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Written Disclosure Therapy for Anxiety and Stress in Patients With Chronic Lung Disease

Primary Purpose

Chronic Lung Diseases, COPD, Pulmonary Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Disclosure Writing (Written Disclosure Therapy)
Neutral (Sham) Writing
Sponsored by
Winthrop University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lung Diseases focused on measuring Dyspnea, Written Disclosure Therapy, COPD, Pulmonary Fibrosis, Chronic Lung Diseases, Pulmonary Rehabilitation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of COPD or Pulmonary Fibrosis
  • First time participants in Pulmonary Rehabilitation program

Exclusion Criteria:

  • Dementia
  • Prior significant psychiatric illness
  • Inability to complete the questionnaires
  • Inability cooperate with spirometry
  • Inability or to participate in outpatient follow-up over the six-month

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Written Disclosure Therapy

    Controls

    Arm Description

    Outcomes

    Primary Outcome Measures

    Dyspnea and quality of life

    Secondary Outcome Measures

    Six-minute walk distance
    Spirometry values (FEV1 and FVC)

    Full Information

    First Posted
    May 29, 2009
    Last Updated
    June 1, 2009
    Sponsor
    Winthrop University Hospital
    Collaborators
    Stony Wold-Herbert Fund, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00911794
    Brief Title
    Written Disclosure Therapy for Anxiety and Stress in Patients With Chronic Lung Disease
    Official Title
    Pulmonary Therapy and Supplemental Written Disclosure Therapy for Chronic Lung Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Winthrop University Hospital
    Collaborators
    Stony Wold-Herbert Fund, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Written Disclosure Therapy (WDT) is of any benefit to patients with chronic lung diseases who are participating in pulmonary rehabilitation.
    Detailed Description
    Chronic lung diseases are typically associated with impaired quality of life, stress, and anxiety. Written disclosure therapy (WDT) reduces stress in patients with a variety of chronic illnesses. We sought to determine if written disclosure therapy benefits patients with chronic lung diseases when it is added as a component to the pulmonary rehabilitation program.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Lung Diseases, COPD, Pulmonary Fibrosis
    Keywords
    Dyspnea, Written Disclosure Therapy, COPD, Pulmonary Fibrosis, Chronic Lung Diseases, Pulmonary Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Written Disclosure Therapy
    Arm Type
    Experimental
    Arm Title
    Controls
    Arm Type
    Sham Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Disclosure Writing (Written Disclosure Therapy)
    Other Intervention Name(s)
    Written Disclosure Therapy
    Intervention Description
    Patients write about a stressful life experience
    Intervention Type
    Other
    Intervention Name(s)
    Neutral (Sham) Writing
    Other Intervention Name(s)
    Sham Writing (Controls that wrote about neutral subjects)
    Intervention Description
    Patients write about neutral subjects
    Primary Outcome Measure Information:
    Title
    Dyspnea and quality of life
    Time Frame
    Two-month and six-month time
    Secondary Outcome Measure Information:
    Title
    Six-minute walk distance
    Time Frame
    Two-month and six-month time
    Title
    Spirometry values (FEV1 and FVC)
    Time Frame
    Two-month and six-month time

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of COPD or Pulmonary Fibrosis First time participants in Pulmonary Rehabilitation program Exclusion Criteria: Dementia Prior significant psychiatric illness Inability to complete the questionnaires Inability cooperate with spirometry Inability or to participate in outpatient follow-up over the six-month
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adam Hurewitz, M.D.
    Organizational Affiliation
    Winthrop University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Written Disclosure Therapy for Anxiety and Stress in Patients With Chronic Lung Disease

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