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

NCT ID: NCT02217735

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-06-30

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.

Conditions

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Parkinson's Disease Coping Skills

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Writing Intervention

Intervention Type 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.

Writing Intervention - Neutral Arm

Participants are asked to write about what they did the day before, refraining from including emotional details.

Group Type ACTIVE_COMPARATOR

Writing Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah K. Lageman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

James P. Bennett, M.D., Ph.D.

Role: STUDY_CHAIR

Virginia Commonwealth University

Locations

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VCU Parkinson's and Movement Disorders Center

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26621025 (View on PubMed)

Other Identifiers

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HM#13659

Identifier Type: -

Identifier Source: org_study_id

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