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The ACORN study: Coping and Relaxation in Pregnancy

Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95282830
Enrollment
66
Registered
2014-10-29
Start date
2014-11-11
Completion date
Unknown
Last updated
2021-08-24

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

Conditions

Topic: Mental Health, Reproductive health and childbirth

Interventions

1. Intervention: This study will adapt an existing guided self-help psychological intervention, Towards Parenthood (Milgrom et al, 2011), to be delivered in a group format, designed to

Sponsors

Central and Northwest London NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Over 18 years of age 2. First-time parents in second trimester of pregnancy 3. Women who score in the top quartile of population norms on screening measure for anxiety symptoms

Exclusion criteria

Exclusion criteria: 1. Insufficient understanding of English 2. Significant illness/disability in parent that would make it difficult for them to take part

Design outcomes

Primary

MeasureTime frame
Feasibility assessed by: 1. % of individuals consenting to the study 2. % completing the anxiety screening questionnaire and entering the randomisation phase 3. The number of sessions completed by those in the treatment arm 4. % completing the outcome measures at post-treatment follow-up

Secondary

MeasureTime frame
1. Generalised Anxiety Disorder Questionnaire (GAD-7). Timepoint(s): Pre-treatment, Post-treatment, Post-workbook (8 weeks after the end of treatment), 8 weeks postnatally 2. Edinburgh Postnatal Depression Scale (EPDS). Timepoint(s): Pre-treatment, Post-treatment, Post-workbook (8 weeks after the end of treatment), 8 weeks postnatally 3. Between group pre-post effect sizes and confidence intervals on the GAD-7 and EPDS. Timepoint(s): Post-treatment 4. Pregnancy-specific worries. Timepoint(s): Pre-treatment, Post-treatment, Post-workbook (8 weeks after the end of treatment), 8 weeks postnatally 5. Dyadic Adjustment Scale. Timepoint(s): Pre-treatment, Post-treatment, Post-workbook (8 weeks after the end of treatment), 8 weeks postnatally 6. EQ-5D-3L; Timepoint(s): Pre-treatment, Post-treatment, Post-workbook (8 weeks after the end of treatment), 8 weeks postnatally 7. Adult service use schedule (AD-SUS). Timepoint(s): Pre-treatment, Post-treatment, Post-workbook (8 weeks after the end of treatment), 8 weeks postnatally 8. Parental Bonding Questionnaire. Timepoint(s): 8 weeks postnatally 9. Infant Sleep Questionnaire. Timepoint(s): 8 weeks postnatally 10. Infant Behaviour Questionnaire. Timepoint(s): 8 weeks postnatally

Countries

United Kingdom

Contacts

Public ContactDot King
dorothy.king@imperial.ac.uk+44 (0)208 383 4161

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 13, 2026