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Trial registered on ANZCTR


Registration number
ACTRN12620000135910
Ethics application status
Approved
Date submitted
16/01/2020
Date registered
11/02/2020
Date last updated
13/07/2021
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a one-week overcoming shyness program
Scientific title
A pilot study exploring the efficacy of an intensive online CBT program for reducing symptoms of social anxiety disorder
Secondary ID [1] 300274 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder 315854 0
Condition category
Condition code
Mental Health 314134 314134 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet-delivered Cognitive Behavioural Therapy Program comprises 6 lessons completed over 7 days. It includes psychoeducation about anxiety and management of its physical symptoms, graded exposure to overcome avoidance, behavioural experiments to test maladaptive beliefs, thought challenging to address unhelpful thoughts, social skills training 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). The participant is able to email or phone the clinician at any point during the trial.

The participant completes a measure of social anxiety symptoms before the first lesson, on Day 7, and 1 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 before the first lesson, on Day 7, and 1 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 improve 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] 316549 0
Behaviour
Intervention code [2] 316661 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322524 0
Changes in social performance anxiety symptoms, according to the mean scores on the Social Phobia Scale (SPS).
Timepoint [1] 322524 0
Baseline, post-treatment (week 2), and 1-month post-treatment (week 6). Primary time-point is post-treatment.
Primary outcome [2] 322665 0
Changes in social interaction anxiety symptoms, according to the mean scores on the Social Interaction Anxiety Scale (SIAS).
Timepoint [2] 322665 0
Baseline, post-treatment (week 2), and 1-month post-treatment (week 6). Primary time-point is post-treatment.
Secondary outcome [1] 378824 0
Changes in quality of life according to mean scores on the Work and Social Adjustment Scale (WSAS).
Timepoint [1] 378824 0
Baseline, post-treatment (week 2), and 1-month post-treatment (week 6).
Secondary outcome [2] 378825 0
Treatment Satisfaction according to the mean scores on the Treatment Satisfaction Questionnaire (TSQ).
Timepoint [2] 378825 0
Post-treatment (week 2).
Secondary outcome [3] 378865 0
Changes in depression according to the Patient Health Questionnaire 9-item (PHQ-9).
Timepoint [3] 378865 0
Baseline, post-treatment (week 2), and 1-month post-treatment (week 6).
Secondary outcome [4] 378866 0
Changes in suicidal ideation according to item 9 of the Beck Depression Inventory II.
Timepoint [4] 378866 0
Baseline, post-treatment (week 2), and 1-month post-treatment (week 6).

Eligibility
Key inclusion criteria
- Self-identified as experiencing social anxiety.
- Meet DSM-5 criteria for social anxiety as assessed by ADIS-5 for DSM-5.
- At least 18 years of age.
- Live in Australia.
- Fluent in English.
- Have access to a phone and a computer that is connected to the internet.
- Currently under the care of a General Practitioner (able to provide contact details for GP).
- If taking medication for mental-health, must be on a stable dose of medication (past 8 weeks prior to intake).
- 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 social anxiety disorder.
- Self-reported diagnosis of schizophrenia, bipolar disorder, substance dependence or current psychotic symptoms.
- Current suicidal ideation (deemed 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).
- On an unstable dose of medication, which is used to manage symptoms of a mental health condition.
- 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention to treat linear mixed model analyses and paired samples t-tests will be used to analyse the data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2020
Actual
20/07/2020
Date of last participant enrolment
Anticipated
24/07/2020
Actual
17/08/2020
Date of last data collection
Anticipated
4/09/2020
Actual
10/10/2020
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 15625 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 29027 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 304696 0
University
Name [1] 304696 0
University of New South Wales
Country [1] 304696 0
Australia
Funding source category [2] 304697 0
Hospital
Name [2] 304697 0
Clinical Research Unit for Anxiety and Depression
Country [2] 304697 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] 305008 0
Hospital
Name [1] 305008 0
Clinical Research Unit for Anxiety and Depression
Address [1] 305008 0
Level 4, O’Brien Centre,
St Vincent’s Hospital,
390 Victoria St,
Darlinghurst
NSW, 2010
Country [1] 305008 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305116 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 305116 0
Ethics committee country [1] 305116 0
Australia
Date submitted for ethics approval [1] 305116 0
26/09/2019
Approval date [1] 305116 0
22/11/2019
Ethics approval number [1] 305116 0
2019/ETH13123

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

Contacts
Principal investigator
Name 99322 0
Dr Alison Mahoney
Address 99322 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 99322 0
Australia
Phone 99322 0
+61 2 8382 1400
Fax 99322 0
Email 99322 0
alison.mahoney@svha.org.au
Contact person for public queries
Name 99323 0
Natasha Jain
Address 99323 0
Mathews Building
University of New South Wales
Sydney NSW 2052
Country 99323 0
Australia
Phone 99323 0
+61293853425
Fax 99323 0
Email 99323 0
natasha.jain@student.unsw.edu.au
Contact person for scientific queries
Name 99324 0
Jill Newby
Address 99324 0
Mathews Building
University of New South Wales
Sydney NSW 2052
Country 99324 0
Australia
Phone 99324 0
+61293853425
Fax 99324 0
Email 99324 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
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
EmbaseA pilot study of intensive 7-day internet-based cognitive behavioral therapy for social anxiety disorder.2021https://dx.doi.org/10.1016/j.janxdis.2021.102473
N.B. These documents automatically identified may not have been verified by the study sponsor.