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Trial registered on ANZCTR


Registration number
ACTRN12614001319662
Ethics application status
Approved
Date submitted
4/12/2014
Date registered
16/12/2014
Date last updated
9/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of the efficacy of the Panic eHealth wellbeing program.
Scientific title
A randomised controlled trial of the efficacy of the Panic eHealth wellbeing program in decreasing panic, anxiety and depressive symptoms in adults who experience panic.
Secondary ID [1] 285785 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Panic 293729 0
Condition category
Condition code
Mental Health 293972 293972 0 0
Anxiety
Mental Health 294029 294029 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A simple randomised controlled trial (RCT) design will be used to evaluate the effectiveness of a online Cognitive Behavioural Therapy (CBT) program for decreasing the symptoms of panic and anxiety (called Panic eHealth).

Those that consent will be randomly allocated to one of 3 groups: 1) Panic eHealth program (with immediate access to all of the program modules) group, 2) Panic eHealth program (with weekly, sequential release of the program modules) group or to 3) a wait control group (delayed access to the Panic eHealth program with weekly, sequential release of modules).

Panic eHealth has six modules:

1. Psycho-education and self monitoring instruction of panic and anxiety
2. Physiological Control and Relaxation (e.g., controlled breathing to reduce symptoms)
3. Cognitive restructuring to reduce unhelpful thinking (catastrophising and probability over estimations) and cognitive flexibility strategies
4. Exposure and biofeedback – gradual exposure to panic symptoms and to feared/avoided places (situational)
5. Relapse prevention and increasing wellness


It should take approximately 20 minutes to complete each module, with the addition of 20-30 minutes to engage in recommended offline activities that serve to reinforce the information contained within each specific module.

Participants will also receive automated emails when they need to complete the questionnaires (and additional reminders when they fail to do so in a timely manner) as well as when they do not log on for a period of time, while they are undertaking the Panic eHealth program.

There will also be a booster session delivered two weeks following the post intervention assessment. This module will reinforce the key messages from the Panic eHealth modules and should take about 15 minutes to complete. An automated email will inform participants when the Booster module is available/released.

The two immediate access condition groups will continue to have access to the Panic eHealth program for the duration of the study (i.e., 19 weeks). Given the 10 week delay for the participants in the the wait list control, they will receive access to Panic eHealth for 9 weeks.
Intervention code [1] 290747 0
Treatment: Other
Intervention code [2] 290748 0
Behaviour
Comparator / control treatment
The delayed access group will receive the Panic eHealth intervention following a 10-week waiting period.
Control group
Active

Outcomes
Primary outcome [1] 293748 0
Panic severity using the PDSS.
Timepoint [1] 293748 0
Pre-intervention, during intervention (Week 3, Week 5), post intervention and at the 1 and 3 month follow-up.
Primary outcome [2] 293749 0
Depressive symptoms using the PHQ-9
Timepoint [2] 293749 0
Pre-intervention, during intervention (Week 3, Week 5), post intervention and at the 1 and 3 month follow-up.
Secondary outcome [1] 311741 0
Body vigilance will be measured by the Body Vigilance Scale.
Timepoint [1] 311741 0
Pre-intervention, post intervention and at the 1 and 3 month follow-up.
Secondary outcome [2] 311742 0
Generalised Anxiety will be measured by the GAD-7
Timepoint [2] 311742 0
Pre-intervention, post intervention and at the 1 and 3 month follow-up.
Secondary outcome [3] 311743 0
Social Anxiety will be measured by the SPIN.
Timepoint [3] 311743 0
Pre-intervention, post intervention and at the 1 and 3 month follow-up.
Secondary outcome [4] 311744 0
Specific fears will be measured by the Fear Questionnaire.
Timepoint [4] 311744 0
Pre-intervention, post intervention and at the 1 and 3 month follow-up.
Secondary outcome [5] 311745 0
Psychological Distress will be measured by the Kessler 6
Timepoint [5] 311745 0
Pre-intervention, post intervention and at the 1 and 3 month follow-up.
Secondary outcome [6] 311746 0
Emotional Regulation will be measured by the Difficulties in Emotional Regulation Scale.
Timepoint [6] 311746 0
Pre-intervention, post intervention and at the 1 and 3 month follow-up.
Secondary outcome [7] 311747 0
Wellbeing will be measured by the Mental Health Continuum and the Revised - Life Orientation Test
Timepoint [7] 311747 0
Pre-intervention, post intervention and at the 1 and 3 month follow-up.
Secondary outcome [8] 311748 0
Cost utility will be measured by the EQ-5D and the TiC-P.
Timepoint [8] 311748 0
Pre-intervention, during intervention, post intervention and at the 1 month follow-up.
Secondary outcome [9] 311749 0
Treatment Credibility will be measured by the Treatment Credibility Scale.
Timepoint [9] 311749 0
Pre-Intervention.
Secondary outcome [10] 311750 0
Treatment Satisfaction will be measured by the Treatment Satisfaction Questionnaire.
Timepoint [10] 311750 0
Post Intervention.

Eligibility
Key inclusion criteria
Participants must be 18 years or older, experience panic, have access to the internet, and be able to register online using an email address. Panic will be assessed via the Panic Disorder Severity Scale (PDSS) (1) as part of the baseline assessments. Those participants scoring below sub-clinical cut-offs for panic will be advised that this program would not have any benefit for them and they will be referred to MindHealthConnect (an online government funded e-mental health portal that provides information about various Australian mental health and wellbeing online services).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with no panic symptoms.

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)
This is a fully automated online trial, as such the participant self registers online. If the screening criteria are met, the program software randomizes each participant to one of the three conditions and informs of this outcome.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The computer generated randomization procedure will employ a block design method.
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
Repeated measures MANOVA and ANOVA.

Previous research has reported medium effects can be expected. Therefore, assuming a medium effect (i.e. GPower f(v) test = 0.40), significance set at 5% (p = .05), power at 80%, a sample of 40 will be required to demonstrate statistical significance. However allowing for a 50% attrition rate, we will be required to recruit 80 participants.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Given delays with getting the first digital platform ready to go 'live', a new program was written and uploaded during this 'delay wait time' and so this particular program was replaced with the more recent version. Therefore, there was no longer a need to run a trial on this 'older' version and so the study never commenced.
Date of first participant enrolment
Anticipated
1/02/2015
Actual
Date of last participant enrolment
Anticipated
30/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290349 0
University
Name [1] 290349 0
Federation University
Country [1] 290349 0
Australia
Primary sponsor type
University
Name
Federation Unversity
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 289072 0
None
Name [1] 289072 0
Address [1] 289072 0
Country [1] 289072 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292052 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 292052 0
Federation University Australia. Office 218, Building F, Mt Helen
Campus. PO Box 663 Ballarat VIC 3353
Ethics committee country [1] 292052 0
Australia
Date submitted for ethics approval [1] 292052 0
Approval date [1] 292052 0
12/09/2014
Ethics approval number [1] 292052 0
14-122

Summary
Brief summary
A simple randomised controlled trial (RCT) design will be used to evaluate the effectiveness of a online Cognitive Behavioural Therapy (CBT) program for decreasing the symptoms of panic and anxiety (called Panic eHealth).

The Panic eHealth program is placed within the Federation eHealth Platform, which is a platform containing multiple eHealth programs. People who visit the website, either directly or through seeing the program advertised, will be invited to take part in the Panic eHealth evaluation study. Those that consent will be randomly allocated to one of 3 groups: 1) Panic eHealth program (with immediate access to all of the program modules) group, 2) Panic eHealth program (with weekly, sequential release of the program modules) group or to 3) a wait control group (delayed access to the Panic eHealth program with weekly, sequential release of modules). The delayed access group will receive the intervention following a 10-week waiting period.

Panic eHealth contains six modules, delivered over six weeks. It is designed to provide people with strategies to address their panic and anxiety. Each module will take approximately 20 minutes to complete. In addition, in order to reinforce the module-based information there are 20-30 minutes of offline activities each week. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked several questions at the beginning of each week, to monitor their progress.

Participants randomised to the Panic eHealth program groups will complete a pre-intervention assessment (Week 0), during intervention (Week 1-6) assessment, post-intervention assessment (Week 7) and a 1 and 3 month follow-up assessment (Week 11 & Week 19 respectively). Participants randomised to the delayed access program group will complete the same assessment phases, except for the 3 month follow-up assessment, as they will be given access to Panic eHealth program following the 1 month follow-up assessment (Week 11). However the delayed access group will be asked to complete the post intervention assessment after they complete the Panic eHealth program (Week 17).
Trial website
www.panic.fedehealth.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53258 0
Prof Britt Klein
Address 53258 0
Federation University
University Drive, Mt Helen Campus, Victoria, 3350
Country 53258 0
Australia
Phone 53258 0
+61 3 53276717
Fax 53258 0
Email 53258 0
b.klein@federation.edu.au
Contact person for public queries
Name 53259 0
Ms Sue Lauder
Address 53259 0
Federation University
University Drive, Mt Helen Campus, Victoria, 3350
Country 53259 0
Australia
Phone 53259 0
+61 3 53279845
Fax 53259 0
Email 53259 0
s.lauder@federation.edu.au
Contact person for scientific queries
Name 53260 0
Prof Britt Klein
Address 53260 0
Federation University
University Drive, Mt Helen Campus, Victoria, 3350
Country 53260 0
Australia
Phone 53260 0
+61 3 53276717
Fax 53260 0
Email 53260 0
b.klein@federation.edu.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.