Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial

Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial
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DOI:
10.1016/j.cct.2015.06.010
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发表时间:
2015-07-01
影响因子:
2.2
通讯作者:
Blonstein, Andrea C.
Blonstein, Andrea C.
中科院分区:
医学4区
文献类型:
--
作者:
Ma, Jun;Yank, Veronica;Blonstein, Andrea C.

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鉴于肥胖和抑郁症患者的患病率不断增加且预后恶化,针对肥胖和抑郁症共病的有效干预措施至关重要。 RAINBOW 是一项 1 型混合设计随机对照试验。目的是评估用于治疗初级保健中肥胖和抑郁症共病的综合、技术增强、协作护理模式的临床和成本效益以及实施潜力。肥胖和抑郁成年人 (n = 404) 将被随机分配到常规护理,并通过提供计步器和有关卫生系统情绪或体重管理服务的信息(控制)或通过改善情绪和体重综合辅导 (I-CARE) 计划(干预)来加强。为期 12 个月的 I-CARE 计划协同整合了两种行之有效的行为干预措施:根据需要强化抑郁症药物治疗的问题解决疗法 (PEARLS) 和肥胖症的标准化行为治疗 (团体生活方式平衡 (TM))。它利用传统的(例如办公室访问和电话咨询)和新兴的护理提供方式(例如患者门户网站和移动应用程序)。后续评估将在 6、12、18 和 24 个月时进行。我们假设,与对照组相比,I-CARE 参与者在 12 个月时的体重和抑郁严重程度(通过 20 项抑郁症状检查表衡量)将有更大的改善,并且这种改善将持续到 24 个月。我们还将评估 I-CARE 的成本效益,并使用混合方法来检验其覆盖范围、采用、实施和维护的潜力。这项研究提供了改变肥胖和抑郁成年人治疗方式的潜力——通过初级保健中易于获得的综合生活方式医学和心理健康专业知识的新模式。 (C) 2015 Elsevier Inc. 保留所有权利。
Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n = 404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health system's services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance (TM)). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE's cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated-through a new model of accessible and integrative lifestyle medicine and mental health expertise-in primary care. (C) 2015 Elsevier Inc. All rights reserved.