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Evaluation of an Online Mindfulness-based Course for New Mothers

NCT ID: NCT04674124

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-13

Study Completion Date

2021-07-01

Brief Summary

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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

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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

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New Mothers Well-being Mindfulness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Online Mindfulness Course

Participants will be enrolled on a 9 week online mindfulness course.

Group Type EXPERIMENTAL

Brief Online Mindfulness Intervention

Intervention Type BEHAVIORAL

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.

Delayed course materials

Participants will have access to the course materials at the closure of their involvement in the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Brief Online Mindfulness Intervention

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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10ofZen

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University College, London

OTHER

Sponsor Role collaborator

Canterbury Christ Church University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicola Pitman, BSc, MRes

Role: PRINCIPAL_INVESTIGATOR

Canterbury Christ Church University

Locations

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Canterbury Christ Church University

Royal Tunbridge Wells, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UPID1920-0332

Identifier Type: -

Identifier Source: org_study_id