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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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
Universal Trial Number (UTN)
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
Mental Health 309457 309457 0 0
Mental Health 309458 309458 0 0
Other mental health disorders

Study type
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
Intervention code [3] 313134 0
Comparator / control treatment
A wait list control group will receive the same intervention 6 weeks after the intervention group completes the program
Control group

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Not UNSW students

Study design
Purpose of the study
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
Not Applicable
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 25122 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 301424 0
Name [1] 301424 0
Black Dog Institute, University of New South Wales
Address [1] 301424 0
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country [1] 301424 0
Primary sponsor type
Black Dog Institute, University of New South Wales
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Secondary sponsor category [1] 301102 0
Name [1] 301102 0
Address [1] 301102 0
Country [1] 301102 0

Ethics approval
Ethics application status
Ethics committee name [1] 302157 0
University of New South Wales Human Research Ethics Committee (HREC)
Ethics committee address [1] 302157 0
Ethics Secretariat
UNSW Grants Management Office
Rubert Myers Building, Level 3, South Wing
The University of New South Wales
Sydney, NSW, 2052
Ethics committee country [1] 302157 0
Date submitted for ethics approval [1] 302157 0
Approval date [1] 302157 0
Ethics approval number [1] 302157 0

Brief summary
Aim: To deliver and evaluate a Mindfulness App (Headspace) in the student population.
Study design: This study will be a pilot randomised controlled trial with a waitlist control condition. There will be three measurement occasions: pretest, 6-week post-test, and 3-month follow-up, and they will receive 3 reminder text messages to complete the questionnaires on these 3 occasions.

Hypotheses: It is hypothesised that students receiving the Headspace app will have greater reductions in anxiety, depression and stress when compared to the control. App users will also show greater improvements in sleep quality, academic achievement, mindfulness, and self-efficacy.
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary