Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy
Introduction One in eight women suffer from depression during pregnancy. Currently, low-intensity brief treatment based on cognitive behavioural therapy (CBT) is the only talking treatment widely available in the National Health Service (NHS) for mild and moderate depression. CBT involves identifyin...
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BMJ Publishing Group
2019-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/8/e032649.full |
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| author | Sarah Johnson Debbie Johnson Jeff Round Jonathan Evans Jenny Ingram Heather A O'Mahen Hazel Taylor Roslyn Law Jenny Ford Rebecca Hopley Joel Glynn Iryna Culpin |
| author_facet | Sarah Johnson Debbie Johnson Jeff Round Jonathan Evans Jenny Ingram Heather A O'Mahen Hazel Taylor Roslyn Law Jenny Ford Rebecca Hopley Joel Glynn Iryna Culpin |
| author_sort | Sarah Johnson |
| collection | DOAJ |
| description | Introduction One in eight women suffer from depression during pregnancy. Currently, low-intensity brief treatment based on cognitive behavioural therapy (CBT) is the only talking treatment widely available in the National Health Service (NHS) for mild and moderate depression. CBT involves identifying and changing unhelpful negative thoughts and behaviours to improve mood. Mothers in our patient advisory groups requested greater treatment choice. Interpersonal counselling (IPC) is a low-intensity version of interpersonal therapy. It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage). We aim to compare CBT and IPC for pregnant women with depression in a feasibility study.Methods and analysis A two-arm non-blinded randomised feasibility study of 60 women will be conducted in two UK localities. Women with depression will be identified through midwife clinics and ultrasound scanning appointments and randomised to receive six sessions of IPC or CBT. In every other way, these women will receive usual care. Women thought to have severe depression will be referred for more intensive treatment. After 12 weeks, we will measure women’s mood, well-being, relationship satisfaction and use of healthcare. Women, their partners and staff providing treatments will be interviewed to understand whether IPC is an acceptable approach and whether changes should be introduced before applying to run a larger trial.Several groups of patients with depression during pregnancy have contributed to our study design. A patient advisory group will meet and advise us during the study.Ethics and dissemination Study results will inform the design of a larger multicentre randomised controlled trial (RCT). Our findings will be shared through public engagement events, papers and reports to organisations within the NHS. National Research Ethics Service Committee approved the study protocol.Trial registration number ISRCTN11513120. |
| format | Article |
| id | doaj-art-4b64f7171b3f40a4a6f4f4bc09834552 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-4b64f7171b3f40a4a6f4f4bc098345522024-11-25T12:45:09ZengBMJ Publishing GroupBMJ Open2044-60552019-08-019810.1136/bmjopen-2019-032649Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapySarah Johnson0Debbie Johnson1Jeff Round2Jonathan Evans3Jenny Ingram4Heather A O'Mahen5Hazel Taylor6Roslyn Law7Jenny Ford8Rebecca Hopley9Joel Glynn10Iryna Culpin11Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomics Cancer, University of Birmingham, Birmingham, UK1 Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UKInstitute of Health Economics, Edmonton, Alberta, Canada1 Population Health Sciences, University of Bristol Medical School, Bristol, UK1 Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UKMood Disorders Centre, Department of Psychology, University of Exeter, Exeter, Devon, UK3University of Bristol, UK5 Anna Freud Centre, London, UK2 University Hospitals Bristol NHS Foundation Trust, Bristol, UK3 Department of Psychology, University of Exeter, Exeter, UKUniversity of Bristol Medical School, Bristol, UK4 Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UKIntroduction One in eight women suffer from depression during pregnancy. Currently, low-intensity brief treatment based on cognitive behavioural therapy (CBT) is the only talking treatment widely available in the National Health Service (NHS) for mild and moderate depression. CBT involves identifying and changing unhelpful negative thoughts and behaviours to improve mood. Mothers in our patient advisory groups requested greater treatment choice. Interpersonal counselling (IPC) is a low-intensity version of interpersonal therapy. It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage). We aim to compare CBT and IPC for pregnant women with depression in a feasibility study.Methods and analysis A two-arm non-blinded randomised feasibility study of 60 women will be conducted in two UK localities. Women with depression will be identified through midwife clinics and ultrasound scanning appointments and randomised to receive six sessions of IPC or CBT. In every other way, these women will receive usual care. Women thought to have severe depression will be referred for more intensive treatment. After 12 weeks, we will measure women’s mood, well-being, relationship satisfaction and use of healthcare. Women, their partners and staff providing treatments will be interviewed to understand whether IPC is an acceptable approach and whether changes should be introduced before applying to run a larger trial.Several groups of patients with depression during pregnancy have contributed to our study design. A patient advisory group will meet and advise us during the study.Ethics and dissemination Study results will inform the design of a larger multicentre randomised controlled trial (RCT). Our findings will be shared through public engagement events, papers and reports to organisations within the NHS. National Research Ethics Service Committee approved the study protocol.Trial registration number ISRCTN11513120.https://bmjopen.bmj.com/content/9/8/e032649.full |
| spellingShingle | Sarah Johnson Debbie Johnson Jeff Round Jonathan Evans Jenny Ingram Heather A O'Mahen Hazel Taylor Roslyn Law Jenny Ford Rebecca Hopley Joel Glynn Iryna Culpin Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy BMJ Open |
| title | Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy |
| title_full | Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy |
| title_fullStr | Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy |
| title_full_unstemmed | Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy |
| title_short | Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy |
| title_sort | protocol for a feasibility randomised trial of low intensity interventions for antenatal depression adagio trial comparing interpersonal counselling with cognitive behavioural therapy |
| url | https://bmjopen.bmj.com/content/9/8/e032649.full |
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