New Mothers Well-beingNCT04674124
Evaluation of an Online Mindfulness-based Course for New Mothers
A study testing Brief Online Mindfulness Intervention in people with New Mothers Well-being and Mindfulness, run by Canterbury Christ Church University at 1 site in United Kingdom.
Trial summary
This research study is aiming to explore whether an online mindfulness programme is accessible and supportive for first time mothers who has a child who is less than 12 months old. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- New Mothers Well-being, Mindfulness
- What is being tested?
- Brief Online Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Dec 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who identify as a mother (Biological, adoptive, foster-carer or step-mum)
- Have an infant under the age of 12 months at baseline measures
- Sufficient English reading and listening abilities
- Access to the internet via an electronic device (phone, tablet, laptop or computer)
- Access to a mobile phone
- No prior experience of parenting a baby (under 12 months of age)
Who cannot join
- Previous completion of a formal 8-week mindfulness course or current mindfulness/meditation practice
- Currently pregnant
- Severe levels of depression and/or anxiety as measured by 15+ point on the Generalised Anxiety Disorder-7 and Patient Health Questionnaire-9 (NICE, 2011).
- Suicidal ideation or thoughts of self-harm in the last two weeks
- Currently experiencing symptoms of psychosis
- Diagnosis of Post Traumatic Stress Disorder (PTSD)
- Bereavement within the last six months which they still feel affected by.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Canterbury Christ Church University
Royal Tunbridge Wells, TN1 2YG
About this study
Official title: Feasibility and Acceptability of an Online Mindfulness-based Intervention for Mothers Within the Postpartum Period
This research study is aiming to explore whether an online mindfulness programme is accessible and supportive for first time mothers who has a child who is less than 12 months old.
Read the detailed description
This study is a randomised controlled trial (RCT) comparing an online mindfulness based course (10ofZen) with a treatment as usual group (delayed 10ofZen course materials). Participants will be informed about the study and asked to undertake a screening questionnaire to ensure the eligibility criteria is met. Following this, participants will be invited to give online consent. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 10) and at follow-up (week 14). A sleep measure will also be undertaken and used as a co-variate during data analysis. At the end of participation in the research study, all participants will gain access to the course materials, including audio recordings of meditations and any written materials used within the course.
- Conditions
- New Mothers Well-being, Mindfulness
- Being tested
- Brief Online Mindfulness Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Online Mindfulness InterventionBehavioural
Also called 10ofZen
A nine-week mindfulness course compromising of 9x weekly 15 minute group sessions which will be on an online platform and daily micro meditations for participants to undertake.
| Study group | Role | What they receive |
|---|---|---|
| Online Mindfulness Course | Experimental | Participants will be enrolled on a 9 week online mindfulness course. Receives: Behavioral: Brief Online Mindfulness Intervention |
| Delayed course materials | No intervention | Participants will have access to the course materials at the closure of their involvement in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in scores between groups at post intervention (10) and follow up (14) on the Short Warwick-Edinburgh Mental Well-Being Scale
Self-report measure of perceived well-being. Scores can range from 0-35. Higher scores are indicative of higher levels of subjective wellbeing.
Measured: Post-intervention and follow up ( i.e 10 & 14 weeks post baseline)
Secondary outcomes (4)
Differences in scores between groups at post intervention (10) and follow up (14) on the Maternal Postnatal Attachment Scale
Self-report measure of maternal emotional bond to the infant. Scores range from 0-95. Higher scores are indicative of higher levels of maternal emotional attachment.
Measured: Post-intervention ( i.e 10 & 14 weeks post baseline)
Differences in scores between groups at post intervention (10) and follow up (14) on the Depression Anxiety Stress Scale - 21
Self-report measure of depression, anxiety and stress. Scores range from 0-63 with higher scores being indicative of higher levels of depression, anxiety and/or stress.
Measured: Post-intervention ( i.e 10 & 14 weeks post baseline)
Differences in scores between groups at post intervention (10) and follow up (14) Five Facet Mindfulness Questionnaire - 15
Self-report measure of mindfulness traits. Scores can range between 15-75 with higher scores being indicative of higher levels of mindfulness traits.
Measured: Post-intervention ( i.e 10 & 14 weeks post baseline)
Differences in scores between groups at post intervention (10) and follow up (14) on sleep quality
Self report measures on sleep quality ranging from 0 (very poor) to 10 (excellent)
Measured: Post-intervention ( i.e 10 & 14 weeks post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start13 Dec 2020
- Primary completion1 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Mothers Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
- Investigators
- Nicola Pitman, BSc, MRes, Principal investigator, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674124
- Sponsor's protocol ID
- UPID1920-0332
- Status last verified
- Oct 2021
- First submitted
- 14 Dec 2020
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Online Mindfulness-based Intervention for Mothers Within the Postpartum Period
- ClinicalTrials.gov ID
- NCT04674124
- Acronym / sponsor ID
- UPID1920-0332
- Conditions
- New Mothers Well-being, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is aiming to explore whether an online mindfulness programme is accessible and supportive for first time mothers who has a child who is less than 12 months old.
Detailed description
This study is a randomised controlled trial (RCT) comparing an online mindfulness based course (10ofZen) with a treatment as usual group (delayed 10ofZen course materials). Participants will be informed about the study and asked to undertake a screening questionnaire to ensure the eligibility criteria is met. Following this, participants will be invited to give online consent. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 10) and at follow-up (week 14). A sleep measure will also be undertaken and used as a co-variate during data analysis. At the end of participation in the research study, all participants will gain access to the course materials, including audio recordings of meditations and any written materials used within the course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Mindfulness Course | Experimental | Behavioral: Brief Online Mindfulness InterventionParticipants will be enrolled on a 9 week online mindfulness course. |
| Delayed course materials | No intervention | –Participants will have access to the course materials at the closure of their involvement in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women who identify as a mother (Biological, adoptive, foster-carer or step-mum)
- Have an infant under the age of 12 months at baseline measures
- Sufficient English reading and listening abilities
- Access to the internet via an electronic device (phone, tablet, laptop or computer)
- Access to a mobile phone
Key exclusion criteria (7 listed)
- Previous completion of a formal 8-week mindfulness course or current mindfulness/meditation practice
- Currently pregnant
- Severe levels of depression and/or anxiety as measured by 15+ point on the Generalised Anxiety Disorder-7 and Patient Health Questionnaire-9 (NICE, 2011).
- Suicidal ideation or thoughts of self-harm in the last two weeks
- Currently experiencing symptoms of psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Online Mindfulness InterventionAlso: 10ofZenA nine-week mindfulness course compromising of 9x weekly 15 minute group sessions which will be on an online platform and daily micro meditations for participants to undertake. | Behavioural | Online Mindfulness Course |
Primary outcome
Differences in scores between groups at post intervention (10) and follow up (14) on the Short Warwick-Edinburgh Mental Well-Being Scale
Time frame: Post-intervention and follow up ( i.e 10 & 14 weeks post baseline)
Self-report measure of perceived well-being. Scores can range from 0-35. Higher scores are indicative of higher levels of subjective wellbeing.
4 secondary outcomes
Differences in scores between groups at post intervention (10) and follow up (14) on the Maternal Postnatal Attachment Scale
Time frame: Post-intervention ( i.e 10 & 14 weeks post baseline)
Differences in scores between groups at post intervention (10) and follow up (14) on the Depression Anxiety Stress Scale - 21
Time frame: Post-intervention ( i.e 10 & 14 weeks post baseline)
Differences in scores between groups at post intervention (10) and follow up (14) Five Facet Mindfulness Questionnaire - 15
Time frame: Post-intervention ( i.e 10 & 14 weeks post baseline)
Differences in scores between groups at post intervention (10) and follow up (14) on sleep quality
Time frame: Post-intervention ( i.e 10 & 14 weeks post baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Pitman, BSc, MRes principal investigator
Canterbury Christ Church University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Online Mindfulness Intervention in people with New Mothers Well-being and Mindfulness, run by Canterbury Christ Church University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in scores between groups at post intervention (10) and follow up (14) on the Short Warwick-Edinburgh Mental Well-Being Scale (time frame: Post-intervention and follow up ( i.e 10 & 14 weeks post baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.