Clinical trial NCT02523157: Wellbeing in Pregnancy: Evaluating an Intervention to Improve Women's Emotional Wellbeing in Pregnancy
Official title: Wellbeing in Pregnancy: Evaluating an Intervention to Improve Women's Emotional Wellbeing in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripartum Period
Mental Health
Pregnant Women
Lead sponsor: City, University of London
Sponsor class: OTHER
Collaborators: name: Boots Family Trust
name: Tommy's
name: Netmums
name: Institute of Health Visiting
name: Royal College of Midwives
First posted: 2015-08-14
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in knowledge and beliefs about perinatal mental health from baseline at 1 month
timeFrame: Baseline to 1 month
Secondary outcomes:
measure: Changes in mood from baseline at 1 month
timeFrame: Baseline to 1 month
measure: Changes in mood from baseline at 6 weeks postpartum
timeFrame: Baseline to 6 weeks postpartum
measure: Changes in general psychological health from baseline at 1 month
timeFrame: Baseline to 1 month
measure: Changes in general psychological health from baseline at 6 weeks postpartum
timeFrame: Baseline to 6 weeks postpartum
measure: Changes in depressive symptoms from baseline at 1 month
timeFrame: Baseline to 1 month
measure: Changes in depressive symptoms from baseline at 6 weeks postpartum
timeFrame: Baseline to 6 weeks postpartum
measure: Changes in general anxiety symptoms from baseline at 1 month
timeFrame: Baseline to 1 month
measure: Changes in general anxiety symptoms from baseline at 6 weeks postpartum
timeFrame: Baseline to 6 weeks postpartum
measure: Changes in perceived support from baseline at 1 month
timeFrame: Baseline to 1 month
measure: Changes in perceived support from baseline at 6 weeks postpartum
timeFrame: Baseline to 6 weeks postpartum
measure: Changes in help-seeking behaviors from baseline at 1 month
timeFrame: Baseline to 1 month
measure: Changes in help-seeking behaviors from baseline at 6 weeks postpartum
timeFrame: Baseline to 6 weeks postpartum
measure: Changes in knowledge and beliefs about perinatal mental health from baseline to 6 weeks postpartum
timeFrame: Baseline to 6 weeks postpartum
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: City University London
Study officials:
affiliation: City, University of London
name: Susan Ayers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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