Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000374662
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
13/09/2005
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive-behavioral interventions targeting improved adult asthma control and quality of life.
Scientific title
Cognitive-behavioral interventions targeting improved adult asthma control and quality of life.
Universal Trial Number (UTN)
Trial acronym
CBT for asthma study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 469 0
Condition category
Condition code
Respiratory 547 547 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Duration of intervention 4 x one hourly sessions one session per week.Randomised control trial designed to test Cognitive behavioral interventions which will entail 1) Education about anxiety and asthma and differentiating between an asthma attack and a panic attack.2) Setting individual goals, anxiety management using slow breathing techniques and relaxation training.3) Thought management: challenging catastrophic and unhelpful thinking4) Problem solving skills, imagery and relapse prevention identifying high-risk situations.
Intervention code [1] 359 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 639 0
Juniper Asthma Quality of life
Timepoint [1] 639 0
Recorded pre-intervention, post-intervention and at a 3-month follow-up, the output of which will be uploaded into the study computer
Secondary outcome [1] 1315 0
Asthma control questionnaire (ACQ), asthma related medical visits and missed days at work.
Timepoint [1] 1315 0
These measures will be recorded pre-intervention, post -intervention and at 3-month follow-up, the output of which will be uploaded into the study computer.
Secondary outcome [2] 1316 0
The HADS which is a measure of anxiety symptoms, depressive symptoms, and questionnaires identifying illness focused panic fears, generalized panic fears, panic symptoms
Timepoint [2] 1316 0
These measures will be recorded pre-intervention, post -intervention and at 3-month follow-up, the output of which will be uploaded into the study computer.
Secondary outcome [3] 1317 0
The health locus of control questionnaire identifying self-perceived ability to control asthma symptoms.
Timepoint [3] 1317 0
These measures will be recorded pre-intervention, post -intervention and at 3-month follow-up, the output of which will be uploaded into the study computer.

Eligibility
Key inclusion criteria
Phase one: (Questionnaire to identify people with asthma and anxiety/panic disorder. Diagnosis of asthma and an asthma related medical visit over the previous 12 months. Ability to give informed consent. Ability to read and write English. Phase two: Patients with one or more panic symptoms as identified in phase one. Significant anxiety scores on the HADS as identified in phase one. Phase three: All participants who complete the CBT intervention sessions.
Minimum age
15 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Phase two: Exclude if: any serious mental illness including bipolar disorder or cyclothymia evidence of psychosis or organic brain syndrome, currently involved in any psychotherapy or counseling, women who reprort being pregnant.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed evelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software and blocking
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2005
Actual
15/08/2005
Date of last participant enrolment
Anticipated
Actual
15/08/2006
Date of last data collection
Anticipated
Actual
15/08/2006
Sample size
Target
300
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 605 0
Self funded/Unfunded
Name [1] 605 0
Country [1] 605 0
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research and University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 493 0
None
Name [1] 493 0
None
Address [1] 493 0
Country [1] 493 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1698 0
Sydney West Area Health Services
Ethics committee address [1] 1698 0
Ethics committee country [1] 1698 0
Australia
Date submitted for ethics approval [1] 1698 0
15/06/2005
Approval date [1] 1698 0
15/06/2005
Ethics approval number [1] 1698 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35367 0
Address 35367 0
Country 35367 0
Phone 35367 0
Fax 35367 0
Email 35367 0
Contact person for public queries
Name 9548 0
Ms Wendy Taylor
Address 9548 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9548 0
Australia
Phone 9548 0
+61 2 95156578
Fax 9548 0
+61 2 95505865
Email 9548 0
[email protected]
Contact person for scientific queries
Name 476 0
Dr Vandana Deshmukh
Address 476 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 476 0
Australia
Phone 476 0
+61 2 95158710
Fax 476 0
+61 2 95505865
Email 476 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.