Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000464561
Ethics application status
Approved
Date submitted
12/04/2015
Date registered
13/05/2015
Date last updated
4/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of mobile mindfulness meditation apps on psychological well-being
Scientific title
The effect of mobile mindfulness meditation apps on resilience, college readiness, stress, anxiety and depression symptoms in college students.
Secondary ID [1] 286515 0
Nil.
Universal Trial Number (UTN)
U1111-1169-1915
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 294731 0
Depression 294732 0
Stress 294733 0
Condition category
Condition code
Mental Health 295019 295019 0 0
Depression
Mental Health 295020 295020 0 0
Anxiety
Mental Health 295021 295021 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised into one of three conditions which are outlined below:

Arm 1: Mobile mindfulness meditation app 1. Participants assigned to this condition will be guided through mindfulness meditation practice using an app once daily for 10 minutes for 10 days. Participants will receive push notifications to encourage them to practice mindfulness. Participants will set daily reminders to complete daily mindfulness practice. Daily self-reports of adherence occur over the 10 day trial.


Arm 2. Mobile mindfulness meditation app 2. Participants assigned to this condition will be guided through mindfulness meditation practice using an app once daily for 10 minutes for 10 days. Participants will set daily reminders to complete daily mindfulness practice. Daily self-reports of adherence occur over the 10 day trial.

Arm 3: Control condition. Participants assigned to this condition will use an app-based organisational tool to complete a neutral task once daily for 10 minutes for 10 days. Daily self-reports of adherence occur over the 10 day trial.
Intervention code [1] 291606 0
Prevention
Intervention code [2] 291607 0
Lifestyle
Intervention code [3] 291608 0
Behaviour
Comparator / control treatment
Placebo - participants will use an app-based organisational tool to complete a neutral task (e.g. creating an outline of what the individual did on this day last week) once daily for 10 minutes for 10 days using the note taking function of the app.
Control group
Placebo

Outcomes
Primary outcome [1] 294774 0
Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
Timepoint [1] 294774 0
At baseline, post-10 day trial, and at 1 month follow-up.
Primary outcome [2] 294775 0
Anxiety as measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 294775 0
At baseline, post-10 day trial, at 1 month follow-up
Primary outcome [3] 294776 0
Stress as measured by the Perceived Stress Scale
Timepoint [3] 294776 0
At baseline (10 item scale), daily during intervention (4 item scale), post-10 day trial (10 item scale), and at 1 month follow-up (10 item scale)
Secondary outcome [1] 314018 0
Psychological well-being as measured by the flourishing scale
Timepoint [1] 314018 0
At baseline, daily during intervention (shortened scale 3 items), post-10 day trial, and at 1 month follow-up
Secondary outcome [2] 314019 0
Mindfulness as measured by the Cognitive and Affective Mindfulness Scale-Revised
Timepoint [2] 314019 0
At baseline, daily during intervention (shortened scale 4 items), post-10 day trial, and at 1 month follow-up
Secondary outcome [3] 314020 0
College adjustment as measured by the College Adjustment Test and Interpersonal Support Evaluation List
Timepoint [3] 314020 0
At baseline, post-10 day trial, and at 1 month follow-up

Eligibility
Key inclusion criteria
Must be a current college student and have a smartphone capable of running downloaded applications
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
13/04/2015
Actual
13/04/2015
Date of last participant enrolment
Anticipated
17/04/2016
Actual
21/08/2015
Date of last data collection
Anticipated
Actual
29/09/2015
Sample size
Target
240
Accrual to date
Final
210
Recruitment outside Australia
Country [1] 6805 0
New Zealand
State/province [1] 6805 0
Otago

Funding & Sponsors
Funding source category [1] 291081 0
University
Name [1] 291081 0
Funded from the Office of the Vice-Chancellor, University of Otago.
Country [1] 291081 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
P.O. Box 56
Dunedin 9016
New Zealand
Country
New Zealand
Secondary sponsor category [1] 289868 0
None
Name [1] 289868 0
Address [1] 289868 0
Country [1] 289868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292664 0
Human Ethics Commitee, Department of Sciences, University of Otago
Ethics committee address [1] 292664 0
Ethics committee country [1] 292664 0
New Zealand
Date submitted for ethics approval [1] 292664 0
27/02/2015
Approval date [1] 292664 0
12/03/2015
Ethics approval number [1] 292664 0
D15/063

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

Contacts
Principal investigator
Name 56358 0
Dr Tamlin S. Conner
Address 56358 0
Department of Psychology,
University of Otago,
P.O. Box 56
Dunedin 9016
Country 56358 0
New Zealand
Phone 56358 0
+6434797624
Fax 56358 0
Email 56358 0
[email protected]
Contact person for public queries
Name 56359 0
Tamlin S. Conner
Address 56359 0
Department of Psychology,
University of Otago,
P.O. Box 56
Dunedin 9016
Country 56359 0
New Zealand
Phone 56359 0
+6434797624
Fax 56359 0
Email 56359 0
[email protected]
Contact person for scientific queries
Name 56360 0
Tamlin S. Conner
Address 56360 0
Department of Psychology,
University of Otago,
P.O. Box 56
Dunedin 9016
Country 56360 0
New Zealand
Phone 56360 0
+6434797624
Fax 56360 0
Email 56360 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.