Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002010279
Ethics application status
Approved
Date submitted
11/12/2018
Date registered
14/12/2018
Date last updated
20/11/2019
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a mindfulness mobile phone app in a University student population
Scientific title
A randomised controlled trial to evaluate the effect of a mindfulness app on university students mental health compared to a wait list control.
Secondary ID [1] 296852 0
None
Universal Trial Number (UTN)
U1111-1225-3775
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 310758 0
Depression 310759 0
Anxiety 310760 0
Condition category
Condition code
Mental Health 309450 309450 0 0
Anxiety
Mental Health 309457 309457 0 0
Depression
Mental Health 309458 309458 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The mindfulness app that will be used is Headspace, a commercially available app. The questionnaires will be delivered via computer or mobile phone, and the mindfulness content will be delivered via mobile phone. The content within the app is delivered via audio files and streamed video demonstrations. The intervention will be 6 weeks in duration and participants are requested to complete 30 meditation sessions (an average of 5 per week) during this time. Each session lasts 10-15 minutes. The content of the sessions focus on introducing the concept of mindfulness, practical tips for practicing mindfulness meditation and a guided body-scan meditation. Later sessions introduce a breath counting exercise during the guided meditations and develop a greater emphasis on non-judgmental awareness. This content was developed and delivered by Andy Puddicombe who is an internationally recognised expert in mindfulness practice and teaching. Objective adherence data will be collected through the Headspace accounts of the participants. The following data will be collected from the Headspace app: Pack name (e.g. Basics); session number (e.g. 1), time and date stamp for each completed session; session duration; platform the session was completed on.
Intervention code [1] 313132 0
Treatment: Other
Intervention code [2] 313133 0
Behaviour
Intervention code [3] 313134 0
Prevention
Comparator / control treatment
A wait list control group will receive the same intervention 6 weeks after the intervention group completes the program
Control group
Active

Outcomes
Primary outcome [1] 308400 0
Stress measured by the Perceived Stress Scale
Timepoint [1] 308400 0
Baseline, 6 weeks, 3 months
Secondary outcome [1] 354873 0
Depression symptoms as measured by the Patient Health Questionnaire (PHQ9)
Timepoint [1] 354873 0
Baseline, 6 weeks, 3 months
Secondary outcome [2] 354874 0
Anxiety symptoms as measured by the Generalised Anxiety Disorder Questionnaire (GAD7)
Timepoint [2] 354874 0
Baseline, 6 weeks, 3 months
Secondary outcome [3] 354875 0
Self efficacy/coping as measured by the General Self Efficacy Scale (GSE)
Timepoint [3] 354875 0
Baseline, 6 weeks, 3 months
Secondary outcome [4] 354876 0
Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [4] 354876 0
Baseline, 6 weeks, 3 months

Eligibility
Key inclusion criteria
Be 18 years and older
Be enrolled at UNSW as determined by self-report
Own a smart phone (android or IOS)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not UNSW students

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Other design features
Parallel group
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A meta-analysis of 15 online mindfulness- based interventions showed that for the outcome of stress, mindfulness had a moderate effect size (g=0.51) (Spijkerman et al., 2016). For the current study, power was set at 0.80 to detect a moderate effect size (f2 = 0.50) at a significance level of p < .05. Based on a repeated measures ANOVA test, this would require a sample size of 63 participants in each condition, with a total sample size of 126. Taking into account an anticipated dropout rate of 40%, the recruitment target will be set to 178 participants. Quantitative data will be analysed using SPSS software, version 23. App usage information will be descriptive only. Changes in pre- and postintervention scores between treatment conditions for measurements of stress, depression, anxiety, sleep quality, mindfulness and self-efficacy subscales will be assessed using analysis of variance (ANOVA). The primary outcome will be a self-reported measure of stress assessed using the Perceived Stress Scale.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/02/2019
Actual
13/02/2019
Date of last participant enrolment
Anticipated
4/03/2019
Actual
15/03/2019
Date of last data collection
Anticipated
29/07/2019
Actual
1/08/2019
Sample size
Target
178
Accrual to date
Final
312
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 25122 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 301424 0
University
Name [1] 301424 0
Black Dog Institute, University of New South Wales
Country [1] 301424 0
Australia
Primary sponsor type
University
Name
Black Dog Institute, University of New South Wales
Address
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 301102 0
None
Name [1] 301102 0
Address [1] 301102 0
Country [1] 301102 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302157 0
University of New South Wales Human Research Ethics Committee (HREC)
Ethics committee address [1] 302157 0
Ethics committee country [1] 302157 0
Australia
Date submitted for ethics approval [1] 302157 0
04/12/2018
Approval date [1] 302157 0
10/12/2018
Ethics approval number [1] 302157 0
HC180822

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

Contacts
Principal investigator
Name 89322 0
Ms Laura Kampel
Address 89322 0
Black Dog Institute
University of New South Wales
Hospital Road
Randwick, NSW, 2031
Country 89322 0
Australia
Phone 89322 0
+61 2 9382 4530
Fax 89322 0
Email 89322 0
[email protected]
Contact person for public queries
Name 89323 0
Laura Kampel
Address 89323 0
Black Dog Institute
University of New South Wales
Hospital Road
Randwick, NSW, 2031
Country 89323 0
Australia
Phone 89323 0
+61 2 9382 4530
Fax 89323 0
Email 89323 0
[email protected]
Contact person for scientific queries
Name 89324 0
Laura Kampel
Address 89324 0
Black Dog Institute
University of New South Wales
Hospital Road
Randwick, NSW, 2031
Country 89324 0
Australia
Phone 89324 0
+61 2 9382 4530
Fax 89324 0
Email 89324 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No Individual participant data will be available however group level data will be published


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.