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Evaluation of an Online Mindfulness-based Course for New Mothers

C

Canterbury Christ Church University

Status

Completed

Conditions

New Mothers Well-being
Mindfulness

Treatments

Behavioral: Brief Online Mindfulness Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04674124
UPID1920-0332

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 2 patient groups

Online Mindfulness Course
Experimental group
Description:
Participants will be enrolled on a 9 week online mindfulness course.
Treatment:
Behavioral: Brief Online Mindfulness Intervention
Delayed course materials
No Intervention group
Description:
Participants will have access to the course materials at the closure of their involvement in the study.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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