A randomized trial to decrease risk for diabetes among Cambodian Americans with depression: Intervention development, baseline characteristics and process outcomes.
A randomized trial to decrease risk for diabetes among Cambodian Americans with depression: Intervention development, baseline characteristics and process outcomes.
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DOI：
10.1016/j.cct.2021.106427
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发表时间：
2021-07
影响因子：
2.2
通讯作者：
Scully M
中科院分区：
文献类型：
--
作者：
Wagner J;Bermudez-Millan A;Buckley T;Buxton OM;Feinn R;Kong S;Kuoch T;Nahmod NG;Scully M
抑郁和抗抑郁药物会增加患2型糖尿病的风险。目前尚不清楚是否可以在抑郁的情况下预防糖尿病。柬埔寨裔美国人患抑郁症和糖尿病的比例都很高。本文报道了柬埔寨裔美国抑郁症患者糖尿病预防干预措施的发展、实验设计、基线特征和过程结果，“通过饮食、行走、睡眠和药物治疗管理降低糖尿病风险”（DREAM）。参与者年龄在35-75岁之间，说高棉语，患糖尿病的风险高，符合可能患有抑郁症的标准，a)抗抑郁药物和/或b)在研究资格期间的两个时间点抑郁症状升高。治疗组为：1)社区健康教育者（CHE）提供的生活方式干预，称为“吃、走、睡”（EWS）， 2) EWS加药剂师/CHE提供的药物治疗管理（EWS + MTM），以及3)社会服务（SS；对照组）。188名参与者被随机分组。治疗保真度很高（98%的检查表依从性），在0到3的量表上，参与者报告了较高的EWS治疗满意度（M = 2.9, SD = 0.2），群体凝聚力（M = 2.9, SD = 0.3），以及与CHEs （M = 2.9, SD = 0.2）和药剂师（2.9,SD = 0.3）的治疗联盟。出勤率很有挑战性，但非常成功；在EWS中，99%参加≥1次治疗，86%完成≥24次治疗，M = 27.3 （SD = 3.7）次治疗。在随机分到EWS + MTM组的患者中，98%的患者至少参加了一次MTM治疗，77%的患者完成了≥4次MTM治疗。留存率很高，12个月时为95%，15个月时为96%。干预措施成功实施。总结了经验教训，并对今后的试验提出了建议。ClinicalTrials.gov识别码：NCT02502929
Depression and antidepressant medications are associated with increased risk for type 2 diabetes. It is not known if diabetes can be prevented in the setting of depression. Cambodian Americans have high rates of both depression and diabetes. This paper reports intervention development, experimental design, baseline characteristics, and process outcomes of diabetes prevention interventions for Cambodian Americans with depression, “Diabetes Risk Reduction through Eat, Walk, Sleep and Medication Therapy Management” (DREAM). Participants were aged 35–75, Khmer speaking, at high risk for developing diabetes, and met criteria for likely depression by either a) antidepressant medication and/or b) elevated depressive symptoms at two time-points during a study eligibility period. Treatment arms were: 1) community health educator (CHE) delivered lifestyle intervention called Eat, Walk, Sleep (EWS), 2) EWS plus pharmacist/CHE-delivered medication therapy management (EWS + MTM), and, 3) social services (SS; control). 188 participants were randomized. Treatment fidelity was high (98% checklist adherence) and on a scale from 0 to 3, participants reported high EWS treatment satisfaction (M = 2.9, SD = 0.2), group cohesion (M = 2.9, SD = 0.3), and therapeutic alliance to CHEs (M = 2.9, SD = 0.2) and to pharmacists (2.9, SD = 0.3). Attendance was challenging but highly successful; in EWS, 99% attended ≥ one session and 86% completed ≥ 24 sessions, M = 27.3 (SD = 3.7) sessions. Of those randomized to EWS + MTM, 98% attended at least one MTM session and 77%) completed ≥ 4 sessions. Retention was high, 95% at 12-month and 96% at 15-month assessments. The interventions were successfully implemented. Lessons learned and suggestions for future trials are offered. ClinicalTrials.gov identifier: NCT02502929
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