New Mothers' Well-beingNCT02778815
The Development and Initial Evaluation of a Web-based, Compassion-focussed Course for New Mothers
A study testing Kindness for Mums in people with New Mothers' Well-being, run by Canterbury Christ Church University.
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. 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
- What is being tested?
- Kindness for Mums
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 11 May 2017
- 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
- 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
Who cannot join
- Experiencing suicidal ideation at the time of enrolment
About this study
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.
Read the detailed 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.
- Conditions
- New Mothers' Well-being
- Being tested
- Kindness for Mums
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kindness for MumsOther
| Study group | Role | What they receive |
|---|---|---|
| Kindness for Mums | Experimental | An online self-help course designed to promote self-kindness and self-compassion in new mothers Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at 6-weeks on the Warwick-Edinburgh Mental Well-Being Scale
Measured: Post-intervention (i.e. 6-weeks after baseline)
Secondary outcomes (7)
Change from baseline at 6-weeks on the Self-Compassion Scale
Measured: 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
Measured: Post-intervention (i.e. 6 weeks post baseline)
Change from baseline at 6-weeks on the Depression, Anxiety and Stress Scale 21-item version
Measured: Post-intervention (i.e. 6 weeks post baseline)
Change from baseline at 12-weeks on the Warwick-Edinburgh Mental Well-Being Scale
Measured: 12-weeks after baseline
Change from baseline at 12-weeks on the Self-Compassion Scale
Measured: 12-weeks after baseline
Change from baseline at 12-weeks on the Forms of Self-Criticising/Attacking and Self-Reassuring Scale
Measured: 12-weeks after baseline
Change from baseline at 12-weeks on the Depression, Anxiety and Stress Scale 21-item version
Measured: 12-weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startSep 2016
- Primary completion11 May 2017
- Study completion11 May 2017
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isobel Gammer, BA, MSc, Principal investigator, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778815
- Sponsor's protocol ID
- IsobelGammerMRP2015
- Status last verified
- Feb 2018
- First submitted
- 16 May 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Initial Evaluation of a Web-based, Compassion-focussed Course for New Mothers
- ClinicalTrials.gov ID
- NCT02778815
- Acronym / sponsor ID
- IsobelGammerMRP2015
- Conditions
- New Mothers' Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 20 May 2016 (estimated)
- 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 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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kindness for Mums | Experimental | Other: Kindness for MumsAn online self-help course designed to promote self-kindness and self-compassion in new mothers |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Experiencing suicidal ideation at the time of enrolment
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 |
|---|---|---|
| Kindness for Mums | Other | Kindness for Mums |
Primary outcome
Change from baseline at 6-weeks on the Warwick-Edinburgh Mental Well-Being Scale
Time frame: Post-intervention (i.e. 6-weeks after baseline)
7 secondary outcomes
Change from baseline at 6-weeks on the Self-Compassion Scale
Time frame: 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
Time frame: Post-intervention (i.e. 6 weeks post baseline)
Change from baseline at 6-weeks on the Depression, Anxiety and Stress Scale 21-item version
Time frame: Post-intervention (i.e. 6 weeks post baseline)
Change from baseline at 12-weeks on the Warwick-Edinburgh Mental Well-Being Scale
Time frame: 12-weeks after baseline
Change from baseline at 12-weeks on the Self-Compassion Scale
Time frame: 12-weeks after baseline
Change from baseline at 12-weeks on the Forms of Self-Criticising/Attacking and Self-Reassuring Scale
Time frame: 12-weeks after baseline
Change from baseline at 12-weeks on the Depression, Anxiety and Stress Scale 21-item version
Time frame: 12-weeks after 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 22 Feb 2018.
- Individual participant dataSharing planned: No
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Implementation of a Psychoeducational Intervention in New Mothers
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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.
Isobel Gammer, BA, MSc principal investigator
Canterbury Christ Church University
Questions about this trial
What is this clinical trial studying?
A study testing Kindness for Mums in people with New Mothers' Well-being, run by Canterbury Christ Church University.
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 5 inclusion and 1 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline at 6-weeks on the Warwick-Edinburgh Mental Well-Being Scale (time frame: Post-intervention (i.e. 6-weeks after 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 22 Feb 2018.