Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000548336
Ethics application status
Approved
Date submitted
12/09/2008
Date registered
30/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of clinician assisted internet based Cognitive Behaviour Therapy for Panic Disorder
Scientific title
Does a clinician-assisted Internet-based cognitive behavioural treatment program for panic disorder result in reduced symptoms of panic relative to a control group as measured using the Panic Disorder Severity Scale? A randomised controlled trial of active treatment versus wait list control.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Panic Disorder (with or without Agoraphobia) 3680 0
Condition category
Condition code
Mental Health 3845 3845 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised controlled trial of internet based program termed the Panic Program for treatment of Panic Disorder. The Panic Program is a package of six Cognitive Behaviour Therapy lessons focussing on Psychoeducation, Controlled Breathing, Cognitive Therapy, Behavioural experiments and graded exposure. Participants read the first 3 lessons in week one then fortnightly thereafter. After each lesson they will download "Homework assignments" to complete in their own time. Lessons are completed in the location of the participants choice; whether that be home, work or even internet cafe. In addition they participate in an online forum for futher education and support from peers and the treating clinician. They also have additional support from the treating clinician via email; responding to questions or providing feedback to homework assignments. The program will take 9 weeks in total to complete. All participants will meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) criteria for Panic Disorder. The control group will be treated after the intervention group complete the course.
Intervention code [1] 3392 0
Treatment: Other
Comparator / control treatment
Once the intervention group have completed the program the control goup will also be treated using the Panic Program.
Control group
Active

Outcomes
Primary outcome [1] 4744 0
Panic Disorder Severity Scale
Timepoint [1] 4744 0
Pre treatment, mid treatment, post treatment, one month and six months post treatment
Primary outcome [2] 4745 0
PHQ - 9 (Patient Health Questionnaire 9) This makes a tentative diagnosis of depression and measures severity of depression.
Timepoint [2] 4745 0
Pre treatment, post treatment, one month and six months post treatment
Secondary outcome [1] 8012 0
Agoraphobic Cognitions Questionnaire. This scale measures patients beliefs regarding what might happen during a panic attack
Timepoint [1] 8012 0
Pre treatment, post treatment, one month and six months post treatment
Secondary outcome [2] 8013 0
Body Sensations Questionnaire. This scale measures the amount of distress different physical symptoms experienced during a panic attack cause the patient.
Timepoint [2] 8013 0
Pre treatment, post treatment, one month and six months post treatment
Secondary outcome [3] 8014 0
Mobility Inventory. This scale measures the amount the individual is avoiding certain situations.
Timepoint [3] 8014 0
Pre treatment, post treatment, one month and six months post treatment

Eligibility
Key inclusion criteria
Panic Disorder with or without Agoraphobia as per DSM IV
Access to a computer and internet access.
Access to a printer
Australian resident
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe depression as measured by a PHQ-9 score greater than 22. Suicidality.Current substance use/dependence, Active Psychosis Change in antidepressant medication for Panic Disorder in last month or intended change, Current Cognitive Behaviour Therapy (CBT) for Panic Disorder or anticipated during the course of the trial

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)
Participants apply on-line, followed by a telephone interview to confirm diagnosis via a structured diagnostic interview (MINI). The interviewer is unaware prior to the interview whether the patient will be included or excluded, nor to which group the participant will be allocated. After the interview participants will be randomly allocated to treatment or control group using a list generated prior to the study. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization list will be generated prior to the study using computer software (www.random.org).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
13/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3860 0
University
Name [1] 3860 0
Clinical Research Unit for Anxiety and Depression
Country [1] 3860 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital: Clinical Research Unit for Anxiety and Depression
Address
299 Forbes Street,
Darlinghurst,
NSW 2010
Country
Australia
Secondary sponsor category [1] 3466 0
None
Name [1] 3466 0
Address [1] 3466 0
Country [1] 3466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5914 0
St Vincent's Hospital HREC
Ethics committee address [1] 5914 0
380 Victoria Street, Darlinghurst, NSW 2010
Ethics committee country [1] 5914 0
Australia
Date submitted for ethics approval [1] 5914 0
Approval date [1] 5914 0
28/04/2008
Ethics approval number [1] 5914 0
08/SVH/35

Summary
Brief summary
Our previous research indicates that the Shyness Program, an Internet-based treatment program for people with social phobia, is effective at helping people to learn to manage their symptoms of social phobia.

This trial is to assess whether a similar approach to Panic Disorder would be as effective. CBT is well recognised as the treatment of choice for Panic Disorder and trials of internet based CBT have been shown to be effective, however they tend to have high drop out rates. We aim to see if retention is improved by addition of a clinician and if this treatment is effective.
Trial website
www.climateclinc.tv
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28924 0
Address 28924 0
Country 28924 0
Phone 28924 0
Fax 28924 0
Email 28924 0
Contact person for public queries
Name 12081 0
Dr Edward Wims
Address 12081 0
CRUFAD at St. Vincents,
299 Forbes Street,
Darlinghurst,
NSW 2010
Country 12081 0
Australia
Phone 12081 0
+61 2 83821747/1730/1720
Fax 12081 0
+61 2 83821721
Email 12081 0
ewims@stvincents.com.au
Contact person for scientific queries
Name 3009 0
Dr Edward Wims
Address 3009 0
299 Forbes Street,
Darlinghurst,
NSW 2010
Country 3009 0
Australia
Phone 3009 0
+61 2 83821747/1730/1720
Fax 3009 0
+61 2 83821721
Email 3009 0
ewims@stvincents.com.au

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.