ISRCTN - ISRCTN44902048: Cognitive therapy for antenatal depression

Plain English Summary

Background and study aims
We conducted a study to compare cognitive behaviour therapy (CBT) plus usual care with usual care. The study aimed to help women with depression recover before the end of pregnancy and to look at the feasibility of conducting a full trial. Therefore, we tested procedures for recruiting, assessing and randomly allocating women to treatment, and to assess if it was possible to provide therapy before the end of pregnancy. We also tested how well the 3 depression screening questions used by midwives at booking appointments worked.

Who can participate?
Pregnant women in North Bristol aged 16 or over and between 8 and 18 weeks pregnant were able to take part.

What does the study involve?
Women who agreed to be contacted were asked to complete some questionnaires, including a detailed assessment of depression. Women were randomly allocated either to the CBT group plus usual care or usual care. Those who received CBT were visited at home by the therapist for up to 12 sessions. Follow up assessments were repeated once more during pregnancy and again postnatally.
Women who reported no low mood symptoms on the 3 depression screening questions were asked to take part in a validation study. Women who agreed were asked to complete some questionnaires.

What are the possible benefits and risks of participating?
The benefit of taking part in this study meant that the results could help midwives and GPs in the future to decide on the best treatment for women who experience low mood during their pregnancy.
Women may have found some of the questions asked during their assessment upsetting, but the researchers were able to offer support during the appointment, but they could also contact the midwives or GPs who normally provide care for them if necessary. There were no other disadvantages or risks associated with taking part in the study.

Where is the study run from?
The University of Bristol

When is the study starting and how long is it expected to run for?
ANTICIPATE started recruiting pregnant women in North Bristol in May 2010 until February 2011. Follow up of trial participants continued until June 2011.

Who is funding the study?
The National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) Programme.

Who is the main contact?
Dr Jonathan Evans
j.evans@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonathan Evans

ORCID ID

Contact details

Academic Unit of Psychiatry
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
j.evans@bris.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.0

Study information

Scientific title

A randomised controlled trial of cognitive therapy for antenatal depression

Acronym

ANTICIPATE

Study hypothesis

ANTICIPATE is a pilot randomised controlled trial focusing on depression during pregnancy and aims to compare cognitive behavioural therapy (CBT) plus usual care with usual care alone. The study seeks to pilot procedures for recruiting, assessing and randomising women to treatment, and assess the feasibility and acceptability of the intervention (up to 12 sessions of one-to-one CBT to take place in womens homes or GP surgeries) during pregnancy.

Ethics approval

Southmead Research Ethics Committee approval pending as of 16th December 2009.

Study design

Randomised controlled pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression during pregnancy

Intervention

Group 1 (Intervention arm plus usual care):
Involvement in the study will last 33 weeks. Patients will be invited to attend up to 12 once weekly one-to-one CBT sessions, 60 minutes per sessions. These are to take place at home or at GP surgery or other NHS premises - at patients' choice. During these sessions patients will work with their therapist to develop ways of managing their low mood.

Group 2 (usual care):
Involvement in the study will last 33 weeks. Patients will continue to be under the normal care of their midwife/GP for the management of their low mood. There will be no restrictions on the treatments that they can receive.

Patients will be contacted by telephone 15 and 33 weeks after entering the study to arrange follow up meetings to ask about their symptoms and to find out whether their low mood has improved or not. These meetings will normally last about 40 - 45 minutes.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

CIS-R diagnosis, conducted at baseline, 1st follow-up (15 weeks post-randomisation), and 2nd follow-up (33 weeks post-randomisation).

Secondary outcome measures

Other symptom measures (e.g. EPDS, PHQ-9, SF-12, EQ-5D), conducted at baseline, 1st follow-up (15 weeks post-randomisation), and 2nd follow-up (33 weeks post-randomisation).

Overall trial start date

01/03/2010

Overall trial end date

07/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women in North Bristol
2. Aged 16 or over
3. Between 8 and 18 weeks pregnant
4. Screen positive on the three question depression screen
5. Meet criteria for International Classification of Diseases, version 10 (ICD-10) depression (assessed using the Clinical Interview Schedule - Revised [CIS-R] version)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

210

Participant exclusion criteria

1. Currently receiving CBT or another individual psychological therapy
2. Known to have a psychotic illness
3. Receiving care from secondary mental health services
4. Do not have sufficient English to complete questionnaires, as translation might affect the validity of the scales, and they would not be able to benefit from a talking therapy without an interpreter
5. Taking part in any other intervention trial

Recruitment start date

01/03/2010

Recruitment end date

07/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Psychiatry
Bristol
BS6 6JL
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Research & Enterprise Development (RED)
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

http://www.bris.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-1207-15063)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data