NCT07804953

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
Last Updated

September 4, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 27, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

feasibilityguided-writingself-compassiononlineInformal caregiversParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • State and Trait Anxiety Inventory

    20-item measure

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

Other Outcomes (3)

  • Self-compassion Scale

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

  • Emotional Regulation Questionnaire

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

  • Positive and Negative Affect Scale-Extended version

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

Study Arms (1)

Experience intervention

OTHER

All caregiver's experienced the intervention

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

Interventions

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

Experience intervention

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Psychology and Clinical Language Sciences

Reading, RG6 6ES, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Aileen K Ho, PhD

    University of Reading

    STUDY DIRECTOR
  • Jacqueline Sin, PhD

    The Hong Kong Polytechnic University

    STUDY DIRECTOR
  • Neil Boyt, MSc

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 4, 2026

Study Start

April 30, 2024

Primary Completion

March 31, 2025

Study Completion

September 30, 2025

Last Updated

September 4, 2026

Record last verified: 2026-08

Locations