A psychological intervention by community pharmacies to prevent depression in adults with subthreshold depression and long-term conditions: the CHEMIST pilot RCT

E. Littlewood, C. Chew‐Graham, Elizabeth Coleman, S. Gascoyne, C. Sloan, Shehzad Ali, J. Badenhorst, D. Bailey, S. Crosland, C. E. Kitchen, D. McMillan, C. Pearson, A. Todd, C. Whittlesea, C. Bambra, C. Hewitt, Claire Jones, A. Keding, E. Newbronner, Alastair Paterson, Shelley Rhodes, E. Ryde, Paul Toner, Michelle Watson, S. Gilbody, D. Ekers
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The community pharmacy may be an alternative setting to offer mental health support; however, insufficient evidence exists to support implementation.\n \n \n \n To conduct a feasibility study and pilot randomised controlled trial of a community pharmacy-delivered psychological intervention aimed at preventing depression in adults with long-term health conditions.\n \n \n \n A feasibility study with nested qualitative evaluation and an external pilot, two-arm, 1 : 1 individually randomised controlled trial with nested process and economic evaluations.\n \n \n \n Community pharmacies in the north of England.\n \n \n \n Adults aged ≥ 18 years with subthreshold depression and at least one long-term health condition.\n \n \n \n A bespoke enhanced support intervention (behavioural activation within a collaborative care framework) involving up to six sessions delivered by trained community pharmacy staff (intervention facilitators) compared with usual care.\n \n \n \n Recruitment and retention rates, completeness of outcome measures and intervention engagement. The intended primary outcome was depression severity at 4 months, assessed by the Patient Health Questionnaire-9.\n \n \n \n In the feasibility study, 24 participants were recruited. Outcome measure completeness was 95–100%. Retention at 4 months was 83%. Seventeen participants (71%) commenced intervention sessions and all completed two or more sessions. Depression symptoms reduced slightly at 4 months. The process evaluation suggested that the intervention was acceptable to participants and intervention facilitators. In the pilot randomised controlled trial, 44 participants (target of 100 participants) were randomised (intervention, n = 24; usual care, n = 20). Outcome measure completeness was 100%. Retention at 4 months was 93%. Eighteen participants (75%) commenced intervention sessions and 16 completed two or more sessions. 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Despite these challenges, good retention rates and intervention engagement were demonstrated, and process evaluation suggested that the intervention was acceptable in this setting. To the best of our knowledge, this is the first study to demonstrate that community pharmacy staff can be trained to deliver a depression prevention intervention.\n \n \n \n Further work is needed to address barriers to recruitment, intervention delivery and implementation of psychological interventions in the community pharmacy setting.\n \n \n \n This trial is registered as ISRCTN11290592.\n \n \n \n This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 10, No. 5. 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引用次数: 3

Abstract

Depression is common in people with long-term health conditions, and this combination can lead to worsened health outcomes and increased health-care costs. Subthreshold depression, a risk factor for major depression, is prevalent in this population, but many people remain untreated due to the demand on services. The community pharmacy may be an alternative setting to offer mental health support; however, insufficient evidence exists to support implementation. To conduct a feasibility study and pilot randomised controlled trial of a community pharmacy-delivered psychological intervention aimed at preventing depression in adults with long-term health conditions. A feasibility study with nested qualitative evaluation and an external pilot, two-arm, 1 : 1 individually randomised controlled trial with nested process and economic evaluations. Community pharmacies in the north of England. Adults aged ≥ 18 years with subthreshold depression and at least one long-term health condition. A bespoke enhanced support intervention (behavioural activation within a collaborative care framework) involving up to six sessions delivered by trained community pharmacy staff (intervention facilitators) compared with usual care. Recruitment and retention rates, completeness of outcome measures and intervention engagement. The intended primary outcome was depression severity at 4 months, assessed by the Patient Health Questionnaire-9. In the feasibility study, 24 participants were recruited. Outcome measure completeness was 95–100%. Retention at 4 months was 83%. Seventeen participants (71%) commenced intervention sessions and all completed two or more sessions. Depression symptoms reduced slightly at 4 months. The process evaluation suggested that the intervention was acceptable to participants and intervention facilitators. In the pilot randomised controlled trial, 44 participants (target of 100 participants) were randomised (intervention, n = 24; usual care, n = 20). Outcome measure completeness was 100%. Retention at 4 months was 93%. Eighteen participants (75%) commenced intervention sessions and 16 completed two or more sessions. Depression symptoms reduced slightly at 4 months, with a slightly larger reduction in the usual-care arm, although the small sample size limits any conclusions. The process evaluation reported good acceptability of the intervention and identified barriers associated with study implementation and its impact on core pharmacy functions. The economic analysis revealed some indication of reduced resource use/costs associated with the intervention, but this is limited by the small sample size. Intervention costs were low. The main limitation is the small sample size due to difficulties with recruitment and barriers to implementing the study within existing pharmacy practices. The community pharmacy represents a new setting to deliver a depression prevention intervention. Recruitment was a challenge and pharmacy staff encountered barriers to effective implementation of the study within busy pharmacy practice. Despite these challenges, good retention rates and intervention engagement were demonstrated, and process evaluation suggested that the intervention was acceptable in this setting. To the best of our knowledge, this is the first study to demonstrate that community pharmacy staff can be trained to deliver a depression prevention intervention. Further work is needed to address barriers to recruitment, intervention delivery and implementation of psychological interventions in the community pharmacy setting. This trial is registered as ISRCTN11290592. This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 10, No. 5. See the NIHR Journals Library website for further project information.
社区药房的心理干预预防阈下抑郁症成人和长期条件:化学家试点RCT
抑郁症在有长期健康状况的人中很常见,这种组合可能导致健康状况恶化和医疗费用增加。阈下抑郁症是严重抑郁症的一个风险因素,在这一人群中很普遍,但由于对服务的需求,许多人仍然没有得到治疗。社区药房可能是提供心理健康支持的替代场所;然而,没有足够的证据支持执行。对社区药房提供的心理干预进行可行性研究和试点随机对照试验,旨在预防患有长期健康状况的成年人患抑郁症。具有嵌套定性评估和外部试点的可行性研究,双臂,1 : 1项具有嵌套过程和经济评估的单独随机对照试验。英格兰北部的社区药房。年龄≥ 患有阈下抑郁症18年,至少有一种长期健康状况。与常规护理相比,定制的强化支持干预(在协作护理框架内的行为激活)包括由受过培训的社区药房工作人员(干预促进者)提供的多达六次会议。征聘率和留用率、成果衡量标准的完整性和干预参与度。预期的主要结果是通过患者健康问卷-9评估4个月时的抑郁严重程度。在可行性研究中,招募了24名参与者。结果测量的完整性为95–100%。4个月时的保留率为83%。17名参与者(71%)开始了干预课程,所有参与者都完成了两次或两次以上的课程。抑郁症状在4个月时略有减轻。过程评估表明,参与者和干预促进者可以接受干预措施。在试点随机对照试验中,44名参与者(目标为100名参与者)被随机分配(干预 = 24;常规护理,n = 20) 。结果测量的完整性为100%。4个月时的保留率为93%。18名参与者(75%)开始了干预课程,16名参与者完成了两次或两次以上的课程。抑郁症症状在4个月时略有减轻,常规护理组的症状减轻幅度略大,尽管样本量小限制了任何结论。过程评估报告了干预措施的良好可接受性,并确定了与研究实施相关的障碍及其对核心药学功能的影响。经济分析显示,与干预相关的资源使用/成本有所减少,但这受到样本量小的限制。干预成本很低。主要限制是由于招募困难和在现有药学实践中实施研究的障碍,样本量较小。社区药房代表了一个提供抑郁症预防干预的新环境。招聘是一项挑战,药房工作人员在繁忙的药房工作中遇到了有效实施该研究的障碍。尽管存在这些挑战,但仍证明了良好的保留率和干预参与度,过程评估表明,在这种情况下,干预是可以接受的。据我们所知,这是第一项证明社区药房工作人员可以接受抑郁症预防干预培训的研究。需要进一步的工作来解决在社区药房环境中招募、提供干预和实施心理干预的障碍。本试验注册号为ISRCTN11290592。该项目由国家卫生研究所公共卫生研究计划资助,并将在《公共卫生研究》上全文发表;第10卷第5期。有关更多项目信息,请访问NIHR期刊图书馆网站。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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