ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617000875303

Ethics application status

Approved

Date submitted

13/06/2017

Date registered

15/06/2017

Date last updated

1/11/2019

Date data sharing statement initially provided

1/11/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Compassionate Brain: Evaluation of a psychoeducational workshop program for middle school students

Scientific title

Compassionate Brain: Evaluation of a psychoeducational workshop program for middle school students

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

CBP

Linked study record

Health condition

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

Emotional Regulation Difficulties

Negative Affect

Perfectionism

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Compassionate Brain Program is a novel 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 emotional regulation, perfectionism, low mood, anxiety, stress and self-compassion in an adolescent population.

The Compassionate Brain program has been developed within a Cognitive Behavioral Therapy 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. Content will be interactive, including experiential exercises, role plays, and mindfulness practice.

The program will be delivered by a registered clinical psychologist face-to-face and involve both lectures and small group work. School teachers will be involved in assisting the small group work. The intervention will be delivered over a total of 8 sessions for the intervention group. The duration of each session will be approximately one hour, conducted at the school the students are currently attending. Dependent on school timetabling, the sessions will be run either once a week or once a fortnight. Thus total duration of the intervention will be 8-16 weeks.

A series of questionnaires will be administered to measure outcomes prior to the program starting, at the end of the program and a follow-up set of questionnaires will be administered approximately 3-4months later post-program completion. The primary outcomes to be measured are difficulties in emotional regulation, perfectionism, low mood, stress, and anxiety. Intervention adherence will also be assessed by recording attendance of students during each session.

Intervention code [1]

Prevention

Comparator / control treatment

This is a cohort-controlled trial. The control group will be a year cohort either above or below the intervention group. The control group will receive the same questionnaire administered to the intervention group. At the same time as the Compassionate Brain Program received by the intervention group, the control group will be receiving the equivalent of "treatment as usual", with an internal school pastoral care program.

Control group

Active

Outcomes

Primary outcome [1]

The primary objective of the project is to evaluate the efficacy of the Compassionate Brain program in relation to difficulties in emotional regulation.
Scale: the 18-item short version of the Difficulties in Emotion Regulation Scale (DERS-18; Victor & Klonsky, 2016).

Timepoint [1]

Primary outcome data will be collected at;
1) baseline; prior to the start of the intervention
2) post; at the conclusion of the intervention,
3) follow-up; 3 - 4 months post workshop completion.

Primary outcome [2]

Negative Affect
Scale: the 21-item Depression, Anxiety Stress Scales, (DASS-21-Y; Szabo, unpublished scale).

Timepoint [2]

Primary outcome data will be collected at;
1) baseline; prior to the start of the intervention
2) post; at the conclusion of the intervention,
3) follow-up; 3 - 4 months post workshop completion.
.

Primary outcome [3]

Perfectionism
Scale: the 23-item Almost Perfect Scale (APC; Slaney, Mobley, Trippi, Ashby & Johnson, 1996).

Timepoint [3]

Primary outcome data will be collected at;
1) baseline; prior to the start of the intervention
2) post; at the conclusion of the intervention,
3) follow-up; 3 - 4 months post workshop completion.

Secondary outcome [1]

Self-compassion
Scale: Self-compassion Short Scale (Raes, Pommier, Neff & Van Gucht, 2011).

Timepoint [1]

Secondary outcome data will be collected at;
1) baseline; prior to the start of the intervention
2) post; at the conclusion of the intervention,
3) follow-up; 3 - 4 months post workshop completion.

Secondary outcome [2]

Open-ended qualitative reports of how helpful or unhelpful students found the program

Timepoint [2]

This secondary outcome data will be collected at post; at the conclusion of the intervention,

Eligibility

Key inclusion criteria

Middle school students

Minimum age

10 Years

Maximum age

15 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Not providing consent or not being enrolled in the specific middle schools involved in the study .

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation will occur at the school level. After consenting to be involved in the study, middle school grades 6 and 7 will be randomly allocated to either intervention or control groups. Allocation will be concealed through the use of sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computerised sequence generation will be used

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

This study will involve two groups: an intervention and control group. 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.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities

Date of first participant enrolment

Anticipated

Actual

8/05/2017

Date of last participant enrolment

Anticipated

8/05/2019

Actual

17/05/2017

Date of last data collection

Anticipated

1/12/2019

Actual

15/12/2017

Sample size

Target

500

Accrual to date

Final

154

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
Australian Catholic University
NSW 2135

Country [1]

Australia

Primary sponsor type

University

Name

Australian Catholic University

Address

25A Barker Rd Strathfield
Australian Catholic University
NSW 2135

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Sydney

Address [1]

Mallett Street Campus,
The University of Sydney,
NSW 2006

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 Oce 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]

29/03/2017

Approval date [1]

07/04/2017

Ethics approval number [1]

2016-44H

Summary

Brief summary

The importance of identifying and targeting early symptoms of poor mental health in adolescence cannot be underestimated. Adolescence offers a critical window for developing emotional resilience and healthy coping strategies, which could improve the trajectory of mental health across the lifespan. Yet 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 full their potential (Klein, et al., 2007; McGorry, Bates, & Birchwood, 2013). 

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 one’s 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 CBT and Self-Compassion has been used to develop a psycho-educational workshop series, Compassionate Brain. In addition, high schools may be 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 Brain program in an adolescent population.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Madeleine Ferrari

Address

Australian Catholic University.
Office 640.G.02, 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.
Office 640.G.02, 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.
Office 640.G.02, 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 form

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically