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Trial registered on ANZCTR
Registration number
ACTRN12616000543482
Ethics application status
Approved
Date submitted
20/04/2016
Date registered
27/04/2016
Date last updated
16/06/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Compassionate Mind: Evaluation of a Positive Psychology Psycho-educational workshop series for Middle School Students
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Scientific title
Compassionate Mind: Evaluation of a Positive Psychology Psycho-educational workshop series for Middle School Students
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Secondary ID [1]
289048
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None
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Universal Trial Number (UTN)
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Trial acronym
CMP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Wellbeing
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Social worry
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Low mood
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Perfectionism
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Condition category
Condition code
Mental Health
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The Compassionate Mind program is a psycho-educational workshop series that has been developed for middle school students. This study is a controlled trial seeking to evaluate the effectiveness of this program, and to also better understand the relationships between perfectionism, self compassion, mindfulness and psychological wellbeing in this population. The Compassionate Mind program has been developed within an Acceptance and Commitment Therapy, Cognitive Behavioral Therapy and Positive Psychology framework. The program seeks to provide psychoeducation about thoughts, emotions and behavior as well as encourage the development of skills such as mindfulness, self-compassion and helping thinking styles. The primary outcomes to be measured are social worry (including fear of both positive and negative evaluation), perfectionism, low mood and general wellbeing. The program will be delivered by a registered psychologist face-to-face and involve both lectures and small group work. The intervention will be delivered over 8 weeks, for a total of 8 sessions for year 7 middle school students (approximately 150-200 students). The duration of each session will be 85 minutes and sessions will be conducted at the school the students are currently attending. Content will include psycho-education delivery, experiential exercises, mindfulness practice, in addition to individual pair and group-based activities to better illustrate relevant concepts. Informational material will include powerpoint slides, short video clips and role plays. A series of questionnaires will be administered to measure outcomes prior to the program starting, 8 weeks later at the end of the program and a follow-up set of questionnaires will be administered approximately 3-4months later post-program completion.
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Intervention code [1]
294490
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Behaviour
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Comparator / control treatment
Year 6 students enrolled at the same middle school who will not be receiving the intervention will serve as a control group. The same questionnaire administered to the Year 7 students will also be administered to the Year 6 students. At the same time as the Compassionate Mind Program received by year 7, year 6 will be receiving the equivalent of "treatment as usual", with an internal school pastoral care program.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary objective of the project is to evaluate the efficacy of the Compassionate Mind program. A number of outcomes are measured as listed below. Firstly, Mindfulness Skill: The 15-itemed Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
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Assessment method [1]
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Timepoint [1]
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Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.
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Primary outcome [2]
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Social worry symptoms: 12-items drawn from the ‘Fear of Negative Evaluation’ and ‘Social Avoidance and Distress-general’ subscales of the Social Anxiety Scale for Adolescents (SASA) (Inderbitzen-Nolan & Waters, 2000; La Greca & Lopez, 1998), and the 10-itemed Fear of Positive Evaluation Scale (FPE, Weeks et al., 2012)
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Assessment method [2]
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Timepoint [2]
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Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.
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Primary outcome [3]
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Self-Compassion: The 12-item self-compassion scale- short form (Raes, et al. 2011).
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Assessment method [3]
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Timepoint [3]
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Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.
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Secondary outcome [1]
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Wellbeing: The brief 14-item version of the Mental Health Continuum – Short Form (MHCSF) (Keyes, 2005)
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Assessment method [1]
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Timepoint [1]
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Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.
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Secondary outcome [2]
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Perfectionism: The 14-itemed Child and Adolescent Perfectionism Scale-Short Form (CAPS; O'Connor et al., 2009)
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Assessment method [2]
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Timepoint [2]
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Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.
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Secondary outcome [3]
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Demographics: age, postcode, country of birth for mother and father, language spoken at home, family characteristics, self-reported average school grades, and physical activity
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Assessment method [3]
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Timepoint [3]
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Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.
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Eligibility
Key inclusion criteria
Year 6 and 7 students attending a specific Sydney-based middle school.
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Minimum age
10
Years
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Maximum age
15
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Not providing consent or not being enrolled in the specific middle school .
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Correlation, Regression, t-test, ANOVA, Mediation, Moderation
Differences between groups will be examined using hierarchical mixed models containing random intercept and random slope terms as well as fixed effects for treatment received. We are also interested in further investigating self compassion and mindfulness as potential mediating variables in predicting outcomes such as low mood, social worry and overall well being. Anticipated sample size is 150-200 students in the intervention group and approximately 100 in the control group, which is comparable to other similar controlled trials. power analyses will also be conducted post-hoc when analysing the results.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
12/04/2016
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Actual
12/04/2016
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Date of last participant enrolment
Anticipated
7/05/2016
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Actual
2/05/2016
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Date of last data collection
Anticipated
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Actual
14/11/2016
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Sample size
Target
300
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Accrual to date
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Final
158
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
13143
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2135 - Strathfield
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Australian Catholic University
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Address [1]
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25A Barker Rd
Strathfield 2135
NSW
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Australian Catholic University
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Address
25A Barker Rd
Strathfield 2135
NSW
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Research Ethics Committee at Australian Catholic University
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Ethics committee address [1]
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Manager, Ethics c/o Office of the Deputy Vice Chancellor (Research) Australian Catholic University North Sydney Campus PO Box 968 NORTH SYDNEY, NSW 2059
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Ethics committee country [1]
294834
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Australia
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Date submitted for ethics approval [1]
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22/02/2016
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Approval date [1]
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12/04/2016
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Ethics approval number [1]
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2016-44H
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Summary
Brief summary
Background & Project Aims Mental health disorders form a substantial proportion of overall disease burden in young people in all societies (Patel, Flisher, Hetrick, & McGorry, 2007). Internalising disorders, such as anxiety and depression, are consistently reported as the most common mental health problems amongst Australian children aged between 7 and 14 years and are often less likely to be detected compared to externalising disorders (Australian Institute of Health, 2012; Klein, Jacobs, & Reinecke, 2007; Letcher, Sanson, Smart, & Toumbourou, 2012; Seligman, Ernst, Gillham, Reivich, & Linkins, 2009). Poor mental health often begins in early adolescence (12 years of age), and a shift toward early intervention has seen some promise in preventing the trajectory of later diagnosable conditions as well as enabling adolescents to fulfil their potential (Klein, et al., 2007; McGorry, Bates, & Birchwood, 2013). Within this context of rising mental health disorder incident rates, early interventions which target underlying contributors to poor mental health are likely to prevent later trajectories of disorders. Perfectionism has recently gained attention as is a transdiagnositic entity. This means it underlies many other series pathologies such as depression, social anxiety, generalized anxiety disorder, eating disorders and even personality disorders (Dimaggio et al., 2015; Holland, Bodell, & Keel, 2013). Perfectionism refers to a tendency to strive for flawlessness and set exceedingly high standards for performance, accompanied by tendencies for overly critical evaluations (Stoeber, Eklund, & Tenenbaum, 2014). Its transdiagnostic nature positions perfectionism to be an ideal target for early intervention in addition to low mood and social worry to prevent the longitudinal development of future mental health disorders. Self-compassion is a construct gaining prominence over recent years and may directly target the key features of perfectionism, low mood and social worry (Neff, 2011; Neff & Germer, 2013; Neff, 2010). Self-compassion refers to an adaptive way of relating to ones self when considering personal inadequacies or difficult life circumstances. Self-compassion has also been shown to be an effective intervention target for adolescents suffering from negative world views (Neff, 2010). When working with a non-clinical high school population, it is important to ensure content is relevant and engaging, and appropriate for this population. Thus the combined framework of ACT, CBT and positive psychology approaches have been adopted in developing a psycho-educational workshop series, COmpassionate Mind. In addition, high schools are an appropriate target for early intervention programs given their access to a large group and capacity for the provision of ongoing support. The current study seeks to evaluate the effectiveness of the Compassionate Mind program which targets self-compassion and mindfulness.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Madeleine Ferrari
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Address
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Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
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Country
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Australia
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Phone
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+61297014726
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Madeleine Ferrari
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Address
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Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
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Country
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Australia
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Phone
65179
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+61297014726
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Madeleine Ferrari
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Address
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Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
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Country
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Australia
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Phone
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+61297014726
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
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.
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