A study to support women with mild to moderate anxiety in pregnancy

Not Applicable

Completed

• Conditions: Pregnant women with symptoms of mild to moderate anxiety; Mental and Behavioural Disorders; Anxiety disorder, unspecified

• Registration Number: ISRCTN12834758
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36288833/ (added 27/10/2022)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-18
• Study Completion: 2023-07-31
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Women attending for or accessing maternity care in the study site NHS Trusts at approximately 16-20 weeks of pregnancy
2. Nulliparous pregnant women aged 18 years or older at the time of enrolment (no upper age limit)
3. Self-reported symptoms of mild to moderate anxiety
4. Able to read, write and speak the English language

Self-reported symptoms of anxiety:
A study website will present potential participants with an example of the GAD-7 scale and advise that women with scores between 3 - 14 are suited to participate in the study. Women will be advised to contact their GP or community midwife if they feel they require further assessment and support (current practice guidelines). Participants with a GAD-7 score of 15 or more will be thanked for their interest and advised that the type of intervention the study is aiming to assess may not be suited to them. A score of 15 or more may indicate severe anxiety (Spitzer et al. 2006) and these women will be advised to contact their GP or community midwife for further assessment and support.

Exclusion Criteria

Pregnant women receiving treatment for a severe and enduring mental health condition

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Recruitment, retention and completion rates measured at recruitment using the:<br>1.1. The number of women accessing the site and completing eligibility screening<br>1.2. The number of eligible women<br>1.3. The number of women who consent to participate<br>4. Women’s and facilitators’ views on participating in the intervention and the acceptability and experiences of random allocation to a usual care group, assessed using face-to-face semi-structured interviews conducted in the community, women’s homes or via video conferencing platforms (women’s preference and following local and national guidance re: COVID-19 following Sponsors Standard Operating Procedures) at post-intervention (follow-up)

Secondary Outcome Measures

Name	Time	Method
Measured at baseline, 7 and 13-14 weeks:<br>1. Anxiety assessed using the Generalised Anxiety Disorder scale (GAD-7) <br>2. Anxiety and depression assessed using the Edinburgh Postnatal Depression Scale (EPDS)<br>3. Pregnancy-related anxiety assessed using the Pregnancy Related Anxiety Questionnaire - Revised (PRAQ-R) <br>4. Quality of life assessed using the Short-Form Health Survey (SF-12)<br>5. Social support assessed using the Multidimensional Scale for Perceived Social Support (MSPSS)<br>6. Service and support use assessed using the Client Service Receipt Inventory (CSRI)