The Development and Initial Evaluation of a Web-based, Compassion-focussed Course for New Mothers

New Mothers' Well-being Clinical Trial

Official title:

The Development and Initial Evaluation of a Web-based, Compassion-focussed Course for New Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778815
• Other study ID #: IsobelGammerMRP2015
• Status: Completed
• Phase: N/A
• First received: May 16, 2016
• Last updated: February 20, 2018
• Start date: September 2016
• Est. completion date: May 11, 2017

Study information

• Verified date: February 2018
• Source: Canterbury Christ Church University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines the relationship between self-compassion and wellbeing in new mothers and whether an online self-help course for new mothers can help to improve their wellbeing and self-compassion.

Description:

This study is a randomised controlled trial (RCT) comparing an online self-help course ('Kindness for Mums') with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 6) and at follow-up (week 12). Baseline data will also be used to examine the relationship between self-compassion and wellbeing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: May 11, 2017
• Est. primary completion date: May 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• New mothers (can be biological, adoptive or full-time foster mother)

• Able to complete baseline measures when infant aged 0-12 months

• Fluent in English

• Live in the United Kingdom

• Able to access the internet

Exclusion Criteria:

• Experiencing suicidal ideation at the time of enrolment

Related Conditions & MeSH terms

• New Mothers' Well-being

Intervention

Other:
• Kindness for Mums

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Canterbury Christ Church University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline at 6-weeks on the Warwick-Edinburgh Mental Well-Being Scale		Post-intervention (i.e. 6-weeks after baseline)
Secondary	Change from baseline at 6-weeks on the Self-Compassion Scale		Post-intervention (i.e. 6 weeks post baseline)
Secondary	Change from baseline at 6-weeks on the Forms of Self-Criticising/Attacking and Self-Reassuring Scale		Post-intervention (i.e. 6 weeks post baseline)
Secondary	Change from baseline at 6-weeks on the Depression, Anxiety and Stress Scale 21-item version		Post-intervention (i.e. 6 weeks post baseline)
Secondary	Change from baseline at 12-weeks on the Warwick-Edinburgh Mental Well-Being Scale		12-weeks after baseline
Secondary	Change from baseline at 12-weeks on the Self-Compassion Scale		12-weeks after baseline
Secondary	Change from baseline at 12-weeks on the Forms of Self-Criticising/Attacking and Self-Reassuring Scale		12-weeks after baseline
Secondary	Change from baseline at 12-weeks on the Depression, Anxiety and Stress Scale 21-item version		12-weeks after baseline