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Trial registered on ANZCTR


Registration number
ACTRN12623000313639
Ethics application status
Approved
Date submitted
9/03/2023
Date registered
22/03/2023
Date last updated
3/04/2024
Date data sharing statement initially provided
22/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability and Efficacy of Remote Treatment for Social Anxiety Disorder
Scientific title
A Randomised Controlled Trial of the Acceptability and Efficacy of Remote Cognitive Behavioural Therapy for Social Anxiety Disorder in Adults
Secondary ID [1] 309127 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder 329221 0
Condition category
Condition code
Mental Health 326181 326181 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those in the immediate treatment condition will receive a manualised cognitive behaviour therapy (CBT) protocol that is informed by the Rapee and Heimberg (1997) model of social anxiety disorder. The treatment will be delivered by internet-videoconferencing. Treatment is delivered one-on-one in 50-minute sessions over an 8 week period. In total, participants will receive 8 sessions as one 50-minute per week. Participants will be asked to complete at-home activities between sessions such as symptom monitoring, problem solving using restructured thoughts, graded exposure. It is anticipated that participants will spend at least 10 minutes per day practicing cognitive restructuring and exposure techniques learned in session.

The treatment will comprise of five modules and will cover the following topics:
Module 1: Psychoeducation (week 1)
Module 2: Challenging automatic thoughts (weeks 2 - 3)
Module 3: Challenging core beliefs (week 4)
Module 4: Exposure (weeks 5 - 7)
Module 5: Relapse prevention/consolidation (week 8)

Treatment will be delivered by provisionally registered psychologists in their final year of a Master of Clinical Psychology degree or a clinical psychology registrar, under the supervision of an experienced clinical psychologist. All treating clinicians will be thoroughly trained in the administration of the treatment protocol by the project investigators and receive weekly supervision. All sessions will be recorded and at least 10% of sessions will be randomly selected for treatment fidelity.
Intervention code [1] 325576 0
Behaviour
Intervention code [2] 325706 0
Treatment: Other
Comparator / control treatment
During the eight-week wait-list period, participants will be asked to refrain from seeking external psychological counselling. Following the eight-week wait-list period, participants in the wait-list control condition will be offered eight weekly, 50-minute sessions of imagery rescripting (ImR) for social anxiety disorder following the protocol established by Wild and Clark (2011). ImR is a collection of imagery techniques that alter negative meanings associated with autobiographical memories of distressing experiences. Treatment is delivered one-on-one in 50-minute sessions over an 8 week period. In total, participants will receive 8 sessions as one 50-minute per week. Participants will be asked to complete at-home activities between sessions such as symptom monitoring. It is anticipated that participants will spend at least 10 minutes per day practicing cognitive restructuring techniques learned in session.

ImR treatment will comprise of four modules and will cover the following topics:
Module 1: Psychoeducation (week 1)
Module 2: Identification and exploration of core beliefs (week 2)
Module 3: Imagery rescripting (weeks 3 - 7)
Module 4: Relapse prevention/consolidation (week 8)

Treatment will be delivered by provisionally registered psychologists in their final year of a Master of Clinical Psychology degree or a clinical psychology registrar, under the supervision of an experienced clinical psychologist. All treating clinicians will be thoroughly trained in the administration of the treatment protocol by the project investigators and receive weekly supervision. All sessions will be recorded and at least 10% of sessions will be randomly selected for treatment fidelity.
Control group
Active

Outcomes
Primary outcome [1] 334058 0
Social anxiety disorder symptom severity will be measured with the Social Interaction Anxiety Scale-Short Form (SIAS-6) (Mattick & Clarke, 1998)
Timepoint [1] 334058 0
Baseline
Mid-treatment (week 4)
Post treatment (week 9, primary endpoint)
3-month follow-up post treatment completion
Primary outcome [2] 334059 0
Social anxiety disorder symptom severity will be measured with the Social Phobia Scale-Short Form (SPS) (Mattick & Clarke, 1998)
Timepoint [2] 334059 0
Baseline
Mid-treatment (week 4)
Post treatment (week 9, primary endpoint)
3-month follow-up post treatment completion
Primary outcome [3] 334105 0
Acceptability will be measured with the Client Satisfaction Questionnaire (CSQ) (Attkisson & Zwick, 1982)
Timepoint [3] 334105 0
Mid-treatment (week 4)
Post treatment (week 9, primary endpoint)
Secondary outcome [1] 419206 0
Social anxiety disorder symptom severity will be measured with the Social Anxiety Disorder Dimensional Scale (SAD-D) (LeBeau et al., 2012)
Timepoint [1] 419206 0
Baseline
Mid-treatment (week 4)
Post treatment (week 9)
3-month follow-up post treatment completion
Secondary outcome [2] 419207 0
Depression symptom severity will be measured with the Patient Health Questionnaire - 9 item (PHQ-9) (Kroenke et al., 2001)
Timepoint [2] 419207 0
Baseline
Mid-treatment (week 4)
Post treatment (week 9)
3-month follow-up post treatment completion
Secondary outcome [3] 419208 0
Social anxiety disorder symptom severity will be measured with the NIMH Clinician Global Impression (CGI) Scale (self-report version) (Guy, 1976)
Timepoint [3] 419208 0
Baseline
Mid-treatment (week 4)
Post treatment (week 9)
3-month follow-up post treatment completion
Secondary outcome [4] 419209 0
Disability will be measured with the Sheehan Disability Scale (SDS) (Sheehan, 1983)
Timepoint [4] 419209 0
Baseline
Mid-treatment (week 4)
Post treatment (week 9)
3-month follow-up post treatment completion
Secondary outcome [5] 419210 0
Strength of core beliefs will be measured with the Core Beliefs Questionnaire (CBQ) - Trait Version (Wong & Moulds, 2011)
Timepoint [5] 419210 0
Baseline
Mid-treatment (week 4)
Post treatment (week 9)
3-month follow-up post treatment completion
Secondary outcome [6] 419211 0
Symptoms of perfectionism will be measured with the Clinical Perfectionism Questionnaire (CPQ) (Fairburn et al., 2003)
Timepoint [6] 419211 0
Baseline
Mid-treatment (week 4)
Post treatment (week 9)
3-month follow-up post treatment completion
Secondary outcome [7] 419212 0
Symptoms of shame will be measured with The Experience of Shame Scale (Andrews et al., 2002)
Timepoint [7] 419212 0
Baseline
Mid-treatment (week 4)
Post treatment (week 9)
3-month follow-up post treatment completion
Secondary outcome [8] 419213 0
Self-compassion will be measured witih the Self-Compassion Scale-Short Form (SCS-SF) (Raes et al., 2011)
Timepoint [8] 419213 0
Baseline
Mid-treatment (week 4)
Post treatment (week 9)
3-month follow-up post treatment completion

Eligibility
Key inclusion criteria
1. Currently resides in Australia
2. Aged 18+ years
3. Fluent in English
4. Meets criteria for social anxiety disorder as primary diagnosis and the disorder is of at least 'moderate severity' (defined as a score of 4 on the DIAMOND module severity measure (Tolin et al., 2018))
5. Medication free or on a stable dose of psychotropic medication
6. Not currently receiving regular psychological services for their social anxiety symptoms (defined as sessions at least once a week with a qualified mental health professional)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe depressive symptoms as assessed by a score of 20 or above on the PHQ-9
2. Are at suicide risk by a score of "2" (more than half the days) or higher on item 9 of the PHQ-9 on the screening questions or via clinician judgement during the interview using the Columbia-Suicide Severity Rating Scale (C-SSRS)
3. Engage in daily alcohol use or daily illicit drug use
4. Presence of schizophrenia spectrum disorder as assessed by the DIAMOND
5. Significant cognitive/intellectual impairment as assessed during the diagnostic interview
6. A medical condition that may interfere with treatment
7. Does not have access to a computer with a camera and stable internet on a regular basis
8. Is not willing to engage in treatment via internet videoconferencing software

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by the Chief Investigator using a random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be randomly assigned to an immediate treatment group (n = 39) or wait-list control group (n = 39). Group 1 will receive immediate access to eight-session CBT intervention, and Group 2 will receive ImR treatment after an eight-week wait period.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
20/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
66
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313330 0
University
Name [1] 313330 0
University of Technology Sydney
Country [1] 313330 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Discipline of Clinical Psychology, Graduate School of Health, PO Box 123 Broadway, Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 315116 0
None
Name [1] 315116 0
Address [1] 315116 0
Country [1] 315116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312552 0
University of Technology Sydney Health and Medical Research Ethics Committee (HMREC)
Ethics committee address [1] 312552 0
C/- Research Office
University of Technology Sydney
PO Box 123 Broadway NSW 2007
Ethics committee country [1] 312552 0
Australia
Date submitted for ethics approval [1] 312552 0
16/01/2023
Approval date [1] 312552 0
28/03/2023
Ethics approval number [1] 312552 0

Summary
Brief summary
The primary objective of this program of research is to examine the acceptability and efficacy of videoconferencing delivered cognitive behavioural therapy (CBT) for social anxiety disorder. The secondary objective of this research project is to examine the efficacy of an imagery rescripting (ImR) enhanced cognitive behavioural therapy intervention for individuals with social anxiety disorder.

It is anticipated that high-intensity videoconferencing delivered CBT will (1) be acceptable to individuals with SAD; (2) result in significant reductions in symptoms of social anxiety compared to waitlist control at post-treatment and follow up; (3) ImR enhanced CBT will result in similar reductions to standard CBT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125062 0
A/Prof Bethany Wootton
Address 125062 0
Discipline of Clinical Psychology. Graduate School of Health. PO Box 123. Broadway. NSW 2007.
Country 125062 0
Australia
Phone 125062 0
+61 2 9514 3942
Fax 125062 0
Email 125062 0
bethany.wootton@uts.edu.au
Contact person for public queries
Name 125063 0
A/Prof Bethany Wootton
Address 125063 0
Discipline of Clinical Psychology. Graduate School of Health. PO Box 123. Broadway. NSW 2007.
Country 125063 0
Australia
Phone 125063 0
+61 2 9514 3942
Fax 125063 0
Email 125063 0
bethany.wootton@uts.edu.au
Contact person for scientific queries
Name 125064 0
A/Prof Bethany Wootton
Address 125064 0
Discipline of Clinical Psychology. Graduate School of Health. PO Box 123. Broadway. NSW 2007.
Country 125064 0
Australia
Phone 125064 0
+61 2 9514 3942
Fax 125064 0
Email 125064 0
bethany.wootton@uts.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable individual participant data of published results for primary outcome measures.
When will data be available (start and end dates)?
At the completion of the study and after all relevant manuscripts are published for a period of 5 years.
Available to whom?
Any academic who has expertise in the field of social anxiety disorder.
Available for what types of analyses?
Any
How or where can data be obtained?
From the Chief Investigator (bethany.wootton@uts.edu.au)


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInternet videoconferencing delivered cognitive behavioral therapy for social anxiety disoder: Protocol for a randomized controlled trial.2023https://dx.doi.org/10.1016/j.cct.2023.107298
N.B. These documents automatically identified may not have been verified by the study sponsor.