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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peripartum Period, Mental Health, Pregnant Women

Intervention / Treatment
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* Other: Wellbeing Plan
* Other: Control task


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 26-38 weeks pregnant Sufficient proficiency in English to understand and complete the Wellbeing Plan Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |