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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson's Disease, Coping Skills

Intervention / Treatment
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* Behavioral: Writing Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Writing Intervention - Expressive Arm<br>Participants are asked to write about the most traumatic or stressful experience of their entire lives in three, 20 minute writing sessions. | Behavioral: Writing Intervention<br>* 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.<br>|
| Active Comparator: Writing Intervention - Neutral Arm<br>Participants are asked to write about what they did the day before, refraining from including emotional details. | Behavioral: Writing Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson's Disease Quality of Life (PDQ-39) |  | Baseline to immediate post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Caregivers, Expressive Writing, Complementary Medicine, Cortisol