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Trial registered on ANZCTR


Registration number
ACTRN12621000610831
Ethics application status
Approved
Date submitted
2/06/2020
Date registered
21/05/2021
Date last updated
1/07/2022
Date data sharing statement initially provided
21/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized pretest-posttest waitlist-controlled trial to examine the effects of an online mindfulness-based intervention.
Scientific title
A randomized pretest-posttest waitlist-controlled trial to examine the effects of an online mindfulness-based intervention.
Secondary ID [1] 301426 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological stress 317707 0
Condition category
Condition code
Mental Health 315785 315785 0 0
Other mental health disorders
Public Health 315788 315788 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention name:
Mindfulness for Wellbeing and Peak Performance

Intervention procedure and activities:
The mindfulness-based intervention involved in this trial is an online adaptation of a 6-week face-to-face intervention called mindfulness-based Stress Release Program. This online adaptation is a 4-week intervention called Mindfulness for Wellbeing and Peak Performance. This program is readily accessible and endorsed as a stress reduction program for tertiary education students and employees at Monash University, Melbourne Australia.

The training approach in this program adheres to the formal defining features of mindfulness-based interventions in that it involves weekly meditation practices using the body, breath, and sound, as well as cognitive strategies trained in activities that center around focused-attention meditation and acceptance of thoughts. Each week the program will deliver a series of topics that require participants to watch videos, perform formal mindfulness meditation practices, and engage in reflection and discussion tasks related to the course content. These discussions will be facilitated by mindfulness mentors who will monitor participant progress throughout the course. The main topics covered each week include: the problem of mindfulness; empirical research on mindfulness; mindful stress reduction and managing emotions; using mindfulness to improve work and study performance; mindfulness in memory and learning; cultivating self-compassion and emotional health; mindful communication; the role of mindfulness in relationships and empathy; and maintaining a mindful life. There are also homework tasks related to the weekly topics. These tasks include identifying unhelpful cognitive patterns in real time as participants go about their usual daily lives, as well as integrating mindfulness practices into everyday tasks.

Several topics are delivered each week and are made available to participants as part of four weekly modules. One module is delivered by the FutureLearn platform each week over the four-week program. The estimated time to complete weekly tasks is three hours per week and the participant can spread this time across each week at their own discretion. The intervention is not personalized to individual participants.

Adherence Monitoring:
Adherence will be monitored via a weekly emails each week for four weeks asking participants to report: (1) whether or not they participated in the program that given week, and (2) an estimate of the time (in minutes) spent engaging in formal meditation practices that week (e.g., focused attention meditation).

Adherence Requirements:
While participants are recommended to complete all tasks and spend three hours engaging with the intervention materials each week, there will be no formal adherence requirement to the intervention. This will be a pragmatic experiment that investigates the effect of participating in this intervention in a manner that generalisable to typical usage in the target population, which may be more or less than the recommended intervention prescription.
Intervention code [1] 317741 0
Behaviour
Comparator / control treatment
Waitlist control group procedures and activities:
Participants allocated to the waitlist control will be asked to go about their lives as normal for the duration of the trial period (i.e., four weeks). Following the trial period, the participants in this group will be debriefed and will be provided with instructions on how to participate in Mindfulness for Wellbeing and Peak Performance via the FutureLearn platform at a later date.
Control group
Active

Outcomes
Primary outcome [1] 324001 0
Psychological stress (Perceived Stress Scale; PSS-10).
Timepoint [1] 324001 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [1] 383523 0
Resilience (Brief Resilience Scale: BRS)
Timepoint [1] 383523 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [2] 383524 0
Frequency of use of positive reappraisal (Positive Reappraisal subscale of the Cognitive Emotion Regulation Questionnaire).
Timepoint [2] 383524 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [3] 383525 0
Positive affect (positive component of the Scale of Positive and Negative Experience; SPANE).
Timepoint [3] 383525 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [4] 383526 0
Mindfulness (Five Facet Mindfulness Questionnaire Short Form: FFMQ-short form).
Timepoint [4] 383526 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [5] 383527 0
Sleep quality (Pittsburgh Sleep Quality Index; PSQI )
Timepoint [5] 383527 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [6] 383528 0
Cognitive component of wellbeing measured through the Satisfaction with Life Scale (SWLS)
Timepoint [6] 383528 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [7] 383529 0
Disposition to use self-compassion (Self-compassion scale-short form; SCS-short form) .
Timepoint [7] 383529 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [8] 383530 0
Self-reported loneliness (UCLA Loneliness Scale-short form)
Timepoint [8] 383530 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [9] 383531 0
Depression and anxiety subscales of the Depression Anxiety Stress Scale (DASS-21) .
Timepoint [9] 383531 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [10] 383532 0
Self-reported self-esteem (Rosenberg Self-Esteem Scale; RSES
Timepoint [10] 383532 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [11] 383533 0
Affective and hedonistic dimensions of wellbeing measured by the World Health Organization - Five Wellbeing Index (WHO-5)
Timepoint [11] 383533 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.
Secondary outcome [12] 383534 0
Worry (Penn-state Worry questionnaire-short form; PSWQ-8)
Timepoint [12] 383534 0
T0 (Baseline): Prior to the trial period
T1 (Post-intervention): Following completion of the 4-week trial period.

Eligibility
Key inclusion criteria
1. English is their first language or university-level English (i.e., 80 on TOEFL or 6.5 on IELTS).

2. Individuals who consider they can realistically complete a four-week online course requiring approximately three hours of activities each week spread out over the week.

3. Willingness to be randomly allocated to the intervention or a waitlist control group (and to remain in that group), where the waitlist control will be provided access to the intervention at a later date.

4. Willingness for responses to be stripped of all identifying information and deposited in a scientific public database (https://osf.io/). This is critical to ensure the integrity of the current research project so that scientists can independently verify our findings, and potentially use these data in future research for the betterment of human knowledge.

5. Willingness to be contacted by the researchers by email and phone if you choose to withdraw or end participation in the trial in order to describe (briefly) your reasons for doing so. Participants agree to four contact attempts: two emails and two phone calls. After one contact attempt, the next attempt cannot be performed by the researcher for at least one week. Participants are informed that they are not obliged to give a reason for withdrawing, and if they communicate to the researcher that they do not want to provide a reason then all contact attempts will cease.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Past completion of a formal mindfulness meditation program at any time in the past.

2. Current or history of physical medical conditions that include head injury, spinal injury, epilepsy, or cardiovascular disease, or any other health issue that would impact capacity to engage with the course.

3. Currently suffering from severe periods of depression or anxiety. This might include feelings of sadness, hopelessness, excessive anxiety, or a loss of interest or pleasure in normal activities occurring nearly every day for more than two months and which impairs normal daily functioning. This also includes a formal clinical diagnosis of a depressive or anxiety disorder.

4. Past or present incidence of any other serious mental or physical health issues that would impact one’s capacity to engage with the course. This includes past or present psychotic disorders.

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 will involve contacting the holder of the allocation schedule who is "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization sequence will be generated using the blockrand package (Snow, 2020) in R statistical software (v-3.6.1; R Core Team). The randomization procedure will be stratified by baseline self-reported psychological stress with a 1:1 allocation ratio using random block sizes of 2 and 4. Baseline stress will be assessed using a single item question measuring frequency of stress over the past month (“How often have you felt stressed during the past month?”) on a scale ranging from 0 (never) to 4 (very often). A score of 0 or 1 will be categorized as low stress and a score or 2 or above will be categorized as high stress. There will be two strata:

1. Low stress
2. High stress
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
Power analysis:
The pwr package (v. 1.2-2; Champely, 2018) in R statistical software (v. 3.6.1; R Core Team) was used to perform a power analysis to determine the sample size required to detect a differences psychological stress when comparing the posttest means of the treatment group against a passive waitlist control. A correction based on the formula given in Borm and colleagues (2007) was applied to the attained sample size to make this sample size estimation applicable to an ANCOVA model.

A recent meta-analysis of randomized controlled trials conducted in tertiary student populations indicated that the standardized mean difference between these groups is a magnitude of -0.47 units (Dawson et al., 2019). This indicates that mindfulness-based interventions, on average, are associated with lower responses to distress-related measures when compared to a waitlist control. This meta-analytic effect size was used as an estimate of the population effect size and entered into the power analysis with the following parameters:

d = -0.47, a = .05 (two-sided), power = .80, estimated correlation between pretest covariate and posttest outcome measure = .50.

Based on this analysis, a sample size of 110 (n = 55 per group) will allow us to attain 80% power in this study for the hypothesis test of our primary dependent measure.

Primary and secondary outcome analyses:
All dependent measures will be analysed using analysis of covariance (ANCOVA) by comparing the difference in the posttest means between the intervention group and control group, with the pre-test score included as a covariate.

Analyses will follow an intention-to-treat analysis (i.e., participants are analysed as part of the group they are randomized to regardless of protocol deviations, non-compliance, or dropout) will be performed for each dependent measure.

Missing data methods:
If the missing at random (MAR) assumption is plausible, missing data will be imputed using a multiple imputation routine and an inclusive analysis strategy.

References:
Borm, G. F., Fransen, J., & Lemmens, W. A. J. G. (2007). A simple sample size formula for analysis of covariance in randomized clinical trials. Journal of Clinical Epidemiology, 60(12), 1234–1238. https://doi.org/10.1016/j.jclinepi.2007.02.006

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2021
Actual
31/05/2021
Date of last participant enrolment
Anticipated
Actual
31/05/2021
Date of last data collection
Anticipated
Actual
6/07/2021
Sample size
Target
110
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305864 0
University
Name [1] 305864 0
ISN Psychology
Country [1] 305864 0
Australia
Primary sponsor type
University
Name
ISN Psychology
Address
443 Upper Heidelberg Rd, Ivanhoe VIC 3081
Country
Australia
Secondary sponsor category [1] 306319 0
None
Name [1] 306319 0
Address [1] 306319 0
Country [1] 306319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306124 0
ISN Psychology HREC
Ethics committee address [1] 306124 0
Ethics committee country [1] 306124 0
Australia
Date submitted for ethics approval [1] 306124 0
30/04/2020
Approval date [1] 306124 0
13/04/2021
Ethics approval number [1] 306124 0

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

Contacts
Principal investigator
Name 102794 0
Dr Guy Prochilo
Address 102794 0
ISN Psychology Pty Ltd, 443 Upper Heidelberg Rd, Ivanhoe VIC 3081
Country 102794 0
Australia
Phone 102794 0
+61 3 8900 0000
Fax 102794 0
Email 102794 0
gprochilo@isn.edu.au
Contact person for public queries
Name 102795 0
Guy Prochilo
Address 102795 0
ISN Psychology Pty Ltd, 443 Upper Heidelberg Rd, Ivanhoe VIC 3081
Country 102795 0
Australia
Phone 102795 0
+61 3 8900 0000
Fax 102795 0
Email 102795 0
gprochilo@isn.edu.au
Contact person for scientific queries
Name 102796 0
Guy Prochilo
Address 102796 0
ISN Psychology Pty Ltd, 443 Upper Heidelberg Rd, Ivanhoe VIC 3081
Country 102796 0
Australia
Phone 102796 0
+61 3 8900 0000
Fax 102796 0
Email 102796 0
gprochilo@isn.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified responses to each of the measures collected as part of this project.
When will data be available (start and end dates)?
Following completion of the trial (expected completion date = January 2022). De-identified data will be deposited on the Open Science Framework (https://osf.io/) and available indefinitely for scientific use.
Available to whom?
These data will be publicly deposited on the Open Science Framework (https://osf.io/).
Available for what types of analyses?
Data will be publicly available to all scientists for replication and use of data in their own research projects.
How or where can data be obtained?
These data will be publically available on the Open Science Framework (https://osf.io/).


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.