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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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 (
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 3860 0
Name [1] 3860 0
Clinical Research Unit for Anxiety and Depression
Address [1] 3860 0
School of Psychiatry Faculty of Medicine, University of New South Wales, Gate 9a, High St, Randwick, Sydney, NSW 2052
Country [1] 3860 0
Primary sponsor type
St Vincent's Hospital: Clinical Research Unit for Anxiety and Depression
299 Forbes Street,
NSW 2010
Secondary sponsor category [1] 3466 0
Name [1] 3466 0
Address [1] 3466 0
Country [1] 3466 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 5914 0
Approval date [1] 5914 0
Ethics approval number [1] 5914 0

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
Trial related presentations / publications
Public notes

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,
NSW 2010
Country 12081 0
Phone 12081 0
+61 2 83821747/1730/1720
Fax 12081 0
+61 2 83821721
Email 12081 0
Contact person for scientific queries
Name 3009 0
Dr Edward Wims
Address 3009 0
299 Forbes Street,
NSW 2010
Country 3009 0
Phone 3009 0
+61 2 83821747/1730/1720
Fax 3009 0
+61 2 83821721
Email 3009 0

No information has been provided regarding IPD availability
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