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

Primary Purpose

Parkinson's Disease, Coping Skills

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Writing Intervention
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Caregivers, Expressive Writing, Complementary Medicine, Cortisol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VCU Parkinson's and Movement Disorders Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Writing Intervention - Expressive Arm

Writing Intervention - Neutral Arm

Arm Description

Participants are asked to write about the most traumatic or stressful experience of their entire lives in three, 20 minute writing sessions.

Participants are asked to write about what they did the day before, refraining from including emotional details.

Outcomes

Primary Outcome Measures

Parkinson's Disease Quality of Life (PDQ-39)

Secondary Outcome Measures

Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)

Full Information

First Posted
August 13, 2014
Last Updated
August 17, 2014
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT02217735
Brief Title
Expressive Writing for Individuals With Parkinson's Disease and Their Caregivers
Acronym
PDEWS
Official Title
Randomized Controlled Expressive Writing Pilot in Individuals With Parkinson's Disease and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Coping Skills
Keywords
Parkinson's Disease, Caregivers, Expressive Writing, Complementary Medicine, Cortisol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Writing Intervention - Expressive Arm
Arm Type
Experimental
Arm Description
Participants are asked to write about the most traumatic or stressful experience of their entire lives in three, 20 minute writing sessions.
Arm Title
Writing Intervention - Neutral Arm
Arm Type
Active Comparator
Arm Description
Participants are asked to write about what they did the day before, refraining from including emotional details.
Intervention Type
Behavioral
Intervention Name(s)
Writing Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parkinson's Disease Quality of Life (PDQ-39)
Time Frame
Baseline to immediate post
Secondary Outcome Measure Information:
Title
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Time Frame
Immediate post to 4-month follow up
Title
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Time Frame
4 month follow up to 10 month follow up
Other Pre-specified Outcome Measures:
Title
Expressive Writing
Description
The three writing samples from each participant in the Expressive Arm will be qualitatively examined for themes about traumatic events.
Time Frame
three samples collected during the intervention period (which occurs between baseline and immediate post assessments)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah K. Lageman, Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James P. Bennett, M.D., Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Chair
Facility Information:
Facility Name
VCU Parkinson's and Movement Disorders Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26621025
Citation
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.
Results Reference
derived

Learn more about this trial

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

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