Reducing levels of anxiety in pregnancy and after birth: a study to see if a new online training can reduce anxiety in pregnant women and new mothers

Phase 2

• Conditions: Pregnant women (16-28 weeks gestation) with high levels of repetitive negative thinking and up to a moderate level of anxiety; Mental and Behavioural Disorders

• Registration Number: ISRCTN12754931
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-25
• Last Update Posted: 5 June 2023
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 268

Inclusion Criteria

1. Pregnant women between 16-28 weeks gestation
2. Aged 18 years or older
3. Based in the United Kingdom
4. High levels of RNT (RTQ-10 [trait] =32; McEvoy et al., 2014)
5. Anxiety up to only a moderate level (GAD-7 <15)
6. Ability to understand oral and written English
7. Normal or corrected-to-normal hearing and vision
8. Ability to access the internet on a PC, laptop, or tablet (rather than a mobile phone)
9. Provision of an email address and phone number for contact with the team

Exclusion Criteria

1. Current psychiatric diagnosis (this will be assessed via the clinical interview schedule revised (CIS-R; Lewis & Pelosi, 1992) which participants will complete as part of the screening questionnaire as well as via general questions about a current diagnosis of a psychotic disorder, eating disorder, substance use disorder or personality disorder)
2. Past diagnosis of a psychotic disorder (e.g., schizophrenia), bipolar disorder, an eating disorder, a substance use disorder (e.g., alcohol dependence) and/or a personality disorder (e.g., borderline personality disorder)
3. Current or recent history of risk: current suicidal intent (PHQ-9 item 9 >1), suicide attempt <2 years and/or self-harm <1 year
4. History of stillbirth, neonatal death, or multiple (i.e., =3) miscarriages
5. Current participation in another study that is investigating a treatment for a mental health problem
6. Not registered with a GP in the UK

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T2 anxiety measured by the Generalised Anxiety Disorder Questionnaire-7 (GAD-7) at 8 weeks post-randomisation; 24-36 weeks gestation