Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000077763
Ethics application status
Approved
Date submitted
17/12/2021
Date registered
21/01/2022
Date last updated
15/02/2023
Date data sharing statement initially provided
21/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of the Groups 4 Health program for People with Social Anxiety
Scientific title
Effectiveness of the Groups 4 Health program for People with Social Anxiety
Secondary ID [1] 306037 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety 324673 0
Condition category
Condition code
Mental Health 322121 322121 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Groups 4 Health (G4H) Group Psychotherapy Program.
G4H is a manualised group-based intervention, which is designed to reduce social isolation through increased group-based belonging and social identification with these groups (Haslam et al., 2021a, 2021b). The G4H program was developed using leading social and clinical psychology research, which suggests that people’s group-based connections are important buffers against poor health and reduced well-being (see Haslam et al., 2018). G4H has been found to be efficacious in Phase I, II, and III trials (see Cruwys et al., 2021; Haslam et al., 2016, 2019). Across all three trials, G4H produced significant reductions in participants’ depression and loneliness symptoms. In Phase I and II trials, participants also experienced significant improvement in social anxiety symptoms. Further, in the Phase III trial G4H was found to be non-inferior to cognitive-behavioural therapy, which is considered the gold-standard treatment for many mental health conditions.

In G4H, participants will complete 5 modules over the course of 2 months, each of which will run between 60 to 90 minutes. These will be run face-to-face in the Australian National University Psychology Clinic in groups of 5 to 8 participants. Each module will be run by two trained and supervised facilitators (i.e., psychology postgraduate students who are provisionally registered as psychologists). Modules 1 to 4 will be run weekly, and Module 5 is run one month later, which will allow participants to apply the social plans developed in Module 4 (i.e., total duration of 2 months).

In addition to the facilitator manual, the program will be supported by a client workbook (Haslam et al., 2016). This contains a summarised version of the facilitator’s manual highlighting the main activities and learning points for each session, with space to complete in session and homework activities to support their learning. How long participants want to spend on the workbook each week will be at their discretion.
Citation: Haslam, C., Cruwys, T., Haslam, S. A., Bentley, S. V., Dingle, G. A., & Jetten, J. (2021). GROUPS 4 HEALTH Workbook (Version 4.0). Social Identity and Groups Network: University of Queensland, Australia.

Treatment fidelity will be assessed by brief questionnaires completed by facilitators at the end of each session. This will require facilitators to indicate how long the session ran, if any issues arose, rate the social connectedness within the group members, and rate their own leadership during the session. All sessions will also be video-recorded to investigate the behaviours of facilitators during the session. Participants will also be asked to indicate on their end of session questionnaires whether they completed last week's homework.

Module content is summarised below:

The first session will involve discussion of the importance of groups for health and well-being. In the second session participants will complete a "social identity map", which visually represents their own group memberships (e.g., the importance of each group) and how these groups interact (e.g., whether their groups are compatible or not); this will also include planning what their groups could look like in the future. The third session will focus on how groups work, including factors which stop people from enjoying being a member of certain groups and how they can maximise the helpfulness of their groups. The fourth session will help participants make a plan to join additional meaningful groups. The fifth and final session will ask participants to evaluate their progress and re-complete their social identity maps.
Intervention code [1] 322435 0
Treatment: Other
Intervention code [2] 322573 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329889 0
Social anxiety symptoms, as measured using the The Social Phobia Scale (SPS; Mattick & Clarke, 1998) and the Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998).
Timepoint [1] 329889 0
1) Baseline (in screening survey)
2 ) After each group therapy session
3) 3-month post intervention completion (primary endpoint)
Primary outcome [2] 329908 0
Loneliness, as measured using Revised UCLA Loneliness Scale (Russell et al., 1980)
Timepoint [2] 329908 0
1) Baseline (in screening survey)
2 ) After each group therapy session
3) 3-month post intervention completion (primary endpoint)

Note that 20-item version will be used at baseline, on completion of G4H, and at 3-month follow up. The 4-item version will be used after sessions 1-4.
Secondary outcome [1] 404178 0
Facilitator Identity Leadership, as measured using the Identity Leadership Inventory (Steffens et al., 2014) and coding facilitator behaviours that are video-recorded during sessions.
Timepoint [1] 404178 0
1) After each group therapy session
2) 3-month post intervention completion

Note that 15-item version will be used after session 1, on completion of G4H, and at 3-month follow up. The 4-item version will be used after sessions 2-4.
Secondary outcome [2] 404239 0
Social identification with therapy group, measured using Four-item Social Identification Scale (Postmes et al., 2013).
Timepoint [2] 404239 0
1) Baseline (in screening survey)
2 ) After each group therapy session
3) 3-month post intervention completion
Secondary outcome [3] 404240 0
Social support from facilitators, measured using Medical Outcomes Survey Social Support Scale (Emotional and Informational Support Subscale; (Sherbourne & Stewart, 1991)
Timepoint [3] 404240 0
1) After session 1
2) On completion of G4H intervention
3) At 3-month post intervention completion
Secondary outcome [4] 404241 0
Membership of multiple groups, as measured using The Exeter Identity Transition Scale (EXITS; Haslam et al., 2008).
Timepoint [4] 404241 0
1) Baseline (in screening survey)
2 ) On completion of G4H intervention
3) 3-month post intervention completion
Secondary outcome [5] 404242 0
Social isolation schema, as measured using The Young Schema Questionnaire Short Form social isolation schema items (Schmidt et al., 1995; Welburn et al., 2002), which captures the degree to which people feel isolated and disconnected from other people.
Timepoint [5] 404242 0
1) Baseline (in screening survey)
2 ) On completion of G4H intervention
3) 3-month post intervention completion
Secondary outcome [6] 404243 0
Self-focused attention, measured using 2 items from Clarks (2003) Social Anxiety Process Measures.
Timepoint [6] 404243 0
1) Baseline (in screening survey)
2 ) On completion of G4H intervention
3) 3-month post intervention completion
Secondary outcome [7] 404245 0
Mental wellbeing, as measured using the Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWS; Stewart-Brown et al., 2009)
Timepoint [7] 404245 0
1) Baseline (in screening survey)
2 ) On completion of G4H intervention
3) 3-month post intervention completion
Secondary outcome [8] 404246 0
Depression symptoms, as measured using Patient Health Questionnaire 9-item version (PHQ-9; Kroenke et al., 2001).
Timepoint [8] 404246 0
1) Baseline (in screening survey)
2 ) On completion of G4H intervention
3) 3-month post intervention completion
Secondary outcome [9] 404331 0
Facilitator identity prototypicality (how well facilitators represent the identity of the group they lead). This will be assessed using facilitator's ratings of their own social anxiety symptoms (using Social Phobia Inventory) and social identification with people (a) experiencing social anxiety and (b) in recovery from social anxiety.
Timepoint [9] 404331 0
1) After facilitator training 2) After the final group therapy session (for each group that a facilitator leads)

Eligibility
Key inclusion criteria
Inclusion criteria for participants include:
1) being over 18 years of age
2) scoring above or equal to 12 on the Social Phobia Scale (which indicates clinically-significant social anxiety symptoms)
3) having sufficient English language skills to understand and join in group discussions.

Inclusion criteria for facilitators include:
1) Registration as a provisional psychologist with the Psychology Board of Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participants include:
1) severe suicidal ideation (endorsement of item 9 on the Patient Health Questionnaire-9)
2) severe psychological symptoms (e.g., a current psychotic episode)
3) substance dependence or intoxication
4) severe neurological conditions or intellectual impairment.

These will be assessed via questionnaire in the screening survey. Additionally, if facilitators judge that a person is unable to contribute to group discussions due to apparent intellectual impairment or intoxication, this person may be excluded from the trial and referred to more appropriate mental health services.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We plan on screening 170 participants and, assuming 50% eligibility (like Haslam et al., 2016), we aim to recruit an initial sample of 80 participants with elevated social anxiety symptoms. To have 0.80 power to detect a medium effect size with an alpha level of 0.05, a minimum of N = 47 people would need to retained for follow-up. Assuming 60% survival rates (like Haslam et al., 2016), we expect that our initial sample of 80 eligible participants will lead to a sample of 51 participants at 3-month follow-up.

Statistical Analysis Plan:
We plan to use multi-level modelling to determine how the primary and secondary outcomes change over the course of therapy and at follow-up. This approach allows us to statistically account for both the repeated measures within our data and the clustering of participants into therapy groups. We also plan to use multi-level mediation analysis and structural equation modelling to investigate potential paths through which other variables affect our outcomes (e.g., whether social identification mediates the relationship between identity leadership and improved social anxiety symptoms).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
12/08/2022
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
80
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 36206 0
2600 - Canberra
Recruitment postcode(s) [2] 36207 0
2601 - Canberra

Funding & Sponsors
Funding source category [1] 310374 0
University
Name [1] 310374 0
Australian National University
Country [1] 310374 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Tegan Cruwys
Address
Research School of Psychology,
Building 39, The Australian National University, Science Rd, Canberra, ACT, 2601
Country
Australia
Secondary sponsor category [1] 311511 0
Individual
Name [1] 311511 0
Alysia Robertson
Address [1] 311511 0
Research School of Psychology,
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country [1] 311511 0
Australia
Secondary sponsor category [2] 311513 0
Individual
Name [2] 311513 0
Jessica Donaldson
Address [2] 311513 0
Research School of Psychology,
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country [2] 311513 0
Australia
Secondary sponsor category [3] 311515 0
Individual
Name [3] 311515 0
Dr Joanne Rathbone
Address [3] 311515 0
Research School of Psychology,
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country [3] 311515 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310027 0
Australian National University Human Ethics Committee
Ethics committee address [1] 310027 0
Ethics committee country [1] 310027 0
Australia
Date submitted for ethics approval [1] 310027 0
26/11/2021
Approval date [1] 310027 0
25/03/2022
Ethics approval number [1] 310027 0
2021/794

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

Contacts
Principal investigator
Name 116234 0
A/Prof Tegan Cruwys
Address 116234 0
Research School of Psychology,
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country 116234 0
Australia
Phone 116234 0
+612 6125 5023
Fax 116234 0
Email 116234 0
[email protected]
Contact person for public queries
Name 116235 0
Tegan Cruwys
Address 116235 0
Research School of Psychology,
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country 116235 0
Australia
Phone 116235 0
+612 6125 5023
Fax 116235 0
Email 116235 0
[email protected]
Contact person for scientific queries
Name 116236 0
Tegan Cruwys
Address 116236 0
Research School of Psychology,
Building 39, The Australian National University, Science Rd, Canberra ACT 2601
Country 116236 0
Australia
Phone 116236 0
+612 6125 5023
Fax 116236 0
Email 116236 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?
De-identified data underlying published results, which may also include demographic information (e.g., age, gender). Steps will be taken to ensure all data is completely anonymous. Participants will also provide consent to have their de-identified data made available on public data repositories, consistent with Open Science practices.
When will data be available (start and end dates)?
Data would be available immediately after publication. There is no determined end date.
Available to whom?
To anyone who wishes to conduct further analyses of this data.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
On the Australian Data Archive website: https://ada.edu.au and the Open Science Framework website: https://osf.io/


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.