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Trial registered on ANZCTR


Registration number
ACTRN12622000024741
Ethics application status
Approved
Date submitted
22/11/2021
Date registered
13/01/2022
Date last updated
11/10/2022
Date data sharing statement initially provided
13/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of Self-Stigma in the Australia Mental Health Youth Population
Scientific title
Investigation of Self-Stigma in the Australia Mental Health Youth Population
Secondary ID [1] 305861 0
NIL Known
Universal Trial Number (UTN)
U1111-1271-8576
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 324407 0
self-stigma 324408 0
sub-optimal health 324409 0
Condition category
Condition code
Mental Health 321887 321887 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Quantitative online cross-sectional survey evaluating the occurrence and profile of self-stigma in youth with mental health complications.
Convenient sampling of youth engaged with WA mental health services will be used for this study. Recruitment will be ongoing and occur over a 15-month period (known as ‘rolling recruitment’) and involve dissemination of study information to eligible participants by mental health nurses and the multidisciplinary team at approved sites. Participants will also be targeted through advertisements, where they can request information from mental health staff regarding the study.
Briefly, eligible youth will be invited to participate in the survey and provided with a participant information sheet and consent form, which they will access online. Posters will also be made and placed in suitable areas with information about the study.
Participants will provide informed consent primarily through Research Electronic Data Capture (REDCap); an online digital platform developed to maintain research data integrity. Participant information sheets and consent forms will be accessed through an online link, via a computer, mobile phone, or tablet. Paper-based information sheets and consent forms will also be made available as required.
The information sheets and consent form will provide contact details to the Chief Principal Investigator (CPI), who will contact potential participants via telephone and confirm that informed consent was provided.
After telephone consultation with the CPI, participants who provide valid informed consent will be sent a link to the online survey complete in REDCap. A paper-based questionnaire can be mailed to their home or treatment location on request.
This project will assess SS and general indicators of QoL in the youth with mental health complications. These self-report questionnaires can generally be completed with little or no intervention from an interviewer and take approximately 30 minutes to complete in its entirety at a measured pace. The participants will not receive any feedback after completing the survey and they will not be provided with a copy of their results unless requested.
Intervention code [1] 322256 0
Early Detection / Screening
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329640 0
Assess severity of self-stigma using The Internalized Stigma of Mental Illness Scale.
Timepoint [1] 329640 0
Cumulative data will assessed at the completion of the 15 month study.
Primary outcome [2] 329946 0
Assess suboptimal health status using the Suboptimal Health Status Questionnaire.
Timepoint [2] 329946 0
Cumulative data will be assessed at the completion of the 15 month study.
Secondary outcome [1] 404390 0
Assess the participants subjective measure of quality of life us the Manchester Quality-of-Life Questionnaire
Timepoint [1] 404390 0
Cumulative data will be assessed at the completion of the 15 month study.

Eligibility
Key inclusion criteria
1. Are aged 16 to 24 years
2. Meet diagnostic criteria for a mental illness in the International Classification of Diseases 10th Revision (ICD-10)
3. Are fluent in English
Minimum age
16 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Are unable to complete the survey or speak English.
2. Are assessed as unable to have the capacity to understand their role in completing the survey and therefore provide valid consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Description of the statistical methods to be employed, including timing of any planned interim analysis.
Data will be downloaded, checked, and cleaned for inconsistencies. All data cleaning documentation will be filed, with the raw and cleaned data in separate subfolders.
Exploratory analyses will evaluate the distributions and frequencies of continuous (means, standard deviations, medians, and range) and categorical (counts and proportions) data, respectively. Histograms, boxplots, and scatterplots will be used to visually inspect data. The occurrence of SS will be derived by assessing the proportions of SS severity within the study sample (low, high). Univariate analyses using Generalised Linear Model (GLM) will quantify the relationship between SS and each dependent variable of interest (ES, RAS, SHS-25, MANSA, SCQ, technology use).
Multivariable analyses (GLMs) will quantify the independent effects between SS and the dependent variables, while controlling for age, gender, mental health service, diagnosis and level of education. These GLMs will be of the Gaussian family when describing the SS scores and of the Binomial family when dichotomising SS scores as high vs low.
All analyses will be conducted with R (RStudio, 2020).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
436
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21182 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 21183 0
Bentley Health Service - Bentley
Recruitment postcode(s) [1] 36047 0
6102 - Bentley
Recruitment postcode(s) [2] 36046 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 310213 0
University
Name [1] 310213 0
Edith Cowan University
Country [1] 310213 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Australia
Country
Australia
Secondary sponsor category [1] 311571 0
None
Name [1] 311571 0
NONE
Address [1] 311571 0
NONE
Country [1] 311571 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309894 0
South Metropolitan Health Service
Ethics committee address [1] 309894 0
11 Robin Warren Drive
Murdoch Western Australia
6150
Ethics committee country [1] 309894 0
Australia
Date submitted for ethics approval [1] 309894 0
20/01/2022
Approval date [1] 309894 0
01/04/2022
Ethics approval number [1] 309894 0

Summary
Brief summary
This quantitative project will involve a cross-sectional study which will measure self-stigma (SS) prevalence and severity among the Western Australian youth (16 -24 years) mental health population. It will also profile SS by exploring its relationship with several measures of demographic, mental and physical health, behaviours, and wellbeing. A minimum of 436 youth with a mental illness are required for the cross-sectional survey. It is hypothesised that moderate to severe internalised stigma will affect approximately 25% of youth with a mental illness. Additionally, it is hypothesised that those with lower SS severity will present as relatively more recovered, demonstrate stronger self-orientation towards empowerment and have better quality of life.
Trial website
Trial related presentations / publications
Public notes
Mental illness affects 20-25% of people aged 16-24 years in Australia each year and is the age demographic in this country where psychiatric disorders are most represented (Australian Bureau of Statistics, 2008). The first onset of mental illness usually appears in childhood and adolescence and peaks during late adolescence and 75% of people report a diagnosis of a lifetime mental illness before the age of 24 (Kessler et al., 2007; Kessler et al., 2005). Mental illness contributes to approximately 50% of the disease burden among those aged 10 to 24 years and is the leading cause of disability for this age group (Gore et al., 2011). Furthermore, youth have high rates of self-harm and suicide is one of the most common causes of death for young people (Australian Bureau of Statistics, 2015; Collishaw, 2015; Patel et al., 2007).

Individuals who have had a mental disorder between 18 and 25 years are more likely to have lower employment rates, income, and living standards by age 30 years (Gibb et al., 2010). Correspondingly, people with a mental disorder diagnosis through ages 14-24 have been found to have poor socioeconomic and educational outcomes, impaired interpersonal relationships, pregnancy complications, and increased drug use and suicide attempts at ten-year follow-up (Asselmann et al., 2018). While symptoms may reduce in the late 20s following treatment, having a mental illness earlier in life remains associated with reduced life quality as an adult in economic, educational and vocational domains (Copeland et al., 2015; Gibb et al., 2010). This illustrates that even with clinical recovery, an individual’s ability to function economically and socially throughout their life may be affected by having a mental illness earlier in life.

The strongest predictor for mental illness in adulthood is psychological distress, mental health symptoms or a psychiatric diagnosis during adolescence or childhood, even after controlling for other variables (Fryers & Brugha, 2013). There is also strong evidence that a mental illness in childhood and adolescence predicts the development of additional psychiatric disorders later in life (Asselmann et al., 2018; Collishaw, 2015; Lahey, 2015; National Mental Health Commission, 2019; WHO, 2014). Further, more severe mental illness usually develops later in life after less severe, more easily treatable mental illness has occurred (Kessler et al., 2007; Patton et al., 2014). Thus, treatment for mental illness in youth needs to account for the progression of treatable mental illnesses, risk of relapse and long-term outcomes of mental illness in youth.

Currently, treatments for youth mental illness are centred on addressing acute symptoms with an insufficient focus on long-term recovery and functional impairments (Hickie et al., 2019; Mei et al., 2020). This may be evidenced by their short- and long-term results. Up to half of young people with mental disorders fail to respond to first-line therapies (Ginsburg et al., 2014) and as many as 50% of youth are involved in multiple episodes of care (Gibb et al., 2010). Some early interventions for some mental illnesses have demonstrated efficacy in providing long-term benefits (Barrett et al., 2001; Hazell, 2007; Kaushik et al., 2016), yet the rates of treatment utilisation for children and adolescents with mental disorders are low (Islam et al., 2020; Lahey, 2015; Rickwood et al., 2005).

In Australia, typically, less than 25% of youth with a mental illness receive mental health care each year (Australian Institute of Health and Welfare, 2011; Reavley et al., 2010). In contrast to adults, youth may be less likely to engage in mental health treatment due to concerns surrounding confidentiality, social alienation and poor knowledge of mental illness and available treatments (Gulliver et al., 2010; Radez et al., 2021). Furthermore, a key factor impacting treatment utilisation in youth may be stigma (Bulanda et al., 2014; Gronholm et al., 2017; Rickwood et al., 2005). Young people who endorse stigma are less likely to seek help (Kaushik et al., 2016; Silke et al., 2016). Congruent with the ‘why try effect,’ lack of the belief in treatment efficacy may also play a role in reduced treatment engagement. Increased SS in youth is correlated with the perception of less control over mental illness and the belief that mental health problems are life-long (Moses, 2009a).

Suboptimal Health Status
Wider health impacts may accumulate in people with a diagnosis of mental illness with long-term health consequences. From the onset of mental illness, poor physical health starts to accumulate. People with a mental illness have increased physical illnesses compared to the reset of the population and die up to three decades earlier (Orygen, 2021).

Psychological distress in young adults is correlated with poor outcomes in each dimension of validated suboptimal health status (SHS) measures (e.g., fatigue, cardiovascular, digestive, immune system, and mental status) (Hou et al., 2018). SHS is a subclinical physical state between health and disease (Wang et al., 2014). Symptoms in this state may include non-specific pain, chronic fatigue, headaches, weakness, depression and anxiety (Chen et al., 2014; Hou et al., 2018; Joustra et al., 2015). Although, SHS is viewed as reversable, it is associated with a reduced QoL (Serra-Sutton et al., 2009) and is a risk factor for the development cardiovascular, metabolic, and other chronic diseases (Adua et al., 2017; Wang et al., 2014; Yan et al., 2012). As the World Health Organization (WHO) defines health as a state of total mental, physical, and social well-being and not simply the absence of disease or illness (WHO, 2006), a holistic approach to care is needed to address the total health status of the youth mental health cohort.

From the paradigm shift from reactive to predictive, preventive, and personalised medicine (PPPM), strategies for early, personalised interventions are needed at the SHS stage in youth mental health treatment. PPPM is an integrative concept in health care which enables the identification of risk, early prevention, and optimal therapy planning targeted for individual needs (Golubnitschaja et al., 2014). Personalised interventions which improve SHS are needed to foster young peoples’ capacities to manage psychological distress and to improve their total health status. When young people are in good health, they are more likely to achieve better educational outcomes, make a successful transition into employment, develop healthier lifestyles, and experience an improved QoL throughout adulthood (Australian Institute of Health and Welfare, 2011).

Research Gap

While SS is evident in the Australian adult mental health population (Lyon & Mortimer-Jones, 2020), there have been no studies assessing its occurrence in Australia's mental health youth cohort. In addition, no studies have assessed sub-optimal health status in the Australian youth community. Importantly, understanding the association of SS with recovery and overall health will have important implications for research initiatives and treatment programs.

Contacts
Principal investigator
Name 115754 0
Miss Andrea Lyon
Address 115754 0
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Australia
Country 115754 0
Australia
Phone 115754 0
+61 0426252897
Fax 115754 0
Email 115754 0
alyon0@our.ecu.edu.au
Contact person for public queries
Name 115755 0
Miss Andrea Lyon
Address 115755 0
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Australia
Country 115755 0
Australia
Phone 115755 0
+61 0426252897
Fax 115755 0
Email 115755 0
alyon0@our.ecu.edu.au
Contact person for scientific queries
Name 115756 0
Miss Andrea Lyon
Address 115756 0
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Australia
Country 115756 0
Australia
Phone 115756 0
+61 0426252897
Fax 115756 0
Email 115756 0
alyon0@our.ecu.edu.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.