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

Overview

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.

Full Title of Study: “Randomized Controlled Expressive Writing Pilot in Individuals With Parkinson’s Disease and Their Caregivers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2013

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Writing Intervention – Expressive Arm
    • Participants are asked to write about the most traumatic or stressful experience of their entire lives in three, 20 minute writing sessions.
  • Active Comparator: Writing Intervention – Neutral Arm
    • Participants are asked to write about what they did the day before, refraining from including emotional details.

Clinical Trial Outcome Measures

Primary Measures

  • Parkinson’s Disease Quality of Life (PDQ-39)
    • Time Frame: Baseline to immediate post

Secondary Measures

  • Parkinson’s Disease Quality of Life Questionnaire (PDQ-39)
    • Time Frame: Immediate post to 4-month follow up
  • Parkinson’s Disease Quality of Life Questionnaire (PDQ-39)
    • Time Frame: 4 month follow up to 10 month follow up

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Virginia Commonwealth University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sarah K. Lageman, Ph.D., Principal Investigator, Virginia Commonwealth University
    • James P. Bennett, M.D., Ph.D., Study Chair, Virginia Commonwealth University

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