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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

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
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

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.

Antidepressants, Deprescribing, Depression, Digital intervention, Discontinuation, Primary care, Withdrawal
1745-6215
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Kendrick, Tony
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Geraghty, Adam W.A.
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Bowers, Hannah
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Stuart, Beth
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Leydon, Geraldine
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May, Carl
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Yao, Guiqing
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O'Brien, Wendy
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Glowacka, Marta
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Holley, Simone
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Williams, Samantha
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Zhu, Shihua
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Dewar-Haggart, Rachel
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Palmer, Bryan
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Bell, Margaret
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Collinson, Sue
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Fry, Imogen
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Lewis, Glyn
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Dowrick, Christopher
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Kendrick, Tony
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O'Brien, Wendy
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Glowacka, Marta
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Williams, Samantha
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Zhu, Shihua
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Bell, Margaret
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Fry, Imogen
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Lewis, Glyn
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Moore, Michael
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Kendrick, Tony, Geraghty, Adam W.A., Bowers, Hannah, Stuart, Beth, Leydon, Geraldine, May, Carl, Yao, Guiqing, O'Brien, Wendy, Glowacka, Marta, Holley, Simone, Williams, Samantha, Zhu, Shihua, Dewar-Haggart, Rachel, Palmer, Bryan, Bell, Margaret, Collinson, Sue, Fry, Imogen, Lewis, Glyn, Griffiths, Gareth, Gilbody, Simon, Moncrieff, Joanna, Moore, Michael, Macleod, Una, Little, Paul and Dowrick, Christopher (2020) 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. Trials, 21 (1), 1-15, [419]. (doi:10.1186/s13063-020-04338-7).

Record type: Review

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.

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More information

Accepted/In Press date: 23 April 2020
e-pub ahead of print date: 24 May 2020
Published date: 24 May 2020
Additional Information: Publisher Copyright: © 2020 The Author(s). Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
Keywords: Antidepressants, Deprescribing, Depression, Digital intervention, Discontinuation, Primary care, Withdrawal

Identifiers

Local EPrints ID: 442513
URI: http://eprints.soton.ac.uk/id/eprint/442513
ISSN: 1745-6215
PURE UUID: d451e3c9-ffd5-4631-a8c2-386e75300401
ORCID for Tony Kendrick: ORCID iD orcid.org/0000-0003-1618-9381
ORCID for Adam W.A. Geraghty: ORCID iD orcid.org/0000-0001-7984-8351
ORCID for Beth Stuart: ORCID iD orcid.org/0000-0001-5432-7437
ORCID for Geraldine Leydon: ORCID iD orcid.org/0000-0001-5986-3300
ORCID for Carl May: ORCID iD orcid.org/0000-0002-0451-2690
ORCID for Simone Holley: ORCID iD orcid.org/0000-0003-4631-2862
ORCID for Samantha Williams: ORCID iD orcid.org/0000-0001-9505-6485
ORCID for Rachel Dewar-Haggart: ORCID iD orcid.org/0000-0002-3757-1152
ORCID for Gareth Griffiths: ORCID iD orcid.org/0000-0002-9579-8021
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

Catalogue record

Date deposited: 17 Jul 2020 16:30
Last modified: 12 Jan 2022 02:44

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Contributors

Author: Tony Kendrick ORCID iD
Author: Hannah Bowers
Author: Beth Stuart ORCID iD
Author: Carl May ORCID iD
Author: Guiqing Yao
Author: Wendy O'Brien
Author: Marta Glowacka
Author: Simone Holley ORCID iD
Author: Shihua Zhu
Author: Rachel Dewar-Haggart ORCID iD
Author: Bryan Palmer
Author: Margaret Bell
Author: Sue Collinson
Author: Imogen Fry
Author: Glyn Lewis
Author: Simon Gilbody
Author: Joanna Moncrieff
Author: Michael Moore ORCID iD
Author: Una Macleod
Author: Paul Little
Author: Christopher Dowrick

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