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A randomized pretest-posttest waitlist-controlled trial to examine the effects of an online mindfulness-based intervention.

A randomized pretest-posttest waitlist-controlled trial to examine the effects of an online mindfulness-based intervention.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000610831
Enrollment
120
Registered
2021-05-21
Start date
2021-05-31
Completion date
2021-05-31
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Mindfulness-based interventions are interventions that aim to address the causes of psychological stress and the pathways to relieving it (Crane et al., 2016). Furthermore, mindfulness-based intervention we will be evaluating is endorsed as a stress reduction program specifically for student populations (Monash University, 2020). For these reasons, the primary aim of the current study is to evaluate the effect of Mindfulness for Wellbeing and Peak Performance on psychological stress in a non-clinical (i.e., healthy) sample of tertiary education students. The chosen research design will be a pragmatic randomized pretest-posttest waitlist-controlled study, which will yield an unbiased estimate of the effect of this intervention on this dependent measure. A second exploratory aim of this study will be to evaluate the effect of this intervention on secondary outcomes, including mental health outcomes associated with stress (e.g., wellbeing, depressive symptoms, anxiety symptoms), physical health factors (e.g., sleep quality), interpersonal factors (e.g., loneliness), and factors that have been associated with improvements in mental health (e.g., mindfulness, emotion regulation strategies, self-compassion, and self-esteem). This study will be critical to determine whether participation in Mindfulness for Wellbeing and Peak Performance in a manner that is generalizable to typical usage in the target population is associated with the type of salutary mental health outcomes that are typically reported in more established mindfulness-based interventions, and which are claimed of this intervention in the course outline.

Interventions

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 employ

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.

Sponsors

ISN Psychology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026