PsychologicalNCT07804953
Testing the Feasibility of an Online Guided-writing Intervention Designed for Informal Caregivers of People With Parkinson's Disease
A study testing An online guided-writing intervention that uses guidance based on self-compassion principles in people with Psychological, run by University of Reading at 1 site in United Kingdom.
Trial summary
When informal caregivers of people with Parkinson's disease treat themselves harshly, they can experience psychological distress. To help them show themselves the same kindness and understanding that they would show another person in the same situation, we developed an online guided-writing intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological
- What is being tested?
- An online guided-writing intervention that uses guidance based on self-compassion principles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2024to 30 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: provides unpaid, community-based and non-institutional care to a person with Parkinson's disease -
Exclusion Criteria: paid and/or professional caregivers, or those providing care to someone in an institutional setting
-
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Psychology and Clinical Language Sciences
Reading, RG6 6ES
About this study
Official title: Single-group Feasibility Study and Process Evaluation of a Guided Reflective Writing Intervention for Informal Caregivers of People With Parkinson's Disease
When informal caregivers of people with Parkinson's disease treat themselves harshly, they can experience psychological distress. To help them show themselves the same kindness and understanding that they would show another person in the same situation, we developed an online guided-writing intervention. This involved submitting four writing exercises where they first described a difficult situation, then wrote about how a compassionate other would respond to them during that challenge. The goal of this feasibility study was to learn if caregivers could complete the full intervention alongside providing care. We also interviewed some of those caregivers who completed the full intervention about their experiences of writing and submitting exercises.
Read the detailed description
All quantitative data collection, alongside writing-exercise completion, was hosted by REDCap, a secure online platform. After providing online consent and setting their login details, caregivers completed a demographic questionnaire and pre-intervention outcome measures. This facilitated access to the first writing exercise. If the caregiver had not started this or any of the later exercises within three days of receiving the link, they received an automated reminder. If they did not access the exercise for another three and six days, they received further reminders. For each exercise, they saw a brief description of self-compassion, followed by writing guidance that was individual to that exercise. Caregivers were encouraged to write for at least 15 minutes but had limitless use of a 'save and return' function, which also had no maximum time-limit for returning. Submitting an exercise triggered next-day receipt of the link to the proceeding exercise, whilst submitting the fourth exercise led straight to the post-intervention outcome measures. These concluded with a question about whether they would take part in a semi-structured interview to discuss their experiences. All interviews were hosted, recorded and transcribed using MS Teams. Caregivers answered pre-determined questions, with flexibility for follow-up questions dependent on their answers. Post-interview, transcripts were downloaded and corrected for errors prior to analysis. All caregivers also received a link to follow-up measures two weeks after completing the intervention. At the end of the study, quantitative data was downloaded from REDCap in excel format and prepared for analysis.
- Conditions
- Psychological
- Being tested
- An online guided-writing intervention that uses guidance based on self-compassion principles
- Keywords
- feasibility, guided-writing, self-compassion, online, Informal caregivers, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An online guided-writing intervention that uses guidance based on self-compassion principlesBehavioural
Four writing exercises that can be completed at the caregiver's convenience, albeit a maximum of one exercise per day. Caregivers can also use a 'save and return function' so do not have to write continuously and complete in one sitting
| Study group | Role | What they receive |
|---|---|---|
| Experience intervention | Other | All caregiver's experienced the intervention Receives: Behavioral: An online guided-writing intervention that uses guidance based on self-compassion principles |
What is being measured
The primary outcome is the main question the study is designed to answer.
State and Trait Anxiety Inventory
20-item measure
Measured: Pre- and post-intervention; which is completion of the four intervention exercises, an average of 20 days; two-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start30 Apr 2024
- Primary completion31 Mar 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychologicalStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Boyt, University of Reading
- Investigators
- Aileen K Ho, PhD, Study director, University of ReadingJacqueline Sin, PhD, Study director, The Hong Kong Polytechnic UniversityNeil Boyt, MSc, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804953
- Sponsor's protocol ID
- 2024-086-AH
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-group Feasibility Study and Process Evaluation of a Guided Reflective Writing Intervention for Informal Caregivers of People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07804953
- Acronym / sponsor ID
- 2024-086-AH
- Conditions
- Psychological
- Keywords
- feasibility, guided-writing, self-compassion, online, Informal caregivers, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 4 Sep 2026 (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.
When informal caregivers of people with Parkinson's disease treat themselves harshly, they can experience psychological distress. To help them show themselves the same kindness and understanding that they would show another person in the same situation, we developed an online guided-writing intervention. This involved submitting four writing exercises where they first described a difficult situation, then wrote about how a compassionate other would respond to them during that challenge. The goal of this feasibility study was to learn if caregivers could complete the full intervention alongside providing care. We also interviewed some of those caregivers who completed the full intervention about their experiences of writing and submitting exercises.
Detailed description
All quantitative data collection, alongside writing-exercise completion, was hosted by REDCap, a secure online platform. After providing online consent and setting their login details, caregivers completed a demographic questionnaire and pre-intervention outcome measures. This facilitated access to the first writing exercise. If the caregiver had not started this or any of the later exercises within three days of receiving the link, they received an automated reminder. If they did not access the exercise for another three and six days, they received further reminders. For each exercise, they saw a brief description of self-compassion, followed by writing guidance that was individual to that exercise. Caregivers were encouraged to write for at least 15 minutes but had limitless use of a 'save and return' function, which also had no maximum time-limit for returning. Submitting an exercise triggered next-day receipt of the link to the proceeding exercise, whilst submitting the fourth exercise led straight to the post-intervention outcome measures. These concluded with a question about whether they would take part in a semi-structured interview to discuss their experiences. All interviews were hosted, recorded and transcribed using MS Teams. Caregivers answered pre-determined questions, with flexibility for follow-up questions dependent on their answers. Post-interview, transcripts were downloaded and corrected for errors prior to analysis. All caregivers also received a link to follow-up measures two weeks after completing the intervention. At the end of the study, quantitative data was downloaded from REDCap in excel format and prepared for analysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experience intervention | Other | Behavioral: An online guided-writing intervention that uses guidance based on self-compassion principlesAll caregiver's experienced the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| An online guided-writing intervention that uses guidance based on self-compassion principlesFour writing exercises that can be completed at the caregiver's convenience, albeit a maximum of one exercise per day. Caregivers can also use a 'save and return function' so do not have to write continuously and complete in one sitting | Behavioural | Experience intervention |
Primary outcome
State and Trait Anxiety Inventory
Time frame: Pre- and post-intervention; which is completion of the four intervention exercises, an average of 20 days; two-week follow-up
20-item measure
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 4 Sep 2026.
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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 study director
University of Reading
Jacqueline Sin, PhD study director
The Hong Kong Polytechnic University
Neil Boyt, MSc 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 An online guided-writing intervention that uses guidance based on self-compassion principles in people with Psychological, run by University of Reading 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?
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 4 Sep 2026. 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. 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?
State and Trait Anxiety Inventory (time frame: Pre- and post-intervention; which is completion of the four intervention exercises, an average of 20 days; two-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.