Clinical trial NCT02217735: Expressive Writing for Individuals With Parkinson's Disease and Their Caregivers
Official title: Randomized Controlled Expressive Writing Pilot in Individuals With Parkinson's Disease and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Coping Skills
Keywords: Parkinson's Disease
Caregivers
Expressive Writing
Complementary Medicine
Cortisol
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Parkinson's Disease Quality of Life (PDQ-39)
timeFrame: Baseline to immediate post
Secondary outcomes:
measure: Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
timeFrame: Immediate post to 4-month follow up
measure: Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
timeFrame: 4 month follow up to 10 month follow up
Other outcomes:
measure: Expressive Writing
timeFrame: three samples collected during the intervention period (which occurs between baseline and immediate post assessments)
Locations:
city: Richmond
country: United States
facility: VCU Parkinson's and Movement Disorders Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Sarah K. Lageman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: James P. Bennett, M.D., Ph.D.
role: STUDY_CHAIR
References:
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.