REDUCE (Reviewing long-term antidepressant use by careful monitoring in everyday practice) internet and telephone support to people coming off long-term antidepressants: protocol for a randomised controlled trial
Tony Kendrick,
Adam W. A. Geraghty,
Hannah Bowers,
Beth Stuart,
Geraldine Leydon,
Carl May,
Guiqing Yao,
Wendy O’Brien,
Marta Glowacka,
Simone Holley,
Samantha Williams,
Shihua Zhu,
Rachel Dewar-Haggart,
Bryan Palmer,
Margaret Bell,
Sue Collinson,
Imogen Fry,
Glyn Lewis,
Gareth Griffiths,
Simon Gilbody,
Joanna Moncrieff,
Michael Moore,
Una Macleod,
Paul Little,
Christopher Dowrick
Affiliations
Tony Kendrick
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Adam W. A. Geraghty
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Hannah Bowers
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Beth Stuart
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Geraldine Leydon
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Carl May
Department of Health Services Research and Policy, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine
Guiqing Yao
Department of Health Sciences, University of Leicester, George Davies Centre
Wendy O’Brien
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Marta Glowacka
Department for Rehabilitation and Sport Sciences, Faculty of Health and Social Sciences, Bournemouth University
Simone Holley
School of Psychology, Building 44 Highfield Campus, University of Southampton
Samantha Williams
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Shihua Zhu
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Rachel Dewar-Haggart
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Bryan Palmer
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Margaret Bell
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Sue Collinson
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Imogen Fry
School of Psychology, Building 44 Highfield Campus, University of Southampton
Glyn Lewis
Division of Psychiatry, Faculty of Brain Sciences, University College London
Gareth Griffiths
Southampton Clinical Trials Unit, University of Southampton and University Hospitals Southampton NHS Foundation Trust, Southampton General Hospital
Simon Gilbody
Department of Health Sciences, Seebohm Rowntree Building, University of York
Joanna Moncrieff
Division of Psychiatry, Faculty of Brain Sciences, University College London
Michael Moore
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Una Macleod
Hull York Medical School, Allam Medical Building, University of Hull
Paul Little
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre
Christopher Dowrick
Institute of Psychology Health and Society, University of Liverpool
Abstract Background Around one in ten adults take antidepressants for depression in England, and their long-term use is increasing. Some need them to prevent relapse, but 30–50% could possibly stop them without relapsing and avoid adverse effects and complications of long-term use. However, stopping is not always easy due to withdrawal symptoms and a fear of relapse of depression. When general practitioners review patients on long-term antidepressants and recommend to those who are suitable to stop the medication, only 6–8% are able to stop. The Reviewing long-term antidepressant use by careful monitoring in everyday practice (REDUCE) research programme aims to identify safe and cost-effective ways of helping patients taking long-term antidepressants taper off treatment when appropriate. Methods Design: REDUCE is a two-arm, 1:1 parallel group randomised controlled trial, with randomisation clustered by participating family practices. Setting: England and north Wales. Population: patients taking antidepressants for longer than 1 year for a first episode of depression or longer than 2 years for repeated episodes of depression who are no longer depressed and want to try to taper off their antidepressant use. Intervention: provision of ‘ADvisor’ internet programmes to general practitioners or nurse practitioners and to patients designed to support antidepressant withdrawal, plus three patient telephone calls from a psychological wellbeing practitioner. The control arm receives usual care. Blinding of patients, practitioners and researchers is not possible in an open pragmatic trial, but statistical and health economic data analysts will remain blind to allocation. Outcome measures: the primary outcome is self-reported nine-item Patient Health Questionnaire at 6 months for depressive symptoms. Secondary outcomes: depressive symptoms at other follow-up time points, anxiety, discontinuation of antidepressants, social functioning, wellbeing, enablement, quality of life, satisfaction, and use of health services for costs. Sample size: 402 patients (201 intervention and 201 controls) from 134 general practices recruited over 15–18 months, and followed-up at 3, 6, 9 and 12 months. A qualitative process evaluation will be conducted through interviews with 15–20 patients and 15–20 practitioners in each arm to explore why the interventions were effective or not, depending on the results. Discussion Helping patients reduce and stop antidepressants is often challenging for practitioners and time-consuming for very busy primary care practices. If REDUCE provides evidence showing that access to internet and telephone support enables more patients to stop treatment without increasing depression we will try to implement the intervention throughout the National Health Service, publishing practical guidance for professionals and advice for patients to follow, publicised through patient support groups. Trial registration ISRCTN:12417565 . Registered on 7 October 2019.
