Chronic Lung DiseasesNCT00911794
Written Disclosure Therapy for Anxiety and Stress in Patients With Chronic Lung Disease
A study testing Disclosure Writing (Written Disclosure Therapy) in people with Chronic Lung Diseases and COPD, run by Winthrop University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Lung Diseases, COPD, Pulmonary Fibrosis
- What is being tested?
- Disclosure Writing (Written Disclosure Therapy)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD or Pulmonary Fibrosis
- First time participants in Pulmonary Rehabilitation program
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Lung Diseases, COPD, Pulmonary Fibrosis
- Being tested
- Disclosure Writing (Written Disclosure Therapy), Neutral (Sham) Writing
- Keywords
- Dyspnea, Written Disclosure Therapy, COPD, Pulmonary Fibrosis, Chronic Lung Diseases, Pulmonary Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disclosure Writing (Written Disclosure Therapy)Other
Also called Written Disclosure Therapy
Patients write about a stressful life experience
Neutral (Sham) WritingOther
Also called Sham Writing (Controls that wrote about neutral subjects)
Patients write about neutral subjects
| Study group | Role | What they receive |
|---|---|---|
| Written Disclosure Therapy | Experimental | Not described Receives: Other: Disclosure Writing (Written Disclosure Therapy) |
| Controls | Sham comparator | Not described Receives: Other: Neutral (Sham) Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea and quality of life
Measured: Two-month and six-month time
Secondary outcomes (2)
Six-minute walk distance
Measured: Two-month and six-month time
Spirometry values (FEV1 and FVC)
Measured: Two-month and six-month time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2009 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stony Wold-Herbert Fund, Inc.
- Investigators
- Adam Hurewitz, M.D., Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911794
- Sponsor's protocol ID
- 07300
- Status last verified
- Jun 2009
- First submitted
- 29 May 2009
- Last updated
- 2 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Therapy and Supplemental Written Disclosure Therapy for Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT00911794
- Acronym / sponsor ID
- 07300
- Conditions
- Chronic Lung Diseases, COPD, Pulmonary Fibrosis
- Keywords
- Dyspnea, Written Disclosure Therapy, COPD, Pulmonary Fibrosis, Chronic Lung Diseases, Pulmonary Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Collaborators
- Stony Wold-Herbert Fund, Inc.
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written Disclosure Therapy | Experimental | Other: Disclosure Writing (Written Disclosure Therapy) |
| Controls | Sham comparator | Other: Neutral (Sham) Writing |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of COPD or Pulmonary Fibrosis
- First time participants in Pulmonary Rehabilitation program
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disclosure Writing (Written Disclosure Therapy)Also: Written Disclosure TherapyPatients write about a stressful life experience | Other | Written Disclosure Therapy |
| Neutral (Sham) WritingAlso: Sham Writing (Controls that wrote about neutral subjects)Patients write about neutral subjects | Other | Controls |
Primary outcome
Dyspnea and quality of life
Time frame: Two-month and six-month time
2 secondary outcomes
Six-minute walk distance
Time frame: Two-month and six-month time
Spirometry values (FEV1 and FVC)
Time frame: Two-month and six-month time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Hurewitz, M.D. principal investigator
Winthrop University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Disclosure Writing (Written Disclosure Therapy) in people with Chronic Lung Diseases and COPD, run by Winthrop University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea and quality of life (time frame: Two-month and six-month time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2009; AzTrials last refreshed its copy on 7 Nov 2026.