Self-CompassionNCT06507826
Self-Compassionate Writing for Caregivers of Older Adults
A study testing Self-Compassionate Writing for Caregivers of Older Adults in people with Self-Compassion and Control, run by Farah Wiita at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-Compassion, Control
- What is being tested?
- Self-Compassionate Writing for Caregivers of Older Adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 652 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Feb 2022to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Family carer.
- Caring for a person over 65 years of age.
- Participants over 18 years of age.
Who cannot join
- Professional carers.
- Caring person under 65 years of age.
- Participants under 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online Intervention Using Self-Compassionate Writing to Induce Positive Mood in Family Caregivers of Older Adults
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.
Read the detailed description
After being informed and consenting to participate in the study, participants were allocated to a self-compassion or control condition. The study was designed to target state self-compassion and mood. The research was carried out over three studies, with refinements being made each time based on previous outcomes. In Studies 1 and 2, participants were tested for self-compassion and mood (guilt, sadness, and serenity). after the writing tasks. In Study 3, participants were asked to complete measures for these both before and after the writing tasks. The experiments were carried out online for all three studies.
- Conditions
- Self-Compassion, Control
- Being tested
- Self-Compassionate Writing for Caregivers of Older Adults
- Keywords
- Mindfulness, Self-kindness, Common humanity, Self-compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Compassionate Writing for Caregivers of Older AdultsBehavioural
Self-compassionate writing focusing on one or more self-compassion components (mindfulness, self-kindness, common humanity).
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Descriptive writing. Receives: Behavioral: Self-Compassionate Writing for Caregivers of Older Adults |
| Mindfulness | Active comparator | Writing with mindfulness. Receives: Behavioral: Self-Compassionate Writing for Caregivers of Older Adults |
| Mindfulness with Self-Kindness | Active comparator | Writing with mindfulness and self-kindness. Receives: Behavioral: Self-Compassionate Writing for Caregivers of Older Adults |
| Mindfulness with Common Humanity | Active comparator | Writing with mindfulness and common humanity. Receives: Behavioral: Self-Compassionate Writing for Caregivers of Older Adults |
| Control with Timed Response | Placebo comparator | Descriptive writing. Receives: Behavioral: Self-Compassionate Writing for Caregivers of Older Adults |
| Mindfulness with Timed Response | Active comparator | Writing with mindfulness. Receives: Behavioral: Self-Compassionate Writing for Caregivers of Older Adults |
| Self-Kindness with Timed Response | Active comparator | Writing with self-kindness. Receives: Behavioral: Self-Compassionate Writing for Caregivers of Older Adults |
| Common Humanity with Timed Response | Active comparator | Writing with common humanity. Receives: Behavioral: Self-Compassionate Writing for Caregivers of Older Adults |
| Revised Control | Placebo comparator | Descriptive writing. Receives: Behavioral: Self-Compassionate Writing for Caregivers of Older Adults |
| Self-Compassion | Active comparator | Writing with mindfulness, self-kindness, and common humanity. Receives: Behavioral: Self-Compassionate Writing for Caregivers of Older Adults |
| Self-Compassion Without Mindfulness | Active comparator | Writing with self-kindness and common humanity. Receives: Behavioral: Self-Compassionate Writing for Caregivers of Older Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: State measured immediately after intervention
Secondary outcomes (3)
Guilt measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999)
Scores closer to 1 expected on a scale of 1 to 5
Measured: State measured immediately after intervention
Sadness measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999)
Scores closer to 1 expected on a scale of 1 to 5
Measured: State measured immediately after intervention
Serenity measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999)
Scores closer to 5 expected on a scale of 1 to 5
Measured: State measured immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start18 Feb 2022
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Self-CompassionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farah Wiita
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Farah Wiita, University of Reading
- Investigators
- Aileen K Ho, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507826
- Sponsor's protocol ID
- 2021-193-AH
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data to be made available on OSF.
Publications
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.
Watson, David & Clark, Lee. (1999). The PANAS-X: Manual for the positive and negative affect schedule-expanded form. Psychology Publications.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Intervention Using Self-Compassionate Writing to Induce Positive Mood in Family Caregivers of Older Adults
- ClinicalTrials.gov ID
- NCT06507826
- Acronym / sponsor ID
- 2021-193-AH
- Conditions
- Self-Compassion, Control
- Keywords
- Mindfulness, Self-kindness, Common humanity, Self-compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Farah WiitaUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After being informed and consenting to participate in the study, participants were allocated to a self-compassion or control condition. The study was designed to target state self-compassion and mood. The research was carried out over three studies, with refinements being made each time based on previous outcomes. In Studies 1 and 2, participants were tested for self-compassion and mood (guilt, sadness, and serenity). after the writing tasks. In Study 3, participants were asked to complete measures for these both before and after the writing tasks. The experiments were carried out online for all three studies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Self-Compassionate Writing for Caregivers of Older AdultsDescriptive writing. |
| Mindfulness | Active comparator | Behavioral: Self-Compassionate Writing for Caregivers of Older AdultsWriting with mindfulness. |
| Mindfulness with Self-Kindness | Active comparator | Behavioral: Self-Compassionate Writing for Caregivers of Older AdultsWriting with mindfulness and self-kindness. |
| Mindfulness with Common Humanity | Active comparator | Behavioral: Self-Compassionate Writing for Caregivers of Older AdultsWriting with mindfulness and common humanity. |
| Control with Timed Response | Placebo comparator | Behavioral: Self-Compassionate Writing for Caregivers of Older AdultsDescriptive writing. |
| Mindfulness with Timed Response | Active comparator | Behavioral: Self-Compassionate Writing for Caregivers of Older AdultsWriting with mindfulness. |
| Self-Kindness with Timed Response | Active comparator | Behavioral: Self-Compassionate Writing for Caregivers of Older AdultsWriting with self-kindness. |
| Common Humanity with Timed Response | Active comparator | Behavioral: Self-Compassionate Writing for Caregivers of Older AdultsWriting with common humanity. |
| Revised Control | Placebo comparator | Behavioral: Self-Compassionate Writing for Caregivers of Older AdultsDescriptive writing. |
| Self-Compassion | Active comparator | Behavioral: Self-Compassionate Writing for Caregivers of Older AdultsWriting with mindfulness, self-kindness, and common humanity. |
| Self-Compassion Without Mindfulness | Active comparator | Behavioral: Self-Compassionate Writing for Caregivers of Older AdultsWriting with self-kindness and common humanity. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Family carer.
- Caring for a person over 65 years of age.
- Participants over 18 years of age.
Key exclusion criteria (3 listed)
- Professional carers.
- Caring person under 65 years of age.
- Participants under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Compassionate Writing for Caregivers of Older AdultsSelf-compassionate writing focusing on one or more self-compassion components (mindfulness, self-kindness, common humanity). | Behavioural | Common Humanity with Timed Response, Control, Control with Timed Response, Mindfulness, Mindfulness with Common Humanity, Mindfulness with Self-Kindness, Mindfulness with Timed Response, Revised Control, Self-Compassion, Self-Compassion Without Mindfulness, Self-Kindness with Timed Response |
Primary outcome
Self-kindness measured with the State Self-Compassion Scale (Neff et al., 2021)
Time frame: State measured immediately after intervention
Scores closer to 5 expected on a scale of 1 to 5
Common humanity measured with the State Self-Compassion Scale (Neff et al., 2021)
Time frame: State measured immediately after intervention
Scores closer to 5 expected on a scale of 1 to 5
Mindfulness measured with the State Self-Compassion Scale (Neff et al., 2021)
Time frame: State measured immediately after intervention
Scores closer to 5 expected on a scale of 1 to 5
3 secondary outcomes
Guilt measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999)
Time frame: State measured immediately after intervention
Sadness measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999)
Time frame: State measured immediately after intervention
Serenity measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999)
Time frame: State measured immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Results publicationNeff, 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.
- Results publicationWatson, David & Clark, Lee. (1999). The PANAS-X: Manual for the positive and negative affect schedule-expanded form. Psychology Publications.
- Individual participant dataSharing planned: Yes. Anonymised data to be made available on OSF.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aileen K Ho, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Compassionate Writing for Caregivers of Older Adults in people with Self-Compassion and Control, run by Farah Wiita at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-kindness measured with the State Self-Compassion Scale (Neff et al., 2021) (time frame: State measured immediately after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06507826, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.