Written Disclosure Therapy for Anxiety and Stress in Pati... | NCT00911794

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

NCT00911794

Sponsor

Winthrop University Hospital

Status

Completed

Last Update Posted

Jun 2, 2009Estimated

Enrollment

66Actual

Phase

Not Applicable

Conditions

Chronic Lung Diseases
COPD
Pulmonary Fibrosis

Interventions

Disclosure Writing (Written Disclosure Therapy)
Neutral (Sham) Writing

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Mar 2009Actual

First Submitted Date

May 29, 2009

First Submission Date that Met QC Criteria

Jun 1, 2009

First Posted Date

Jun 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2009

Last Update Posted Date

Jun 2, 2009Estimated

Name	Class
Stony Wold-Herbert Fund, Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Written Disclosure Therapy	Experimental		Other: Disclosure Writing (Written Disclosure Therapy)
Controls	Sham Comparator		Other: Neutral (Sham) Writing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Disclosure Writing (Written Disclosure Therapy)	Other	Patients write about a stressful life experience	Written Disclosure Therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam Hurewitz, M.D.	Winthrop University Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D011658	Pulmonary Fibrosis
D004417	Dyspnea

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C005703	salicylhydroxamic acid

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided