Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000300370
Ethics application status
Approved
Date submitted
17/02/2017
Date registered
27/02/2017
Date last updated
5/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of mobile mindfulness meditation on distress in two cohorts: Incoming university students and university staff.
Scientific title
A randomised, controlled trial to evaluate the effectiveness of a mobile mindfulness meditation tool at reducing distress, and improving wellness, resilience, and mindfulness in two cohorts: incoming university students and university staff.
Secondary ID [1] 291101 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distress 301920 0
Condition category
Condition code
Mental Health 301579 301579 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed study is a 90-day intervention to evaluate the effectiveness of a mobile mindfulness meditation tool (Headspace app vs. wait list control) at reducing distress and improving wellness, resilience, and mindfulness in two cohorts: incoming residential colleges student users, and academic and general staff at the University of Otago. The 90 days access to the app will be provided to intervention participants via the internet (either on their mobile phone or personal computer) following the completion of the baseline survey and will be available for them to use during the 90 days as they see fit.

Headspace is a commonly available mindfulness meditation app available through your app store or online. Over the 90 days of access to Headspace the participants will have access to hundreds of hours of original meditation content that is organized into five categories: Foundation, health, relationships, performance, and Headspace pro (see below for more details). The app is structured so that participants must complete at least Foundation Level 1 before accessing other content in the app. Although Foundation 2 and 3 are not compulsory, we will recommend they be completed. These sessions are not only an introduction to mindfulness meditation but also an opportunity to get used to Headspace's style of teaching. The other packs in the series library build on what is taught in these sessions and assume that they have progressed through them. It is important to note that it is not possible to move between multiple packs while maintaining progress on each. Using feedback from our pilot study and focus groups in 2015 we will not limit participants’ access to Foundation Series, however, we will advise that users take the time to work through the Foundation Series before progressing to any chosen series. Participants will choose to use any series and may choose to stop any series at any time to start another. Participants will be encouraged to use the Headspace website to troubleshoot any queries (headspace.com).

Each of the packs outlined below contain guided and unguided meditations varying in duration from 2 minutes to an hour which focus on improving the self in the topic mentioned (e.g., improving creativity),

Foundation Series: Level 1 (10 sessions – 10 minute each); Level 2 (10 sessions – 10 or 15 minutes each); Level 3 (10 sessions – 10, 15 or 20 minutes each)

Performance: Creativity (30 sessions); Focus (30 sessions); Happiness (10 sessions); Balance (10 sessions)

Relationships: Relationships (30 sessions); Change (10 sessions); Appreciation (10 sessions); Acceptance (10 sessions)

Health: Depression (30 sessions); Self-Esteem (30 sessions); Stress (30 sessions); Anxiety (30 sessions); Sleep (30 sessions); Pregnancy (30 sessions)

Headspace Pro: Level 1 (10 sessions); Level 2 (10 sessions); Level 3 (10 sessions); Level 4 (10 sessions); Level 5 (10 sessions)

During the information and consent process, participants will agree to allow Headspace to provide researchers with user data. This will allow us to more stringently track participants’ mindfulness meditation practice. This user data will include: UserID, Date & time of session, Session duration (e.g. 10, 15, 20 mins…), PackID (e.g. 46 = foundation level 1), Status (completed vs uncompleted), Gender (‘M’ for male or ‘F’ for female) (if provided by participant), Birthdate of user (if provided by participant), Country code, Previous meditation experience (1=novice meditator, 2=some experience, 3=proficient meditator) (if provided by participant)
Intervention code [1] 297090 0
Lifestyle
Intervention code [2] 297229 0
Behaviour
Comparator / control treatment
All participants will be randomly assigned to either a 90-day trial of Headspace in Semester 1 or a wait list control (receiving Headspace in Semester 2).
Control group
Active

Outcomes
Primary outcome [1] 300985 0
Distress as measured by the K10 + Distress Scale
Timepoint [1] 300985 0
At baseline (Semester 1 Week 2), follow up (Semester 2 Week 2) and final (End of academic year)
Secondary outcome [1] 331333 0
College adjustment (for student cohort), as measured by the College Adjustment Test
Timepoint [1] 331333 0
At baseline (Semester 1 Week 2), follow up (Semester 2 Week 2) and final (End of academic year)
Secondary outcome [2] 331334 0
Risk of burnout (for staff cohort) as measured by the Maslach Burnout Scale - General
Timepoint [2] 331334 0
At baseline (Semester 1 Week 2), follow up (Semester 2 Week 2) and final (End of academic year)
Secondary outcome [3] 331335 0
Resilience, as measured by the Brief Resilience Scale
Timepoint [3] 331335 0
At baseline (Semester 1 Week 2), follow up (Semester 2 Week 2) and final (End of academic year)
Secondary outcome [4] 331336 0
Self-efficacy, as measured by the New General Self-efficacy Scale
Timepoint [4] 331336 0
At baseline (Semester 1 Week 2), follow up (Semester 2 Week 2) and final (End of academic year)
Secondary outcome [5] 331337 0
Mindfulness as measured by the Cognitive Affective Mindfulness Scale - Revised
Timepoint [5] 331337 0
At baseline (Semester 1 Week 2), follow up (Semester 2 Week 2) and final (End of academic year)
Secondary outcome [6] 331338 0
Academic achievement (for student cohort) as measured by 2017 academic grades
Timepoint [6] 331338 0
End of Semester 1 and end of academic year

Eligibility
Key inclusion criteria
Student cohort participants must be enrolled at the University of Otago and be living at one of the participating residential colleges.

Staff cohort participants must be employed by the University of Otago
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who own a Blackberry or Windows Phone (who are unwilling to use the computer desktop version of the app) will be unable to participate as the app is not Blackberry or Windows Phone capable.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer
software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Wait list control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our primary analysis will test the change in psychological distress (as measured by K10, Kessler et al., 2003) from baseline to the follow up time point (Semester 2, Week 2) between conditions (Headspace vs wait list). Secondary analyses will focus on testing changes in resilience, mindfulness, self-efficacy, college adjustment and academic achievement (student cohort only) and risk of burnout (staff cohort only) from baseline to follow up and baseline to final between the two conditions (Headspace vs. wait list). Secondary analyses will also examine whether gender or demographic factors moderate the change in psychological distress and other psychological outcome variables as a function of experimental condition. We will also examine the uptake and sign up rate in both cohorts, that is, all students at 2 residential colleges and all academic and general staff will be invited to participate.
Overall, the goal is to understand whether this population will choose to use Headspace and whether using Headspace translates into noticeable improvements in well-being (primarily lower psychological distress; secondarily all other outcome variables: college adjustment, academic achievement, risk of burnout, self-efficacy, mindfulness, and resilience), and whether such changes in well-being are moderated by demographic factors such as gender or ethnicity.
We consider a clinically interesting difference for the K10 (measure of distress) to be regarded as a 4-point change (or roughly 0.4 of a standard deviation). The design requires a sample size of at least 100 participants per condition arm in order to provide 80% power to detect a difference in change scores using a two-sided test at the 0.05 level. Conservatively allowing for around 50% drop out/unusable data, n = 400 will be recruited for each cohort.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2017
Actual
6/03/2017
Date of last participant enrolment
Anticipated
Actual
15/03/2017
Date of last data collection
Anticipated
Actual
23/12/2017
Sample size
Target
400
Accrual to date
Final
303
Recruitment outside Australia
Country [1] 8637 0
New Zealand
State/province [1] 8637 0
Otago

Funding & Sponsors
Funding source category [1] 295541 0
University
Name [1] 295541 0
Office of the Vice Chancellor, University of Otago
Country [1] 295541 0
New Zealand
Primary sponsor type
Individual
Name
Tamlin Conner
Address
Department of Psychology
University of Otago
P.O. Box 56,
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 294361 0
None
Name [1] 294361 0
Address [1] 294361 0
Country [1] 294361 0
Other collaborator category [1] 279417 0
Individual
Name [1] 279417 0
Harlene Hayne
Address [1] 279417 0
Department of Psychology
University of Otago
P.O. Box 56
Dunedin 9054
Country [1] 279417 0
New Zealand
Other collaborator category [2] 279418 0
Individual
Name [2] 279418 0
Tess Patterson
Address [2] 279418 0
Department of Psychological Medicine
School of Medicine
University of Otago
P.O. Box 56
Dunedin 9054
Country [2] 279418 0
New Zealand
Other collaborator category [3] 279419 0
Individual
Name [3] 279419 0
Kim Ma'ia'i
Address [3] 279419 0
Student Health Services
University of Otago
P.O. Box 56
Dunedin 9054
Country [3] 279419 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296862 0
Departmental Ethics, Human Ethics Commitee, Department of Sciences, University of Otago
Ethics committee address [1] 296862 0
P.O. Box 56
Dunedin 9054
Ethics committee country [1] 296862 0
New Zealand
Date submitted for ethics approval [1] 296862 0
31/01/2017
Approval date [1] 296862 0
31/01/2017
Ethics approval number [1] 296862 0

Summary
Brief summary
The proposed study is a 90-day intervention to evaluate the effectiveness of a mobile mindfulness meditation tool (Headspace vs. waitlist control) at reducing distress, and improving wellness, resilience, and mindfulness in two cohorts: incoming residential colleges student users, and academic and general staff.

The proposed project will involve innovative intervention delivery methods utilizing a mobile phone application (app) to increase positive psychological wellbeing in naturalistic environments over time.

We hypothesise that implementing mindfulness techniques will increase psychological and university wellbeing over a 90-day period and that continued use of mindfulness techniques will result in long-term positive effects on wellbeing and resilience.

Approximately 400 incoming residential colleges students, who are currently enrolled at the University of Otago, and 400 academic and general staff who own and use a smartphone will be recruited via email, flyer drop, and population specific social media pages in the second week of Semester 1.

All participants will be randomly assigned to either a 90-day trial of Headspace in Semester 1 or a waitlist control (receiving Headspace in Semester 2).

All participants will complete an initial 10-15 min online survey of baseline measures (demographics, distress, resilience, college adjustment – students only, risk of burnout – staff only, mindfulness, self-efficacy, and experience with mindfulness). Half of all participants will be provided with a code and instructed to download their apps after the initial survey. The URL to that survey will be sent to them via text message. Use of the app will take approximately 10 minutes per day.

All participants will then be followed up with a survey of all measures in the second week of Semester 2. At this point, all wait-list control participants will be invited to download the app.

All participants will be sent a final survey following the end of the academic year (approx. 3rd week of November). Recruitment for the staff will continue into the 2018 academic year following an identical design. Students academic marks will be accessed with their consent to determine whether mindfulness engagement improves academic outcomes in addition to the wellbeing outcomes.

Participation in this study is expected to take a maximum of 16 hours over the course of an entire semester (15 mins at baseline, follow up, and final survey: 45 minutes; daily app use for 90 days: 15 hours; total: 15.75 hours).

We are recruiting a healthy, normal population of students and staff who may withdraw from participation in the project at any time. We do not anticipate any issues or problems. Previous studies of mindfulness applications in similar populations have showed benefits and no harm.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72262 0
Dr Tamlin Conner
Address 72262 0
Department of Psychology,
University of Otago
P.O. Box 56
Dunedin 9054
Country 72262 0
New Zealand
Phone 72262 0
+6434797624
Fax 72262 0
Email 72262 0
tconner@psy.otago.ac.nz
Contact person for public queries
Name 72263 0
Dr Tamlin Conner
Address 72263 0
Department of Psychology,
University of Otago
P.O. Box 56
Dunedin 9054
Country 72263 0
New Zealand
Phone 72263 0
+6434797624
Fax 72263 0
Email 72263 0
tconner@psy.otago.ac.nz
Contact person for scientific queries
Name 72264 0
Dr Tamlin Conner
Address 72264 0
Department of Psychology,
University of Otago
P.O. Box 56
Dunedin 9054
Country 72264 0
New Zealand
Phone 72264 0
+6434797624
Fax 72264 0
Email 72264 0
tconner@psy.otago.ac.nz

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
SourceTitleYear of PublicationDOI
EmbaseApp-based mindfulness meditation for psychological distress and adjustment to college in incoming university students: a pragmatic, randomised, waitlist-controlled trial.2020https://dx.doi.org/10.1080/08870446.2019.1711089
N.B. These documents automatically identified may not have been verified by the study sponsor.