Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001501235
Ethics application status
Approved
Date submitted
4/09/2018
Date registered
6/09/2018
Date last updated
22/08/2019
Date data sharing statement initially provided
8/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the feasibility and efficacy of intensive online Cognitive Behavioural Therapy for panic and anxiety: A pilot study
Scientific title
A pilot study exploring the feasibility and efficacy of intensive online CBT for reducing symptoms of panic disorder and agoraphobia in adults,
Secondary ID [1] 295924 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Panic Disorder 309413 0
Agoraphobia 309414 0
Condition category
Condition code
Mental Health 308271 308271 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet-delivered Exposure-based Cognitive Behavioural Therapy Program comprises 6 lesson completed over 7 days. It includes psychoeducation about panic and anxiety, graded exposure to test negative predictions, and relapse prevention. A new lesson will become available each day (with the exception of Day 6, which is devoted to practicing challenging skills), with participants expected to complete one lesson per day. Each lesson will take approximately 30-40 minutes to read. 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 day (for a 7 days) 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 two scheduled calls within the treatment week and additional contact 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 the first lesson, on Day 7, 1 week post-treatment, and at 2 month follow-up. 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, 1 week post-treatment and 2 month follow-up. 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] 312246 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307233 0
Changes in panic symptoms, according to the mean scores on the Panic Disorder Severity Scale - Self-report (PDSS-SR).
Timepoint [1] 307233 0
Baseline, Day 7, one week post-treatment (week 2), and 2-months post-treatment (week 9). Primary time-point is post-treatment.
Primary outcome [2] 307234 0
Changes in agoraphobia symptoms, according to mean scores on the Mobility Inventory - Alone subscale (MI).
Timepoint [2] 307234 0
Baseline, Day 7, one week post-treatment (week 2), and 2-months post-treatment (week 9). Primary time-point is post-treatment.
Secondary outcome [1] 351206 0
Changes in in functional impairment and disability according to mean scores on the Work and Social Adjustment Scale (WSAS).
Timepoint [1] 351206 0
Baseline and 2-month follow-up.
Secondary outcome [2] 351207 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] 351207 0
Baseline and 2 month follow-up.
Secondary outcome [3] 351208 0
Treatment Satisfaction according to the mean scores on the Treatment Satisfaction Questionnaire.
Timepoint [3] 351208 0
One week post-treatment (week 2).
Secondary outcome [4] 351209 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] 351209 0
Post-treatment,
Secondary outcome [5] 351210 0
Change in depression symptoms, according to mean scores on the Patient Health Questionnaire (PHQ-9).
Timepoint [5] 351210 0
Baseline, Day 7, one week post-treatment, and 2 month follow-up.

Eligibility
Key inclusion criteria
- Self-identified as experiencing panic and/or anxiety.
- Meet DSM-5 criteria for panic and/or 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 (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 or agoraphobia
- 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants allocated to treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants allocated to treatment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models and paired samples t-tests will be used to analyse the data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/10/2018
Actual
7/02/2019
Date of last participant enrolment
Anticipated
28/06/2019
Actual
29/04/2019
Date of last data collection
Anticipated
30/08/2019
Actual
17/07/2019
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 11745 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 23827 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 300523 0
University
Name [1] 300523 0
University of New South Wales
Country [1] 300523 0
Australia
Funding source category [2] 300525 0
Hospital
Name [2] 300525 0
Clinical Research Unit for Anxiety and Depression
Country [2] 300525 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] 299998 0
Hospital
Name [1] 299998 0
Clinical Research Unit for Anxiety and Depression
Address [1] 299998 0
Level 4, O’Brien Centre,
St Vincent’s Hospital,
390 Victoria St,
Darlinghurst
NSW, 2010
Country [1] 299998 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301312 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 301312 0
Ethics committee country [1] 301312 0
Australia
Date submitted for ethics approval [1] 301312 0
Approval date [1] 301312 0
02/08/2018
Ethics approval number [1] 301312 0
HREC/18/SVH/170

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

Contacts
Principal investigator
Name 86594 0
Dr Alison Mahoney
Address 86594 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 86594 0
Australia
Phone 86594 0
+612 8382 1400
Fax 86594 0
Email 86594 0
[email protected]
Contact person for public queries
Name 86595 0
Eileen Stech
Address 86595 0
Mathews Building
University of New South Wales, Sydney,
NSW, 2052
Country 86595 0
Australia
Phone 86595 0
+61293853425
Fax 86595 0
Email 86595 0
[email protected]
Contact person for scientific queries
Name 86596 0
Jill Newby
Address 86596 0
Mathews Building
University of New South Wales, Sydney,
NSW, 2052
Country 86596 0
Australia
Phone 86596 0
+61293853425
Fax 86596 0
Email 86596 0
[email protected]

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


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
SourceTitleYear of PublicationDOI
EmbaseIntensive one-week internet-delivered cognitive behavioral therapy for panic disorder and agoraphobia: A pilot study.2020https://dx.doi.org/10.1016/j.invent.2020.100315
N.B. These documents automatically identified may not have been verified by the study sponsor.