfulness measured with the State Self-Compassion Scale (Neff et al., 2021)

    Scores closer to 5 expected on a scale of 1 to 5

    State measured immediately after intervention

Secondary Outcomes (3)

  • Guilt measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999)

    State measured immediately after intervention

  • Sadness measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999)

    State measured immediately after intervention

  • Serenity measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999)

    State measured immediately after intervention

Study Arms (11)

Control

PLACEBO COMPARATOR

Descriptive writing.

Behavioral: Self-Compassionate Writing for Caregivers of Older Adults

Mindfulness

ACTIVE COMPARATOR

Writing with mindfulness.

Behavioral: Self-Compassionate Writing for Caregivers of Older Adults

Mindfulness with Self-Kindness

ACTIVE COMPARATOR

Writing with mindfulness and self-kindness.

Behavioral: Self-Compassionate Writing for Caregivers of Older Adults

Mindfulness with Common Humanity

ACTIVE COMPARATOR

Writing with mindfulness and common humanity.

Behavioral: Self-Compassionate Writing for Caregivers of Older Adults

Control with Timed Response

PLACEBO COMPARATOR

Descriptive writing.

Behavioral: Self-Compassionate Writing for Caregivers of Older Adults

Mindfulness with Timed Response

ACTIVE COMPARATOR

Writing with mindfulness.

Behavioral: Self-Compassionate Writing for Caregivers of Older Adults

Self-Kindness with Timed Response

ACTIVE COMPARATOR

Writing with self-kindness.

Behavioral: Self-Compassionate Writing for Caregivers of Older Adults

Common Humanity with Timed Response

ACTIVE COMPARATOR

Writing with common humanity.

Behavioral: Self-Compassionate Writing for Caregivers of Older Adults

Revised Control

PLACEBO COMPARATOR

Descriptive writing.

Behavioral: Self-Compassionate Writing for Caregivers of Older Adults

Self-Compassion

ACTIVE COMPARATOR

Writing with mindfulness, self-kindness, and common humanity.

Behavioral: Self-Compassionate Writing for Caregivers of Older Adults

Self-Compassion Without Mindfulness

ACTIVE COMPARATOR

Writing with self-kindness and common humanity.

Behavioral: Self-Compassionate Writing for Caregivers of Older Adults

Interventions

Self-compassionate writing focusing on one or more self-compassion components (mindfulness, self-kindness, common humanity).

Common Humanity with Timed ResponseControlControl with Timed ResponseMindfulnessMindfulness with Common HumanityMindfulness with Self-KindnessMindfulness with Timed ResponseRevised ControlSelf-CompassionSelf-Compassion Without MindfulnessSelf-Kindness with Timed Response

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Family carer.
  • Caring for a person over 65 years of age.
  • Participants over 18 years of age.

You may not qualify if:

  • Professional carers.
  • Caring person under 65 years of age.
  • Participants under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

Location

Related Publications (2)

  • Neff, K. D., Tóth-Király, I., Knox, M. C., Kuchar, A., & Davidson, O. (2021). The development and validation of the state self-compassion scale (long-and short form). Mindfulness, 12, 121-140.

    RESULT
  • Watson, David & Clark, Lee. (1999). The PANAS-X: Manual for the positive and negative affect schedule-expanded form. Psychology Publications.

    RESULT

Study Officials

  • Aileen K Ho, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were unaware of condition assignment until after the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

July 5, 2024

First Posted

July 18, 2024

Study Start

February 18, 2022

Primary Completion

November 15, 2022

Study Completion

November 15, 2022

Last Updated

July 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Anonymised data to be made available on OSF.

Shared Documents
SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will become available on publication of the research report. It will be made available for 5 years.
Access Criteria
Access permitted under the conditions of the informed consent agreement.

Locations