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Trial registered on ANZCTR


Registration number
ACTRN12616000634471p
Ethics application status
Not yet submitted
Date submitted
12/05/2016
Date registered
17/05/2016
Date last updated
17/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobile Mindfulness Meditation as an Adjunct to Treatment-as-usual: A Randomised Controlled Trial
Scientific title
Mobile Mindfulness Meditation as an Adjunct to Treatment-as-usual for Distressed University Students who Require Counselling: A Randomised Controlled Trial
Secondary ID [1] 289203 0
None
Universal Trial Number (UTN)
U1111-1182-8250
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 298758 0
Distress 298797 0
Depression 298798 0
Anxiety 298799 0
Condition category
Condition code
Mental Health 298807 298807 0 0
Depression
Mental Health 298808 298808 0 0
Anxiety
Mental Health 298810 298810 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We aim to recruit a representative sample of 360 Dunedin-based students from the University of Otago who are considered distressed (as indicated by opting in to the counselling service at Student Health Services). Participants will be guided through mindfulness meditation practice using an application (app) once daily for 10- 20 minutes for 30 days.

Participants will be randomised into one of three conditions:
Arm1: Mobile Mindfulness Meditation beginning before formal treatment (in the interim between initial assessment and beginning of treatment), This will be sent to participants immediately following enrolment (irrespective of when they are scheduled to begin their treatment at the Counselling Service which due to the nature of this setting could be 1 day to several weeks).
Arm 2: Mobile Mindfulness Meditation beginning during treatment-as-usual, This will be sent to participants on the day that they begin treatment.
Arm 3: Wait-list control with Mobile Mindfulness Meditation following treatment-as-usual. This will be sent to participants on the day they end treatment.

All participants will be asked to download and integrate the mindfulness meditation app into their daily routine for 30 days. The app will be downloaded to their personal smartphone. All participants will be asked to answer surveys of psychological outcomes at the outset of app-use, and 14-28 days into app-use. Other than recruitment, all aspects of this study will occur via mobile or email.

In order to obtain adherence data, during the information and consent process, participants will agree to allow the Mobile Mindfulness Meditation app (Headspace) to provide researchers with user data such as, number of sessions completed, and date/time of session.
Intervention code [1] 294733 0
Treatment: Devices
Intervention code [2] 294737 0
Treatment: Other
Comparator / control treatment
Arm 3: Wait-list control with Mobile Mindfulness Meditation following treatment-as-usual. Participants in Arm 3 will receive treatment-as-usual through Student Health Services' Counselling Service. At the end of their treatment they will be asked to download and use the mobile mindfulness meditation app for 30 days.
Control group
Active

Outcomes
Primary outcome [1] 298281 0
Distress as measured by the K10
Timepoint [1] 298281 0
At baseline, at beginning of intervention exposure, 14 days after access to app is made available, at beginning of treatment-as-usual, at end of treatment-as-usual.
Secondary outcome [1] 323736 0
Depression as measured by the Beck Depression Inventory II (BDI II)
Timepoint [1] 323736 0
At baseline, at beginning of intervention exposure, 14 days after access to app is made available, at beginning of treatment-as-usual, at end of treatment-as-usual.
Secondary outcome [2] 323737 0
Anxiety as measured by the Beck Anxiety Inventory (BAI)
Timepoint [2] 323737 0
At baseline, at beginning of intervention exposure, 14 days after access to app is made available, at beginning of treatment-as-usual, at end of treatment-as-usual.
Secondary outcome [3] 323738 0
Mindfulness as measured by the Cognitive and Affective Mindfulness Scale-Revised
Timepoint [3] 323738 0
At baseline, at beginning of intervention exposure, 14 days after access to app is made available, at beginning of treatment-as-usual, at end of treatment-as-usual.
Secondary outcome [4] 323739 0
Psychological well-being as measured by the flourishing scale
Timepoint [4] 323739 0
At baseline, at beginning of intervention exposure, 14 days after access to app is made available, at beginning of treatment-as-usual, at end of treatment-as-usual.
Secondary outcome [5] 323740 0
Perceived stress as measured by the Perceived Stress Scale 10
Timepoint [5] 323740 0
At baseline, at beginning of intervention exposure, 14 days after access to app is made available, at beginning of treatment-as-usual, at end of treatment-as-usual.
Secondary outcome [6] 323741 0
Resilience as measured by the Brief Resilience Scale
Timepoint [6] 323741 0
At baseline, at beginning of intervention exposure, 14 days after access to app is made available, at beginning of treatment-as-usual, at end of treatment-as-usual.

Eligibility
Key inclusion criteria
To be eligible for this study, participants must be at least part-time University of Otago students, and own a smartphone (roughly 97% of student body; Flett et al., 2015). As this study aims to recruit distressed participants, all participants will be invited to participate by their Student Health Services Counselling clinician if the clinician deems them to need further assistance through the Counselling Service.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with pre-existent or prodromal psychotic illness, including schizophrenia, psychosis, bipolar disorder; high and imminent risk of suicide, or post-traumatic stress disorder will not be eligible to participate in the present study.

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)
Allocation involves central randomisation via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) with additional stratified allocation using gender to stratify the sample.
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
We aim to recruit a representative sample of 360 Dunedin-based students from the University of Otago who are considered distressed (as indicated by opting in to the counselling service at Student Health Services). A clinically interesting difference for the K10 is regarded as 5 points (equivalent to a 0.5 unit change on each of the 10 items or roughly 0.5 of a standard deviation). In order to provide 80% power to detect such a difference in change scores between any two arms of the study using a two-sided test at the 0.0167 level (i.e., conservatively allowing for a Bonferroni adjustment over the three post-hoc comparisons), based on an SD for changes of 8 (obtained via personal communication with Prof. Sunny Collings and Dr. James Stanley who conducted semantically similar studies of this nature in similar study populations e.g., Collings et al, 2012), this would require n = 56/arm. Allowing for around 50% dropout/unusable data, n = 120 will be recruited for each group or n = 360 overall.

Analyses will test for differences between both the intervention groups (Mobile Mindfulness before and during Treatment-as-usual) and the waitlist control group (Mobile Mindfulness after Treatment-as-usual) on changes in psychological health at each stage of treatment (initial consult, onset of treatment, end of treatment) and the beginning and mid-point of access to the intervention. The effectiveness of the time of delivery in improving psychological health will also be tested by comparing changes between these groups. We will use a combination of difference scores, reliable change indices, and crossing clinical thresholds analysis to determine clinically meaningful change.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/07/2016
Actual
Date of last participant enrolment
Anticipated
1/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment outside Australia
Country [1] 7874 0
New Zealand
State/province [1] 7874 0
Otago

Funding & Sponsors
Funding source category [1] 293579 0
University
Name [1] 293579 0
Funded from the Office of the Vice-Chancellor, University of Otago.
Country [1] 293579 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
P.O. Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292401 0
None
Name [1] 292401 0
Address [1] 292401 0
Country [1] 292401 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 295026 0
Human Disability Ethics Committee
Ethics committee address [1] 295026 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington, 6011
Ethics committee country [1] 295026 0
New Zealand
Date submitted for ethics approval [1] 295026 0
23/05/2016
Approval date [1] 295026 0
Ethics approval number [1] 295026 0

Summary
Brief summary
The proposed study is a micro-longitudinal, 3-arm randomized controlled trial (RCT) investigating the influence of mobile mindfulness meditation on psychological well-being in an adult student population who report experiencing distress. This design will allow further investigation of whether there is a relationship between mobile mindfulness meditation and improved psychological outcomes and whether this relationship is contingent upon time of delivery of intervention.
Prior to the commencement of this intervention, a pilot study, of similar design, was conducted in a normative population to ensure that the current research program was feasible, that Headspace was a suitable tool, and that the mobile mindfulness meditation app did no harm.
The proposed project will involve innovative assessment and intervention delivery methods utilizing mobile phone technology to increase positive psychological wellbeing in naturalistic environments over time.
Overall, the goal is to understand whether our intervention increases mindfulness practice and whether that increase in mindfulness practice translates into noticeable improvements in psychological well-being (better mood, lower depression), and whether such changes in well-being are mediated by psychological expectancies or therapeutic alliance with their clinician.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65818 0
Dr Tess Patterson
Address 65818 0
Department of Psychological Medicine,
Dunedin School of Medicine,
Health Sciences,
University of Otago,
P.O. Box 56,
Dunedin 9054
Country 65818 0
New Zealand
Phone 65818 0
+6434709451
Fax 65818 0
+6434709684
Email 65818 0
[email protected]
Contact person for public queries
Name 65819 0
Jayde Flett
Address 65819 0
Department of Psychology
University of Otago,
P.O. Box 56,
Dunedin 9054
Country 65819 0
New Zealand
Phone 65819 0
+6434799427
Fax 65819 0
Email 65819 0
[email protected]
Contact person for scientific queries
Name 65820 0
Tess Patterson
Address 65820 0
Dunedin School of Medicine,
Health Sciences,
University of Otago,
P.O. Box 56,
Dunedin 9054
Country 65820 0
New Zealand
Phone 65820 0
+6434709451
Fax 65820 0
Email 65820 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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