<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02217735</url>
  </required_header>
  <id_info>
    <org_study_id>HM#13659</org_study_id>
    <nct_id>NCT02217735</nct_id>
  </id_info>
  <brief_title>Expressive Writing for Individuals With Parkinson's Disease and Their Caregivers</brief_title>
  <acronym>PDEWS</acronym>
  <official_title>Randomized Controlled Expressive Writing Pilot in Individuals With Parkinson's Disease and Their Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized, controlled trial (RCT) evaluates the benefits of expressive compared to&#xD;
      neutral writing in individuals with Parkinson's Disease and their support persons.&#xD;
      Participants will be randomly assigned to complete three, 20 minute sessions of expressive or&#xD;
      neutral writing. Participants will complete evaluation of outcomes at baseline, immediate&#xD;
      post, 4 month and 10 month follow ups to establish if benefits remain over time. Impact of&#xD;
      these therapies on thinking abilities, physical health, and patient and support person&#xD;
      ratings of thinking skills, mood and quality of life will be evaluated. Expressive writing is&#xD;
      hypothesized to result in greater improvements and/or stability of function on&#xD;
      neuropsychological tests of attention, working memory, learning, and memory skills compared&#xD;
      to the neutral writing condition.&#xD;
&#xD;
      Results from this study will determine whether brief writing exercises are easily used by and&#xD;
      beneficial for individuals with Parkinson's Disease and their support persons. If positive&#xD;
      benefit is observed, information from this study will be used to further optimize these&#xD;
      therapies for larger trials designed to evaluate the value of the therapies for individuals&#xD;
      with Parkinson's Disease and their support persons.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The expressive writing condition asks participants to write about the most stressful or&#xD;
      traumatic experience of their entire lives over three, 20 minute private writing sessions.&#xD;
      The neutral control writing conditions asks participants to write about how they spent their&#xD;
      time the day before.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parkinson's Disease Quality of Life (PDQ-39)</measure>
    <time_frame>Baseline to immediate post</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parkinson's Disease Quality of Life Questionnaire (PDQ-39)</measure>
    <time_frame>Immediate post to 4-month follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parkinson's Disease Quality of Life Questionnaire (PDQ-39)</measure>
    <time_frame>4 month follow up to 10 month follow up</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Expressive Writing</measure>
    <time_frame>three samples collected during the intervention period (which occurs between baseline and immediate post assessments)</time_frame>
    <description>The three writing samples from each participant in the Expressive Arm will be qualitatively examined for themes about traumatic events.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Parkinson's Disease</condition>
  <condition>Coping Skills</condition>
  <arm_group>
    <arm_group_label>Writing Intervention - Expressive Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are asked to write about the most traumatic or stressful experience of their entire lives in three, 20 minute writing sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Writing Intervention - Neutral Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are asked to write about what they did the day before, refraining from including emotional details.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Writing Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Writing Intervention - Expressive Arm</arm_group_label>
    <arm_group_label>Writing Intervention - Neutral Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of Parkinson's Disease Caregiver of an individual with Parkinson's&#xD;
        Disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of Dementia Clinical diagnosis of other Parkinson's Disease-associated&#xD;
        comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or&#xD;
        psychosis) that significantly influence cognitive testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah K. Lageman, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James P. Bennett, M.D., Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VCU Parkinson's and Movement Disorders Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 17, 2014</last_update_submitted>
  <last_update_submitted_qc>August 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>Caregivers</keyword>
  <keyword>Expressive Writing</keyword>
  <keyword>Complementary Medicine</keyword>
  <keyword>Cortisol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02217735
org study id: HM#13659
nct id: NCT02217735
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Parkinson's Disease Quality of Life (PDQ-39)
time frame: Baseline to immediate post
measure: Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
time frame: Immediate post to 4-month follow up
measure: Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
time frame: 4 month follow up to 10 month follow up
measure: Expressive Writing
time frame: three samples collected during the intervention period (which occurs between baseline and immediate post assessments)
description: The three writing samples from each participant in the Expressive Arm will be qualitatively examined for themes about traumatic events.
arm group label: Writing Intervention - Expressive Arm
arm group type: Experimental
description: Participants are asked to write about the most traumatic or stressful experience of their entire lives in three, 20 minute writing sessions.
arm group label: Writing Intervention - Neutral Arm
arm group type: Active Comparator
description: Participants are asked to write about what they did the day before, refraining from including emotional details.
intervention type: Behavioral
intervention name: Writing Intervention
description: 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.
arm group label: Writing Intervention - Expressive Arm
arm group label: Writing Intervention - Neutral Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah K. Lageman, Ph.D.
role: Principal Investigator
affiliation: Virginia Commonwealth University
last name: James P. Bennett, M.D., Ph.D.
role: Study Chair
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease