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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
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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.
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Secondary ID [1]
306512
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Nil known.
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
The current study is a follow-up to the pilot study: ACTRN12620000135910
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Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder
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Condition category
Condition code
Mental Health
322764
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
322937
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Behaviour
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Intervention code [2]
322938
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Treatment: Other
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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).
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Control group
Active
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Outcomes
Primary outcome [1]
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Changes in social performance anxiety symptoms, according to the mean scores on the Social Phobia Scale (SPS).
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Assessment method [1]
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Timepoint [1]
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Baseline, post-treatment (week 2), 1-month post-treatment (week 6). Primary time point is post-treatment.
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Primary outcome [2]
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Changes in social interaction anxiety symptoms, according to the mean scores on the Social Interaction Anxiety Scale (SIAS).
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Assessment method [2]
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Timepoint [2]
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Baseline, post-treatment (week 2), 1-month post-treatment (week 6). Primary time point is post-treatment.
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Secondary outcome [1]
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Changes in quality of life according to mean scores on the Work and Social Adjustment Scale (WSAS).
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Assessment method [1]
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Timepoint [1]
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Baseline, post-treatment (week 2), 1-month post-treatment (week 6).
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Secondary outcome [2]
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Treatment Satisfaction according to the mean scores on the Treatment Satisfaction Questionnaire (TSQ).
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Assessment method [2]
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Timepoint [2]
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post-treatment (week 2).
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Secondary outcome [3]
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Changes in depression according to the Patient Health Questionnaire 9-item (PHQ-9).
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Assessment method [3]
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Timepoint [3]
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Baseline, post-treatment (week 2), 1-month post-treatment (week 6).
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Secondary outcome [4]
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Current diagnosis of Social Anxiety Disorder or Major Depressive Disorder according to the Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5).
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Assessment method [4]
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Timepoint [4]
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Baseline, 1 month post-treatment (6 weeks).
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Secondary outcome [5]
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Unwanted side effects, according to a bespoke self-report measure of unwanted negative side effects.
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Assessment method [5]
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Timepoint [5]
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After each lesson, and at post-treatment.
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Secondary outcome [6]
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Frequency of use of CBT skills, according to a bespoke self-report measure of the use of CBT skills
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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Frequency of use of CBT skills, according to a bespoke self-report measure of the use of CBT skills
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Assessment method [7]
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Timepoint [7]
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Immediately Post-treatment
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
18/03/2024
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Actual
26/03/2024
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Date of last participant enrolment
Anticipated
31/05/2024
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Actual
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Date of last data collection
Anticipated
12/07/2024
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Actual
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Sample size
Target
50
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Accrual to date
41
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
310858
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Charities/Societies/Foundations
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Name [1]
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Perpetual Impact Philanthropy Application
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Address [1]
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Angel Place
Level 18
128 Pitt Street
Sydney NSW 2000
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Country [1]
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Australia
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Primary sponsor type
University
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Name
UNSW Sydney
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Address
Research Ethics & Compliance Support
UNSW Sydney
Sydney NSW 2052 Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
312132
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Country [1]
312132
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of New South Wales Human Research Ethics Committee
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Ethics committee address [1]
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University of New South Wales, Sydney, NSW, 2052
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Ethics committee country [1]
310420
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Australia
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Date submitted for ethics approval [1]
310420
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22/02/2022
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Approval date [1]
310420
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18/03/2022
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Ethics approval number [1]
310420
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Summary
Brief summary
This randomised controlled trial seeks to explore the feasibility of a novel treatment format for social anxiety disorder; online cognitive behavioural therapy delivered in an intensive format across just one week. Outcomes will be compared between the intervention and control groups from pre- to post-treatment, and one-month follow-up.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Jill Newby
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Address
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Black Dog Institute
Hospital Road
Randwick, NSW
2031
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Country
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Australia
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Phone
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+61293853425
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Jill Newby
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Address
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Black Dog Institute
Hospital Road
Randwick, NSW
2031
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Country
117603
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Australia
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Phone
117603
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+61293853425
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Fax
117603
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Email
117603
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Jill Newby
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Address
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Black Dog Institute
Hospital Road
Randwick, NSW
2031
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Country
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Australia
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Phone
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+61293853425
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Fax
117604
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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