NCT02778815

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2017

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

May 16, 2016

Last Update Submit

February 20, 2018

Conditions

New Mothers' Well-being

Outcome Measures

Primary Outcomes (1)

  • Change from baseline at 6-weeks on the Warwick-Edinburgh Mental Well-Being Scale

    Post-intervention (i.e. 6-weeks after baseline)

Secondary Outcomes (7)

  • Change from baseline at 6-weeks on the Self-Compassion Scale

    Post-intervention (i.e. 6 weeks post baseline)

  • 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)

  • Change from baseline at 6-weeks on the Depression, Anxiety and Stress Scale 21-item version

    Post-intervention (i.e. 6 weeks post baseline)

  • Change from baseline at 12-weeks on the Warwick-Edinburgh Mental Well-Being Scale

    12-weeks after baseline

  • Change from baseline at 12-weeks on the Self-Compassion Scale

    12-weeks after baseline

  • +2 more secondary outcomes

Study Arms (2)

Kindness for Mums

EXPERIMENTAL

An online self-help course designed to promote self-kindness and self-compassion in new mothers

Other: Kindness for Mums

Wait list control

NO INTERVENTION

A waiting list control group, who will receive access to the online self-help intervention once the RCT is complete.

Interventions

Kindness for MumsOTHER
Kindness for Mums

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Experiencing suicidal ideation at the time of enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Isobel Gammer, BA, MSc

    Canterbury Christ Church University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 20, 2016

Study Start

September 1, 2016

Primary Completion

May 11, 2017

Study Completion

May 11, 2017

Last Updated

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share