Peripartum PeriodWiPNCT02523157
Wellbeing in Pregnancy: Evaluating an Intervention to Improve Women's Emotional Wellbeing in Pregnancy
A study testing Wellbeing Plan in people with Peripartum Period and Mental Health, run by City, University of London at 1 site in United Kingdom.
Trial summary
The Wellbeing in Pregnancy (WiP) project is an online pilot randomized controlled trial which aims to evaluate an intervention to improve women's emotional wellbeing in pregnancy. 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
- Peripartum Period, Mental Health, Pregnant Women
- What is being tested?
- Wellbeing Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Feb 2016
- 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
- 26-38 weeks pregnant
- Sufficient proficiency in English to understand and complete the Wellbeing Plan
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The Wellbeing in Pregnancy (WiP) project is an online pilot randomized controlled trial which aims to evaluate an intervention to improve women's emotional wellbeing in pregnancy.
Read the detailed description
It is estimated that mental health problems affect 10-20% of postnatal women. Many of these women do not seek help for their mental health for numerous reasons, including lack of awareness about symptoms, available treatments, and stigma. The Wellbeing Plan is a brief self-help leaflet developed by experts in perinatal mental health, and is designed to improve emotional wellbeing of women during and after pregnancy by providing information, raising awareness, helping a woman identify her own symptoms, provide coping strategies, and identify key people who can support the woman during this time. The Wellbeing in Pregnancy project is a online pilot randomized controlled trial which aims to evaluate the efficacy of the Wellbeing Plan in improving women's emotional wellbeing in pregnancy.
- Conditions
- Peripartum Period, Mental Health, Pregnant Women
- Being tested
- Wellbeing Plan, Control task
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellbeing PlanOther
The Wellbeing Plan is a short self-help leaflet designed to improve emotional wellbeing of women during and after pregnancy by providing information, raising awareness, helping a woman identify her own symptoms, provide coping strategies, and identify key people who can support the woman during this time.
Control taskOther
Information about physical health in pregnancy, matched for readability (Flesch score) and length/duration with the Wellbeing Plan
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Wellbeing Plan Receives: Other: Wellbeing Plan |
| Control | Active comparator | Control task. Information about physical health in pregnancy, matched for readability (Flesch score) and length/duration with the Wellbeing Plan Receives: Other: Control task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in knowledge and beliefs about perinatal mental health from baseline at 1 month
Knowledge and beliefs about perinatal mental health will be measured using a 12-item self-report questionnaire scored on a 5-point Likert scale from 1 = Strongly agree to 5 = Strongly disagree. It has been developed in consultation with the research team and with a parental advisory group. It will explore women's knowledge and beliefs about perinatal mental health problems, including perceived stigma, incidence of psychological distress in the perinatal period, as well as knowledge and beliefs regarding sources of potential support for women.
Measured: Baseline to 1 month
Secondary outcomes (13)
Changes in mood from baseline at 1 month
Small changes in mood will be examined using the UWIST Mood Adjective Checklist (UMACL; Mathews, Jones \& Chamberlain, 1990). The UMACL includes 24 mood adjectives. Participants indicate whether each adjective relates to their current mood on a 4-point scale with higher scores indicating stronger mood. It has 3 subscales of tense arousal (8 items), energetic arousal (8 items) and hedonic tone (8 items), which have been confirmed by factor analysis. For this study, the items relating to energetic arousal will be omitted, as energy levels will be affected by the late pregnancy stage/early postpartum period.
Measured: Baseline to 1 month
Changes in mood from baseline at 6 weeks postpartum
Small changes in mood will be examined using the UWIST Mood Adjective Checklist (UMACL; Mathews, Jones \& Chamberlain, 1990). The UMACL includes 24 mood adjectives. Participants indicate whether each adjective relates to their current mood on a 4-point scale with higher scores indicating stronger mood. It has 3 subscales of tense arousal (8 items), energetic arousal (8 items) and hedonic tone (8 items), which have been confirmed by factor analysis. For this study, the items relating to energetic arousal will be omitted, as energy levels will be affected by the late pregnancy stage/early postpartum period.
Measured: Baseline to 6 weeks postpartum
Changes in general psychological health from baseline at 1 month
General psychological health will be measured using the CORE-10 (Barkham et al, 2013; Connell \& Barkham, 2007).
Measured: Baseline to 1 month
Changes in general psychological health from baseline at 6 weeks postpartum
General psychological health will be measured using the CORE-10 (Barkham et al, 2013; Connell \& Barkham, 2007).
Measured: Baseline to 6 weeks postpartum
Changes in depressive symptoms from baseline at 1 month
The Whooley questions (NICE, 2014) will be used to measure clinically relevant depression.
Measured: Baseline to 1 month
Changes in depressive symptoms from baseline at 6 weeks postpartum
The Whooley questions (NICE, 2014) will be used to measure clinically relevant depression.
Measured: Baseline to 6 weeks postpartum
Changes in general anxiety symptoms from baseline at 1 month
The GAD-2 (Kroenke et al, 2007) will be used to measure clinically relevant anxiety.
Measured: Baseline to 1 month
Changes in general anxiety symptoms from baseline at 6 weeks postpartum
The GAD-2 (Kroenke et al, 2007) will be used to measure clinically relevant anxiety.
Measured: Baseline to 6 weeks postpartum
Changes in perceived support from baseline at 1 month
Perceived support will be measured using the Maternity Social Support Scale (MSSS) (Webster et al, 2000). The MSSS is a 6-item self-report questionnaire rated on a 5-point Likert scale which measures perceived social support in the prenatal period. It examines the woman's relationship with her partner, exploring the nature of the relationship, in addition to perceived support from family and friends.
Measured: Baseline to 1 month
Changes in perceived support from baseline at 6 weeks postpartum
Perceived support will be measured using the Maternity Social Support Scale (MSSS) (Webster et al, 2000). The MSSS is a 6-item self-report questionnaire rated on a 5-point Likert scale which measures perceived social support in the prenatal period. It examines the woman's relationship with her partner, exploring the nature of the relationship, in addition to perceived support from family and friends.
Measured: Baseline to 6 weeks postpartum
Changes in help-seeking behaviors from baseline at 1 month
Help-seeking behaviours will be assessed by asking women if they have spoken to anyone about their feelings, if they have been worried about their mental wellbeing.
Measured: Baseline to 1 month
Changes in help-seeking behaviors from baseline at 6 weeks postpartum
Help-seeking behaviours will be assessed by asking women if they have spoken to anyone about their feelings, if they have been worried about their mental wellbeing.
Measured: Baseline to 6 weeks postpartum
Changes in knowledge and beliefs about perinatal mental health from baseline to 6 weeks postpartum
Knowledge and beliefs about perinatal mental health will be measured using a 12-item self-report questionnaire scored on a 5-point Likert scale from 1 = Strongly agree to 5 = Strongly disagree. It has been developed in consultation with the research team and with a parental advisory group. It will explore women's knowledge and beliefs about perinatal mental health problems, including perceived stigma, incidence of psychological distress in the perinatal period, as well as knowledge and beliefs regarding sources of potential support for women.
Measured: Baseline to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Peripartum PeriodStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Boots Family Trust, Tommy's, Netmums, Institute of Health Visiting, Royal College of Midwives
- Responsible party
- Sponsor
- Investigators
- Susan Ayers, PhD, Principal investigator, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523157
- Sponsor's protocol ID
- CityULondon
- Acronym
- WiP
- Status last verified
- Aug 2015
- First submitted
- 29 Jul 2015
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Barkham M, Bewick B, Mullin T, Gilbody S, Connell J, Cahill J, ... & Evans C. The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Counselling and Psychotherapy Research, 13(1): 3-13, 2013. doi: 10.1080/14733145.2012.729069
Boots Family Trust Alliance. Perinatal Mental Health Experiences of Women and Health Professionals, 2013. Retrieved from: http://www.tommys.org/file/Perinatal_Mental_Health_2013.pdf
Boyatzis RE. Transforming qualitative information: thematic analysis and code development. London: Sage; 1998.
Connell J, & Barkham M. CORE-10 User Manual, Version 1.1. CORE System Trust & CORE Information Management Systems Ltd, 1-40, 2007.
Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
PubMed 17339617Leadsom A, Field F, Burstow P & Lucas C. The 1001 Critical Days: The Importance of the Conception to Age Two Period, 2014. Retrieved from: http://www.andrealeadsom.com/downloads/1001cdmanifesto.pdf
Maternal Mental Health Alliance. The Costs of Perinatal Mental Health Problems. London: Centre for Mental Health, 2014.
Matthews G, Jones DM, & Chamberlain AG. Refining the measurement of mood: The UWIST Mood Adjective Checklist. British Journal of Psychology 81: 17-42, 1990.
NICE. Guideline CG192: Antenatal and Postnatal Mental Health: clinical management and service guidance, 2014. Retrieved from: http://www.nice.org.uk/guidance/cg192/chapter/1-recommendations#recognising-mental-health-problems-in-pregnancy-and-the-postnatal-period-and-referral-2
NSPCC. Prevention in Mind. All Babies Count: Spotlight on Perinatal Mental Health, 2013. Retrieved from: http://www.nspcc.org.uk/globalassets/documents/research-reports/all-babies-count-spotlight-perinatal-mental-health.pdf
Office for National Statistics. Statistical Bulletin: Births and deaths in England and Wales 2011. Newport: Office for National Statistics, 2012.
O'Hara MW, & Swain AM. Rates and risk of postpartum depression - a meta-analysis. International review of psychiatry 8(1): 37-54, 1996.
Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):289-95. doi: 10.1016/j.genhosppsych.2004.02.006.
PubMed 15234824Webster J, Linnane JW, Dibley LM, Hinson JK, Starrenburg SE, Roberts JA. Measuring social support in pregnancy: can it be simple and meaningful? Birth. 2000 Jun;27(2):97-101. doi: 10.1046/j.1523-536x.2000.00097.x.
PubMed 11251486
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellbeing in Pregnancy: Evaluating an Intervention to Improve Women's Emotional Wellbeing in Pregnancy
- ClinicalTrials.gov ID
- NCT02523157
- Acronym / sponsor ID
- WiP / CityULondon
- Conditions
- Peripartum Period, Mental Health, Pregnant Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Collaborators
- Boots Family Trust, Tommy's, Netmums, Institute of Health Visiting, Royal College of Midwives
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Aug 2015 (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.
The Wellbeing in Pregnancy (WiP) project is an online pilot randomized controlled trial which aims to evaluate an intervention to improve women's emotional wellbeing in pregnancy.
Detailed description
It is estimated that mental health problems affect 10-20% of postnatal women. Many of these women do not seek help for their mental health for numerous reasons, including lack of awareness about symptoms, available treatments, and stigma. The Wellbeing Plan is a brief self-help leaflet developed by experts in perinatal mental health, and is designed to improve emotional wellbeing of women during and after pregnancy by providing information, raising awareness, helping a woman identify her own symptoms, provide coping strategies, and identify key people who can support the woman during this time. The Wellbeing in Pregnancy project is a online pilot randomized controlled trial which aims to evaluate the efficacy of the Wellbeing Plan in improving women's emotional wellbeing in pregnancy.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Wellbeing PlanWellbeing Plan |
| Control | Active comparator | Other: Control taskControl task. Information about physical health in pregnancy, matched for readability (Flesch score) and length/duration with the Wellbeing Plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 26-38 weeks pregnant
- Sufficient proficiency in English to understand and complete the Wellbeing Plan
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Wellbeing PlanThe Wellbeing Plan is a short self-help leaflet designed to improve emotional wellbeing of women during and after pregnancy by providing information, raising awareness, helping a woman identify her own symptoms, provide coping strategies, and identify key people who can support the woman during this time. | Other | Intervention |
| Control taskInformation about physical health in pregnancy, matched for readability (Flesch score) and length/duration with the Wellbeing Plan | Other | Control |
Primary outcome
Changes in knowledge and beliefs about perinatal mental health from baseline at 1 month
Time frame: Baseline to 1 month
Knowledge and beliefs about perinatal mental health will be measured using a 12-item self-report questionnaire scored on a 5-point Likert scale from 1 = Strongly agree to 5 = Strongly disagree. It has been developed in consultation with the research team and with a parental advisory group. It will explore women's knowledge and beliefs about perinatal mental health problems, including perceived stigma, incidence of psychological distress in the perinatal period, as well as knowledge and beliefs regarding sources of potential support for women.
13 secondary outcomes
Changes in mood from baseline at 1 month
Time frame: Baseline to 1 month
Changes in mood from baseline at 6 weeks postpartum
Time frame: Baseline to 6 weeks postpartum
Changes in general psychological health from baseline at 1 month
Time frame: Baseline to 1 month
Changes in general psychological health from baseline at 6 weeks postpartum
Time frame: Baseline to 6 weeks postpartum
Changes in depressive symptoms from baseline at 1 month
Time frame: Baseline to 1 month
Changes in depressive symptoms from baseline at 6 weeks postpartum
Time frame: Baseline to 6 weeks postpartum
Changes in general anxiety symptoms from baseline at 1 month
Time frame: Baseline to 1 month
Changes in general anxiety symptoms from baseline at 6 weeks postpartum
Time frame: Baseline to 6 weeks postpartum
Changes in perceived support from baseline at 1 month
Time frame: Baseline to 1 month
Changes in perceived support from baseline at 6 weeks postpartum
Time frame: Baseline to 6 weeks postpartum
Changes in help-seeking behaviors from baseline at 1 month
Time frame: Baseline to 1 month
Changes in help-seeking behaviors from baseline at 6 weeks postpartum
Time frame: Baseline to 6 weeks postpartum
Changes in knowledge and beliefs about perinatal mental health from baseline to 6 weeks postpartum
Time frame: Baseline to 6 weeks postpartum
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 4 Mar 2016.
- BackgroundBarkham M, Bewick B, Mullin T, Gilbody S, Connell J, Cahill J, ... & Evans C. The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Counselling and Psychotherapy Research, 13(1): 3-13, 2013. doi: 10.1080/14733145.2012.729069
- BackgroundBoots Family Trust Alliance. Perinatal Mental Health Experiences of Women and Health Professionals, 2013. Retrieved from: http://www.tommys.org/file/Perinatal_Mental_Health_2013.pdf
- BackgroundBoyatzis RE. Transforming qualitative information: thematic analysis and code development. London: Sage; 1998.
- BackgroundConnell J, & Barkham M. CORE-10 User Manual, Version 1.1. CORE System Trust & CORE Information Management Systems Ltd, 1-40, 2007.
- Background: PubMed 17339617Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
- BackgroundLeadsom A, Field F, Burstow P & Lucas C. The 1001 Critical Days: The Importance of the Conception to Age Two Period, 2014. Retrieved from: http://www.andrealeadsom.com/downloads/1001cdmanifesto.pdf
- BackgroundMaternal Mental Health Alliance. The Costs of Perinatal Mental Health Problems. London: Centre for Mental Health, 2014.
- BackgroundMatthews G, Jones DM, & Chamberlain AG. Refining the measurement of mood: The UWIST Mood Adjective Checklist. British Journal of Psychology 81: 17-42, 1990.
- BackgroundNICE. Guideline CG192: Antenatal and Postnatal Mental Health: clinical management and service guidance, 2014. Retrieved from: http://www.nice.org.uk/guidance/cg192/chapter/1-recommendations#recognising-mental-health-problems-in-pregnancy-and-the-postnatal-period-and-referral-2
- BackgroundNSPCC. Prevention in Mind. All Babies Count: Spotlight on Perinatal Mental Health, 2013. Retrieved from: http://www.nspcc.org.uk/globalassets/documents/research-reports/all-babies-count-spotlight-perinatal-mental-health.pdf
- BackgroundOffice for National Statistics. Statistical Bulletin: Births and deaths in England and Wales 2011. Newport: Office for National Statistics, 2012.
- BackgroundO'Hara MW, & Swain AM. Rates and risk of postpartum depression - a meta-analysis. International review of psychiatry 8(1): 37-54, 1996.
- The 1001 Critical Days: The Importance of the Conception to Age Two PeriodLink provided by the sponsor.
- Guideline CG192: Antenatal and Postnatal Mental Health: clinical management and service guidance.Link provided by the sponsor.
- Wellbeing PlanLink provided by the sponsor.
Related trials for Peripartum Period
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Active, not recruitingObservational study
A Study of Disease Modifying Therapy Use in Women With Multiple Sclerosis Before, During, and After Pregnancy
Multiple Sclerosis
RecruitingPhase 3
Brexanolone Lifting Outcomes Of Moms
Depression, Postpartum, Postpartum Depression (PPD)
Not yet recruiting
Effect of Peripartum 40 Hz Audiovisual Stimulation on Postpartum Depression in Women Undergoing Elective Cesarean Section: A Randomized Clinical Trial
Depression, Postpartum
RecruitingObservational study
Ultrasound Detection of Body Composition in Critical Care
Muscle Loss, Extracellular Fluid Alteration
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.
Susan Ayers, PhD principal investigator
City, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellbeing Plan in people with Peripartum Period and Mental Health, run by City, University of London at 1 site 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 2 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 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Changes in knowledge and beliefs about perinatal mental health from baseline at 1 month (time frame: Baseline to 1 month). 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 NCT02523157, which also lists 14 linked publications.
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 4 Mar 2016.