NCT02217735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

August 13, 2014

Last Update Submit

October 30, 2023

Conditions

Parkinson's DiseaseCoping Skills

Keywords

Parkinson's DiseaseCaregiversExpressive WritingComplementary MedicineCortisol

Outcome Measures

Primary Outcomes (1)

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

    Baseline to immediate post

Secondary Outcomes (2)

  • 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

Other Outcomes (1)

  • Expressive Writing

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

Study Arms (2)

Writing Intervention - Expressive Arm

EXPERIMENTAL

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

Writing Intervention - Neutral Arm

ACTIVE COMPARATOR

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

Behavioral: Writing Intervention

Interventions

Writing InterventionBEHAVIORAL

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 - Expressive ArmWriting Intervention - Neutral Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Parkinson's Disease Caregiver of an individual with Parkinson's Disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VCU Parkinson's and Movement Disorders Center

Richmond, Virginia, 23230, United States

Location

Related Publications (1)

  • 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.

    PMID: 26621025DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Sarah K. Lageman, Ph.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

  • James P. Bennett, M.D., Ph.D.

    Virginia Commonwealth University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 15, 2014

Study Start

August 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

US(1)