Wellbeing in Pregnancy: Evaluating an Intervention to Improve Women's Emotional Wellbeing in Pregnancy

Mental Health Clinical Trial

— WiP  

Official title:

Wellbeing in Pregnancy: Evaluating an Intervention to Improve Women's Emotional Wellbeing in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523157
• Other study ID #: CityULondon
• Status: Completed
• Phase: N/A
• First received: July 29, 2015
• Last updated: March 3, 2016
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: August 2015
• Source: City University, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 26-38 weeks pregnant

• Sufficient proficiency in English to understand and complete the Wellbeing Plan

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Mental Health
• Peripartum Period
• Pregnant Women

Intervention

Other:
• Wellbeing Plan
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 task
Information about physical health in pregnancy, matched for readability (Flesch score) and length/duration with the Wellbeing Plan

Locations

Country	Name	City	State
United Kingdom	City University London	London

Sponsors (6)

Lead Sponsor	Collaborator
City University, London	Boots Family Trust, Institute of Health Visiting, Netmums, Royal College of Midwives, Tommys

Country where clinical trial is conducted

United Kingdom, 

References & Publications (14)

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, Löwe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. — View Citation

Leadsom 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

O'Hara MW, & Swain AM. Rates and risk of postpartum depression - a meta-analysis. International review of psychiatry 8(1): 37-54, 1996.

Office for National Statistics. Statistical Bulletin: Births and deaths in England and Wales 2011. Newport: Office for National Statistics, 2012.

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. Review. — View Citation

Webster 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 1 month	No
Secondary	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.	Baseline to 1 month	No
Secondary	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.	Baseline to 6 weeks postpartum	No
Secondary	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).	Baseline to 1 month	No
Secondary	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).	Baseline to 6 weeks postpartum	No
Secondary	Changes in depressive symptoms from baseline at 1 month	The Whooley questions (NICE, 2014) will be used to measure clinically relevant depression.	Baseline to 1 month	No
Secondary	Changes in depressive symptoms from baseline at 6 weeks postpartum	The Whooley questions (NICE, 2014) will be used to measure clinically relevant depression.	Baseline to 6 weeks postpartum	No
Secondary	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.	Baseline to 1 month	No
Secondary	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.	Baseline to 6 weeks postpartum	No
Secondary	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.	Baseline to 1 month	No
Secondary	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.	Baseline to 6 weeks postpartum	No
Secondary	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.	Baseline to 1 month	No
Secondary	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.	Baseline to 6 weeks postpartum	No
Secondary	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.	Baseline to 6 weeks postpartum	No

External Links

•   Boots Family Trust. Perinatal Mental Health Experiences of Women and Health Professionals
•   Prevention in Mind. All Babies Count: Spotlight on Perinatal Mental Health.
•   The 1001 Critical Days: The Importance of the Conception to Age Two Period
•   Wellbeing Plan