Expressive Writing for Individuals With Parkinson's Disease and Their Caregivers
PDEWS
Randomized Controlled Expressive Writing Pilot in Individuals With Parkinson's Disease and Their Caregivers
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
Typical duration for not_applicable
1 active site
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
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 13, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedOctober 31, 2023
October 1, 2023
1.8 years
August 13, 2014
October 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parkinson's Disease Quality of Life (PDQ-39)
Baseline to immediate post
Secondary Outcomes (2)
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Immediate post to 4-month follow up
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
4 month follow up to 10 month follow up
Other Outcomes (1)
Expressive Writing
three samples collected during the intervention period (which occurs between baseline and immediate post assessments)
Study Arms (2)
Writing Intervention - Expressive Arm
EXPERIMENTALParticipants are asked to write about the most traumatic or stressful experience of their entire lives in three, 20 minute writing sessions.
Writing Intervention - Neutral Arm
ACTIVE COMPARATORParticipants are asked to write about what they did the day before, refraining from including emotional details.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Parkinson's Disease Caregiver of an individual with Parkinson's Disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VCU Parkinson's and Movement Disorders Center
Richmond, Virginia, 23230, United States
Related Publications (1)
Cash TV, Lageman SK. Randomized controlled expressive writing pilot in individuals with Parkinson's disease and their caregivers. BMC Psychol. 2015 Nov 30;3:44. doi: 10.1186/s40359-015-0101-4.
PMID: 26621025DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah K. Lageman, Ph.D.
Virginia Commonwealth University
- STUDY CHAIR
James P. Bennett, M.D., Ph.D.
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2014
First Posted
August 15, 2014
Study Start
August 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
October 31, 2023
Record last verified: 2023-10