RELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practice
Abstract Background Many people experience withdrawal symptoms when they attempt to stop antidepressants. Withdrawal symptoms are readily misconstrued for relapse or ongoing need for medication, contributing to long-term use (> 12 months). Long-term antidepressant use is increasing internationall...
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| Format: | Article |
| Language: | English |
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BMC
2023-09-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07646-w |
| _version_ | 1827708525734789120 |
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| author | Katharine A. Wallis Maria Donald Mark Horowitz Joanna Moncrieff Robert S. Ware Joshua Byrnes Karen Thrift MaryAnne Cleetus Idin Panahi Nicholas Zwar Mark Morgan Chris Freeman Ian Scott |
| author_facet | Katharine A. Wallis Maria Donald Mark Horowitz Joanna Moncrieff Robert S. Ware Joshua Byrnes Karen Thrift MaryAnne Cleetus Idin Panahi Nicholas Zwar Mark Morgan Chris Freeman Ian Scott |
| author_sort | Katharine A. Wallis |
| collection | DOAJ |
| description | Abstract Background Many people experience withdrawal symptoms when they attempt to stop antidepressants. Withdrawal symptoms are readily misconstrued for relapse or ongoing need for medication, contributing to long-term use (> 12 months). Long-term antidepressant use is increasing internationally yet is not recommended for most people. Long-term use is associated with adverse effects including weight gain, sexual dysfunction, lethargy, emotional numbing and increased risk of falls and fractures. This study aims to determine the effectiveness of two multi-strategy interventions (RELEASE and RELEASE+) in supporting the safe cessation of long-term antidepressants, estimate cost-effectiveness, and evaluate implementation strategies. Methods Design 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1. Setting: primary care general practices in southeast Queensland, Australia. Population: adults 18 years or older taking antidepressants for longer than 1 year. Practices will be randomised on a 1.5:1:1 ratio of Usual care:RELEASE:RELEASE+. Intervention: RELEASE for patients includes evidence-based information and resources and an invitation to medication review; RELEASE for GPs includes education, training and printable resources via practice management software. RELEASE+ includes additional internet support for patients and prescribing support including audit and feedback for GPs. Outcome measures: the primary outcome is antidepressant use at 12 months self-reported by patients. Cessation is defined as 0 mg antidepressant maintained for at least 2 weeks. Secondary outcomes: at 6 and 12 months are health-related quality of life, antidepressant side effects, well-being, withdrawal symptoms, emotional numbing, beliefs about antidepressants, depressive symptoms, and anxiety symptoms; and at 12 months 75% reduction in antidepressant dose; aggregated practice level antidepressant prescribing, and health service utilisation for costs. Sample size: 653 patients from 28 practices. A concurrent evaluation of implementation will be through mixed methods including interviews with up to 40 patients and primary care general practitioners, brief e-surveys, and study administrative data to assess implementation outcomes (adoption and fidelity). Discussion The RELEASE study will develop new knowledge applicable internationally on the effectiveness, cost-effectiveness, and implementation of two multi-strategy interventions in supporting the safe cessation of long-term antidepressants to improve primary health care and outcomes for patients. Trial registration ANZCTR, ACTRN12622001379707p. Registered on 27 October 2022. |
| first_indexed | 2024-03-10T17:05:52Z |
| format | Article |
| id | doaj.art-5c409ea8e94c46a7a93554d32f8af41c |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-10T17:05:52Z |
| publishDate | 2023-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-5c409ea8e94c46a7a93554d32f8af41c2023-11-20T10:49:55ZengBMCTrials1745-62152023-09-0124111410.1186/s13063-023-07646-wRELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practiceKatharine A. Wallis0Maria Donald1Mark Horowitz2Joanna Moncrieff3Robert S. Ware4Joshua Byrnes5Karen Thrift6MaryAnne Cleetus7Idin Panahi8Nicholas Zwar9Mark Morgan10Chris Freeman11Ian Scott12General Practice Clinical Unit, Medical School, The University of QueenslandGeneral Practice Clinical Unit, Medical School, The University of QueenslandNHS Foundation Trust, Research and Development DepartmentUniversity College LondonGriffith UniversityGriffith UniversityGeneral Practice Clinical Unit, Medical School, The University of QueenslandGeneral Practice Clinical Unit, Medical School, The University of QueenslandGeneral Practice Clinical Unit, Medical School, The University of QueenslandFaculty of Health Sciences and Medicine, Bond UniversityFaculty of Health Sciences and Medicine, Bond UniversityThe University of QueenslandThe University of QueenslandAbstract Background Many people experience withdrawal symptoms when they attempt to stop antidepressants. Withdrawal symptoms are readily misconstrued for relapse or ongoing need for medication, contributing to long-term use (> 12 months). Long-term antidepressant use is increasing internationally yet is not recommended for most people. Long-term use is associated with adverse effects including weight gain, sexual dysfunction, lethargy, emotional numbing and increased risk of falls and fractures. This study aims to determine the effectiveness of two multi-strategy interventions (RELEASE and RELEASE+) in supporting the safe cessation of long-term antidepressants, estimate cost-effectiveness, and evaluate implementation strategies. Methods Design 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1. Setting: primary care general practices in southeast Queensland, Australia. Population: adults 18 years or older taking antidepressants for longer than 1 year. Practices will be randomised on a 1.5:1:1 ratio of Usual care:RELEASE:RELEASE+. Intervention: RELEASE for patients includes evidence-based information and resources and an invitation to medication review; RELEASE for GPs includes education, training and printable resources via practice management software. RELEASE+ includes additional internet support for patients and prescribing support including audit and feedback for GPs. Outcome measures: the primary outcome is antidepressant use at 12 months self-reported by patients. Cessation is defined as 0 mg antidepressant maintained for at least 2 weeks. Secondary outcomes: at 6 and 12 months are health-related quality of life, antidepressant side effects, well-being, withdrawal symptoms, emotional numbing, beliefs about antidepressants, depressive symptoms, and anxiety symptoms; and at 12 months 75% reduction in antidepressant dose; aggregated practice level antidepressant prescribing, and health service utilisation for costs. Sample size: 653 patients from 28 practices. A concurrent evaluation of implementation will be through mixed methods including interviews with up to 40 patients and primary care general practitioners, brief e-surveys, and study administrative data to assess implementation outcomes (adoption and fidelity). Discussion The RELEASE study will develop new knowledge applicable internationally on the effectiveness, cost-effectiveness, and implementation of two multi-strategy interventions in supporting the safe cessation of long-term antidepressants to improve primary health care and outcomes for patients. Trial registration ANZCTR, ACTRN12622001379707p. Registered on 27 October 2022.https://doi.org/10.1186/s13063-023-07646-wAntidepressantsDiscontinuationDeprescribingPrimary careWithdrawalTapering |
| spellingShingle | Katharine A. Wallis Maria Donald Mark Horowitz Joanna Moncrieff Robert S. Ware Joshua Byrnes Karen Thrift MaryAnne Cleetus Idin Panahi Nicholas Zwar Mark Morgan Chris Freeman Ian Scott RELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practice Trials Antidepressants Discontinuation Deprescribing Primary care Withdrawal Tapering |
| title | RELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practice |
| title_full | RELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practice |
| title_fullStr | RELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practice |
| title_full_unstemmed | RELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practice |
| title_short | RELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practice |
| title_sort | release redressing long term antidepressant use protocol for a 3 arm pragmatic cluster randomised controlled trial effectiveness implementation hybrid type 1 in general practice |
| topic | Antidepressants Discontinuation Deprescribing Primary care Withdrawal Tapering |
| url | https://doi.org/10.1186/s13063-023-07646-w |
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