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Trial registered on ANZCTR


Registration number
ACTRN12606000177550
Ethics application status
Approved
Date submitted
12/05/2006
Date registered
16/05/2006
Date last updated
16/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing the development of panic disorder in vulnerable patients with chronic obstructive pulmonary disease
Scientific title
Psychological and physiological correlates of panic disorder in patients with chronic obstructive pulmonary disease, and efficacy of prevention of panic anxiety using cognitive behaviour therapy
Universal Trial Number (UTN)
Trial acronym
Anxiety in COPD project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 1150 0
Condition category
Condition code
Respiratory 1230 1230 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20 patients with COPD receive a one hour session of cognitive behaviour therapy per week for four weeks - this is the intervention. All continue to receive active treatment as usual for their COPD. All subjects are then assessed every six months over an 18 month follow-up period.
Intervention code [1] 1034 0
Prevention
Comparator / control treatment
20 control patients with COPD don't receive this intervention.
Control group
Active

Outcomes
Primary outcome [1] 1669 0
The effectiveness of the brief, standardised CBT intervention in decreasing the likelihood that patients will develop symptoms of panic disorder
Timepoint [1] 1669 0
An assessment session every six months over 18 month follow-up period.
Secondary outcome [1] 2989 0
To reduce the personal and economic burder associated with the development of panic disorder in COPD patients.
Timepoint [1] 2989 0
An assessment session every six months over 18 month follow-up period.

Eligibility
Key inclusion criteria
Diagnosis of COPD, with no age limits on enrolment.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of written fluency in EnglishA co-existing severe disease and/or mental illness.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1344 0
Hospital
Name [1] 1344 0
The Prince of Wales Hospital
Address [1] 1344 0
Country [1] 1344 0
Australia
Funding source category [2] 1345 0
University
Name [2] 1345 0
The University of Sydney
Address [2] 1345 0
Country [2] 1345 0
Australia
Primary sponsor type
Individual
Name
Nicole Livermore (enrolled in part-time PhD degree at University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 1190 0
Individual
Name [1] 1190 0
Dr. Louise Sharpe, School of Psychology, University of Sydney, (N. Livermore's primary supervisor)
Address [1] 1190 0
Country [1] 1190 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2697 0
Prince of Wales Hospital
Ethics committee address [1] 2697 0
Ethics committee country [1] 2697 0
Australia
Date submitted for ethics approval [1] 2697 0
Approval date [1] 2697 0
29/05/2002
Ethics approval number [1] 2697 0
02/120
Ethics committee name [2] 2698 0
University of Sydney
Ethics committee address [2] 2698 0
Ethics committee country [2] 2698 0
Australia
Date submitted for ethics approval [2] 2698 0
Approval date [2] 2698 0
10/09/2002
Ethics approval number [2] 2698 0
2998

Summary
Brief summary
40 patients with COPD are randomly allocated to either receive a four session preventative CBT intervention, or not receive this intervention in addition to usual treatment. Subjects are then followed up every six months for 18 months to investigate the efficacy of the intervention in preventing the development/worsening of panic anxiety symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35771 0
Address 35771 0
Country 35771 0
Phone 35771 0
Fax 35771 0
Email 35771 0
Contact person for public queries
Name 10223 0
Dr. Louise Sharpe
Address 10223 0
School of Psychology
University of Sydney
F - 12 Transient Building
Camperdown NSW 2006
Country 10223 0
Australia
Phone 10223 0
+61 2 93514558
Fax 10223 0
+61 2 93517328
Email 10223 0
louises@psych.usyd.edu.au
Contact person for scientific queries
Name 1151 0
Dr. Louise Sharpe
Address 1151 0
School of Psychology
University of Sydney
F - 12 Transient Building
Camperdown NSW 2006
Country 1151 0
Australia
Phone 1151 0
+61 2 93514558
Fax 1151 0
+61 2 93517328
Email 1151 0
louises@psych.usyd.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary