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Trial registered on ANZCTR


Registration number
ACTRN12622000361707
Ethics application status
Approved
Date submitted
25/02/2022
Date registered
1/03/2022
Date last updated
8/05/2024
Date data sharing statement initially provided
1/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a one-week overcoming social anxiety program
Scientific title
A randomised controlled trial exploring the efficacy of an intensive 7-day online CBT program for reducing symptoms of social anxiety disorder compared to waitlist control.
Secondary ID [1] 306512 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record
The current study is a follow-up to the pilot study: ACTRN12620000135910

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder 325381 0
Condition category
Condition code
Mental Health 322764 322764 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 to participants randomly allocated to the intervention group in the form of email or phone contact from the clinicians (registered clinical psychologist; registered provisional psychologist undertaking postgraduate training). Participants in the intervention group are able to email or phone the clinician at any point during the trial. Participants in the waitlist control group can contact research staff for technical assistance at any point via phone or email.

Participants in the intervention group will complete a measure of social anxiety symptoms, depression, and personality traits and functioning before the first lesson (baseline), one week after the program (two weeks post baseline), and at 1-month follow-up (six weeks post baseline). Participants in the control group will complete these same measures at baseline, two weeks post baseline, and six weeks post baseline before being offered the intervention program.

Across both groups, if participants' scores deteriorate by 4 or more points, the clinician is automatically alerted and initiates contact with the participant by phone or email. 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] 322937 0
Behaviour
Intervention code [2] 322938 0
Treatment: Other
Comparator / control treatment
Participants in the waitlist control condition will receive access to the intervention after a 6-week waiting period. Participants will be asked to complete questionnaires at three time points during this waiting period (baseline, two weeks post baseline, six weeks post baseline). The wait list control group will be able to access any other treatment they were already receiving during the 6 week waiting period. They will be offered the intervention after they complete the final assessment questionnaires and follow-up interview (at 6 weeks post baseline).
Control group
Active

Outcomes
Primary outcome [1] 330561 0
Changes in social performance anxiety symptoms, according to the mean scores on the Social Phobia Scale (SPS).
Timepoint [1] 330561 0
Baseline, post-treatment (week 2), 1-month post-treatment (week 6). Primary time point is post-treatment.
Primary outcome [2] 330562 0
Changes in social interaction anxiety symptoms, according to the mean scores on the Social Interaction Anxiety Scale (SIAS).
Timepoint [2] 330562 0
Baseline, post-treatment (week 2), 1-month post-treatment (week 6). Primary time point is post-treatment.
Secondary outcome [1] 406685 0
Changes in quality of life according to mean scores on the Work and Social Adjustment Scale (WSAS).
Timepoint [1] 406685 0
Baseline, post-treatment (week 2), 1-month post-treatment (week 6).
Secondary outcome [2] 406686 0
Treatment Satisfaction according to the mean scores on the Treatment Satisfaction Questionnaire (TSQ).
Timepoint [2] 406686 0
post-treatment (week 2).
Secondary outcome [3] 406687 0
Changes in depression according to the Patient Health Questionnaire 9-item (PHQ-9).
Timepoint [3] 406687 0
Baseline, post-treatment (week 2), 1-month post-treatment (week 6).
Secondary outcome [4] 428283 0
Current diagnosis of Social Anxiety Disorder or Major Depressive Disorder according to the Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5).
Timepoint [4] 428283 0
Baseline, 1 month post-treatment (6 weeks).
Secondary outcome [5] 428284 0
Unwanted side effects, according to a bespoke self-report measure of unwanted negative side effects.
Timepoint [5] 428284 0
After each lesson, and at post-treatment.
Secondary outcome [6] 434814 0
Frequency of use of CBT skills, according to a bespoke self-report measure of the use of CBT skills
Timepoint [6] 434814 0
Secondary outcome [7] 434815 0
Frequency of use of CBT skills, according to a bespoke self-report measure of the use of CBT skills
Timepoint [7] 434815 0
Immediately Post-treatment

Eligibility
Key inclusion criteria
- Self-identified as experiencing social anxiety.
- Meet DSM-5 criteria for social anxiety as assessed by abbreviated diagnostic interview 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.
- 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, 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
- Severe or very severe depression (PHQ-9 scores of 24 and above)
- Commencement of a new mental health medication or change in dose of existing mental health medication in the two months prior to intake.
- 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)
Randomisation will be completed during the telephone call conducted at screening by the clinician completing the call using sealed opaque envelopes. The sealed opaque envelopes will have been prepared in advance by an independent person using a random number generator (e.g., www.random.org). Participants will be informed which condition they have been randomly allocated to over the phone by the interviewer and again in the information provided via email. Due to the nature of the treatment, it is not possible for treatment allocation to be concealed from the participants or the researchers. Primary outcome data is based on self-report assessment which protects from experimenter bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomly allocated to either the intervention group or wait list control using a 1:1 ratio. The sealed opaque envelopes will have been prepared in advance by an independent person using a random number generator (e.g., www.random.org).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Intention to treat linear mixed model analyses and paired samples t-tests will be used to analyse the data. Unadjusted and adjusted mixed models will be used (controlling for appropriate covariates). Categorical variables will be compared using chi squre analyses. Logistic and linear regression will be used to analyse variables associated with completion, adherence, engagement and outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/03/2024
Actual
26/03/2024
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
12/07/2024
Actual
Sample size
Target
50
Accrual to date
41
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310858 0
Charities/Societies/Foundations
Name [1] 310858 0
Perpetual Impact Philanthropy Application
Country [1] 310858 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Research Ethics & Compliance Support

UNSW Sydney

Sydney NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 312132 0
None
Name [1] 312132 0
Address [1] 312132 0
Country [1] 312132 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310420 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 310420 0
Ethics committee country [1] 310420 0
Australia
Date submitted for ethics approval [1] 310420 0
22/02/2022
Approval date [1] 310420 0
18/03/2022
Ethics approval number [1] 310420 0

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

Contacts
Principal investigator
Name 117602 0
Prof Jill Newby
Address 117602 0
Black Dog Institute
Hospital Road
Randwick, NSW
2031
Country 117602 0
Australia
Phone 117602 0
+61293853425
Fax 117602 0
Email 117602 0
[email protected]
Contact person for public queries
Name 117603 0
Jill Newby
Address 117603 0
Black Dog Institute
Hospital Road
Randwick, NSW
2031
Country 117603 0
Australia
Phone 117603 0
+61293853425
Fax 117603 0
Email 117603 0
[email protected]
Contact person for scientific queries
Name 117604 0
Jill Newby
Address 117604 0
Black Dog Institute
Hospital Road
Randwick, NSW
2031
Country 117604 0
Australia
Phone 117604 0
+61293853425
Fax 117604 0
Email 117604 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


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.