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

June 1, 2009 updated by: Winthrop University Hospital

Pulmonary Therapy and Supplemental Written Disclosure Therapy for Chronic Lung Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Controls
Other: Neutral (Sham) Writing
Patients write about neutral subjects
Other Names:
  • Sham Writing (Controls that wrote about neutral subjects)
Experimental: Written Disclosure Therapy
Other: Disclosure Writing (Written Disclosure Therapy)
Patients write about a stressful life experience
Other Names:
  • Written Disclosure Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dyspnea and quality of life
Time Frame: Two-month and six-month time
Two-month and six-month time

Secondary Outcome Measures

Outcome Measure
Time Frame
Six-minute walk distance
Time Frame: Two-month and six-month time
Two-month and six-month time
Spirometry values (FEV1 and FVC)
Time Frame: Two-month and six-month time
Two-month and six-month time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Winthrop University Hospital

Collaborators

Stony Wold-Herbert Fund, Inc.

Investigators

  • Principal Investigator: Adam Hurewitz, M.D., Winthrop University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

June 1, 2009

First Posted (Estimate)

June 2, 2009

Study Record Updates

Last Update Posted (Estimate)

June 2, 2009

Last Update Submitted That Met QC Criteria

June 1, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07300

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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