Department of Neurology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.
Department Psychiatry, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.
JAMA Neurol. 2018 Dec 1;75(12):1487-1493. doi: 10.1001/jamaneurol.2018.2513.
Mild cognitive impairment (MCI) is a transition state between normal cognitive aging and dementia that increases the risk for progressive cognitive decline. Preventing cognitive decline is a public health priority.
To determine whether behavioral activation prevents cognitive and functional decline over 2 years in black individuals with MCI.
DESIGN, SETTING, AND PARTICIPANTS: Single-center, single-masked, attention-controlled randomized clinical trial. Participants were enrolled from June 21, 2011, to October 3, 2014, and follow-up ended December 13, 2016. Community-based recruitment and treatment of black individuals older than 65 years with amnestic MCI. Volunteer sample of 1390 persons with memory complaints were screened. Overall, 536 individuals had baseline assessment, and 315 (58.8%) were ineligible, most often owing to normal cognition (205 of 315 [65%]) or dementia (59 of 315 [18.7%]); 221 fully eligible participants were randomized. Analyses were intention to treat.
Participants were randomized to behavioral activation, which aimed to increase cognitive, physical, and social activity (111 [50.2%]), or supportive therapy, an attention control treatment (110 [49.8%]).
The prespecified primary outcome was a decline of 6 or more recalled words on the total recall score of the Hopkins Verbal Learning Test-Revised assessed at 6, 12, 18, and 24 months. The secondary outcome was functional decline.
Of 221 randomized participants (mean [SD] age, 75.8 [7.0] years, 175 women [79%]), 77 behavioral activation participants (69.4%) and 87 supportive therapy participants (79.1%) had 2-year outcome assessments. After baseline, behavioral activation participants engaged in significantly more cognitive activities than supportive therapy participants. The 2-year incidence of memory decline was 1.2% (95% CI, 0.2-6.4) for behavioral activation vs 9.3% (95% CI, 5.30-16.4) for supportive therapy (relative risk, 0.12; 95% CI, 0.02-0.74; P = .02). Behavioral activation was associated with stable everyday function, whereas supportive therapy was associated with decline (difference in slopes, 2.71; 95% CI, 0.12-5.30; P = .04). Rates of serious adverse events for behavioral activation and supportive therapy, respectively, were: falls (14 [13%] vs 28 [25%]), emergency department visits (24 [22%] vs 24 [22%]), hospitalizations (36 [32%] vs 31 [28%]), and deaths (7 [5%] vs 3 [4%]).
Behavioral activation prevented cognitive and functional decline, but this finding requires further investigation. Black individuals have almost twice the rate of dementia as white individuals; behavioral activation may reduce this health disparity.
ClinicalTrials.gov Identifier: NCT01299766.
轻度认知障碍 (MCI) 是正常认知老化和痴呆之间的过渡状态，增加了认知能力进行性下降的风险。预防认知能力下降是公共卫生的优先事项。
确定行为激活是否可以防止黑人 MCI 患者在 2 年内认知和功能下降。
设计、设置和参与者：单中心、单盲、对照随机临床试验。参与者于 2011 年 6 月 21 日至 2014 年 10 月 3 日招募，并于 2016 年 12 月 13 日结束随访。对 65 岁以上有记忆问题的黑人进行社区招募和治疗。对有记忆抱怨的 1390 人进行了志愿者筛选。共有 536 人进行了基线评估，315 人（58.8%）不符合条件，最常见的原因是认知正常（205/315 [65%]）或痴呆（59/315 [18.7%]）；221 名完全合格的参与者被随机分组。分析为意向治疗。
参与者被随机分配到行为激活组，其目的是增加认知、身体和社会活动（111 [50.2%]），或支持性治疗，一种注意力对照治疗（110 [49.8%]）。
预先规定的主要结局是在 6、12、18 和 24 个月时，Hopkins 言语学习测验修订版的总回忆分数下降 6 个或更多单词。次要结局是功能下降。
在 221 名随机参与者中（平均[标准差]年龄为 75.8 [7.0]岁，175 名女性[79%]），77 名行为激活参与者（69.4%）和 87 名支持性治疗参与者（79.1%）进行了 2 年的结局评估。基线后，行为激活组参与者的认知活动明显多于支持性治疗组。行为激活组的记忆下降 2 年发生率为 1.2%（95%CI，0.2-6.4），而支持性治疗组为 9.3%（95%CI，5.30-16.4）（相对风险，0.12；95%CI，0.02-0.74；P=0.02）。行为激活与稳定的日常功能相关，而支持性治疗与下降相关（斜率差异，2.71；95%CI，0.12-5.30；P=0.04）。行为激活和支持性治疗的严重不良事件发生率分别为：跌倒（14 [13%] vs 28 [25%]）、急诊就诊（24 [22%] vs 24 [22%]）、住院（36 [32%] vs 31 [28%]）和死亡（7 [5%] vs 3 [4%]）。
行为激活可预防认知和功能下降，但这一发现需要进一步研究。黑人患痴呆的比率几乎是白人的两倍；行为激活可能会减少这一健康差距。
ClinicalTrials.gov 标识符：NCT01299766。
