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Completed

NCT Number: NCT07804953

Testing the Feasibility of an Online Guided-writing Intervention Designed 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.

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Key information

Conditions

Psychological Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Psychology and Clinical Language Sciences

Reading, RG6 6ES, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

An online guided-writing intervention that uses guidance based on self-compassion principles

Behavioral

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

Primary outcomes

  1. 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

Other outcomes

  1. Self-compassion Scale

    Time frame: Pre- and post-intervention; which is completion of the four intervention exercises, an average of 20 days; two-week follow-up

    Neff's 26 item scale

  2. Emotional Regulation Questionnaire

    Time frame: Pre- and post-intervention, which is completion of the four intervention exercises, an average of 20 days; two-week follow-up

    ten-item version

  3. Positive and Negative Affect Scale-Extended version

    Time frame: Pre- and post-intervention, which is completion of the four intervention exercises, an average of 20 days; two-week follow-up

    Guilt and Serenity subscales only

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

Single-group Feasibility Study and Process Evaluation of a Guided Reflective Writing Intervention for Informal Caregivers of People With Parkinson's Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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