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Adherence to Depression Treatment in Primary CareA Randomized Clinical Trial
JAMA Psychiatry ( IF 25.8 ) Pub Date : 2017-11-01 , DOI: 10.1001/jamapsychiatry.2017.3047
Jo Anne Sirey 1 , Samprit Banerjee 2 , Patricia Marino 1 , Martha L. Bruce 3 , Ashley Halkett 1 , Molly Turnwald 4 , Claire Chiang 4 , Brian Liles 1 , Amanda Artis 2 , Fred Blow 4 , Helen C. Kales 4
Affiliation  

Importance  Nonadherence to antidepressant medication is common and leads to poor outcomes. Early nonadherence is especially problematic.

Objective  To test the effectiveness of a psychosocial intervention to improve early adherence among older patients whose primary care physician newly initiated an antidepressant for depression.

Design, Setting, and Participants  The Treatment Initiation and Participation Program (TIP) was offered in a 2-site randomized clinical effectiveness study between January 2011 and December 2014 at primary care practices in New York, New York, and Ann Arbor, Michigan. Analyses began in February 2016. All participants were middle-aged and older adults (aged ≥55 years) who received newly initiated depression treatment by their primary care physician and recruited within 10 days of their prescription. Analyses were intention-to-treat.

Interventions  Participants were randomly assigned to the intervention (TIP) or treatment as usual. Participants in the TIP group identified and addressed barriers to adherence, including stigma, misconceptions, and fears about treatment, before developing a personalized adherence strategy. The Treatment Initiation and Participation Program was delivered in three 30-minute contacts scheduled during a 6-week period just after the antidepressant was prescribed.

Main Outcomes and Measures  The primary outcome was self-reported adherence on the Brief Medication Questionnaire, with adequate early adherence defined as taking 80% or more of the prescribed doses at 6 and 12 weeks. The secondary outcome was depression severity.

Results  In total, 231 middle-aged and older adults (167 women [72.3%] and 64 men [27.7%]) without significant cognitive impairment were randomly assigned to the TIP intervention (n = 115) or treatment as usual (n = 116). Participants had a mean (SD) age of 67.3 (8.4) years. Participants in the TIP group were 5 times more likely to be adherent at 6 weeks (odds ratio, 5.54; 95% CI, 2.57 to 11.96; χ21 = 19.05; P < .001) and 3 times more likely to be adherent at both 6 and 12 weeks (odds ratio, 3.27; 95% CI, 1.73 to 6.17; χ21 = 13.34; P < .001). Participants in the TIP group showed a significant earlier reduction (24.9%) in depressive symptoms (95% CI, 13.9 to 35.9; t337 = 4.46; adjusted P < .001). In both groups, participants who were 80% adherent at weeks 6 and 12 had a 15% greater improvement in depressive symptoms from baseline over the course of treatment (95% CI, −0.2 to −30; t369 = 1.93; P = .051).

Conclusions and Relevance  The Treatment Initiation and Participation Program is an effective intervention to improve early adherence to pharmacotherapy. Improved adherence can promote improvement in depression.

Trial Registration  clinicaltrials.gov Identifier: NCT01301859



中文翻译:

在初级保健中坚持抑郁治疗的一项随机临床试验

重要性不  坚持服用抗抑郁药很普遍,并导致不良结果。早期的不遵守尤其成问题。

目的  测试心理社会干预措施对老年患者的早期依从性的有效性,老年患者的初级保健医生新近开始使用抗抑郁药。

设计,设置和参加者  在2011年1月至2014年12月期间,在纽约,纽约和密歇根州的安娜堡的初级保健机构进行了一项2位随机临床有效性研究,其中提供了治疗启动和参与计划(TIP)。分析于2016年2月开始。所有参与者均为中老年和老年人(≥55岁),他们接受了其初级保健医生的新发起的抑郁症治疗,并在处方后的10天内被招募。分析是意向性的。

干预  措施与以往一样,将参与者随机分配到干预措施(TIP)或治疗中。在制定个性化的坚持策略之前,TIP小组的参与者确定并解决了坚持的障碍,包括污名,误解和对治疗的恐惧。在开具抗抑郁药后的6周内,安排了3个30分钟的接触,实施了治疗启动和参与计划。

主要结局和措施  主要结局是自我报告的《简易药物调查表》的依从性,适当的早期依从性定义为在第6周和第12周服用80%或更多的规定剂量。次要结果是抑郁症的严重程度。

结果  总共将231名无明显认知障碍的中老年人(167名妇女[72.3%]和64名男性[27.7%])随机分配到TIP干预(n = 115)或常规治疗(n = 116) )。参与者的平均(SD)年龄为67.3(8.4)岁。在TIP一组的受试者5更可能粘附在第6周(比值比,5.54; 95%CI,2.57至11.96;χ倍2 1  = 19.05; P  <0.001)和3倍更有可能在被粘附既6和12周(比值比,3.27; 95%CI,1.73至6.17;χ 2 1  = 13.34; P  <0.001)。TIP组的参与者表现出抑郁症状的早期显着降低(24.9%)(95%CI,13.9至35.9;t 337) = 4.46; 调整后的P  <0.001)。在两组中,在治疗的第6周和第12周时80%依从性的参与者在治疗过程中抑郁症状的改善均较基线高15%(95%CI,-0.2至-30;t 369  = 1.93;P  =。 051)。

结论和相关性  治疗启动和参与计划是提高早期对药物治疗依从性的有效干预措施。依从性的改善可以促进抑郁症的改善。

试验注册  临床试验.gov标识符:NCT01301859

更新日期:2017-11-01
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