None listed
Conditions
Brief summary
This project aims to pilot a protocol for a randomized controlled trial which will compare the effectiveness of two experimental conditions (online mindfulness training and online compassion and loving-kindness training) with an active control (online progressive muscle relaxation training) for improving maternal mental health (scores on the mental health continuum short form), symptoms of maternal distress (symptoms of stress, anxiety, and depression) during pregnancy. All intervention conditions will be delivered over 8 weeks and will be minimal-contact, meaning that participants will use an online program at home to practice mindfulness, loving-kindness/compassion, or the relaxation condition. Participants will also receive a weekly text message to ask them about their engagement with the program and ask them to complete a short weekly online measure battery (measures of affect, stress, and emotion regulation). The aim of the pilot study is to assess the feasibility of the RCT protocol which compares the three conditions delivered online as a series of instructional material and brief daily practices. Feasibility will be assessed based on recruitment, randomization, retention, acceptability and adherence. Adverse events for all conditions will be monitored and compared. We also aim to explore the experiences of women in the trial by conducting interviews with randomly selected participants in each condition.. Finally, we will use data gathered to estimate standard deviation values for each outcome measure. This will be used to inform sample-size calculates for a full-scale RCT. We aim to recruit 25 participants per treatment arm (75 participants in total). Participants will be eligible if they are over 18 years old, and are participants in The ORIGINS Project longitudinal birth cohort. Participants will be recruited from Joondalup Health Campus at their earliest antenatal visit.
Interventions
1. Online mindfulness meditation
- Participants will receive access to an online program that contains 8 mindfulness meditation practices delivered over 8 weeks (1 per week). Practices are delivered as audio recordings, and are between 7-15 minutes in length. Participants also receive written instructions for an "informal" mindfulness practice (1 per week) plus psychoeducational content (delivered via text/video, no more than 5 minutes duration per week). All content is developed for the purpos
1. Online mindfulness meditation - Participants will receive access to an online program that contains 8 mindfulness meditation practices delivered over 8 weeks (1 per week). Practices are delivered as audio recordings, and are between 7-15 minutes in length. Participants also receive written instructions for an "informal" mindfulness practice (1 per week) plus psychoeducational content (delivered via text/video, no more than 5 minutes duration per week). All content is developed for the purposes of this study. - Participants are encouraged to listen to the allocated meditation practice once per day - Participants receive a text message once per week asking them to self-report adherence and barriers/facilitators to engagement with the program, as well as complete a brief battery of weekly measures. - The meditation recordings are developed for the purposes of this study by registered psychologists with Masters-level training in clinical psychology and certification in Mindfulness- and Compassion-based interventions. - Mindfulness recordings emphasise developing non-judgemental present-moment awareness - All intervention activities are delivered on an individual basis, via the Internet -Participants are part of the ORIGINS Project longitudinal birth cohort study. They are recruited from the ORIGINS study (at an antenatal clinic appointment) but undertake all intervention activities online and are invited to complete the practices wherever it suits them 2. Online loving-kindness and compassion meditation - Participants will receive access to an online program that contains 8 loving-kindness/compassion meditation practices delivered over 8 weeks (1 per week). Practices are delivered as audio recordings, and are between 7-15 minutes in length. Participants also receive written instructions for an "informal" loving-kindness/compassion practice (1 per week) plus psychoeducational content (delivered via text/video, no more than 5 minutes duration per week). All content is developed for the purposes of this study. - Participants are encouraged to listen to the allocated meditation practice once per day - Participants receive a text message once per week asking them to self-report adherence and barriers/facilitators to engagement with the program, as well as complete a brief battery of weekly measures. - The meditation recordings are developed for the purposes of this study by registered psychologists with Masters-level training in clinical psychology and certification in Mindfulness- and Compassion-based interventions. - Loving/Kindness and Compassion recordings emphasise intentional cultivation of feelings of goodwill and compassion towards self and others - All intervention activities are delivered on an individual basis, via the Internet or text message (weekly messages only) -Participants are part of the ORIGINS Project longitudinal birth cohort study. They are recruited from the ORIGINS study (at an antenatal clinic appointment) but undertake all intervention activities online and are invited to complete the practices wherever it suits them
Sponsors
Telethon Kids Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Pregnant (up to 30 weeks GA) Enrolled in the ORIGINS Project Longitudinal Birth Cohort Study
Exclusion criteria
Unable to understand English No access to the Internet
Outcome results
None listed