Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000282785
Ethics application status
Approved
Date submitted
11/02/2022
Date registered
15/02/2022
Date last updated
19/01/2023
Date data sharing statement initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial to examine the effects of an online mindfulness intervention.
Scientific title
A randomized waitlist-controlled trial of an online mindfulness intervention on stress and wellbeing in a general community sample of adults.
Secondary ID [1] 306403 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study to the trial described in registration record ACTRN12621000610831.

Health condition
Health condition(s) or problem(s) studied:
Psychological stress 325238 0
Condition category
Condition code
Mental Health 322636 322636 0 0
Other mental health disorders

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

Intervention duration:
4 weeks (with an additional 4 week follow-up period).

Time commitment per week:
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.

Mode of delivery:
Online via the FutureLearn digital education platform (futurelearn.com)

Intervention description:
The mindfulness-based intervention involved in this trial is a 4-week online 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 and informal mindfulness meditation practices, and engage in reflection and discussion tasks related to the course content.

Each week of the four-week program focuses on a different topic: (1) Week 1: Introducing Mindfulness; (2) Week 2: Mindfulness and mindfulness stress reduction; (3) Week 3: Improving work and study performance; and (4) Week 4: Mindfulness as a way of life. There are also homework tasks related to the weekly topics. These 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.

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) what step of the program they got up to that week, and (3) an estimate of the time spent engaging in formal and informal meditation practices as measured by the Mindfulness Adherence Questionnaire (Hassed et al., 2021).

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.

References:
Hassed, C., Flighty, A., Chambers, R., Hosemans, D., Bailey, N., Connaughton, S., Lee, S., & Kazantzis, N. (2021). Advancing the Assessment of Mindfulness-Based Meditation Practice: Psychometric Evaluation of the Mindfulness Adherence Questionnaire. Cognitive Therapy and Research, 45(1), 190–204. https://doi.org/10.1007/s10608-020-10150-z
Intervention code [1] 322835 0
Behaviour
Comparator / control treatment
Waitlist control group
Participants allocated to the waitlist control will be asked to go about their lives as normal for the duration of the trial period. There will be no special provisions on what participants can and cannot do during this time. Following the full trial period (i.e., after 8 weeks), 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.
Control group
Active

Outcomes
Primary outcome [1] 330435 0
Psychological stress (Perceived Stress Scale; PSS-10).
Timepoint [1] 330435 0
Week 4 (i.e., after completion of the four week intervention).
Primary outcome [2] 330436 0
Affective and hedonistic dimensions of wellbeing measured by the World Health Organization - Five Wellbeing Index (WHO-5)
Timepoint [2] 330436 0
Week 4 (i.e., after completion of the four week intervention).
Secondary outcome [1] 406200 0
Psychological stress (Perceived Stress Scale; PSS-10).
Timepoint [1] 406200 0
Week 8 (i.e., after the 4 week intervention and an additional 4 week follow-up).
Secondary outcome [2] 406201 0
Affective and hedonistic dimensions of wellbeing measured by the World Health Organization - Five Wellbeing Index (WHO-5)
Timepoint [2] 406201 0
Week 8 (i.e., after the 4 week intervention and an additional 4 week follow-up).
Secondary outcome [3] 406202 0
Psychological stress (Perceived Stress Scale; PSS-10).
Timepoint [3] 406202 0
The average of Week 4 and Week 8.
Secondary outcome [4] 406203 0
Affective and hedonistic dimensions of wellbeing measured by the World Health Organization - Five Wellbeing Index (WHO-5)
Timepoint [4] 406203 0
The average of Week 4 and Week 8.

Eligibility
Key inclusion criteria
1. You are proficient in English . For individuals whose first language is English, evidence of proficiency can include completion of secondary or higher education studies in English. For individuals whose first language is not English, evidence of proficiency can include a sufficient score on a language skills test (e.g., overall IELTS score of 6.5 with no band below 6.0).
2. You consent to being randomly allocated to a treatment or no-treatment group and understand that it is essential to remain part of that group for the duration of the study even if it is not your preferred outcome.
3. You consent to being contacted by researchers via email and mobile phone for the duration of the study.
4. You consent to all responses provided in this study being stripped of identifying information and deposited in a scientific public database (osf.io) for independent verification of results and for use of these data in future research for the betterment of human knowledge.
5. You consent to your name and email address being shared with the ISN Psychology Accounts department for the purpose of providing remuneration.
6. You currently reside in Australia and will remain in Australia for at least 10 weeks after the trial start date.
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
Treatment
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" and who is independent of the current research.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization sequence will be created using the blockrand package (Snow, 2020) in R statistical software (v. 3.6.1; R Core Team). The randomization sequence will be stratified by baseline completion of an optional cognitive task (yes completion vs. no completion) to ensure equivalence of groups for individuals who choose to complete this task. The procedure will use a 1:1 allocation ratio using random block sizes of 2 and 4. Randomization will be conducted by an independent third party.

References:

Snow, Greg. (2020). Blockrand: Randomization for Block Random Clinical Trials [v. 1.5]. https://CRAN.R-project.org/package=blockrand
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
Primary Outcome Measures:
- Psychological Stress measured using the Perceived Stress Scale (PSS-10).
- Affective wellbeing measured by the World Health Organization-5 Scale (WHO-5)

Main Research Questions:
R1: Do the groups differ on the primary outcomes at week 4 of the trial period? (Primary Research Question)
R2: Do the groups differ on the primary outcomes at week 8 of the trial period?
R3: Do the groups differ on each primary outcome on average, respectively, across both week 4 and week 8 of the trial period?

Hypotheses for Each Research Question:

Psychological Stress (PSS-10)
H1a: Individuals allocated to the intervention will report lower psychological stress at week 4 compared to those allocated to a waitlist control.
H2a: Individuals allocated to the intervention will report lower psychological stress at week 8 compared to those allocated to a waitlist control.
H3a: Individuals allocated to the intervention will report lower psychological stress across the average week 4 and week 8 compared to those allocated to a waitlist control.

Affective Wellbeing
H1b: Individuals allocated to the intervention will report higher affective wellbeing at week 4 compared to those allocated to a waitlist control.
H2b: Individuals allocated to the intervention will report higher affective wellbeing at week 8 compared to those allocated to a waitlist control.
H3b: Individuals allocated to the intervention will report higher affective wellbeing across the average week 4 and week 8 compared to those allocated to a waitlist control.

Statistical Analysis of Primary Outcome Measures:
H1a/b: A pairwise contrast of the Week 4 scores using the baseline scores (psychological stress or wellbeing, respectively), sex, age, baseline financial wellbeing, and recruitment wave as covariates (i.e., a one-factor between-groups ANCOVA model). The omnibus ANCOVA main effect is not of interest and will not be reported or interpreted. An alpha level of .05 will be used for each contrast.

H2a/b: A pairwise contrast of the Week 8 scores using the baseline scores (psychological stress or wellbeing, respectively), sex, age, baseline financial wellbeing, and recruitment wave as covariates (i.e., a one-factor between-groups ANCOVA model). The omnibus ANCOVA main effect is not of interest and will not be reported or interpreted. An alpha level of .05 will be used for each contrast.

H3a/b: A pairwise contrasts of the average of Week 4 and 8 scores using the baseline scores (psychological stress or wellbeing, respectively), sex, age, baseline financial wellbeing, and recruitment wave as covariates (i.e., a one-factor between-groups ANCOVA model). The omnibus ANCOVA main effect is not of interest and will not be reported or interpreted. An alpha level of .05 will be used for each contrast.

The primary analysis of interest will be an intention-to-treat analysis. A secondary analysis will be a per-protocol analysis where only participants who report to have completed at least 3 of the 4 weeks of the program will be retained in the analyses.

Assumptions and Missing Data:
Assumptions for one-factor between-groups ANCOVA will be assessed (e.g., linearity, normality, and homoskedasticity). Missing data will be handled using the procedures described in Newman, D. A. (2014). Missing Data: Five Practical Guidelines. Organizational Research Methods, 17(4), 372–411. https://doi.org/10.1177/1094428114548590. The primary analysis of interest will be an intention-to-treat analysis. An exploratory analysis will be a per-protocol analysis where only participants who report to have completed at least 3 of the 4 weeks of the program will be retained in the analyses.

Power Analysis:

Power Analysis
Target Sample Size
N = 186 participants (93 per group)

Parameter 1: Target Effect Size
It has been shown that the minimally important difference with respect to health-related quality of life questionnaires falls consistently close to a standardized mean difference (hereby d) of 0.50 standard deviations. Therefore, this study will be designed such that a difference between posttest (and follow-up) means of a magnitude of d = 0.50 is detectable.

Parameter 2: Estimate of the pre-test covariate and post-test outcome correlation
Because the data collected in this trial will be analyzed using an ANCOVA model the sample size required for between-group comparisons at Week 4 and Week 8 can be determined from a power analysis for a simple independent groups t test and then multiplying by a variance deflation factor of 1 – rho2. See the following reference for details: 15. rho is the correlation between the pre-test covariate and the Week 4 and Week 8 outcome measure. Based on a previous study of the same measures of stress and wellbeing (Prochilo et al.; manuscript in preparation) we conservatively estimate that the correlation between pretest and Week 4 and Week 8 data for each primary outcome measure could be as small as rho = .58. Therefore, this value will be used in the power calculation. Four additional covariates have been selected for this study based on their theorized relationship with stress and wellbeing (sex, age, baseline financial wellbeing, and recruitment wave). If these covariates are associated with the outcome, they will increase power even higher, and we will require a smaller sample size. If these covariates are not associated with the outcome, they will lead to a minimal decrease in power by consuming four degrees of freedom. This is equivalent to subtracting four participants from the study. Therefore, to counteract the unlikely event where all four covariates are not associated with the outcome, we will recruit an additional four participants into the study

Parameter 3: Alpha level
An alpha level of .05 will be used for each test.

Parameter 5: Target Power
We will target 95% power in this trial. This reflects that we consider making a Type II error as serious as a Type I error (i.e., alpha = .05, Type II error rate = .05; .05/.05 = 1).

Parameter 6: Expected dropout rate
We expect a dropout rate up to 30%.

Power Analysis Result
The following parameters were entered into a power analysis for an independent groups t test (pwr:pwr.t.test function in R):
d = 0.50, alpha = .05 (two-sided), 1 – alpha = .95
This yielded a required sample size of 210 participants (105 per group). Accounting for the baseline covariate decreases the required sample size to 140 participants (70 per group). Accounting for an expected dropout rate of 30% and the event that our 4 additional covariates are not associated with the outcome, we will target a sample size of 186 (93 per group).

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

Newman, D. A. (2014). Missing Data: Five Practical Guidelines. Organizational Research Methods, 17(4), 372–411. https://doi.org/10.1177/1094428114548590

Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2003). Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation. Medical Care, 41(5), 582–592. https://doi.org/10.1097/01.MLR.0000062554.74615.4C

Champely, S. (2018). Pwr: Basic Functions for Power Analysis. R package version 1.2-2. https://CRAN.R-project.org/package=pwr

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
14/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
186
Accrual to date
59
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24567 0
New Zealand
State/province [1] 24567 0

Funding & Sponsors
Funding source category [1] 310756 0
Other Collaborative groups
Name [1] 310756 0
Monash Centre for Consciousness and Contemplative Studies (M3CS)
Country [1] 310756 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Monash Centre for Consciousness and Contemplative Studies (M3CS)
Address
Monash Centre for Consciousness and Contemplative Studies (M3CS)
Monash University, Wellington Road, Clayton, Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 311989 0
None
Name [1] 311989 0
None
Address [1] 311989 0
Country [1] 311989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310334 0
ISN Psychology Human Research Ethics Committee (HREC)
Ethics committee address [1] 310334 0
Ethics committee country [1] 310334 0
Australia
Date submitted for ethics approval [1] 310334 0
02/02/2022
Approval date [1] 310334 0
28/04/2022
Ethics approval number [1] 310334 0
220202

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

Contacts
Principal investigator
Name 117274 0
Dr Guy Prochilo
Address 117274 0
ISN Psychology
R15/443 Upper Heidelberg Rd (Enter via 15 Bell Street),
Ivanhoe,
Victoria, 3079
Country 117274 0
Australia
Phone 117274 0
+61 3900 81653
Fax 117274 0
Email 117274 0
[email protected]
Contact person for public queries
Name 117275 0
Guy Prochilo
Address 117275 0
ISN Psychology
R15/443 Upper Heidelberg Rd (Enter via 15 Bell Street),
Ivanhoe,
Victoria, 3079
Country 117275 0
Australia
Phone 117275 0
+61 3900 81653
Fax 117275 0
Email 117275 0
[email protected]
Contact person for scientific queries
Name 117276 0
Guy Prochilo
Address 117276 0
ISN Psychology
R15/443 Upper Heidelberg Rd (Enter via 15 Bell Street),
Ivanhoe,
Victoria, 3079
Country 117276 0
Australia
Phone 117276 0
+61 3900 81653
Fax 117276 0
Email 117276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Unrestricted access via web address on the Open Science Framework (web address TBD).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15055Statistical analysis plan    This is described in the current trial registratio... [More Details]
15056Analytic code    This will be made available on the Open Science Fr... [More Details]



Results publications and other study-related documents

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