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Completed

NCT Number: NCT02523157

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

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.

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Key information

Conditions

Peripartum Period Behavior Mental Health Personal Satisfaction Pregnant Women Psychological Well-Being

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City University London

London, EC1V 0HB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Wellbeing Plan

Other

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

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

City, University of London

Other

Collaborators

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

Registry information

Acronym: WiP

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Aug 14, 2015
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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