Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000187741
Ethics application status
Approved
Date submitted
17/12/2021
Date registered
3/02/2022
Date last updated
12/10/2022
Date data sharing statement initially provided
3/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A manualised group program targeted towards internalised stigma.
Scientific title
A manualised group program targeted towards internalised stigma in the youth mental health community.
Secondary ID [1] 303522 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness 320846 0
Condition category
Condition code
Mental Health 318669 318669 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A manualised group program targeted towards the self-stigma (SS) associated with having a mental illness in the western Australian youth population. The NECT program by Yanos (2018). further adapted for use in the Australian youth mental health population will be used. The Australian adaption of NECT for youth will be a manualised group program designed delivered in 12 60–90-minute weekly sessions. NECT groups are conducted by one-two facilitators, with eight persons per group. The intervention will take place in a meeting room at Fiona Stanley Hospital and Zoom sessions will also be made available. Attendance to treatment will be documented for participants in the NECT program.

In each session, group members reading from the manual in each session, complete written tasks, and discuss their opinions and experiences. The NECT program by Yanos (2018) aims to provide improvements in SS and associated outcomes through three approaches:

• Delivering education that challenges and refutes mental health stereotypes
• Offering ‘cognitive restructuring’ to be used as a positive coping strategy in place of avoidant coping strategies
• Teaching ‘narrative insight’, which enables participants to gain empowerment from their personal experiences

The structure of the program is comprised of five core sections:
1. Introduction
• Exploring self and illness and how they relate
2. Psychoeducation
• Mental health, stigma and recovery
• Issues surrounding disclosure
3. Cognitive Restructuring
• Teaching and counteracting internalised stigma
• Develop coping skills for dealing with stigma, stress, anxiety and depressed mood
4. Narrative Enhancement
• Process of telling and retelling stories to gain purpose and meaning
• Intergrading more empowering themes into their personal narratives
5. Conclusion
• Ask each participant to describe themselves and their relationship with mental illness
• Summary of group achievements

All clinicians involved in delivering the program will receive long distance training by the programs authors and treatment fidelity will be monitored using the NECT fidelity scale.
Intervention code [1] 319805 0
Treatment: Other
Comparator / control treatment
Treatment as usual for all participants. This means that all participants will continue to receive services as normal from their healthcare service.
Control group
Active

Outcomes
Primary outcome [1] 326616 0
Change in internalised stigma at the end of treatment measured using the Internalized Stigma of Mental Illness Scale (ISMI)
Timepoint [1] 326616 0
The participants will be recruited from an associated study which is assessing the prevalence of internalised stigma in the mental health community. Cumulative data will be assessed at end of treatment (primary timepoint) and 3-month follow up.
Secondary outcome [1] 392137 0
Change in health status measured using The Suboptimal Health Status Questionnaire (SHSQ-25)
Timepoint [1] 392137 0
Cumulative data will be assessed at end of treatment and 3-month follow up.

Eligibility
Key inclusion criteria
The participants will be recruited from an associated study which is assessing the prevalence of internalised stigma in the mental health community.
Moderate-high measures of internalised stigma
Aged 16-24 years
Capacity to provide consent
Fluent in English
Moderate to high internalised stigma as indicated by a score of 2> on the ISMI, in an associated study.
Minimum age
16 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Are unable to complete the survey
Are assessed as unable to have the capacity to understand their role in completing the survey and therefore provide valid consent.

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)
1:1 allocation ration.
Allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocking with stratification will be used to assign all variables equally. Blocks will be created according to gender, age, ethnicity, diagnosis and treatment location.
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
Efficacy
Statistical methods / analysis
The analysis will include a linear mixed (fixed and random) effects, three-level, multilevel framework with full maximum likelihood under assumption of normality to assess changes in individual response trajectories overtime. Level 1 will be repeated measures within each participant overtime. Level 2 will be between participant characteristics. Level 3 will be between site differences. The Generalised Linear Mixed Model and will include a random intercept by participant and site (multilevel/cluster) and may include random slopes by individual too (as appropriate to fit the model).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
1/01/2024
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 18782 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 23356 0
Bentley Health Service - Bentley
Recruitment postcode(s) [1] 33229 0
6150 - Murdoch
Recruitment postcode(s) [2] 38733 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 310414 0
University
Name [1] 310414 0
Edith Cowan Universtiy
Country [1] 310414 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Australia
Country
Australia
Secondary sponsor category [1] 311572 0
None
Name [1] 311572 0
Address [1] 311572 0
Country [1] 311572 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307792 0
South Metropolitan Health Service research ethics committee.
Ethics committee address [1] 307792 0
Ethics committee country [1] 307792 0
Australia
Date submitted for ethics approval [1] 307792 0
18/02/2022
Approval date [1] 307792 0
01/04/2022
Ethics approval number [1] 307792 0

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

Contacts
Principal investigator
Name 108510 0
Miss Andrea Lyon
Address 108510 0
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Australia
Country 108510 0
Australia
Phone 108510 0
+61 0426252897
Fax 108510 0
Email 108510 0
[email protected]
Contact person for public queries
Name 108511 0
Andrea Lyon
Address 108511 0
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Australia
Country 108511 0
Australia
Phone 108511 0
+61 0426252897
Fax 108511 0
Email 108511 0
[email protected]
Contact person for scientific queries
Name 108512 0
Andrea Lyon
Address 108512 0
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Australia
Country 108512 0
Australia
Phone 108512 0
+61 0426252897
Fax 108512 0
Email 108512 0
[email protected]

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.