COPDNCT00251420
Writing About Disease: Effect on Rehabilitation?
A study testing writing about disease in people with COPD and Asthma, run by LHL Helse at 1 site in Norway.
Trial summary
Therapeutic writing about one's emotions has been described previously (J Pennebaker: Emotions, disclosure and health. Am Psychol. Assoc 1995). The present project will compare the effects (if any) of writing about the emotional versus the physical consequences of lung disease on anxiety, perceived quality of life… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- What is being tested?
- writing about disease
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2005to Dec 2007
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD (age between 35 and 70)
- Clinical diagnosis of asthma (age between 20 and 60)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Therapeutic writing about one's emotions has been described previously (J Pennebaker: Emotions, disclosure and health. Am Psychol. Assoc 1995). The present project will compare the effects (if any) of writing about the emotional versus the physical consequences of lung disease on anxiety, perceived quality of life, and perceived health status.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) patients (age 35-70) and asthma patients (age 20-60) referred to a 4 weeks inpatient rehabilitation program - who agree to participate in the project - are randomly assigned to one of three conditions:
- Writing about emotional consequences of their disease before the program starts
- Writing about physical consequences of their disease before the program starts
- Not writing
All patients are measured (completing questionnaires at home) on: perceived quality of life, perceived health status and trait anxiety - 2 weeks before the program, 2 weeks after the program and 6 months after the program. FEV1 and 6 min walking distance are measured at the beginning and by the end of the program.
In addition to questionnaires, all patients are asked to:
- Write in their own words ( 2 weeks after) to evaluate their stay at the rehabilitation clinic; and
- Write in their own words (6 months after) about how the disease affects their life at that point.
Both quantitative and qualitative data will be used for analysis purposes.
- Being tested
- writing about disease
- Keywords
- copd, asthma, QoL, Perceived health status, Trait anxiety
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
writing about diseaseProcedure or surgery
writing about physical or emotional consequences of pulmonary disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: prospective
Perceived health status
Measured: prospective
Trait anxiety
Measured: prospective
Secondary outcomes (2)
Forced expiratory volume in 1 second (FEV1)
Measured: prospective
6-minute walking distance
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startDec 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Collaborators
- The norwegian association for heart and lung patients
- Investigators
- Einar Haave, Cand Psychol, Principal investigator, LHL Helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251420
- Sponsor's protocol ID
- G22-1
- Status last verified
- May 2009
- First submitted
- 9 Nov 2005
- Last updated
- 7 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Writing About Disease: Effect on Rehabilitation?
- ClinicalTrials.gov ID
- NCT00251420
- Acronym / sponsor ID
- G22-1
- Keywords
- copd, asthma, QoL, Perceived health status, Trait anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Collaborators
- The norwegian association for heart and lung patients
- Study start
- Dec 2005
- Study completion
- Dec 2007 (actual)
- First posted
- 10 Nov 2005 (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.
Therapeutic writing about one's emotions has been described previously (J Pennebaker: Emotions, disclosure and health. Am Psychol. Assoc 1995). The present project will compare the effects (if any) of writing about the emotional versus the physical consequences of lung disease on anxiety, perceived quality of life, and perceived health status.
Detailed description
Chronic obstructive pulmonary disease (COPD) patients (age 35-70) and asthma patients (age 20-60) referred to a 4 weeks inpatient rehabilitation program - who agree to participate in the project - are randomly assigned to one of three conditions:
- Writing about emotional consequences of their disease before the program starts
- Writing about physical consequences of their disease before the program starts
- Not writing
All patients are measured (completing questionnaires at home) on: perceived quality of life, perceived health status and trait anxiety - 2 weeks before the program, 2 weeks after the program and 6 months after the program. FEV1 and 6 min walking distance are measured at the beginning and by the end of the program.
In addition to questionnaires, all patients are asked to:
- Write in their own words ( 2 weeks after) to evaluate their stay at the rehabilitation clinic; and
- Write in their own words (6 months after) about how the disease affects their life at that point.
Both quantitative and qualitative data will be used for analysis purposes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of COPD (age between 35 and 70)
- Clinical diagnosis of asthma (age between 20 and 60)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| writing about diseasewriting about physical or emotional consequences of pulmonary disease | Procedure or surgery | – |
Primary outcome
Quality of life
Time frame: prospective
Perceived health status
Time frame: prospective
Trait anxiety
Time frame: prospective
2 secondary outcomes
Forced expiratory volume in 1 second (FEV1)
Time frame: prospective
6-minute walking distance
Time frame: prospective
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 7 May 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.
Einar Haave, Cand Psychol principal investigator
LHL Helse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing writing about disease in people with COPD and Asthma, run by LHL Helse at 1 site in Norway.
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 0 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 7 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Quality of life (time frame: prospective). The study lists 3 primary outcomes in all. 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 7 May 2009.