NCT02523157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 4, 2016

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

July 29, 2015

Last Update Submit

March 3, 2016

Conditions

Peripartum PeriodMental HealthPregnant Women

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Changes in mood from baseline at 1 month

    Baseline to 1 month

  • Changes in mood from baseline at 6 weeks postpartum

    Baseline to 6 weeks postpartum

  • Changes in general psychological health from baseline at 1 month

    Baseline to 1 month

  • Changes in general psychological health from baseline at 6 weeks postpartum

    Baseline to 6 weeks postpartum

  • Changes in depressive symptoms from baseline at 1 month

    Baseline to 1 month

  • +8 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Wellbeing Plan

Other: Wellbeing Plan

Control

ACTIVE COMPARATOR

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

Other: Control task

Interventions

Wellbeing PlanOTHER

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.

Intervention
Control taskOTHER

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

Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City University London

London, London, EC1V 0HB, United Kingdom

Location

Related Publications (14)

  • Barkham M, Bewick B, Mullin T, Gilbody S, Connell J, Cahill J, ... & Evans C. The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Counselling and Psychotherapy Research, 13(1): 3-13, 2013. doi: 10.1080/14733145.2012.729069

    BACKGROUND

  • Boots Family Trust Alliance. Perinatal Mental Health Experiences of Women and Health Professionals, 2013. Retrieved from: http://www.tommys.org/file/Perinatal_Mental_Health_2013.pdf

    BACKGROUND

  • Boyatzis RE. Transforming qualitative information: thematic analysis and code development. London: Sage; 1998.

    BACKGROUND

  • Connell J, & Barkham M. CORE-10 User Manual, Version 1.1. CORE System Trust & CORE Information Management Systems Ltd, 1-40, 2007.

    BACKGROUND

  • Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.

    PMID: 17339617BACKGROUND

  • Leadsom A, Field F, Burstow P & Lucas C. The 1001 Critical Days: The Importance of the Conception to Age Two Period, 2014. Retrieved from: http://www.andrealeadsom.com/downloads/1001cdmanifesto.pdf

    BACKGROUND

  • Maternal Mental Health Alliance. The Costs of Perinatal Mental Health Problems. London: Centre for Mental Health, 2014.

    BACKGROUND

  • Matthews G, Jones DM, & Chamberlain AG. Refining the measurement of mood: The UWIST Mood Adjective Checklist. British Journal of Psychology 81: 17-42, 1990.

    BACKGROUND

  • NICE. Guideline CG192: Antenatal and Postnatal Mental Health: clinical management and service guidance, 2014. Retrieved from: http://www.nice.org.uk/guidance/cg192/chapter/1-recommendations#recognising-mental-health-problems-in-pregnancy-and-the-postnatal-period-and-referral-2

    BACKGROUND

  • NSPCC. Prevention in Mind. All Babies Count: Spotlight on Perinatal Mental Health, 2013. Retrieved from: http://www.nspcc.org.uk/globalassets/documents/research-reports/all-babies-count-spotlight-perinatal-mental-health.pdf

    BACKGROUND

  • Office for National Statistics. Statistical Bulletin: Births and deaths in England and Wales 2011. Newport: Office for National Statistics, 2012.

    BACKGROUND

  • O'Hara MW, & Swain AM. Rates and risk of postpartum depression - a meta-analysis. International review of psychiatry 8(1): 37-54, 1996.

    BACKGROUND

  • Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):289-95. doi: 10.1016/j.genhosppsych.2004.02.006.

    PMID: 15234824BACKGROUND

  • Webster J, Linnane JW, Dibley LM, Hinson JK, Starrenburg SE, Roberts JA. Measuring social support in pregnancy: can it be simple and meaningful? Birth. 2000 Jun;27(2):97-101. doi: 10.1046/j.1523-536x.2000.00097.x.

    PMID: 11251486BACKGROUND

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Susan Ayers, PhD

    City, University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

August 14, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

March 4, 2016

Record last verified: 2015-08

Locations

GB(1)