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Trial registered on ANZCTR


Registration number
ACTRN12618001500246
Ethics application status
Approved
Date submitted
4/09/2018
Date registered
6/09/2018
Date last updated
3/12/2020
Date data sharing statement initially provided
2/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing two versions of online Cognitive Behavioural Therapy (CBT) for panic and anxiety in adults: A randomised controlled trial
Scientific title
A randomised control trial to compare the efficacy of online exposure-based CBT versus multi-component CBT for reducing symptoms of panic disorder and agoraphobia in adults.
Secondary ID [1] 295123 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Panic Disorder 308463 0
Agoraphobia 308464 0
Condition category
Condition code
Mental Health 307446 307446 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet-delivered Exposure-based Cognitive Behavioural Therapy Program comprises 6 lessons completed over 8 weeks. It includes psychoeducation about panic and anxiety, graded exposure to test negative predictions, and relapse prevention. In contrast to the Multi-component Cognitive Behavioural Therapy Program (Control treatment), the Exposure-based program does not include controlled breathing or thought challenging (cognitive restructuring) techniques. The Exposure-based program introduces exposure in Lesson 2, whereas the Multi-component program teaches the other strategies first and introduces exposure in Lesson 4.
A new lesson will become available after the preceding lesson has been completed (with a minimum of 5 day between lessons), with participants expected to take five to ten days to complete each lesson (8 weeks in total). Each lesson will take approximately 30-40 minutes to complete. Participants will have access to summaries of each lesson, homework exercises and extra resources for each lesson. Participants are advised to spend at least 3-4 hours per week working through the lesson material, revisiting the content and homework tasks/practicing the skills. Clinician guidance will be provided in the form of email or phone contact from the clinicians (registered clinical psychologist; registered provisional psychologist undertaking postgraduate training), including a scheduled call within the first two weeks and then as required. The participant is able to email or phone the clinician at any point during the trial.The participant completes a measure of panic symptoms before each lesson, and if their scores deteriorate by 4 or more points, the clinician is automatically alerted and initiates contact with the participant by phone or email. The participant also completes measures of depression, suicidal ideation and suicidal intent at the start of intervention, mid-intervention, post-treatment and all follow-up points. If the participant has an elevated distress or depression score, the clinician is automatically alerted and initiates contact with the participant by phone or email. The mode of contact is dependent on what is clinically indicated in terms of the participant's distress score and/or what the participant may have communicated (in the form of phone or email contact) to the clinician. The mode of contact (email or phone or both) therefore is dependent on the clinician's clinical judgement of the situation in hand.
Strategies used to improved adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework, and collection of data on how long participants spent reading lessons and practicing skills.
Intervention code [1] 301616 0
Treatment: Other
Intervention code [2] 301617 0
Behaviour
Comparator / control treatment
The internet-delivered Multi-component Cognitive Behavioural Therapy Program comprises 6 lesson completed over 8 weeks. It includes psychoeducation about panic and anxiety, as well as CBT techniques including controlled breathing, thought challenging, graded exposure and relapse prevention. A new lesson will become available after the preceding lesson has been completed (with a minimum of 5 day between lessons), with participants expected to take five to ten days to complete each lesson (8 weeks in total). Each lesson will take approximately 30-40 minutes to complete. Participants will have access to summaries of each lesson, homework exercises and extra resources for each lesson. Participants are advised to spend at least 3-4 hours per week working through the lesson material, revisiting the content and homework tasks/practicing the skills. Clinician guidance will be provided in the form of email or phone contact from the clinicians (registered clinical psychologist; registered provisional psychologist undertaking postgraduate training), including a scheduled call within the first two weeks and then as required. The participant is able to email or phone the clinician at any point during the trial.The participant completes a measure of panic symptoms before each lesson, and if their scores deteriorate by 4 or more points, the clinician is automatically alerted and initiates contact with the participant by phone or email. The participant also completes measures of depression, suicidal ideation and suicidal intent at the start of intervention, mid-intervention, post-treatment and all follow-up points. If the participant has an elevated distress or depression score, the clinician is automatically alerted and initiates contact with the participant by phone or email. The mode of contact is dependent on what is clinically indicated in terms of the participant's distress score and/or what the participant may have communicated (in the form of phone or email contact) to the clinician. The mode of contact (email or phone or both) therefore is dependent on the clinician's clinical judgement of the situation in hand.
Strategies used to improved adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework, and collection of data on how long participants spent reading lessons and practicing skills.
Control group
Active

Outcomes
Primary outcome [1] 306413 0
Changes in panic symptoms, according to the mean scores on the Panic Disorder Severity Scale - Self-report (PDSS-SR).
Timepoint [1] 306413 0
Baseline, mid-treatment (before Lesson 4), one week post-treatment (week 9), 3-month post-treatment (week 20), and 6-month post-treatment (week 32). Primary time-point is post-treatment.
Primary outcome [2] 306414 0
Changes in agoraphobia symptoms, according to mean scores on the Mobility Inventory - Alone subscale (MI).
Timepoint [2] 306414 0
Baseline, mid-treatment (before Lesson 4), one week post-treatment (week 9), 3-month post-treatment (week 20), and 6-month post-treatment (week 32). Primary time-point is post-treatment.
Secondary outcome [1] 348483 0
Changes in in functional impairment and disability according to mean scores on the Work and Social Adjustment Scale (WSAS).
Timepoint [1] 348483 0
Baseline, mid-treatment (before Lesson 4), one week post-treatment (week 9), 3-month post-treatment (week 20), and 6-month post-treatment (week 32).
Secondary outcome [2] 348484 0
Cost-effectiveness, measured by mean cost of treatment provision (clinician time) relative to change in functional impairment (WSAS) and Health Service Utilisation/Days Out of Role (SUDOR module of the National Survey of Mental Health and Well-Being, Andrews et al., 1991).
Timepoint [2] 348484 0
Baseline, one week post-treatment (week 9), 3-month post-treatment (week 20), and 6-month post-treatment (week 32).
Secondary outcome [3] 348485 0
Treatment Satisfaction according to the mean scores on the Treatment Satisfaction Questionnaire.
Timepoint [3] 348485 0
One week post-treatment (week 9).
Secondary outcome [4] 348487 0
Adherence, according to the number of lessons completed, and the number of participants who completed 100% of the 6-lesson program within the 8-week treatment period. The platform records each Lesson as complete once a participant clicks through all slides within a Lesson and downloads the Lesson Summary. Before each new Lesson, participants are also asked to estimate how much time they spent working on the previous lesson (including reading materials and practicing skills homework).
Timepoint [4] 348487 0
Week 8.
Secondary outcome [5] 348489 0
Change in hyper-vigilance to body sensations, as a hypothesised mediator of panic symptom change, measured by mean scores on the Body Vigilance Scale (BVS).
Timepoint [5] 348489 0
Baseline, mid-treatment (before Lesson 4) and one-week post-treatment (week 9).
Secondary outcome [6] 348490 0
Change in catastrophic cognitions, as a hypothesised mediator of panic symptom change, measured by means scores on the Agoraphobia Cognitions Questionnaire (ACQ; adapted to measure strength of belief in addition to frequency).
Timepoint [6] 348490 0
Baseline, mid-treatment (before Lesson 4) and one-week post-treatment (week 9).
Secondary outcome [7] 348491 0
Change in use of safety behaviours, as a hypothesised mediator of symptom change, measured by mean score on a study specific safety behaviours scale.
Timepoint [7] 348491 0
Baseline, mid-treatment (before Lesson 4) and one-week post-treatment (week 9).
Secondary outcome [8] 348492 0
Change in depression symptoms, according to mean scores on the Patient Health Questionnaire (PHQ-9).
Timepoint [8] 348492 0
Baseline, mid-treatment (before Lesson 4), one week post-treatment (week 9), at 3-month post-treatment (week 20) and at 6-month post-treatment (week 32).

Eligibility
Key inclusion criteria
- Self-identified as experiencing panic and/or anxiety.
- Meet DSM-5 criteria for panic (with or without comorbid agoraphobia) as assessed by ADIS-5 for DSM-5.
- At least 18 years of age
- Live in Australia
- Fluent in English
- Have access to a computer that is connected to the internet
- Currently under the care of a General Practitioner (have seen GP in last 3 months for any reason; able to provide contact details for GP so a letter can be sent informing GP that patient is enrolled in the study).
- If taking medication, must have been taking the same dose for at least 8 weeks and not intend to change that dose during the course of the program.
- Prepared to provide name, phone number, and address.
- Willing to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Does not meet criteria for panic disorder
- Self-reported diagnosis of schizophrenia, bipolar disorder or current psychotic symptoms
- Regularly using illicit drugs or regularly consuming more than three standard drinks per day (substance dependence)
- Taking benzodiazepines on a daily basis
- Severe depressive symptoms (score of 23 or above on the PHQ-9)
- Current suicidal ideation (defined as responding 3 to the PHQ-9 question 9 item that assesses the frequency of suicidal ideation, and/or responding greater than 1 on the BDI-II suicide item)
-Those scoring 1 or 2 on the Patient Health Questionnaire-9 Item (PHQ-9) item 9 will require a risk assessment with a study clinician before being admitted into the study.
- Changed medication dosage (including starting new medication) within the past 8 weeks.
- Currently participating in Cognitive Behavioural Therapy.
- Do not complete the online screening questionnaire or unwilling to provide demographic details

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)
Following assessment and offer of treatment, the participant will log into the online portal that delivers the internet-based intervention, at which point the portal will randomly assign them to a condition. That is, the assessor will have no role in randomizing the participant, and randomization will not take place until the participant has been accepted into the trial. Due to the nature of the treatments, allocation cannot be concealed form the participant once they have been allocated to the group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The online portal used for this trial generates a random number sequence to allocate participants to condition when they sign in (the random sequence has been developed based on random number generators using random.org). Randomization occurs after a participants is accepted into the trial and is therefore concealed from the interviewer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models will be used to analyse the data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2018
Actual
4/10/2018
Date of last participant enrolment
Anticipated
31/01/2019
Actual
4/07/2019
Date of last data collection
Anticipated
30/03/2020
Actual
25/03/2020
Sample size
Target
70
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 11689 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 23758 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 299716 0
University
Name [1] 299716 0
University of New South Wales
Country [1] 299716 0
Australia
Funding source category [2] 300447 0
Hospital
Name [2] 300447 0
Clinical Research Unit for Anxiety and Depression
Country [2] 300447 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Mathews building
UNSW Sydney
Kensington Campus
NSW, Australia, 2052
Country
Australia
Secondary sponsor category [1] 299048 0
University
Name [1] 299048 0
Clinical Research Unit for Anxiety and Depression
Address [1] 299048 0
Level 4, O’Brien Centre,
St Vincent’s Hospital,
390 Victoria St,
Darlinghurst
NSW, 2010
Country [1] 299048 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300604 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 300604 0
Ethics committee country [1] 300604 0
Australia
Date submitted for ethics approval [1] 300604 0
Approval date [1] 300604 0
02/08/2018
Ethics approval number [1] 300604 0
HREC/18/SVH/170

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

Contacts
Principal investigator
Name 84190 0
Dr Alison Mahoney
Address 84190 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, O’Brien Centre,
St Vincent’s Hospital,
390 Victoria St,
Darlinghurst NSW 2010
Country 84190 0
Australia
Phone 84190 0
+612 8382 1400
Fax 84190 0
Email 84190 0
alison.mahoney@svha.org.au
Contact person for public queries
Name 84191 0
Eileen Stech
Address 84191 0
Mathews Building
University of New South Wales, Sydney,
NSW, 2052
Country 84191 0
Australia
Phone 84191 0
+61293853425
Fax 84191 0
Email 84191 0
eileen.stech@unsw.edu.au
Contact person for scientific queries
Name 84192 0
Jill Newby
Address 84192 0
Mathews Building
University of New South Wales, Sydney,
NSW, 2052
Country 84192 0
Australia
Phone 84192 0
+61293853425
Fax 84192 0
Email 84192 0
j.newby@unsw.edu.au

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3703Informed consent form    375283-(Uploaded-01-08-2019-17-16-33)-Study-related document.pdf



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.