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Improving Wellness: A randomised controlled trial comparing the Mindfulness eHealth and Physical Activity eHealth programs.

A randomised controlled trial comparing the Mindfulness eHealth and Physical Activity eHealth programs on wellness outcomes in adults.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001282673
Enrollment
79
Registered
2014-12-08
Start date
2015-01-17
Completion date
2015-09-22
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

A randomised controlled trial will be employed to investigate the effectiveness of the Mindfulness eHealth program and the Physical Activity eHealth program in comparison to a delayed access (8 weeks) wait control group as a means to increase wellbeing. People visiting the Wellbeing study website, in response to advertisements or through self interest, will be informed of the availability of the study and invited to participate. Following completion of the pre-intervention assessments, people taking part in the study will be randomly allocated to one of the three groups above. Participants allocated to the immediate start intervention groups (Mindfulness or Physical Activity eHealth) will complete online questionnaires at pre-intervention (Week 0), during-intervention, post-intervention (Week 4), 4 weeks post intervention (Week 8) and at a three month follow-up (Week 16). The delayed start wait group will be provided access to their choice of either the Physical Activity eHealth or Mindfulness eHealth program following the Week 8 assessment phase. Therefore participants allocated to the delayed start wait group will complete pre-intervention (Week 0), during-wait intervention, post-wait intervention (Week 4), 4 weeks post-wait intervention (Week 8) and a post intervention assessment once they have completed a ehealth program (Week 12). All participants will also be asked to meet with the researchers on two occasions (Week 0 and Week 8) to undertake three brief computerised cognitive tests (15 minutes), have their resting heart rate variability measured (10 minutes) and to provide a salivary cortisol and blood sample.

Interventions

A randomized controlled trial will be employed to investigate the effectiveness of the Mindfulness eHealth program and the Physical Activity eHealth program in comparison to a delayed access (8 weeks) wait control group as a means to increase wellbeing. People visiting the Wellbeing study website, in response to advertisements or through self interest, will be informed of the availability of the study and invited to register their interest. Following completion of the pre-intervention assessment

A randomized controlled trial will be employed to investigate the effectiveness of the Mindfulness eHealth program and the Physical Activity eHealth program in comparison to a delayed access (8 weeks) wait control group as a means to increase wellbeing. People visiting the Wellbeing study website, in response to advertisements or through self interest, will be informed of the availability of the study and invited to register their interest. Following completion of the pre-intervention assessments, people taking part in the study will be randomly allocated to one of the three groups above. The Mindfulness eHealth program consists of three weekly online modules designed to help an individual become more mindful or more aware of moment-to-moment experiences (e.g., thoughts, feelings, images, sensations). The Physical Activity eHealth program consists of three weekly online modules designed to increase physical activity, through increased awareness regarding the benefits, understanding the barriers to physical activity. The online modules from both programs will take approximately 15 minutes to complete each week, as well as some offline activities (e.g., engaging in a brief physical activity, practicing mindfulness). All participants are asked to answer questions about how they are feeling and what they have been doing via the secure website and a mobile app survey form. All participants will also wear the BASIS wrist watch continuously, which is just like a normal watch but it also automatically tracks the number of steps taken and their sleep (e.g., total time asleep, number of interruptions, quality of sleep) over the first 7 weeks of the study. Participants will also receive emails (e.g., when to complete post questionnaires) to help keep them on track. Participants allocated to the immediate start intervention groups (Mindfulness or Physical Activity eHealth) will complete online questionnaires via a secure website at pre-intervention (Week 0), during-intervention, post-intervention (Week 4), 4 weeks post intervention (Week 8) and at a three month follow-up (Week 16). The delayed start wait group will be provided access to their choice of either the Physical Activity eHealth or Mindfulness eHealth program following the Week 8 assessment phase. Therefore participants allocated to the delayed start wait group will complete pre-intervention (Week 0), during-wait intervention, post-wait intervention (Week 4), 4 weeks post-wait intervention (Week 8) and a post intervention assessment once they have completed a ehealth program (Week 12). All participants will also be asked to meet with the researchers on two occasions (Week 0 and Week 8) to undertake three brief computerised cognitive tests (15 minutes), have their resting heart rate variability measured (10 minutes) and to provide a salivary cortisol and blood sample.

Sponsors

Federation Universtiy
Lead SponsorUniversity

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

18 years of age or older, have access to the internet, an internet-connected mobile phone, and be able to attend two assessment sessions onsite.

Exclusion criteria

Given the nature of the assessments, self-monitoring and the inclusion of the physical activity intervention, those meeting the following criteria would not be able to participate: pregnant, having a documented life threatening illness (e.g., cancer) or traumatic brain injury, cardiovascular disease, debilitating physical mobility issues or a current untreated severe (psychotic) mental illness.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026