Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000720516
Ethics application status
Approved
Date submitted
30/05/2024
Date registered
12/06/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
12/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating an In-Person, Clinician-Facilitated and an Online, Guided Self-Help Program for University Students with Social Anxiety
Scientific title
A Randomised Controlled Trial Evaluating an In-Person, Clinician-Facilitated and an Online, Guided Self-Help Program for University Students with Social Anxiety
Secondary ID [1] 312043 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety Disorder 333649 0
Condition category
Condition code
Mental Health 330338 330338 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The cognitive behavioural therapy (CBT) social anxiety program is referred to as Anxiety Skills Training in UniversiTy Education (ASTUTE). It will be delivered in two forms: (1) in-person groups facilitated by a psychologist (ASTUTE) and (2) online guided self-help (ASTUTE-Digital).

The ASTUTE program will consist of small groups of participants (maximum of six participants per group) who will meet in-person each week for 90-minute sessions, with eight weekly sessions in total. The groups will be run by a registered Psychologist and Provisional Psychologist who will help participants to learn a wide range of skills that are specifically designed to help people overcome social anxiety. Participants will also be asked to completed approximately 60 minutes of skills practice between sessions each week. Groups will be held in a university psychology clinic. Adherence will be monitored in terms of session attendance.

The ASTUTE-Digital program will consist of eight weekly, online modules of approximately 60-minutes duration each containing the same CBT content of the ASTUTE program. Participants will also attend weekly, 30-minute online sessions with a registered Psychologist and Provisional Psychologist in groups of up to six participants. Participants will also be asked to completed approximately 60 minutes of skills practice each week. The ASTUTE-Digital program will be accessed via the university Learning Management System (LMS). Adherence will be monitored via activity logs available on he LMS which will indicate which, if any, aspects of each module students have engaged with.

The content of both the ASTUTE and ASTUTE-Digital programs is the same and consists of evidence-based CBT strategies for social anxiety that have been modified for the university setting. These modifications were undertaken by the research team (academics who are all experienced researchers, clinical psychologists and educators) in a co-design collaboration with university students with social anxiety disorder. This pilot project entailed an implementation of the ASTUTE program with six university students who provided qualitative feedback throughout the program and in end-of-program focus groups, as well as quantitative feedback through the completion of pre- and post-program questionnaires.

Participants in both the ASTUTE and ASTUTE-Digital will be provided with handouts of the key content and strategies.

The ASTUTE program content is as follows:
Session 1 - Introduction to Social Anxiety
Session 2 - The Thought-Feeling-Behaviour Connection
Session 3 - Behavioural Experiment Stepladders
Session 4 - Progress Review and Behavioural Experiment Troubleshooting
Session 5 - Attentional Training and Safety Behaviours
Session 6 - The Role of Feedback in Social Anxiety
Session 7 - Presentation with Video Feedback
Session 8 - Preparing for Ongoing Progress

The ASTUTE-Digital program content is as follows:
Session 1 - Introduction to Social Anxiety
Session 2 - The Thought-Feeling-Behaviour Connection
Session 3 - Behavioural Experiment Stepladders
Session 4 - Progress Review and Behavioural Experiment Troubleshooting
Session 5 - Attentional Training
Session 6 - Safety Behaviours
Session 7 - The Role of Feedback in Social Anxiety and Presentation with Video Feedback
Session 8 - Preparing for Ongoing Progress
Intervention code [1] 328490 0
Behaviour
Intervention code [2] 328752 0
Treatment: Other
Comparator / control treatment
Participants in the treatment-as-usual control condition will be able to access any services/resources available to them. Examples include:
1. Support services (including crisis supports) available to current Australian National University students can be found at https://www.anu.edu.au/students/health-safety-wellbeing, including ANU Counselling (phone 6125 2211).
2. Support services (including crisis supports) available to current University of Canberra students can be found at https://www.canberra.edu.au/on-campus/health-and-support/medical-counselling, including UC Medical and Counselling service (phone 6201 2351).
3. Support services and resources available to the general public include:
o Your General Practitioner or other regular healthcare professional
o Head to Health is a free mental health service that helps to connect people with the services they need: https://canberraheadtohealth.com.au/about-us/
o Lifeline which provides 24/7 support via phone (13 11 14), text (0477 13 11 14) or chat online (https://www.lifeline.org.au/crisis-chat/)
o Beyond Blue: 1300 224 636
o Suicide Call Back Service: 1300 659 467
o 1800RESPECT: 1800 737 732
o Centre for Clinical Interventions social anxiety self-help resources: https://www.cci.health.wa.gov.au/Resources/Looking-After-Yourself/Social-Anxiety
o SANE provides mental health support, including phone counseling on 1800 187 263 (available 10am-10pm Monday to Friday) and online resources: https://www.sane.org/
4. Crisis (emergency) support services available to the general public include:
o ACT Access Mental Health 1800 629 354 or 02 6205 1065
o Phone 000
o Go to your local hospital Emergency Department

Participants in the treatment-as-usual condition will be given access to ASTUTE-Digital after the four-month assessment has been completed.
Control group
Active

Outcomes
Primary outcome [1] 338380 0
Social Anxiety
Timepoint [1] 338380 0
Baseline, Two Months (post-program, primary timepoint), Four Months post-baseline (follow-up)
Secondary outcome [1] 435694 0
Social Interaction Fears
Timepoint [1] 435694 0
Baseline, Two Months (post-program), Four Months post-baseline (follow-up)
Secondary outcome [2] 435696 0
Negative Evaluation Anxiety
Timepoint [2] 435696 0
Baseline, Two Months (post-program), Four Months post-baseline (follow-up)
Secondary outcome [3] 435697 0
Public Speaking Confidence
Timepoint [3] 435697 0
Baseline, Two Months (post-program), Four Months post-baseline (follow-up)
Secondary outcome [4] 435698 0
Probability and Cost of Negative Evaluation During a Speech
Timepoint [4] 435698 0
Baseline, Two Months (post-program), Four Months post-baseline (follow-up)
Secondary outcome [5] 435700 0
Frequency and Use of Program Strategies
Timepoint [5] 435700 0
Two months (post program) and Four Months post-baseline (follow-up)

Eligibility
Key inclusion criteria
Must be diagnosed with Social Anxiety Disorder by a registered psychologist or provisional psychologist in the Psychology Clinic of the Australian National University.
Enrolled as a student at the Australian National University or the University of Canberra.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current suicidal intent, psychotic illness, substance use disorder or severe depression. Exclusion criteria are assessed during initial screening in individual meetings with a registered psychologist or provisional psychologist in the Psychology Clinic of the Australian National University.

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)
After a participant is deemed eligible for the trial based on the screening assessment meeting with a registered psychologist or provisional psychologist, the participant will be informed of the condition they have been randomly allocated to by the psychologist via a pre-prepared, numbered, sealed, and opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is undertaken via computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The data analysis will be undertaken by members of the research team who are not involved in the implementation of the CBT social anxiety program.

Quantitative data from the survey will be analysed using a series of linear mixed-effects regression models to account for repeated measures over time and include all available data from participants in the relevant randomisation. The models will include categorical fixed factors of time (post-intervention and two-month follow-up) and treatment condition (ASTUTE, ASTUTE-Digital, and treatment-as-usual). The time-by-condition interaction will be modelled as a fixed effect to allow estimation of treatment effect at each timepoint. The covariates will be baseline score on the measure being analysed. Participant will be specified as a random effect to account for between-person variation. All models will use restricted maximum likelihood estimation. Q-Q plots will be used to determine that the normality of residuals assumption is met for all models. Between-group effect sizes (Cohen’s d) will be calculated by dividing the adjusted group difference by the pooled standard deviation.

Qualitative data from the focus groups will be analysed according to Braun and Clarke’s (2006) method for thematic analysis, initially by the Chief Investigator and Project Officer. This involves becoming familiar with the data by reading and re-reading all focus group transcripts and noting any potential themes. A coding framework can then be developed, with codes being collapsed and combined and reviewed throughout multiple stages. Data is then coded semantically based on what is explicitly said, and latently based on underlying meanings. Themes are then identified and reviewed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/06/2024
Actual
27/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 316404 0
University
Name [1] 316404 0
Australian National University Strategic Learning and Teaching Grant
Country [1] 316404 0
Australia
Primary sponsor type
Individual
Name
Professor Elizabeth Rieger
Address
Country
Australia
Secondary sponsor category [1] 318575 0
None
Name [1] 318575 0
Address [1] 318575 0
Country [1] 318575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315199 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 315199 0
Ethics committee country [1] 315199 0
Australia
Date submitted for ethics approval [1] 315199 0
06/05/2024
Approval date [1] 315199 0
24/06/2024
Ethics approval number [1] 315199 0

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

Contacts
Principal investigator
Name 133958 0
Prof Elizabeth Rieger
Address 133958 0
39 University Avenue, Australian National University, New Acton ACT 2601
Country 133958 0
Australia
Phone 133958 0
+61 2 6125 4208
Fax 133958 0
Email 133958 0
[email protected]
Contact person for public queries
Name 133959 0
Elizabeth Rieger
Address 133959 0
39 University Avenue, Australian National University, New Acton ACT 2601
Country 133959 0
Australia
Phone 133959 0
+61 2 6125 4208
Fax 133959 0
Email 133959 0
[email protected]
Contact person for scientific queries
Name 133960 0
Elizabeth Rieger
Address 133960 0
39 University Avenue, Australian National University, New Acton ACT 2601
Country 133960 0
Australia
Phone 133960 0
+61 2 6125 4208
Fax 133960 0
Email 133960 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant questionnaire data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication; no end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approval by the Principal Investigator, Professor Elizabeth Rieger (E: [email protected])


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.