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Completed

NCT Number: NCT02217735

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Coping Skills Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VCU Parkinson's and Movement Disorders Center

Richmond, Virginia, 23230, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Writing Intervention

Behavioral

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 outcomes

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

    Time frame: Baseline to immediate post

Secondary outcomes

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

    Time frame: Immediate post to 4-month follow up

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

    Time frame: 4 month follow up to 10 month follow up

Other outcomes

  1. Expressive Writing

    Time frame: three samples collected during the intervention period (which occurs between baseline and immediate post assessments)

    The three writing samples from each participant in the Expressive Arm will be qualitatively examined for themes about traumatic events.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Acronym: PDEWS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 15, 2014
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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