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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
City, University of London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tommy's
Boots Family Trust
Netmums
Institute of Health Visiting
Royal College of Midwives

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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