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.
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
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
600
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.
Information about physical health in pregnancy, matched for readability (Flesch score) and length/duration with the Wellbeing Plan
City University London
London, London, United Kingdom
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.
Time frame: Baseline to 1 month
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.
Time frame: 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.
Time frame: Baseline to 6 weeks postpartum
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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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 weeks postpartum