Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000670279
Ethics application status
Approved
Date submitted
18/04/2018
Date registered
24/04/2018
Date last updated
27/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Feasibility Study of An Online Mindful Well-being Course.
Scientific title
An Online Compassion Based Mindfulness Course Impact on University Students Mental Health: A Randomized Controlled Trial.
Secondary ID [1] 294631 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 307476 0
Anxiety 307477 0
Stress 307478 0
Self-Compassion 307479 0
Mindfulness 307480 0
General psychological well-being 307481 0
Condition category
Condition code
Mental Health 306559 306559 0 0
Depression
Mental Health 306560 306560 0 0
Anxiety
Alternative and Complementary Medicine 306561 306561 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consent to be enrolled in an online course that fosters the cultivation of compassion through mindfulness. Participants will be randomly allocated to either the compassion-based mindfulness high interactivity (CBM-H) course or the compassion-based mindfulness course low interactivity (CBM-L). Both courses are modulated into six themes, all surrounding differing components of compassion based interventions (Including; self-kindness, mindfulness, interconnection, self-criticism and dealing with difficult emotions). Each module is estimated to take approximately 2-3 hours per week to complete. Each Module contains a brief overview of the weekly theme, introductions the concept, an activity of surrounding the concept, a mindfulness practice (starting at 10 minutes in module one progressing to 20-25 minutes in module six), reading material (the underlying scientific basis of the theme) and a quiz to check understanding. Participants will be asked to reflect on their practices weekly via. diary entry's (displayed as an online personal blog). Weekly announcements of tips suggesting how to manage to incorporate the weekly compassion based theme into daily activities will be posted to the announcements. Weekly emails introducing the theme, topic and activities of the week will be sent to participants to encourage adherence. Engagement data from the online platform of which the course is hosted will be assessed at the end of the course to assess the levels of engagement, points of drop-out and levels of activity. The metrics consist of, activity reports, logs, engagement analytics, a breakdown of downloads and streaming use and log-in reports. Adherence to the intervention will be monitored as the course is structured in modules, competency tracking of each module is enabled, participants will have to complete a quiz at the end of the module to progress. Participants who do not complete the course in the 6-week duration will be asked to complete a questionnaire surrounding their reason for non-completion. Participants who choose to withdraw from the study will be contacted by the chief investigator and questioned surrounding the reason for withdrawing and if necessary referred to other services. The content in both groups is 100% identical. The only differences in the low and high interactivity group are the online structure of activities. Whereby the activities in the high interactivity group are structured around encouraging collaboration, interactivity and communication between participants. These activity's consist of peer-graded assessments, collaborative brainstorms, response and reply to forums, the creation of glossary, a group blog and reflective forums that are open. The low interactivity groups course is structured as an individually based course. Which will not have the levels of interaction with other students.
Intervention code [1] 300937 0
Treatment: Other
Comparator / control treatment
An active control condition involving low interactivity will be used and a natural wait-list control condition. The low interactivity condition has the same content and structure as the primary condition. However, there is minimal interactivity between participants in the online course. Once the initial groups complete the 6-week online course, the wait-list will be enrolled.
Control group
Active

Outcomes
Primary outcome [1] 305580 0
The primary objective of this study is to evaluate whether the compassion based mindfulness course effectively increases levels of self-compassion, mindfulness, and psychological well-being, as well as decreasing levels of depression, anxiety and stress. To measure mindfulness, The Five Facet Mindfulness Questionnaire (FFMQ) will be administered at three-time points. The questionnaire assesses individual differences in mindfulness five factors (observing, describing, awareness, non-judging and non-reactivity).
Timepoint [1] 305580 0
Baseline (pre-test beginning of course), post-test (conclusion of the course, approx six weeks), follow-up (four weeks post course completion)
Primary outcome [2] 305581 0
To assess a change in participant self-compassion is achieved. The Self-Compassion Scale (SCS) will be administered at three time points. The SCS measures how individuals act and treat themselves in times of stress. This is theorised variate with levels of individual self-compassion.
Timepoint [2] 305581 0
Baseline (pre-test beginning of course), post-test (conclusion of the course, approx six weeks), follow-up (four weeks post course completion)
Primary outcome [3] 305582 0
To assess a change in participants psychological well-being the Mental Health Continuum-Short Form (MHC-SF) will be administered at three time points. The MHC-SF measures factors related to positive mental health being emotional, social and psychological well-being. A total score will be used for this study as it is considered an indicator of overall psychological well-being.
Timepoint [3] 305582 0
Baseline (pre-test beginning of course), post-test (conclusion of the course, approx six weeks), follow-up (four weeks post course completion)
Secondary outcome [1] 345818 0
Primary Outcome. To assess a change in participants levels of depression, anxiety and stress will be evaluated using the Depression, Anxiety and Stress Scale 21 (DASS-21). The DASS-21 ask participants to rate the severity of symptoms related to the three constructs specifically. For this study as each factor is considered an outcome. The sub-scores of the DASS-21 will be used to calculate specific outcomes related to the three factors.
Timepoint [1] 345818 0
Baseline (pre-test beginning of course), post-test (conclusion of the course, approx six weeks), follow-up (four weeks post course completion)
Secondary outcome [2] 345819 0
The secondary objective of this study is to determine whether a highly interactive/collaborative online course would have higher program engagement, adherence and completion. To assess this outcome composite measures are warranted, participant self-report measures will be used. These scales are embedded in a single matrix format. Asking the participants at the end of the week's module to rate the frequency of which they attempted the activities in the course (1–not at all to 5–five or more times this week). The frequency of which they practiced with the meditations in the past week (1–not at all to 5–five or more times this week). The frequently they had accessed course materials and information (1–never to 5–Daily) and how beneficial believed the weekly content of the course had been for them (1–not at all to 5–very beneficial). These measures will be combined to assess the overall engagement with the weekly content, practice and participation on a weekly basis.
Timepoint [2] 345819 0
Weekly during course, measures will occur at the end of week one, week two, week three, week four, week five and week six.
Secondary outcome [3] 345831 0
The secondary objective of this study is to determine whether a highly interactive/collaborative online course would have higher program engagement, adherence and completion. To assess this outcome, composite measures are warranted. The online analytics embedded in the platform the course is hosted will be used. Four primary metrics available from the online platform will be tracked. Activity reports (total usage per course activity or resource), participation logs (select activity, period, actions), engagement analytics (group, time spent of activity, date, activity) and completion rates (percentage of students completing each final component of the module). Each of which allows for individual and by-group tracking. By combining and assessing the relationships between these metrics, we are able to assess the levels of engagement in individual activities. As well as areas of attrition in the course.
Timepoint [3] 345831 0
These metrics are intended to be tracked throughout the course using 'heat maps'. At the completion of the course, a more thorough assessment of the analytics surrounding, the point of attrition in the course will be conducted.

Eligibility
Key inclusion criteria
Participants must be a current student of Murdoch University and have a computer with internet access.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No current active diagnosis of a psychiatric condition, or substance/alcohol misuse, no history of schizophrenia or schizoaffective disorder, bipolar disorder, a psychotic mental illness, significant trauma, self-harm, or suicide ideation.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After participants, complete initial (Pre-test) measures participants will be randomly allocated using block randomisation to one of the two active groups. The wait-list will consist of any participants that enrol after the participant cap is reached.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
The proposed study is an adequately powered convenience sample, balanced randomisation (1:1), single-blind, parallel group randomised controlled trial with three arms (Compassion based Mindfulness course - high interactivity [CBM-H], an active control condition Compassion based Mindfulness course – low interactivity [CBM-L] and a natural wait-list control condition. Note that the natural waitlist control condition is due to participants signing up after the start date and having to wait until the next course is due to start. This study design results from a thorough search of the literature, using current recommendations from several recent reviews. This study has been designed to meet the CONSORT Criteria using the CONSORT Checklist (Schulz, Altman, & Moher, 2010).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Similar interventions in the online or distance education have produced small to moderate effect sizes (e.g., d = 0.2 to 0.4). The sample size calculation is based on 3 (group) X 2 (time) mixed-model repeated measures ANOVA. A sample size of 53 participants per condition is needed to detect an effect size of 0.30 (Cohen's d) for the primary outcome measures, with a statistical power of 0.80 in a two-tailed test (p = 0.05). Taking into account the potential and reported dropout rates of 40% (for online-based interventions), 237 people will be needed for randomisation (79 per group) to have a 1:1 ratio.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/08/2018
Actual
13/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
237
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 22464 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 299248 0
University
Name [1] 299248 0
Murdoch University
Country [1] 299248 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street
Murdoch, WA 6150
Country
Australia
Secondary sponsor category [1] 298521 0
None
Name [1] 298521 0
Address [1] 298521 0
Country [1] 298521 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300169 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 300169 0
Ethics committee country [1] 300169 0
Australia
Date submitted for ethics approval [1] 300169 0
19/04/2018
Approval date [1] 300169 0
02/08/2018
Ethics approval number [1] 300169 0
2018/062

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3043 3043 0 0
/AnzctrAttachments/374928-Approval Letter Correia 2018 062.pdf (Ethics approval)

Contacts
Principal investigator
Name 82770 0
Dr Helen Correia
Address 82770 0
School of Psychology and Exercise Sciences
Murdoch University
90 South Street
Murdoch, WA 6150
Country 82770 0
Australia
Phone 82770 0
+61 8 9360 2290
Fax 82770 0
Email 82770 0
[email protected]
Contact person for public queries
Name 82771 0
Christopher Cunningham
Address 82771 0
Center for University Teaching and Learning
Murdoch University
90 South Street
Murdoch, WA 6150
Country 82771 0
Australia
Phone 82771 0
+61 8 9360 6840
Fax 82771 0
Email 82771 0
[email protected]
Contact person for scientific queries
Name 82772 0
Helen Correia
Address 82772 0
School of Psychology and Exercise Sciences
Murdoch University
90 South Street
Murdoch, WA 6150
Country 82772 0
Australia
Phone 82772 0
+61 8 9360 2290
Fax 82772 0
Email 82772 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.