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A group treatment for antenatal anxiety

ACORN-II: A multi-site randomised COntrolled trial to evaluate the impact of a group tReatment for aNtenatal anxiety

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN69012026
Enrollment
484
Registered
2024-02-12
Start date
2024-05-01
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antenatal anxiety Pregnancy and Childbirth

Interventions

Potential participants will be screened for anxiety at first-trimester scanning clinics. If individuals score 8 and above on the GAD-7, they will be eligible for the trial. Eligible participants who

Sponsors

Devon Partnership NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Pregnant women and birthing persons aged 18+ years who score above clinical threshold (8 or more) (on a standard anxiety screening measure (GAD-7)

Exclusion criteria

Exclusion criteria: 1. Actively suicidal 2. Substance abuse 3. Psychosis 4. Have childbirth-related PTSD (i.e., individuals eligible to receive PTSD treatment in maternal mental health services) 5. Receiving current psychological treatment for anxiety at baseline interview

Design outcomes

Primary

MeasureTime frame
Anxiety will be measured using the Generalised Anxiety Disorder -7 PROM at baseline, 22 & 32 weeks pregnant, and postnatally at 3, 6, and 12 months.

Secondary

MeasureTime frame
1. Antenatal anxiety measured using Pregnancy-Related Anxiety Questionnaire – Revised 2 (PRAQ-R2) at baseline, 22 weeks and 32 weeks 2. Depression using Patient Health Questionnaire-9 (PHQ-9) at baseline, 22 & 32 weeks pregnant, and postnatally at 3, 6, and 12 months. 3. Relationship adjustment measured using Revised Dyadic Adjustment Scale (DAS) at baseline, 22 and 32 weeks pregnant. 4. Health related quality of life measured using EuroQol-5 Dimensions-5 Level (EQ-5D-5L) at baseline, 22 & 32 weeks pregnant, and postnatally at 3, 6, and 12 months. 5. Service use measured using Adult Service Use Schedule (AD-SUS) at baseline, 32 weeks pregnant and 12 months postnatal. 6. Infant behaviour and temperament measured using Infant Behavior Questionnaire – Revised (IBQ-R) at 6 months postnatal. 7. Perceptions of childbirth measured using Maternal Perceptions of Support and Control in Birth (SCIB) at 3 months postnatal. 8. Parent and infant interaction measured using 10-minute videoed interaction and coded using the well-validated NICHD parent-infant sensitivity, intrusiveness scales at 12 months postnatal. 9. Social, emotional and behavioural problems in the infant measured using Brief Infant Toddler Social and Emotional Assessment (BITSEA) at 12 months postnatal. 10. Child development measured using Ages and Stages 3rd edition at 12 months postnatal.

Countries

England, United Kingdom

Contacts

Public ContactAntoinette Davey
antoinette.davey@exeter.ac.uk+44 (0)7828843266

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026