Title {1} | REDUCE (reviewing long-term antidepressant use by careful monitoring in everyday practice): protocol for a randomised controlled trial |
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Trial registration {2a and 2b}. | Title: Trial of internet and telephone support to people coming off long-term antidepressants. Trial ID: ISRCTN12417565 Date registered: 7 October 2019. Link: www.isrctn.com/ISRCTN12417565 |
Protocol version {3} | Version 1.4 dated 28 November 2019 |
Funding {4} | National Institute for Health Research (NIHR) Programme Grant for Applied Research (PGfAR; ref. RP-PG-1214-20,004) |
Author details {5a} | Tony Kendrick, Professor of Primary Care, ark1@soton.ac.uk; Adam WA Geraghty, Senior Research Fellow, A.W.Geraghty@soton.ac.uk; Hannah Bowers, Research Fellow, H.M.Bowers@soton.ac.uk; Beth Stuart, Associate Professor, bls1@soton.ac.uk; Geraldine Leydon, Professor of Medical Sociology, G.M.Leydon@soton.ac.uk; Wendy O’Brien, Programme Manager, W.Obrien@soton.ac.uk; Samantha Williams, Senior Research Assistant, S.J.Williams@soton.ac.uk; Shihua Zhu, Senior Research Fellow in Health Economics, S.Zhu@soton.ac.uk; Rachel Dewar-Haggart, Senior Research Assistant, R.V.Dewar-Haggart@soton.ac.uk; Brian Palmer, patient and public involvement (PPI) representative, bryan@palmeradaptation.co.uk; Margaret Bell, PPI representative, embellmrs@btinternet.com; Sue Collinson, PPI representative, sue.collinson@homerton.nhs.uk; Michael Moore, Professor of Primary Health Care Research, M.V.Moore@soton.ac.uk; Paul Little, Professor of Primary Care Research, p.little@soton.ac.uk
Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton SO16 5ST, UK
Carl May, Professor of Medical Sociology, carl.may@lshtm.ac.uk
Department of Health Services Research and Policy, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15–17 Tavistock Place, London WC1H 9SH, UK
Guiqing Yao, Professor of Health Economics, gy38@leicester.ac.uk
Department of Health Sciences, University of Leicester, George Davies Centre, University Road, Leicester LE1 7RH, UK
Marta Glowacka, Lecturer in Occupational Therapy and Health Psychology, mglowacka@bournemouth.ac.uk;
Department for Rehabilitation and Sport Sciences, Faculty of Health and Social Sciences, Royal London House R601, Christchurch Road, Bournemouth BH1 3LT, UK
Simone Holley, Research fellow, S.L.Holley@soton.ac.uk; Imogen Fry, Undergraduate Honorary Assistant Psychologist, ijf1g17@soton.ac.uk
School of Psychology, Building 44 Highfield Campus, University of Southampton, Southampton SO17 1BJ, UK
Glyn Lewis, Professor of Epidemiological Psychiatry, glyn.lewis@ucl.ac.uk; Joanna Moncrieff, Professor of Critical and Social Psychiatry, j.moncrieff@ucl.ac.uk
Division of Psychiatry, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Rd, London W1T 7NF, UK
Gareth Griffiths, Professor of Clinical Trials, G.O.Griffiths@soton.ac.uk
Southampton Clinical Trials Unit, University of Southampton and University Hospitals Southampton NHS Foundation Trust, Southampton General Hospital, Tremona Road, Southampton SO16 6YD, UK
Simon Gilbody, Professor of Psychological Medicine and Health Services Research, Simon.Gilbody@york.ac.uk
Department of Health Sciences, Seebohm Rowntree Building, University of York, Heslington, York, YO10 5DD, UK
Una Macleod, Dean and Professor of Primary Care Medicine, Una.Macleod@hyms.ac.uk
Hull York Medical School, Allam Medical Building, University of Hull, Hull HU6 7RX, UK
Christopher Dowrick, Professor of Primary Medical Care, cfd@liverpool.ac.uk
Institute of Psychology Health and Society, University of Liverpool, Liverpool L69 3GL, UK
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Name and contact information for the trial sponsor {5b} | Dr Alison Knight, Head of Research Governance, Research Governance Office, University of Southampton, Room 4079, Building 37, Highfield Campus, Southampton SO17 1BJ, UK. Tel: 0238059 5058. Fax: 0238059 5781. Email: rgoinfo@soton.ac.uk |
Role of sponsor {5c} | The study sponsor (the University of Southampton) and funder (NIHR) were not involved in the study design, writing of the protocol paper, or the decision to submit for publication. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
- Call 1 (0–2 weeks), for 30 min: to check the patient’s understanding of the ADvisor intervention and encourage confidence in going through the tapering and cessation process
- Call 2 (4–6 weeks), for 15 min: to ask the patient how tapering is going and whether they are following the schedule and, where necessary, to advise the patient to discuss any issues with tapering with their GP
- Call 3 (timing agreed with patient), for 15 min: to ask the patient about any residual withdrawal symptoms and go over techniques to help with relapse prevention.
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Measure | Baseline (face to face) | 3 months (postal or online) | 6 months (face to face) | 9 months (postal or online) | 12 months (face to face) |
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Sociodemographics and past history of depression questionnaire | √ | ||||
Depression (PHQ-9) | √ | √ | √ | √ | √ |
Anxiety (GAD-7) | √ | √ | √ | √ | √ |
Suicidal ideas | √ | √ | √ | √ | √ |
Discontinuation of antidepressants (for at least 2 months, by 6 months) | √ | ||||
Quality of life (EQ-5D-5L, SF-12) | √ | √ | √ | √ | √ |
Wellbeing (WEMWBS) | √ | √ | √ | ||
Withdrawal symptoms (DESS) | √ | √ | √ | ||
Antidepressant side effects (ASEC, CSFQ-C) (if taken) | √ | √ | √ | ||
Satisfaction (MISS-29) | √ | √ | |||
Enablement (PEI) | √ | √ | |||
Questionnaires on use of services, use of antidepressants and sickness absence | √ | √ | √ | ||
Beliefs about antidepressants questionnaire | √ | √ | √ | ||
Collective efficacy questionnaire | √ |