ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615001051538

Ethics application status

Approved

Date submitted

19/02/2015

Date registered

7/10/2015

Date last updated

9/09/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

A comparison in early high school students of the effect of an 8 week course of mindfulness versus normal school lessons on anxiety, depression, eating disorder risk factors and wellbeing

Scientific title

A randomised controlled trial of a the ".b" mindfulness in schools curriculum versus normal lessons in Year 8 male and female Australian students to assess impact on anxiety, depression, weight/shape concerns and wellbeing (primary outcome factors) and self-compassion, difficulties in emotional regulation and mindfulness (secondary outcome factors).

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1157-3112

Trial acronym

Linked study record

Health condition

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

Depression

Anxiety

Wellbeing

Weight and shape concerns

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Mental Health

Eating disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Adolescent mindfulness intervention (.b mindfulness in schools programme). Lesson duration 40-60 minutes delivered once weekly over a period of 8 weeks. Lesson format is a mix of interactive activities, short talks and mindfulness practices. Topics include training attention, cultivating a curious, patient and friendly attitude towards experience, understanding worry, switching out of autopilot back to the present moment, learning to step back from thoughts and befriend difficult emotions, and applying mindfulness to movement. Delivered by external mindfulness teacher. No formal adherence checks will be undertaken.

Intervention code [1]

Prevention

Intervention code [2]

Behaviour

Comparator / control treatment

Lessons as usual

Control group

Active

Outcomes

Primary outcome [1]

Depression score on DASS-21

Timepoint [1]

one week prior to programme, one week post programme completion and 10 weeks later

Primary outcome [2]

Anxiety score on DASS-21

Timepoint [2]

one week prior to programme, one week post programme completion and 10 weeks later

Primary outcome [3]

Weight and Shape concerns subscale of Eating Disorders Examination Questionnaire

Timepoint [3]

one week prior to programme, one week post programme completion and 10 weeks later

Secondary outcome [1]

Wellbeing (Warwick Edinburgh Mental Wellbeing Scale)

Timepoint [1]

one week prior to programme, one week post programme completion and 10 weeks later

Secondary outcome [2]

Mindfulness (Child and Adolescent Mindfulness Measure, CAMM)

Timepoint [2]

one week prior to programme, one week post programme completion and 10 weeks later

Secondary outcome [3]

Mindfulness (Comprehensive Inventory of Mindfulness Experiences, CHIME)

Timepoint [3]

one week prior to programme, one week post programme completion and 10 weeks later

Secondary outcome [4]

Emotional Regulation (Difficulties in Emotional Regulation Scale, DERS)

Timepoint [4]

one week prior to programme, one week post programme completion and 10 weeks later

Secondary outcome [5]

Self-compassion (Self-compassion Scale, SCS)

Timepoint [5]

one week prior to programme, one week post programme completion and 10 weeks later

Eligibility

Key inclusion criteria

Enrolled in Year 8 at selected school, with active consent from parent and student

Minimum age

11 Years

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Nil

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

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

Selected schools provide pairs of classes which are randomly allocated to intervention and control groups. Allocation is not concealed.

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

Excel randomisation will be used with a priori rules about allocation

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

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

21/07/2014

Date of last participant enrolment

Anticipated

Actual

30/07/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

400

Accrual to date

Final

308

Recruitment in Australia

Recruitment state(s)

SA

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

Sturt Road, Bedford Park 5042, South Australia
Postal address : GPO Box 2100, Adelaide 5001, South Australia

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Fraser Mustard Centre

Address [2]

Level 8, 31 Flinders Street

Adelaide

South Australia, 5000

Country [2]

Australia

Primary sponsor type

University

Name

Flinders University

Address

Sturt Road, Bedford Park 5042, South Australia
Postal address : GPO Box 2100, Adelaide 5001, South Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Australian Department of Education and Child Development

Ethics committee address [1]

31 Flinders Street, Adelaide, SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/06/2014

Ethics approval number [1]

CS/14/513-8

Summary

Brief summary

Mindfulness, a form of mental skills training that originally derives from Eastern philosophy, shows promise as a prevention programme targeting a range of mental disorders (anxiety, depression and eating disorders) that often emerge in adolescence. 

Mindfulness involves learning to become fully aware of our present moment experience (both external events, and internally – thoughts, feelings and body sensations). This skill allows us to switch from automatic, habitual reactions, and more consciously/skilfully choose how to respond. Mindfulness training also teaches participants to approach all experience, pleasant and unpleasant (which is a normal part of life) with curiosity, friendliness and acceptance. This fosters an ability to sit with strong negative emotions, without resorting to maladaptive avoidant behaviour, e.g., binge eating or drug abuse.

Robust evidence exists for mindfulness interventions with adults for reducing stress, anxiety and depression (Baer, 2003; Grossman et al., 2004; Khoury et al., 2013). Mindfulness in youth is a much newer field. Evidence to date is promising in terms of similar effects (Burke, 2010; Meiklejohn et al., 2012) but stronger empirical evidence is required. 

One recent study, by Kuyken and colleagues (2013) used the mindfulness in schools “.b” (dot be) curriculum which is an 8-9 lesson, once a week, programme.  Across 522 students aged 12-16 years, results showed significant reductions in depression at programme completion in the group receiving the intervention. At 6 months follow up, reductions in depression had been maintained, and effects had broadened to also include decreased stress and increased wellbeing.  Raes et al. (2013) found similar effects in their study of 408 school students (mean age 15) using an adolescent mindfulness intervention, with decreased depression and fewer new cases of depression in the intervention group both at programme completion and at 6 month follow up. 

Our current study seeks to replicate these results in an Australian context. In addition, we will broaden the outcome factors to include not only depression and wellbeing but also anxiety and eating disorder risk factors to investigate the programme’s potential as a prevention strategy across a range of mental health issues. In addition, for the first time, the proposed study will investigate the mechanisms by which mindfulness exerts its effects in adolescents in order to identify specific active components that could be amplified up to improve the effects. We will also investigate moderation, that is, for whom this intervention works.

This pilot study, commencing in July 2014, will involve 400 students. These students will receive the full 8 lesson curriculum. We will trial an adult, multifactor mindfulness measurement tool for assessing mechanisms of change, as youth measures are single factor scales which do not allow finegrained analysis of the different elements of mindfulness as potential mediator pathways.  Schools will be randomised at the classroom level to intervention or control groups.

Trial website

Trial related presentations / publications

Johnson, C., Burke, C., Brinkman, S., & Wade, T. (2016). Effectiveness of a school-based mindfulness program for transdiagnostic prevention in young adolescents. Behaviour Research and Therapy, 81, 1-11. doi:http://dx.doi.org/10.1016/j.brat.2016.03.002

Public notes

Contacts

Principal investigator

Name

Ms Catherine Johnson

Address

School of Psychology
Flinders University
Sturt Road, Bedford Park 5042, South Australia
Postal address : GPO Box 2100, Adelaide 5001, South Australia

Country

Australia

Phone

+61 8 8201 5122

Fax

Email

catherine.johnson@flinders.edu.au

Contact person for public queries

Name

Catherine Johnson

Address

School of Psychology
Flinders University
Sturt Road, Bedford Park 5042, South Australia
Postal address : GPO Box 2100, Adelaide 5001, South Australia

Country

Australia

Phone

+61 8 8201 5122

Fax

Email

catherine.johnson@flinders.edu.au

Contact person for scientific queries

Name

Catherine Johnson

Address

School of Psychology
Flinders University
Sturt Road, Bedford Park 5042, South Australia
Postal address : GPO Box 2100, Adelaide 5001, South Australia

Country

Australia

Phone

+61 8 8201 5122

Fax

Email

catherine.johnson@flinders.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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.