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

This study has been completed.
Sponsor:
Collaborator:
Stony Wold-Herbert Fund, Inc.
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00911794
First received: May 29, 2009
Last updated: June 1, 2009
Last verified: June 2009
  Purpose

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 Intervention
Chronic Lung Diseases
COPD
Pulmonary Fibrosis
Other: Disclosure Writing (Written Disclosure Therapy)
Other: Neutral (Sham) Writing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulmonary Therapy and Supplemental Written Disclosure Therapy for Chronic Lung Disease

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Dyspnea and quality of life [ Time Frame: Two-month and six-month time ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Six-minute walk distance [ Time Frame: Two-month and six-month time ] [ Designated as safety issue: No ]
  • Spirometry values (FEV1 and FVC) [ Time Frame: Two-month and six-month time ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: January 2007
Study Completion Date: March 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911794

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

No publications provided

Responsible Party: Adam Hurewitz M.D., Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT00911794     History of Changes
Other Study ID Numbers: 07300
Study First Received: May 29, 2009
Last Updated: June 1, 2009
Health Authority: United States: Institutional Review Board

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 Disease, Chronic Obstructive
Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on August 28, 2014