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Trial registered on ANZCTR

Registration number

ACTRN12618000857202

Ethics application status

Approved

Date submitted

2/05/2018

Date registered

22/05/2018

Date last updated

31/05/2019

Date data sharing statement initially provided

31/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Brief Psychoeducational Workshop for High-school students

Scientific title

Brief Self-compassion and CBT Psychoeducational Program for High-school students: a Cohort-Controlled trial Assessing Stress, Perfectionism and Self Compassion

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

This study is linked with two prior studies. The original 2016 trial investigated the efficacy of an intervention which included ACT, CBT and Self-compassion based approaches (ACTRN12616000543482). The subsequent 2017 trial investigated the efficacy of an intervention which included ONLY CBT and Self-compassion based approaches (ACTRN12617000875303). The current trial is a follow-up which shortens the intervention from 8 to 4 weeks.

Health condition

Health condition(s) or problem(s) studied:

Mental Health

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A psychoeducational program called Compassionate Brain (1 X 80min session per week for 4 weeks) will be run for middle school students. The Compassionate Mind program has been developed within a Cognitive Behavioral Therapy (CBT) and Self-Compassion 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. Adherence to the program will be monitored through recording attendance at each session.

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 4 weeks and the 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. Informational material will include powerpoint slides, short video clips and role plays. Finally, a series of questionnaires will be administered to measure outcomes prior to the program starting, 4 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]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

Year 6 students attending the same school as the year 7 students will be the control group. They will recieve the equivalent of "treatment as usual", with an internal school pastoral care program.

Control group

Active

Outcomes

Primary outcome [1]

The Stress Subscale of the Depression and anxiety scale for youth (DASS-Y, Szabo, unpublished) to measure stress symptoms

Timepoint [1]

Primary outcome data will be collected at baseline, 4 weeks later at post [primary timepoint], and 3 - 4 months post program completion.

Primary outcome [2]

Almost Perfect Scale (Slaney, Rice, Mobley, Trippi, & Ashby, 2001) to measure perfectionistic levels.

Timepoint [2]

Primary outcome data will be collected at baseline, 4 weeks later at post [primary timepoint], and 3 - 4 months post program completion.

Primary outcome [3]

The self-compassion scale (Neff, 2003b) to measure self-compassion levels

Timepoint [3]

Primary outcome data will be collected at baseline, 4 weeks later at post [primary timepoint], and 3 - 4 months post program completion.

Secondary outcome [1]

Difficulties in Emotion Regulation Scale Short Form
(DERS-SF): to measure emotion regulation skill

Timepoint [1]

This outcome data will be collected at baseline, 4 weeks later at post, and 3 - 4 months post program completion.

Secondary outcome [2]

Anxiety subscale of the Depression and anxiety scale for youth (DASS-Y, Szabo, unpublished) to measure depression, anxiety and stress symptoms

Timepoint [2]

This outcome data will be collected at baseline, 4 weeks later at post, and 3 - 4 months post program completion.

Secondary outcome [3]

Depression subscale of the Depression and anxiety scale for youth (DASS-Y, Szabo, unpublished) to measure depression, anxiety and stress symptoms

Timepoint [3]

This outcome data will be collected at baseline, 4 weeks later at post, and 3 - 4 months post program completion.

Eligibility

Key inclusion criteria

Year 6 and 7 students attending a specific Sydney-based secondary 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 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

cohort-controlled trial

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 depression, anxiety, stress and perfectionism.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

24/05/2018

Actual

24/05/2018

Date of last participant enrolment

Anticipated

24/05/2018

Actual

24/05/2018

Date of last data collection

Anticipated

24/10/2018

Actual

24/09/2018

Sample size

Target

150

Accrual to date

Final

152

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2135 - Strathfield

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

25A Barker Rd Strathfield 2135 NSW

Country [1]

Australia

Primary sponsor type

University

Name

Australian Catholic University

Address

25A Barker Rd Strathfield 2135 NSW

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Sydney

Address [1]

School of Psychology
88 Mallett Street - Building F
Camperdown
The University of Sydney 2050

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee at Australian Catholic University

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/04/2018

Ethics approval number [1]

2016-44H

Summary

Brief summary

The mental health of young people is important now more than ever as mental health disorders have formed a significant burden 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). However early intervention has been promising in preventing the trajectory of future diagnosable conditions as well as enabling adolescents to fulfil their potential Klein, et al., 2007; McGorry, Bates, & Birchwood, 2013).
Perfectionism has recently gained attention for being a major aspect in sustaining the growth and maintenance of many disorders and underling a series of 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 trans diagnostic nature positions perfectionism to be an ideal target for early intervention.
Self-compassion is a construct gaining prominence over recent years and shown to be an important predictor of wellbeing (Barnard & Curry, 2011) as well as directly targeting the key features of perfectionism (Neff, 2011; Neff & Germer, 2013; Neff, 2010). Self-compassion refers to treating oneself with care and understanding when facing personal mistakes, shortcomings and failures (Neff, 2003).  Self-compassion has also been shown to be an effective intervention target for adolescents suffering from negative world views (Neff, 2010). Self-compassion looks to be a healthy way of targeting perfectionism. This intervention research project examines a self-compassion and CBT based program which is brief (delivered over x4 90 minute modules weekly). We are using a cohort-controlled trial to compare year 7 students who receive the intervention to year 6 students who act as a control group and complete the same outcome measures at the same time, but are not exposed to the intervention. We are interested in the efficacy of the program for mental health, perfectionism, self-compassion and emotion regulation outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Madeleine Ferrari

Address

Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135

Country

Australia

Phone

+61297014726

Fax

[email protected]

Contact person for public queries

Name

Madeleine Ferrari

Address

Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135

Country

Australia

Phone

+61297014726

Fax

[email protected]

Contact person for scientific queries

Name

Madeleine Ferrari

Address

Australian Catholic University
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135

Country

Australia

Phone

+61297014726

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Clinical data will only be reported in aggregate group form, consistent with ACU Human Research Ethics Committee approval

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No additional documents have been identified.

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