Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000349549
Ethics application status
Approved
Date submitted
8/08/2006
Date registered
14/08/2006
Date last updated
25/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Computerised cognitive behaviour therapy (CBT) for the treatment of anxiety and effects on neuropsychological functioning and hormone levels
Scientific title
A randomised clinical trial of computerised cognitive behaviour therapy (CBT) for the treatment of anxiety disorders and effects on neuropsychological functioning and plasma oxytocin levels
Secondary ID [1] 287991 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders - Panic disorder, social anxiety disorder and generalised anxiety disorder (GAD) 1319 0
Condition category
Condition code
Mental Health 1405 1405 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised clinical trial of computerised CBT (using a programme called CLIMATE) for the treatment of patients with anxiety disorders (panic disorder, social anxiety disorder and generalised anxiety disorder) .Treatment duration of CBT 3 months. Follow up for further 3 months after treatment ended.
Intervention code [1] 1271 0
Treatment: Other
Comparator / control treatment
Waiting list control (WLC)
Control group
Active

Outcomes
Primary outcome [1] 1927 0
To compare effectiveness of computerised CBT for the treatment of anxiety disorders with a waiting list control condition
Timepoint [1] 1927 0
Outcome will be assessed at 3 months(end of treatment) and at 6 months (after 3 months follow up).
Secondary outcome [1] 3384 0
a) To evaluate the acceptability and satisfaction of computerised CBT for the treatment of anxiety disorders
Timepoint [1] 3384 0
Outcome will be assessed at 3 months(end of treatment) and at 6 months (after 3 months follow up).
Secondary outcome [2] 3385 0
b)To assess recruitment and retention of participants to this clinical trial
Timepoint [2] 3385 0
Outcome will be assessed at 3 months(end of treatment) and at 6 months (after 3 months follow up).
Secondary outcome [3] 3386 0
c) to compare the effects of computerised CBT on neuropsychological functioning and tests of facial emotion recognition compared with waiting list control
Timepoint [3] 3386 0
Outcome will be assessed at 3 months(end of treatment) and at 6 months (after 3 months follow up).
Secondary outcome [4] 3387 0
d)To investigate plasma oxytocin levels in subjects with anxiety disorders before and after treatment.
Timepoint [4] 3387 0
Outcome will be assessed at 3 months(end of treatment) and at 6 months (after 3 months follow up).

Eligibility
Key inclusion criteria
Current Diagnostic and Statistical Manual of Mental Disorders (DSM IV ) primary diagnosis of panic disorder, social phobia or generalised anxiety disorderAccess to the internet and sufficient competency with English language.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
DSM IV primary diagnosis of obsessive compulsive disorder, specific phobia or post traumatic stress disorder (PTSD)Current diagnosis of psychotic illness, bipolar 1 disorder, alcohol or drug dependenceDisabling cardiac or respiratory disordersSerious neurological disordersStarted on or changed dose of antidepressant medication in last 6 weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 1:1 ration to CLIMATE and WLC. A randomisation list will be generated prior to the study. This randomisation list will be generated separately for each of the 3 anxiety disorder strat (Panic disorder, social phobia, generalised anxiety disorder).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects will be blindly allocated to the treatment arms (CLIMATE or WLC). Ratings at 3 and 6 months are self rated therefore not influenced by blinding of assessors. Data analysis will be done by researchers who will be blind to coding allocation to treatment arms
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2006
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
3/11/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
83
Recruitment outside Australia
Country [1] 384 0
New Zealand
State/province [1] 384 0

Funding & Sponsors
Funding source category [1] 1538 0
Charities/Societies/Foundations
Name [1] 1538 0
Canterbury Medical Research Fund
Country [1] 1538 0
New Zealand
Funding source category [2] 1539 0
Government body
Name [2] 1539 0
Lotteries Health Board (New Zealand)
Country [2] 1539 0
New Zealand
Primary sponsor type
University
Name
University of Otago, New Zealand
Address
Research and Enterprise
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 1352 0
None
Name [1] 1352 0
Nil
Address [1] 1352 0
Country [1] 1352 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2968 0
Upper South B Regional Ethics Committee Ministry of Health
Ethics committee address [1] 2968 0
PO Box 3877
Christchurch
Ethics committee country [1] 2968 0
New Zealand
Date submitted for ethics approval [1] 2968 0
Approval date [1] 2968 0
23/06/2006
Ethics approval number [1] 2968 0
URB/06/05/039

Summary
Brief summary
We will examine a computerised version of a known effective treatment for anxiety disorders (CBT) in the form of a programme called CLIMATE. Partcipants will be recruited from the waiting list of a publicly funded specialist anxiety disorders unit in Christchurch. An intial assessment will determine suitability and written informed consent sought. Consenting patients will then be will be randomly allocated to either stay on the waiting list or to receives the compuertised treatment. Partcipants will be assessed at pre-treatment, at the end of treatment (3 montsh) and at 6 months.
Trial website
Trial related presentations / publications
Caroline J Bell, Helen C Colhoun, Frances A Carter, Christopher M Frampton. Effectiveness of computerised CBT for anxiety disorders in secondary care. Australian New Zealand Journal of Psychiatry 2012; 46; 630-640.

Frances A carter, Caroline J Bell, Helen C Colhoun. Suitability and acceptability of computerised CBT for anxiety disorders in secondary care: a cautionary note. Australian New Zealand Journal of Psychiatry 2013; 47; 142-152.
Public notes

Contacts
Principal investigator
Name 35206 0
A/Prof Caroline Bell
Address 35206 0
Department of Psychological Medicine,
University of Otago
Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country 35206 0
New Zealand
Phone 35206 0
+64 3 3720400
Fax 35206 0
Email 35206 0
[email protected]
Contact person for public queries
Name 10460 0
Dr Caroline Bell
Address 10460 0
Department of Psychological Medicine
4 Oxford Terrace
Christchurch
Country 10460 0
New Zealand
Phone 10460 0
+64 3 3720400
Fax 10460 0
Email 10460 0
[email protected]
Contact person for scientific queries
Name 1388 0
Dr Caroline Bell
Address 1388 0
Department of Psychological Medicine
4 Oxford Terrace
Christchurch
Country 1388 0
New Zealand
Phone 1388 0
+64 3 3720400
Fax 1388 0
Email 1388 0
[email protected]

No information has been provided regarding IPD availability


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.