Mental Health, Peripartum Period, Pregnant Women
Conditions
Brief summary
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
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.
Interventions
OTHERWellbeing 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.
OTHERControl task
Information about physical health in pregnancy, matched for readability (Flesch score) and length/duration with the Wellbeing Plan
Sponsors
City, University of London
Boots Family Trust
Tommy's
Netmums
Institute of Health Visiting
Royal College of Midwives
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 26-38 weeks pregnant * Sufficient proficiency in English to understand and complete the Wellbeing Plan
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in knowledge and beliefs about perinatal mental health from baseline at 1 month | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in mood from baseline at 6 weeks postpartum | 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. |
| Changes in general psychological health from baseline at 1 month | Baseline to 1 month | General psychological health will be measured using the CORE-10 (Barkham et al, 2013; Connell & Barkham, 2007). |
| Changes in general psychological health from baseline at 6 weeks postpartum | Baseline to 6 weeks postpartum | General psychological health will be measured using the CORE-10 (Barkham et al, 2013; Connell & Barkham, 2007). |
| Changes in depressive symptoms from baseline at 1 month | Baseline to 1 month | The Whooley questions (NICE, 2014) will be used to measure clinically relevant depression. |
| Changes in depressive symptoms from baseline at 6 weeks postpartum | Baseline to 6 weeks postpartum | The Whooley questions (NICE, 2014) will be used to measure clinically relevant depression. |
| Changes in general anxiety symptoms from baseline at 1 month | Baseline to 1 month | The GAD-2 (Kroenke et al, 2007) will be used to measure clinically relevant anxiety. |
| Changes in mood from baseline at 1 month | 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. |
| Changes in perceived support from baseline at 1 month | 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. |
| Changes in perceived support from baseline at 6 weeks postpartum | 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. |
| Changes in help-seeking behaviors from baseline at 1 month | 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. |
| Changes in help-seeking behaviors from baseline at 6 weeks postpartum | 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. |
| Changes in knowledge and beliefs about perinatal mental health from baseline to 6 weeks postpartum | 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. |
| Changes in general anxiety symptoms from baseline at 6 weeks postpartum | Baseline to 6 weeks postpartum | The GAD-2 (Kroenke et al, 2007) will be used to measure clinically relevant anxiety. |
Countries
United Kingdom
Outcome results
None listed