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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
Scientific title
Compassionate Mind: Evaluation of a Positive Psychology Psycho-educational workshop series for Middle School Students
Secondary ID [1] 289048 0
None
Universal Trial Number (UTN)
Trial acronym
CMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 298413 0
Social worry 298508 0
Low mood 298509 0
Perfectionism 298510 0
Condition category
Condition code
Mental Health 298511 298511 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 294490 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 298007 0
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).
Timepoint [1] 298007 0
Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.
Primary outcome [2] 298092 0
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)
Timepoint [2] 298092 0
Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.
Primary outcome [3] 298117 0
Self-Compassion: The 12-item self-compassion scale- short form (Raes, et al. 2011).
Timepoint [3] 298117 0
Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.
Secondary outcome [1] 323187 0
Wellbeing: The brief 14-item version of the Mental Health Continuum – Short Form (MHCSF) (Keyes, 2005)
Timepoint [1] 323187 0
Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.
Secondary outcome [2] 323216 0
Perfectionism: The 14-itemed Child and Adolescent Perfectionism Scale-Short Form (CAPS; O'Connor et al., 2009)
Timepoint [2] 323216 0
Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.
Secondary outcome [3] 323217 0
Demographics: age, postcode, country of birth for mother and father, language spoken at home, family characteristics, self-reported average school grades, and physical activity
Timepoint [3] 323217 0
Primary outcome data will be collected at baseline, 8 weeks post workshop commencement, and 3 - 4 months post workshop completion.

Eligibility
Key inclusion criteria
Year 6 and 7 students attending a specific Sydney-based middle school.
Minimum age
10 Years
Maximum age
15 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not providing consent or not being enrolled in the specific middle school .

Study design
Purpose of the study
Educational / counselling / training
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/04/2016
Actual
12/04/2016
Date of last participant enrolment
Anticipated
7/05/2016
Actual
2/05/2016
Date of last data collection
Anticipated
Actual
14/11/2016
Sample size
Target
300
Accrual to date
Final
158
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13143 0
2135 - Strathfield

Funding & Sponsors
Funding source category [1] 293377 0
University
Name [1] 293377 0
Australian Catholic University
Country [1] 293377 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
25A Barker Rd
Strathfield 2135
NSW
Country
Australia
Secondary sponsor category [1] 292252 0
None
Name [1] 292252 0
Address [1] 292252 0
Country [1] 292252 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294834 0
Human Research Ethics Committee at Australian Catholic University
Ethics committee address [1] 294834 0
Manager, Ethics
c/o Office of the Deputy Vice Chancellor (Research)
Australian Catholic University
North Sydney Campus
PO Box 968
NORTH SYDNEY, NSW 2059
Ethics committee country [1] 294834 0
Australia
Date submitted for ethics approval [1] 294834 0
22/02/2016
Approval date [1] 294834 0
12/04/2016
Ethics approval number [1] 294834 0
2016-44H

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65178 0
Dr Madeleine Ferrari
Address 65178 0
Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
Country 65178 0
Australia
Phone 65178 0
+61297014726
Fax 65178 0
Email 65178 0
madeleine.ferrari@acu.edu.au
Contact person for public queries
Name 65179 0
Madeleine Ferrari
Address 65179 0
Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
Country 65179 0
Australia
Phone 65179 0
+61297014726
Fax 65179 0
Email 65179 0
madeleine.ferarri@acu.edu.au
Contact person for scientific queries
Name 65180 0
Madeleine Ferrari
Address 65180 0
Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
Country 65180 0
Australia
Phone 65180 0
+61297014726
Fax 65180 0
Email 65180 0
madeleine.ferarri@acu.edu.au

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

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