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

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ClinicalTrials.gov Identifier: NCT00911794
Recruitment Status : Completed
First Posted : June 2, 2009
Last Update Posted : June 2, 2009
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment
Chronic Lung Diseases COPD Pulmonary Fibrosis Other: Disclosure Writing (Written Disclosure Therapy) Other: Neutral (Sham) Writing

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pulmonary Therapy and Supplemental Written Disclosure Therapy for Chronic Lung Disease
Study Start Date : January 2007
Primary Completion Date : January 2008
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Written Disclosure Therapy Other: Disclosure Writing (Written Disclosure Therapy)
Patients write about a stressful life experience
Other Name: Written Disclosure Therapy
Sham Comparator: Controls Other: Neutral (Sham) Writing
Patients write about neutral subjects
Other Name: Sham Writing (Controls that wrote about neutral subjects)


Outcome Measures

Primary Outcome Measures :
  1. Dyspnea and quality of life [ Time Frame: Two-month and six-month time ]

Secondary Outcome Measures :
  1. Six-minute walk distance [ Time Frame: Two-month and six-month time ]
  2. Spirometry values (FEV1 and FVC) [ Time Frame: Two-month and six-month time ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911794


Sponsors and Collaborators
Winthrop University Hospital
Stony Wold-Herbert Fund, Inc.
Investigators
Principal Investigator: Adam Hurewitz, M.D. Winthrop University Hospital
More Information

Responsible Party: Adam Hurewitz M.D., Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT00911794     History of Changes
Other Study ID Numbers: 07300
First Posted: June 2, 2009    Key Record Dates
Last Update Posted: June 2, 2009
Last Verified: June 2009

Keywords provided by Winthrop University Hospital:
Dyspnea
Written Disclosure Therapy
COPD
Pulmonary Fibrosis
Chronic Lung Diseases
Pulmonary Rehabilitation

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases