Trial Review

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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] 284663 0
Nil
Universal Trial Number (UTN)
U1111-1157-3112
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 291987 0
Anxiety 291988 0
Wellbeing 291989 0
Weight and shape concerns 291990 0
Condition category
Condition code
Mental Health 292334 292334 0 0
Depression
Mental Health 292335 292335 0 0
Anxiety
Mental Health 292336 292336 0 0
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] 289443 0
Prevention
Intervention code [2] 291293 0
Behaviour
Comparator / control treatment
Lessons as usual
Control group
Active

Outcomes
Primary outcome [1] 292195 0
Depression score on DASS-21
Timepoint [1] 292195 0
one week prior to programme, one week post programme completion and 10 weeks later
Primary outcome [2] 292196 0
Anxiety score on DASS-21
Timepoint [2] 292196 0
one week prior to programme, one week post programme completion and 10 weeks later
Primary outcome [3] 292197 0
Weight and Shape concerns subscale of Eating Disorders Examination Questionnaire
Timepoint [3] 292197 0
one week prior to programme, one week post programme completion and 10 weeks later
Secondary outcome [1] 308400 0
Wellbeing (Warwick Edinburgh Mental Wellbeing Scale)
Timepoint [1] 308400 0
one week prior to programme, one week post programme completion and 10 weeks later
Secondary outcome [2] 313227 0
Mindfulness (Child and Adolescent Mindfulness Measure, CAMM)
Timepoint [2] 313227 0
one week prior to programme, one week post programme completion and 10 weeks later
Secondary outcome [3] 313228 0
Mindfulness (Comprehensive Inventory of Mindfulness Experiences, CHIME)
Timepoint [3] 313228 0
one week prior to programme, one week post programme completion and 10 weeks later
Secondary outcome [4] 313229 0
Emotional Regulation (Difficulties in Emotional Regulation Scale, DERS)
Timepoint [4] 313229 0
one week prior to programme, one week post programme completion and 10 weeks later
Secondary outcome [5] 313230 0
Self-compassion (Self-compassion Scale, SCS)
Timepoint [5] 313230 0
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] 289289 0
University
Name [1] 289289 0
Flinders University
Country [1] 289289 0
Australia
Funding source category [2] 289290 0
Charities/Societies/Foundations
Name [2] 289290 0
Fraser Mustard Centre
Country [2] 289290 0
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] 287960 0
None
Name [1] 287960 0
Address [1] 287960 0
Country [1] 287960 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292412 0
South Australian Department of Education and Child Development
Ethics committee address [1] 292412 0
31 Flinders Street, Adelaide, SA 5000
Ethics committee country [1] 292412 0
Australia
Date submitted for ethics approval [1] 292412 0
Approval date [1] 292412 0
17/06/2014
Ethics approval number [1] 292412 0
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 48682 0
Ms Catherine Johnson
Address 48682 0
School of Psychology
Flinders University
Sturt Road, Bedford Park 5042, South Australia
Postal address : GPO Box 2100, Adelaide 5001, South Australia
Country 48682 0
Australia
Phone 48682 0
+61 8 8201 5122
Fax 48682 0
Email 48682 0
[email protected]
Contact person for public queries
Name 48683 0
Ms Catherine Johnson
Address 48683 0
School of Psychology
Flinders University
Sturt Road, Bedford Park 5042, South Australia
Postal address : GPO Box 2100, Adelaide 5001, South Australia
Country 48683 0
Australia
Phone 48683 0
+61 8 8201 5122
Fax 48683 0
Email 48683 0
[email protected]
Contact person for scientific queries
Name 48684 0
Ms Catherine Johnson
Address 48684 0
School of Psychology
Flinders University
Sturt Road, Bedford Park 5042, South Australia
Postal address : GPO Box 2100, Adelaide 5001, South Australia
Country 48684 0
Australia
Phone 48684 0
+61 8 8201 5122
Fax 48684 0
Email 48684 0
[email protected]

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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