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ISRCTN
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ISRCTN44902048
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ClinicalTrials.gov identifier
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Public title
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Cognitive therapy for antenatal depression
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Scientific title
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A randomised controlled trial of cognitive therapy for antenatal depression
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Acronym
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ANTICIPATE
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Serial number at source
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Version 1.0
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Study hypothesis
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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 women’s homes or GP surgeries) during pregnancy.
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Lay summary
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Ethics approval
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Southmead Research Ethics Committee approval pending as of 16th December 2009.
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Study design
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Randomised controlled pilot trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Depression during pregnancy
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2010
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Anticipated end date
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07/09/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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210
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Interventions
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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.
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Primary outcome measure(s)
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CIS-R diagnosis, conducted at baseline, 1st follow-up (15 weeks post-randomisation), and 2nd follow-up (33 weeks post-randomisation).
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Secondary outcome measure(s)
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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).
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-1207-15063)
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Trial website
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Publications
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Contact name
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Dr
Jonathan
Evans
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Address
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Academic Unit of Psychiatry
Cotham House, Cotham Hill
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City/town
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Bristol
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Zip/Postcode
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BS6 6JL
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Country
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United Kingdom
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Email
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j.evans@bris.ac.uk
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Sponsor
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University of Bristol (UK)
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Address
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Research & Enterprise Development (RED)
Senate House, Tyndall Avenue
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City/town
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Bristol
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Zip/Postcode
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BS8 1TH
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Country
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United Kingdom
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Sponsor website:
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http://www.bris.ac.uk/
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Date applied
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14/12/2009
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Last edited
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17/02/2010
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Date ISRCTN assigned
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17/02/2010
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