Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, and Herczeg Institute on Aging, Tel Aviv University, POB 39040, Ramat Aviv, Tel-Aviv, 69978, Israel.
J Clin Psychiatry. 2012 Sep;73(9):1255-61. doi: 10.4088/JCP.12m07918.
A randomized, placebo-controlled clinical trial was undertaken to determine the efficacy of nonpharmacologic individualized interventions (individualized to address unmet needs such as boredom or pain) in decreasing agitation in persons with dementia.
Agitated nursing home residents with advanced dementia (from 9 nursing homes in 5 locations in Maryland, United States) were randomized into an intervention group (n = 89) and a placebo control group (n = 36). On the basis of data from baseline assessment, a systematic methodology for individualizing nonpharmacologic interventions, Treatment Routes for Exploring Agitation (TREA), was used with the intervention group: an unmet need was hypothesized, a corresponding treatment category was identified, and specifics of the treatment were chosen to fit the person's need, past identity, preferences, and abilities. (Unmet needs were hypothesized based on physician evaluations, structured staff interviews, relative questionnaires, direct observations of agitation with the Agitation Behavior Mapping Instrument [the primary outcome measure] and affect with Lawton's Modified Behavior Stream [the secondary outcome measure], and resident assessments.) TREA interventions were implemented for 2 weeks, and observations of agitation and affect were recorded. The study was conducted from June 2006 until December 2011.
Relative to a control group, TREA interventions for unmet needs produced statistically significant declines in total (P < .001), physical nonaggressive (P < .001), and verbal agitation (P = .004) and significant increases in pleasure (P < .001) and interest (P < .05).
This is the first large randomized controlled trial to demonstrate the efficacy of TREA and one of only a few such trials of nonpharmacologic interventions for agitation in persons with dementia. The translation of these findings into practice is sorely needed and would require structural changes dedicating staff time to observing each agitated resident, determining unmet needs, obtaining appropriate intervention materials, conducting the individualized nonpharmacologic interventions, and evaluating results.
ClinicalTrials.gov identifier: NCT00820859.
一项随机、安慰剂对照的临床试验旨在确定非药物个体化干预措施（针对未满足的需求，如无聊或疼痛）在降低痴呆患者激越方面的疗效。
从美国马里兰州 5 个地点的 9 家养老院随机抽取患有晚期痴呆症的激越护理院居民（n=89）进入干预组和安慰剂对照组（n=36）。基于基线评估数据，采用个体化非药物干预措施的系统方法（治疗探索激越途径 TREA），对干预组进行干预：假设存在未满足的需求，确定相应的治疗类别，并选择特定的治疗方法以满足个人的需求、过去的身份、偏好和能力。（未满足的需求是基于医生评估、结构化员工访谈、相对问卷、使用激越行为映射工具（主要结局指标）和影响的直接观察（次要结局指标）以及居民评估，假设未满足的需求。）实施 TREA 干预措施 2 周，并记录激越和影响的观察结果。该研究于 2006 年 6 月至 2011 年 12 月进行。
与对照组相比，针对未满足需求的 TREA 干预措施使总激越（P<.001）、躯体非攻击激越（P<.001）和言语激越（P=.004）显著下降，愉悦感（P<.001）和兴趣（P<.05）显著增加。
这是第一项大规模随机对照试验，证明了 TREA 的疗效，也是为数不多的针对痴呆患者激越的非药物干预措施的此类试验之一。将这些发现转化为实践是非常需要的，这将需要结构上的改变，专门投入工作人员时间观察每个激越的居民，确定未满足的需求，获取适当的干预材料，进行个体化非药物干预，并评估结果。
ClinicalTrials.gov 标识符：NCT00820859。
