Mental Health Wellness 1NCT01590212

Mellow Bumps RCT - Antenatal Intervention for Vulnerable Women

A study testing Mellow Bumps and Chill-out in Pregnancy in people with Mental Health Wellness 1 and Pregnancy, run by University of Glasgow at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 years and older, women only
Conditions the study is for: Mental Health Wellness 1, Pregnancy, Mother-Child Relations
What is being tested?: Mellow Bumps and Chill-out in Pregnancy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 2 sitesUnited Kingdom
Study dates: May 2012to Jun 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 years and older
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

pregnant, between 20 \& 30 weeks gestation at start of intervention
Identified by midwives as meeting Special Needs in Pregnancy (SNiP) criteria
basic understanding of written and spoken English

Who cannot join

not identified as vulnerable through SNiP criteria
less than 20 weeks or more than 30 weeks gestation at start of intervention

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

NHS Greater Glasgow & Clyde
Greenock, Inverclyde
NHS Ayshire & Arran
Irvine, North Ayrshire

Other trials in United Kingdom

About this study

Official title: Antenatal Parenting Support for Women Vulnerable in Pregnancy: an Exploratory Randomised Controlled Trial of Mellow Bumps

The purpose of this study is to compare the effectiveness of a relationships based antenatal intervention (Mellow Bumps) against a comparison intervention (Chillout In Pregnancy) and also against the normal antenatal care which is received during pregnancy (Care As Usual). The Mellow Bumps intervention will seek to improve maternal anxiety and maternal sensitivity whilst the Chillout In Pregnancy intervention will aim to improve only maternal anxiety. This will allow the researchers to determine what type of intervention, if any, is most successful at improving the outcomes of the mother and child. This will be measured by looking at the mother's stress response, anxiety, depression and irritability, the baby's stress response and the interactions between the mother and the baby. Participants in the study will be pregnant women who would be between 20 and 30 weeks pregnant at the start of the antenatal intervention. Participants will be chosen to take part in one of the three conditions (Mellow Bumps, Chillout In Pregnancy or Care As Usual) at random. All participants will be asked to complete questionnaires and give saliva samples prior to the intervention. The questionnaires will also be repeated at the end of the intervention and at a follow up occurring eight to twelve weeks after birth. Consent will also be sought to take saliva samples from the baby before and after a routine blood test when the baby is five days old. This information will then be evaluated to establish the effectiveness of the proposed interventions.

Read the detailed description

Lower than anticipated recruitment numbers have resulted in changes to the planned methodology of this trial. Firstly, participants were allocated to the three arms in groups/blocks of 6. Secondly, randomisation of the final group recruited was abandoned.

Conditions: Mental Health Wellness 1, Pregnancy, Mother-Child Relations
Being tested: Mellow Bumps, Chill-out in Pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mellow BumpsOther
Mellow Bumps is a six week group-based antenatal programme designed to support families with additional health and social care needs. It is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation, to capture the period when the risk of miscarriage is low and fetal movement felt, but before major preoccupation with the delivery.
Chill-out in PregnancyOther
Chill Out in Pregnancy (ChIP) is a relaxation programme that includes all the mother centred components of Mellow Bumps but none of the baby / mother-baby relationship components. It also runs for six weeks at two hours per week and is intended to decrease stress levels.

Study groups in NCT01590212
Study group	Role	What they receive
Care as usual	No intervention	Participants received care in line with local guidelines
Mellow Bumps + care as usual	Active comparator	MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation. Receives: Other: Mellow Bumps
Chill-out in Pregnancy + care as usual	Active comparator	CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels. Receives: Other: Chill-out in Pregnancy

What is being measured

The primary outcome is the main question the study is designed to answer.

Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Anxiety, depression and irritability measured on Adult Wellbeing Scale at 9-12 weeks after baseline.
The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),
Measured: Post intervention (approximately 9-12 weeks after baseline)
Depression Measured on EPDS
Depression as measured on the EPDS at 9-12 weeks after baseline
Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30.
Measured: Post-intervention (approximately 9 -12 weeks after baseline)
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Anxiety, depression and irritability measured on the Adult Wellbeing Scale post-birth (approximately 8-12 weeks postnatal)
The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),
Measured: Post-birth (8-12 weeks postnatal)
Depression Measured on EPDS
Depression scores as measured on the EPDS post-birth (approximately 8-12 weeks postnatal)
Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30.
Measured: Post-birth (8-12 weeks postnatal)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Jun 2013

First posted2 May 2012 (estimated)
Study startMay 2012
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mental Health Wellness 1Studies 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: Investigator
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01590212
Sponsor's protocol ID: 12/WS/0024
Status last verified: Mar 2014
First submitted: 30 Apr 2012
Last updated: 2 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antenatal Parenting Support for Women Vulnerable in Pregnancy: an Exploratory Randomised Controlled Trial of Mellow Bumps
ClinicalTrials.gov ID: NCT01590212
Acronym / sponsor ID: 12/WS/0024
Conditions: Mental Health Wellness 1, Pregnancy, Mother-Child Relations
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of GlasgowUniversity, hospital or other
Collaborators: Scottish Collaboration for Public Health Research and Policy
Study start: May 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 2 May 2012 (estimated)
Results: Posted 5 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Care as usual	No intervention	–Participants received care in line with local guidelines
Mellow Bumps + care as usual	Active comparator	Other: Mellow BumpsMB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
Chill-out in Pregnancy + care as usual	Active comparator	Other: Chill-out in PregnancyCHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.

Who may qualify

Ages: 16 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

pregnant, between 20 \& 30 weeks gestation at start of intervention
Identified by midwives as meeting Special Needs in Pregnancy (SNiP) criteria
basic understanding of written and spoken English

Key exclusion criteria (2 listed)

not identified as vulnerable through SNiP criteria
less than 20 weeks or more than 30 weeks gestation at start of intervention

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
Mellow BumpsMellow Bumps is a six week group-based antenatal programme designed to support families with additional health and social care needs. It is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation, to capture the period when the risk of miscarriage is low and fetal movement felt, but before major preoccupation with the delivery.	Other	Mellow Bumps + care as usual
Chill-out in PregnancyChill Out in Pregnancy (ChIP) is a relaxation programme that includes all the mother centred components of Mellow Bumps but none of the baby / mother-baby relationship components. It also runs for six weeks at two hours per week and is intended to decrease stress levels.	Other	Chill-out in Pregnancy + care as usual

Primary outcome

Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Time frame: Post intervention (approximately 9-12 weeks after baseline)
Anxiety, depression and irritability measured on Adult Wellbeing Scale at 9-12 weeks after baseline. The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),
Depression Measured on EPDS
Time frame: Post-intervention (approximately 9 -12 weeks after baseline)
Depression as measured on the EPDS at 9-12 weeks after baseline Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30.
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Time frame: Post-birth (8-12 weeks postnatal)
Anxiety, depression and irritability measured on the Adult Wellbeing Scale post-birth (approximately 8-12 weeks postnatal) The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),
Depression Measured on EPDS
Time frame: Post-birth (8-12 weeks postnatal)
Depression scores as measured on the EPDS post-birth (approximately 8-12 weeks postnatal) Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30.

Results and safety

Results posted to the registry on 5 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mellow Bumps + Care as Usual	12	9
Chill-out in Pregnancy + Care as Usual	9	5
Care as Usual	14	9

Primary outcome: Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale

Time frame: Post intervention (approximately 9-12 weeks after baseline). Mean (Full Range). Unit: Scores on a scale

Measure	Mellow Bumps + Care as Usual n = 7	Chill-out in Pregnancy + Care as Usual n = 6	Care as Usual n = 10
Depression	6.57 (3.309)	4.67 (2.658)	5.50 (2.915)
Anxiety	5.29 (2.563)	3.17 (2.714)	4.60 (4.061)
Outward directed irritability	3.86 (2.854)	2.00 (1.265)	2.80 (2.251)
Inward directed irritability	2.14 (1.574)	0.83 (0.753)	1.20 (1.814)

Primary outcome: Depression Measured on EPDS

Time frame: Post-intervention (approximately 9 -12 weeks after baseline). Mean (Full Range). Unit: scores on a scale

Measure	Mellow Bumps + Care as Usual n = 7	Chill-out in Pregnancy + Care as Usual n = 6	Care as Usual n = 10
Value	10.71 (4.957)	4.83 (3.251)	7.90 (6.887)

Primary outcome: Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale

Time frame: Post-birth (8-12 weeks postnatal). Mean (Full Range). Unit: scores on a scale

Measure	Mellow Bumps + Care as Usual n = 9	Chill-out in Pregnancy + Care as Usual n = 5	Care as Usual n = 9
Depression	3.44 (1.878)	3.44 (2.345)	5.14 (4.259)
Anxiety	3.56 (1.944)	2.80 (4.087)	4.00 (4.822)
Outward directed irritability	2.00 (1.936)	1.60 (1.140)	2.89 (2.028)
Inward directed irritability	0.89 (1.269)	0.80 (1.789)	0.67 (1.118)

Primary outcome: Depression Measured on EPDS

Time frame: Post-birth (8-12 weeks postnatal). Mean (Full Range). Unit: scores on a scale

Measure	Mellow Bumps + Care as Usual n = 9	Chill-out in Pregnancy + Care as Usual n = 5	Care as Usual n = 9
Value	5.22 (2.906)	2.80 (4.147)	5.56 (6.146)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mellow Bumps + Care as Usual	0 of 12 (0%)	0 of 12 (0%)	Not reported
Chill-out in Pregnancy + Care as Usual	0 of 9 (0%)	0 of 9 (0%)	Not reported
Care as Usual	0 of 14 (0%)	0 of 14 (0%)	Not reported

Limitations and caveats (from the sponsor): Participants lived in one health board area and one community health care partnership (CHCP) in the west of Scotland. Midwives may have approached only those potential participants who were thought to be likely to take part in the group programmes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Philip Wilson principal investigator

University of Glasgow

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mellow Bumps and Chill-out in Pregnancy in people with Mental Health Wellness 1 and Pregnancy, run by University of Glasgow at 2 sites in United Kingdom.

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 3 inclusion and 2 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 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 5 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale (time frame: Post intervention (approximately 9-12 weeks after baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01590212.

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 2 Apr 2014.