Expressive Writing for Individuals With Parkinson's Disease and Their Caregivers

Parkinson's Disease Clinical Trial

— PDEWS  

Official title:

Randomized Controlled Expressive Writing Pilot in Individuals With Parkinson's Disease and Their Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217735
• Other study ID #: HM#13659
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: October 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, controlled trial (RCT) evaluates the benefits of expressive compared to neutral writing in individuals with Parkinson's Disease and their support persons. Participants will be randomly assigned to complete three, 20 minute sessions of expressive or neutral writing. Participants will complete evaluation of outcomes at baseline, immediate post, 4 month and 10 month follow ups to establish if benefits remain over time. Impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. Expressive writing is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the neutral writing condition.

Results from this study will determine whether brief writing exercises are easily used by and beneficial for individuals with Parkinson's Disease and their support persons. If positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with Parkinson's Disease and their support persons.

Description:

The expressive writing condition asks participants to write about the most stressful or traumatic experience of their entire lives over three, 20 minute private writing sessions. The neutral control writing conditions asks participants to write about how they spent their time the day before.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Clinical diagnosis of Parkinson's Disease Caregiver of an individual with Parkinson's Disease

Exclusion Criteria:

Clinical diagnosis of Dementia Clinical diagnosis of other Parkinson's Disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing

Related Conditions & MeSH terms

• Coping Skills
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Writing Intervention
Participants wrote for 20 minutes on three occasions about an emotional or traumatic topic (expressive writing intervention condition) or what they did the day before, while refraining from including emotional details.

Locations

Country	Name	City	State
United States	VCU Parkinson's and Movement Disorders Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expressive Writing	The three writing samples from each participant in the Expressive Arm will be qualitatively examined for themes about traumatic events.	three samples collected during the intervention period (which occurs between baseline and immediate post assessments)
Primary	Parkinson's Disease Quality of Life (PDQ-39)		Baseline to immediate post
Secondary	Parkinson's Disease Quality of Life Questionnaire (PDQ-39)		Immediate post to 4-month follow up
Secondary	Parkinson's Disease Quality of Life Questionnaire (PDQ-39)		4 month follow up to 10 month follow up