Skip to content

Comparing low intensity talking therapies for antenatal depression: a feasibility trial

Low-intensity interventions for antenatal depression: a feasibility study of a randomised controlled trial of interpersonal counselling compared to cognitive behavioural therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11513120
Enrollment
60
Registered
2019-05-02
Start date
2019-01-04
Completion date
Unknown
Last updated
2023-07-04

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

Conditions

Antenatal depression Mental and Behavioural Disorders

Interventions

12 low-intensity practitioners working in NHS psychological treatment services will be randomised to receive training in IPC or booster training in CBT. This will be evenly split across two centres, B

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women who are pregnant 2. Mild or moderate depression with or without co-morbid anxiety 3, Both primiparous and multiparous women 4. Between 10 and 20 weeks of pregnancy 5. Edinburgh Depression Scale (EPDS) score above 10 6. Mild or moderate depression according to Clinical Interview Schedule Revised (CIS-R) (Lewis et al 1992) 7. Whether or not they are taking an antidepressant

Exclusion criteria

Exclusion criteria: 1. Psychotic illness 2. Organic brain disorder 3. Bipolar disorder 4. Personality disorder 5. Alcohol or substance dependency 6. Those with high suicide risk judged to be in need of a more intensive intervention 7. If any women miscarry or have a termination during the trial will be offered to continue with the treatment but not included in the main analyses

Design outcomes

Primary

MeasureTime frame
1. Recruitment rate, measured using trial documentation after 9 months of recruitment (October 2019) 2. Number of women who receive complete IPC treatment as judged by the practitioner from practitioner records at the end of the trial 3. Number of women who complete outcome data, measured 4 months after recruitment for each participant 4. Acceptability of IPC and trial design assessed using in-depth interviews at 4-6 months after recruitment 5. Supervisor’s rating of practitioner’s adherence to the IPC model at the end of the trial

Secondary

MeasureTime frame
Measured at baseline and 12 weeks after recruitment for each participant using validated tools completed on paper or online: 1. Depression symptoms are measured using Edinburgh Depression Scale (EPDS) 2. Partner satisfaction and relationships are measured using Revised Dyadic Adjustment Scales (RDAS) 3. Maternal attachment to her unborn baby is measured using Maternal Antenatal Attachment Scale (MAAS) 4. Health-based wellbeing is measured using EQ-5D-5L 5. Wellbeing, particularly for mental health problems, is measured using ReQol-10

Countries

England, United Kingdom

Contacts

Public ContactJonathan;Debbie Evans;Johnson

;

j.evans@bristol.ac.uk;d.johnson@bristol.ac.uk+44 (0)117 3314030;+44 (0)117 428 3085

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026