Writing About Disease: Effect on Rehabilitation?

Asthma Clinical Trial

Official title:

Writing About Disease: Effect on Rehabilitation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251420
• Other study ID #: G22-1
• Status: Completed
• Phase: N/A
• First received: November 9, 2005
• Last updated: May 6, 2009
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: May 2009
• Source: LHL Helse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical 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, and perceived health status.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of COPD (age between 35 and 70)

• Clinical diagnosis of asthma (age between 20 and 60)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

Procedure:
• writing about disease
writing about physical or emotional consequences of pulmonary disease

Locations

Country	Name	City	State
Norway	Glittreklinikken	Hakadal	Akershus

Sponsors (2)

Lead Sponsor	Collaborator
LHL Helse	The norwegian association for heart and lung patients

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		prospective
Primary	Perceived health status		prospective
Primary	Trait anxiety		prospective
Secondary	Forced expiratory volume in 1 second (FEV1)		prospective
Secondary	6-minute walking distance		prospective