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Trial record 1 of 1 for:    NCT02217735
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Expressive Writing for Individuals With Parkinson's Disease and Their Caregivers (PDEWS)

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ClinicalTrials.gov Identifier: NCT02217735
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Coping Skills Behavioral: Writing Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Expressive Writing Pilot in Individuals With Parkinson's Disease and Their Caregivers
Study Start Date : August 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

Active Comparator: Writing Intervention - Neutral Arm
Participants are asked to write about what they did the day before, refraining from including emotional details.
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.




Primary Outcome Measures :
  1. Parkinson's Disease Quality of Life (PDQ-39) [ Time Frame: Baseline to immediate post ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217735


Locations
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United States, Virginia
VCU Parkinson's and Movement Disorders Center
Richmond, Virginia, United States, 23230
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Sarah K. Lageman, Ph.D. Virginia Commonwealth University
Study Chair: James P. Bennett, M.D., Ph.D. Virginia Commonwealth University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02217735    
Other Study ID Numbers: HM#13659
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014
Keywords provided by Virginia Commonwealth University:
Parkinson's Disease
Caregivers
Expressive Writing
Complementary Medicine
Cortisol
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases