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

COPD Clinical Trial

Official title:

Pulmonary Therapy and Supplemental Written Disclosure Therapy for Chronic Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911794
• Other study ID #: 07300
• Status: Completed
• Phase: N/A
• First received: May 29, 2009
• Last updated: June 1, 2009
• Start date: January 2007
• Est. completion date: March 2009

Study information

• Verified date: June 2009
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lung Diseases
• COPD
• Lung Diseases
• Pulmonary Fibrosis

Intervention

Other:
• Disclosure Writing (Written Disclosure Therapy)
Patients write about a stressful life experience
• Neutral (Sham) Writing
Patients write about neutral subjects

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Winthrop University Hospital	Stony Wold-Herbert Fund, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea and quality of life		Two-month and six-month time	No
Secondary	Six-minute walk distance		Two-month and six-month time	No
Secondary	Spirometry values (FEV1 and FVC)		Two-month and six-month time	No