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Trial registered on ANZCTR


Registration number
ACTRN12619000923167
Ethics application status
Approved
Date submitted
30/05/2019
Date registered
2/07/2019
Date last updated
22/01/2021
Date data sharing statement initially provided
2/07/2019
Date results provided
22/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Entourage Project: A single-group pilot study of an interactive e-mentoring program for young people with social anxiety symptoms attending headspace
Scientific title
The Entourage Project: A single-group pilot study of an interactive e-mentoring program for young people with social anxiety symptoms attending headspace
Secondary ID [1] 298373 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social anxiety 313045 0
Condition category
Condition code
Mental Health 311543 311543 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Entourage is a pilot, single-group pre-post trial of an interactive e-mentoring program. The trial involves moderated online social therapy (MOST), developed by eOrygen, the digital mental health division of Orygen, the National Centre of Excellence in Youth Mental Health (Orygen). The intervention is being piloted among a group of 89 young people attending headspace centres, who experience symptoms of social anxiety, representing an adjunct to treatment as usual provided by headspace. The online platform consists of: peer-to-peer online social networking; individually-tailored interactive psychosocial interventions; and involvement of expert mental health and peer moderators to ensure intervention safety.

The primary objective is to evaluate whether the Entourage intervention demonstrates acceptability, feasibility and safety. A secondary objective is to investigate whether the Entourage intervention demonstrates potential social benefit (i.e., improvement to loneliness, isolation, social connectedness and symptoms of social anxiety).

The intervention consists of evidence-based cognitive approaches to the treatment of social anxiety, delivered online via purpose-developed therapeutic comics. The Entourage therapy comics have been developed through an iterative process of scripting, professional illustration and inter-disciplinary feedback from expert youth mental health clinicians and end-users (i.e., young people). Each comic is approximately 15-25 panels in length, requiring around 5-minutes to read. Entourage includes 7 “Pathways”, covering various therapeutic themes (Communication; Mindfulness; Self compassion; Depression; Anxiety; Social anxiety). Each Pathway contains a series of “Steps”, and each Step has its own unique therapy comic which covers a different aspect of the theme of the Pathway. For example, the Social Anxiety Pathway has 12 Steps, covering a range domains of social anxiety: psychoeducation regarding social anxiety; physiological symptoms of social anxiety; the role of cognition & fear of negative evaluation; safety behaviours associated with social anxiety; building on positive social experiences; etc. All therapy modules in Entourage contain therapeutic comics and a set of associated Actions.

Entourage e-mentors (clinical psychologists) also support participants to complete therapy "Actions", which serve as behavioural experiments within Entourage. Each Step has a set of associate Actions which are designed to help participants apply their learning from reading the Step. For example, the Social Anxiety Pathway contains Actions which encourage participants to work with clinical moderators to develop a set of behavioural experiments, where participants are supported in the process of identifying feared social situations within a graded hierarchy. Participation in the therapy Actions is monitored by the clinical moderation team, who contact participants successively over the course of the 12-week study period to support their progress. Participants are also encouraged to record their completion of Actions in the Entourage system.

Entourage also allows participants to interact anonymously with each other via a peer-to-peer online social networking section. This section is moderated by Entourage peer workers (young people with a lived experience of mental health service access, who have been specially-trained to support others). Whilst all participants have unlimited access to all therapy modules during the study period, the intervention is tailored insofar as the clinical moderation team can suggest particular therapy modules to young people based on presenting concerns.

Following an in-person baseline assessment and induction to the Entourage platform, participants are free to use the system for a 12-week study intervention period. During this time participants receive online clinical moderation and peer support, and can access the therapy modules in their own time. No expectation for duration of use is communicated to participants, however the moderation team encourage participants to complete successive therapy modules (called “steps”) as part of “pathways” throughout the study period. Data analytics regarding participants’ use of the system are automatically recorded online. These will be monitored by the clinical moderation team, alongside communication with participants throughout the study period to monitor adherence to the intervention. This is a pilot study aiming to gauge participants’ experience of Entourage, and as such their level of engagement might vary.

Additional assessments involve a 6-week midpoint questionnaire administered online, and 12-week in-person follow-up assessment involving questionnaire measures and a semi-structured feedback interview, designed to capture participants' perspectives on the acceptability, feasibility and safety of the Entourage intervention.
Intervention code [1] 314616 0
Treatment: Other
Comparator / control treatment
No control group. Entourage is a single-group feasibility study of an adjunct intervention among participants receiving treatment-as-usual. For the purposes of this study, ‘treatment-as-usual’ refers to young people’s biopsychosocial support provided through headspace. All participants are help-seeking young people attending one of four headspace centres.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320250 0
Evaluate whether the Entourage intervention demonstrates acceptability. Acceptability will be indicated if >50% of participants have at least 10 log-ins to Entourage over 10 different weeks; and at least 60% of participants report that the Entourage platform provided timely, relevant and helpful support at semi-structured follow-up interview.
Timepoint [1] 320250 0
12-week follow-up, compared to baseline
Primary outcome [2] 320402 0
Evaluate whether the Entourage intervention demonstrates feasibility. Feasibility will be indicated if recruitment exceeds 75% of the target; if the refusal rate from potential participants is <50%; if positive feedback is received regarding participant usage of Entourage, and perceived benefit of Entourage is obtained from clinical moderators and peer workers; and if at least 50% of recruited participants are retained for follow-up assessment at 12 weeks.
Timepoint [2] 320402 0
12-week follow-up, compared to baseline.
Primary outcome [3] 320403 0
Evaluate whether the Entourage intervention demonstrates safety. Safety will be indicated if: no adverse events including acts of self-harm or suicide attempts are reported (either by participants or their treating clinicians) which may be attributable to the Entourage intervention; no significant deterioration is observed on measures of self-reported depression (PHQ-9) or social anxiety (LSAS), as indicated by significant differences according to the reliable change index; and all Entourage participants report feeling adequately supported by clinical moderators.
Timepoint [3] 320403 0
12-week follow-up, compared to baseline.
Secondary outcome [1] 371634 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvements in their sense of loneliness. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Revised UCLA Loneliness Scale.
Timepoint [1] 371634 0
12-week follow-up, compared to baseline.
Secondary outcome [2] 371635 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvements in their levels of psychological inflexibility. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Acceptance and Action Questionnaire (AAQ).
Timepoint [2] 371635 0
12-week follow-up, compared to baseline.
Secondary outcome [3] 371636 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvements in emotional regulation. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Emotion Regulation Questionnaire (ERQ).
Timepoint [3] 371636 0
12-week follow-up, compared to baseline.
Secondary outcome [4] 371637 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvements in feelings of guilt and shame. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Personal Feelings Questionnaire (Brief; PFQ-2 Brief).
Timepoint [4] 371637 0
12-week follow-up, compared to baseline.
Secondary outcome [5] 371638 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvements in levels of reactivity to anxiety. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Anxiety Sensitivity Index (ASI).
Timepoint [5] 371638 0
12-week follow-up, compared to baseline.
Secondary outcome [6] 372049 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvement to symptoms of depression. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [6] 372049 0
12-week follow-up, compared to baseline.
Secondary outcome [7] 372050 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvement to symptoms of depression. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Male Depression Risk Scale (MDRS-22).
Timepoint [7] 372050 0
12-week follow-up, compared to baseline.
Secondary outcome [8] 372051 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvements in general well-being. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Short Warwick Edinburgh Mental Well-being Scale (SWEMWBS).
Timepoint [8] 372051 0
12-week follow-up, compared to baseline.
Secondary outcome [9] 372052 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvements in general well-being. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of scores on a single item assessing general health and wellbeing from the World Values Survey - Life Satisfaction Scale.
Timepoint [9] 372052 0
12-week follow-up, compared to baseline.
Secondary outcome [10] 372053 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvements in general well-being. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Daily Activities item of the European Social Survey.
Timepoint [10] 372053 0
12-week follow-up, compared to baseline.
Secondary outcome [11] 372054 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvement to feelings of social connection and social support. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Abbreviated Duke Social Support Index (DSSI).
Timepoint [11] 372054 0
12-week follow-up, compared to baseline.
Secondary outcome [12] 372055 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvement to feelings of social connection and social support. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Interpersonal Needs Questionnaire (INQ).
Timepoint [12] 372055 0
12-week follow-up, compared to baseline.
Secondary outcome [13] 372056 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvement to feelings of social connection and social support. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Social Connectedness Scale (SCS).
Timepoint [13] 372056 0
12-week follow-up, compared to baseline.
Secondary outcome [14] 372057 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvement to feelings of social connection and social support. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics the Lubben Social Network Scale (LSNS).
Timepoint [14] 372057 0
12-week follow-up, compared to baseline.
Secondary outcome [15] 372058 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvement to symptoms of social anxiety. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Liebowitz Social Anxiety Scale (LSAS).
Timepoint [15] 372058 0
12-week follow-up, compared to baseline.
Secondary outcome [16] 372059 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvement to symptoms of social anxiety. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the the Social Interaction Anxiety Scale (SIAS).
Timepoint [16] 372059 0
12-week follow-up, compared to baseline.
Secondary outcome [17] 372060 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvement to symptoms of social anxiety. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Brief Fear of Negative Evaluation Scale (BFNE).
Timepoint [17] 372060 0
12-week follow-up, compared to baseline.
Secondary outcome [18] 372061 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvement to symptoms of social anxiety. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Self-Statements During Public Speaking Scale (SSPS).
Timepoint [18] 372061 0
12-week follow-up, compared to baseline.
Secondary outcome [19] 372062 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvements in their self-compassionate attitudes. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Self-Compassion Scale - Short Form (SCS).
Timepoint [19] 372062 0
12-week follow-up, compared to baseline.
Secondary outcome [20] 372063 0
Evaluate whether participants involved in the Entourage intervention demonstrate improvements in their self-esteem. This will be assessed according to appropriate within-subject analyses (e.g., t-tests, mixed-models analysis) of summary statistics from the Rosenberg Self-Esteem Scale (SES).
Timepoint [20] 372063 0
12-week follow-up, compared to baseline.

Eligibility
Key inclusion criteria
- Aged 12 to 25 years inclusive;
- Current symptoms of social anxiety indicated by a score of 30 or higher on the Leibowitz Social Anxiety Scale;
- Attender of one of four headspace centre across north-western Melbourne;
- Ability to give informed consent and comply with study procedures;
- Regular and ongoing internet and/or smartphone and mobile telephone access.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of an intellectual disability;
- Not able to converse in, or read English;
- Presence of comorbid physical health conditions requiring a high level of medical care;
- Current diagnosis of a schizophrenia spectrum or psychotic disorder.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Primary and secondary outcomes will be evaluated using descriptive statistics (to characterise the sample and evaluate feasibility, safety, acceptability), paired samples t-tests (to determine pre-post changes) and an exact binomial test (to determine change in clinical categories).

The goal sample size for recruitment into Entourage was 110 young people (55 males, 55 females, with recruitment open to non-binary people in addition to these targets). This target was set according to the following rationale:
- The sample size of 110 was considered necessary to demonstrate outcomes for the secondary objective (social benefits of Entourage), and whether usage of the system is associated with clinical benefits. This target was also necessary to provide a buffer against expected rates of attrition and failure of participants to complete follow-up assessments.
- In future, there is scope to scale-up the Entourage intervention to a nation-wide trial involving up to 2000 young people. The recruitment target of 110 was therefore necessary to evaluate the Entourage platform in a relatively large pilot sample, to ensure the system can accommodate a large number of active users.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/10/2018
Date of last participant enrolment
Anticipated
Actual
20/05/2019
Date of last data collection
Anticipated
12/08/2019
Actual
12/08/2019
Sample size
Target
110
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13856 0
Headspace Craigieburn - Craigieburn
Recruitment hospital [2] 13857 0
Headspace Sunshine - Sunshine
Recruitment hospital [3] 13858 0
Headspace Werribee - Werribee
Recruitment hospital [4] 13859 0
Headspace Glenroy - Glenroy
Recruitment postcode(s) [1] 26627 0
3064 - Craigieburn
Recruitment postcode(s) [2] 26628 0
3020 - Sunshine
Recruitment postcode(s) [3] 26629 0
3030 - Werribee
Recruitment postcode(s) [4] 26630 0
3046 - Glenroy

Funding & Sponsors
Funding source category [1] 302909 0
Charities/Societies/Foundations
Name [1] 302909 0
Movember Foundation
Country [1] 302909 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen, the National Centre of Excellence in Youth Mental Health
Address
35 Poplar Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 302872 0
None
Name [1] 302872 0
Address [1] 302872 0
Country [1] 302872 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303481 0
The University of Melbourne Psychology Health and Applied Sciences Human Ethics Sub-Committee
Ethics committee address [1] 303481 0
Ethics committee country [1] 303481 0
Australia
Date submitted for ethics approval [1] 303481 0
Approval date [1] 303481 0
24/07/2018
Ethics approval number [1] 303481 0
1851797

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

Contacts
Principal investigator
Name 93802 0
Dr Simon Rice
Address 93802 0
Orygen, The National Centre of Excellence in Youth Mental Health, Locked Bag 10, 35 Poplar Road, Parkville VIC 3052
Country 93802 0
Australia
Phone 93802 0
+61 419497599
Fax 93802 0
Email 93802 0
simon.rice@orygen.org.au
Contact person for public queries
Name 93803 0
Simon Rice
Address 93803 0
Orygen, The National Centre of Excellence in Youth Mental Health, Locked Bag 10, 35 Poplar Road, Parkville VIC 3052
Country 93803 0
Australia
Phone 93803 0
+61 419497599
Fax 93803 0
Email 93803 0
simon.rice@orygen.org.au
Contact person for scientific queries
Name 93804 0
Simon Rice
Address 93804 0
Orygen, The National Centre of Excellence in Youth Mental Health, Locked Bag 10, 35 Poplar Road, Parkville VIC 3052
Country 93804 0
Australia
Phone 93804 0
+61 419497599
Fax 93804 0
Email 93804 0
simon.rice@orygen.org.au

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.