Pregnant women with symptoms of mild to moderate anxiety Mental and Behavioural Disorders Anxiety disorder, unspecified
Conditions
Interventions
Clusters will be randomly allocated to intervention groups and control groups within each stratum. Randomisation will be performed by the statistical team at the Derby Clinical Trials Support Unit. Ra
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria: Pregnant women receiving treatment for a severe and enduring mental health condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment, retention and completion rates measured at recruitment using the: 1.1. The number of women accessing the site and completing eligibility screening 1.2. The number of eligible women 1.3. The number of women who consent to participate 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
| Measure | Time frame |
|---|---|
| Measured at baseline, 7 and 13-14 weeks: 1. Anxiety assessed using the Generalised Anxiety Disorder scale (GAD-7) 2. Anxiety and depression assessed using the Edinburgh Postnatal Depression Scale (EPDS) 3. Pregnancy-related anxiety assessed using the Pregnancy Related Anxiety Questionnaire - Revised (PRAQ-R) 4. Quality of life assessed using the Short-Form Health Survey (SF-12) 5. Social support assessed using the Multidimensional Scale for Perceived Social Support (MSPSS) 6. Service and support use assessed using the Client Service Receipt Inventory (CSRI) | — |
Countries
England, United Kingdom
Outcome results
None listed