NCT00911794

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2009

Completed
Last Updated

June 2, 2009

Status Verified

June 1, 2009

Enrollment Period

1 year

First QC Date

May 29, 2009

Last Update Submit

June 1, 2009

Conditions

Chronic Lung DiseasesCOPDPulmonary Fibrosis

Keywords

DyspneaWritten Disclosure TherapyCOPDPulmonary FibrosisChronic Lung DiseasesPulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Dyspnea and quality of life

    Two-month and six-month time

Secondary Outcomes (2)

  • Six-minute walk distance

    Two-month and six-month time

  • Spirometry values (FEV1 and FVC)

    Two-month and six-month time

Study Arms (2)

Written Disclosure Therapy

EXPERIMENTAL
Other: Disclosure Writing (Written Disclosure Therapy)

Controls

SHAM COMPARATOR
Other: Neutral (Sham) Writing

Interventions

Disclosure Writing (Written Disclosure Therapy)OTHER

Patients write about a stressful life experience

Also known as: Written Disclosure Therapy
Written Disclosure Therapy
Neutral (Sham) WritingOTHER

Patients write about neutral subjects

Also known as: Sham Writing (Controls that wrote about neutral subjects)
Controls

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COPD or Pulmonary Fibrosis
  • First time participants in Pulmonary Rehabilitation program

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePulmonary FibrosisDyspnea

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, InterstitialFibrosisRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Adam Hurewitz, M.D.

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 2, 2009

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

March 1, 2009

Last Updated

June 2, 2009

Record last verified: 2009-06