Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001383459
Ethics application status
Approved
Date submitted
30/09/2016
Date registered
6/10/2016
Date last updated
6/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A mindfulness prevention program based on acceptance and commitment therapy for adolescents: A feasibility study
Scientific title
A mindfulness prevention program for anxiety and depressive symptoms based on acceptance and commitment therapy for adolescents: A feasibility study
Secondary ID [1] 290248 0
Nil
Universal Trial Number (UTN)
U1111-1188-1736
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 300457 0
anxiety 300458 0
Condition category
Condition code
Mental Health 300317 300317 0 0
Depression
Mental Health 300351 300351 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was a quasi-randomised controlled study. Randomisation was conducted by a staff member of the school who was independent of the study using cluster randomisation based on their Tutorial groups of which there were eight in the Year group. Tutorial groups had a name and these were listed alphabetically and the first assigned to the mindfulness condition and the last four to the control condition. Randomisation was completed before enrolment in the study because attendance to the workshops was a required curricular activity for students. It was for this reason that there were disproportionate numbers in each condition and the randomisation was considered ‘quasi’. The control condition received the mindfulness workshops 5 months after the intervention group.

The intervention is a mindfulness prevention program that utilises the ACT components of: Values, Committed Action, Contact with Present Moment, Acceptance of Emotions, and Thought Defusion. It was delivered in an amphitheatre at the school. The aim of each session was to educate the students on a particular concept (e.g. Values) and encourage them to apply the concepts to their everyday life. To achieve this aim in each session, verbal explanations, personal stories, metaphors, PowerPoint slides, videos, and experiential exercises were used. An example of an experiential exercise was the mindful eating of a sultana to help teach the concept of Contact with Present Moment. The lecture-style presentations were supported by four teacher-led exercises between the presentations, during class time and in a smaller group (approximately 15 students). Teacher exercises were based on the ACT components of Thought Defusion, Contact with Present Moment, and Values. All workshops and teacher-led classes were 25 minutes in duration. In total, students received 4.6 hours of the intervention. Workshops were delivered once per week for 7 weeks.

A clinical psychologist delivered each session of the mindfulness program face-to-face to participants. The mindfulness workshop facilitator had 6 years of university training in psychology, including 2 years in a clinical master’s program. He had also received specialist training and supervision in ACT and had previously delivered the same material to a similar sized group of students in the same school. At the time of workshop delivery, he had approximately 2 years’ experience using ACT in both an individual and group context.

Intervention code [1] 296034 0
Prevention
Intervention code [2] 296061 0
Behaviour
Comparator / control treatment
The control condition comprised ‘Pastoral Care’, which was their usual class activity during the time slot that the mindfulness workshops were being delivered. In these classes of around 15 to 20 students, material on social justice and cyber-safety was presented by a schoolteacher who had been assigned to the tutorial at the start of the semester, prior to the study commencing. Duration of both programs was equivalent – all Pastoral Care classes were 25 minutes in duration and students received 4.6 hours of Pastoral Care. The control condition received the mindfulness workshops 5 months after the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 299784 0
Depression symptoms, assessed by Depression Anxiety Stress Scale (DASS-21).
Timepoint [1] 299784 0
Baseline
Post-intervention
5 month follow-up
Primary outcome [2] 299809 0
Anxiety symptoms, assessed by Depression Anxiety Stress Scale (DASS-21)
Timepoint [2] 299809 0
Baseline
Post-intervention
5 month follow-up
Secondary outcome [1] 328106 0
Wellbeing, assessed by the Flourishing Scale (FS).
Timepoint [1] 328106 0
Baseline
Post-intervention
5 month follow-up
Secondary outcome [2] 328107 0
Program evaluation questionnaire, specifically designed for this study
Timepoint [2] 328107 0
Post-intervention

Eligibility
Key inclusion criteria
Year 10 student at selected high school; self-consent; parental consent if under 16 years of age.
Minimum age
13 Years
Maximum age
18 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
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
The present study sought to investigate an ACT-based mindfulness intervention as a school universal prevention program. One problem in the evaluation of a new prevention program is the issue of statistical power. Given there is a low rate of emergence of new cases of anxiety and depression over any given period, it has been estimated that over 30,000 participants are needed to adequately power a prevention program evaluation study. Measuring symptom reduction rather than cases can reduce this figure but still almost 1,000 would be required to demonstrate a statistically significant difference between conditions. However to justify investment in a trial of this size, preliminary evidence, obtained in a feasibility study, is required. The aims of this study were to: a) examine the feasibility and acceptability of using an ACT-based prevention program that targets anxiety and depressive symptoms in a non-clinical sample of adolescents; and b) to compare the impact of the ACT-based program on wellbeing and symptoms of depression and anxiety. It was expected that there would be a trend for the mindfulness participants to demonstrate improvements on a range of measures compared to participants in the control condition. Given the underpowered nature of feasibility studies, this trial sought to use effect sizes as an indication of effectiveness and to provide the evidence required for a large-scale study.

Statistical analysis was completed using SPSS 22.0. For baseline and drop-out comparisons, t-tests were used for continuous variables and Chi-squared tests for independence with Yates Continuity Correction for categorical variables. In the universal analysis comparing outcome scores between the mindfulness and control conditions an intention-to-treat analysis was used. Mixed Models with Repeated Measures (MMRM) is considered to be particularly appropriate for school-based studies or when the dropout rate is above 5% as it accounts for all the available data under the missing-at-random assumption. A single analysis examined the outcome scores across the three time-points. To select the covariance structure, the best fitting model using Akaike’s Information Criterion (AIC) was retained. The parameters of the model were estimated using restricted maximum likelihood as the evidence suggests it is preferable over maximum likelihood when the sample is small. The dppc2, formula was used to estimate Cohen’s d effect sizes were interpreted using Cohen’s standards. A positive number for the DASS-21 and FS scales represents an improvement in symptoms and wellbeing, respectively.
For clinical significance analysis, binary mixed modelling was used to examine if the number of participants in the Normal range compared to those in the clinical range differed significantly between the mindfulness and control conditions. The clinical significance effect sizes were calculated using the Cox Logit method.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/03/2014
Date of last participant enrolment
Anticipated
Actual
10/03/2014
Date of last data collection
Anticipated
Actual
18/08/2014
Sample size
Target
50
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 294615 0
University
Name [1] 294615 0
University of NSW Australian Postgraduate Award
Country [1] 294615 0
Australia
Primary sponsor type
University
Name
University of NSW
Address
University of NSW
Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 293478 0
None
Name [1] 293478 0
Address [1] 293478 0
Country [1] 293478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296056 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 296056 0
Ethics committee country [1] 296056 0
Australia
Date submitted for ethics approval [1] 296056 0
19/02/2014
Approval date [1] 296056 0
27/02/2014
Ethics approval number [1] 296056 0
HC13132

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69386 0
Mr Rowan Burckhardt
Address 69386 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country 69386 0
Australia
Phone 69386 0
+61293824530
Fax 69386 0
Email 69386 0
[email protected]
Contact person for public queries
Name 69387 0
Rowan Burckhardt
Address 69387 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country 69387 0
Australia
Phone 69387 0
+61293824530
Fax 69387 0
Email 69387 0
[email protected]
Contact person for scientific queries
Name 69388 0
Rowan Burckhardt
Address 69388 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country 69388 0
Australia
Phone 69388 0
+61293824530
Fax 69388 0
Email 69388 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.