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

March 3, 2016 updated by: City, University of London
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1V 0HB
        • City University London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 26-38 weeks pregnant
  • Sufficient proficiency in English to understand and complete the Wellbeing Plan

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Wellbeing Plan
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.
Active Comparator: Control
Control task. Information about physical health in pregnancy, matched for readability (Flesch score) and length/duration with the Wellbeing Plan
Other: Control task
Information about physical health in pregnancy, matched for readability (Flesch score) and length/duration with the Wellbeing Plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in mood from baseline at 1 month
Time Frame: Baseline to 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
Changes in mood from baseline at 6 weeks postpartum
Time Frame: Baseline to 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
Changes in general psychological health from baseline at 1 month
Time Frame: Baseline to 1 month
General psychological health will be measured using the CORE-10 (Barkham et al, 2013; Connell & Barkham, 2007).
Baseline to 1 month
Changes in general psychological health from baseline at 6 weeks postpartum
Time Frame: Baseline to 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
Changes in depressive symptoms from baseline at 1 month
Time Frame: Baseline to 1 month
The Whooley questions (NICE, 2014) will be used to measure clinically relevant depression.
Baseline to 1 month
Changes in depressive symptoms from baseline at 6 weeks postpartum
Time Frame: Baseline to 6 weeks postpartum
The Whooley questions (NICE, 2014) will be used to measure clinically relevant depression.
Baseline to 6 weeks postpartum
Changes in general anxiety symptoms from baseline at 1 month
Time Frame: Baseline to 1 month
The GAD-2 (Kroenke et al, 2007) will be used to measure clinically relevant anxiety.
Baseline to 1 month
Changes in general anxiety symptoms from baseline at 6 weeks postpartum
Time Frame: Baseline to 6 weeks postpartum
The GAD-2 (Kroenke et al, 2007) will be used to measure clinically relevant anxiety.
Baseline to 6 weeks postpartum
Changes in perceived support from baseline at 1 month
Time Frame: Baseline to 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
Changes in perceived support from baseline at 6 weeks postpartum
Time Frame: Baseline to 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
Changes in help-seeking behaviors from baseline at 1 month
Time Frame: Baseline to 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
Changes in help-seeking behaviors from baseline at 6 weeks postpartum
Time Frame: Baseline to 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
Changes in knowledge and beliefs about perinatal mental health from baseline to 6 weeks postpartum
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City, University of London

Collaborators

Tommy's
Boots Family Trust
Netmums
Institute of Health Visiting
Royal College of Midwives

Investigators

  • Principal Investigator: Susan Ayers, PhD, City, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CityULondon

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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