基于电话的认知行为疗法治疗围绝经期和绝经后血管舒缩症状妇女失眠:MsFLASH随机临床试验。

PubMed ID
发表日期 2016年Jul月

原始出处 JAMA内科
JAMA internal medicine
作者 McCurry  Susan M  Guthrie  Katherine A  Morin  Charles M  Woods  Nancy F  Landis  Carol A  Ensrud  Kristine E  Larson  Joseph C  Joffe  Hadine  Cohen  Lee S  Hunt  Julie R  Newton  Katherine M  Otte  Julie L  Reed  Susan D  Sternfeld  Barbara  Tinker  Lesley F  LaCroix  Andrea Z 

文献标题 基于电话的认知行为疗法治疗围绝经期和绝经后血管舒缩症状妇女失眠:MsFLASH随机临床试验。
Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor Symptoms: A MsFLASH Randomized Clinical Trial.

文献摘要 IMPORTANCE

有效的,实用的,非药物疗法是必要的治疗更年期相关的失眠症状在初级和妇女的专业护理设置。

OBJECTIVE

评价电话认知行为疗法(CBT-I)与更年期教育对照(MEC)治疗失眠症的疗效。

DESIGN, SETTING, AND PARTICIPANTS

2013年9月1日至2015年8月31日,在华盛顿州西部对106名40至65岁的围绝经期或绝经后妇女进行了一项单点随机临床试验,这些妇女有中度失眠症状(失眠严重指数[ISI]评分,≥12) 每日潮热2次以上。在基线检查时、随机分组后8周和24周进行盲法评估。进行意向治疗分析。

INTERVENTIONS

8周内6次CBT-I或MEC电话会议。参与者每周提交电子睡眠日记,并收到针对特定群体的书面教育材料。CBT-I包括睡眠限制、刺激控制、睡眠卫生教育、认知重建和行为作业;MEC会议提供了有关更年期和妇女健康的信息。

MAIN OUTCOMES AND MEASURES

主要结果是ISI评分(评分范围0-28;分数≥15表示中度至重度失眠)。次要结果是匹兹堡睡眠质量指数评分(评分范围0-21;分数越高说明睡眠质量越差)。其他结果包括睡眠和热闪光日记变量和热闪光干扰。

RESULTS

8周时,53名接受CBT-I治疗的妇女的ISI评分下降了9.9分(平均[SD]年龄55.0[3.5]岁),53名接受MEC治疗的妇女的ISI评分下降了4.7分(年龄54.7[4.7]岁),组间平均差异为5.2分(95%CI,-6.1至-3.3;P < .001). 匹兹堡睡眠质量指数在接受CBT-I治疗的妇女中下降了4.0分,在接受MEC治疗的妇女中下降了1.4分,组间平均差异为2.7分(95%CI,-3.9至-1.5;P < .001). 24周时组间差异显著。在第8周和第24周,CBT-I组的47名女性中有33名(70%)和44名女性中有37名(84%)的ISI得分在无失眠范围内,而MEC组的41名女性中有10名(24%)和37名女性中有16名(43%)的ISI得分在无失眠范围内。CBT-I组在睡眠潜伏期、觉醒时间和睡眠效率方面也有较大改善。组间每日潮热频率无差异,但CBT-I组在8周时潮热干扰显著减少(-15.7;95%可信区间为-20.4至-11.0,与MEC组相比(-7.1;95%CI,-14.6至0.4)(P = .03),CBT-I组维持在24周的差异(-22.8;95%可信区间为-28.6-16.9,MEC组为-11.6;95%可信区间,-19.4至-3.8)(P = .003).

CONCLUSIONS AND RELEVANCE

基于电话的CBT-I改善了围绝经期和绝经后失眠和潮热妇女的睡眠。研究结果支持了治疗更年期失眠症的CBT-I方案的进一步开发和测试。

TRIAL REGISTRATION

clinicaltrials.gov标识符:NCT01936441。


IMPORTANCE

Effective, practical, nonpharmacologic therapies are needed to treat menopause-related insomnia symptoms in primary and women's specialty care settings.

OBJECTIVE

To evaluate the efficacy of telephone-based cognitive behavioral therapy for insomnia (CBT-I) vs menopause education control (MEC).

DESIGN, SETTING, AND PARTICIPANTS

A single-site, randomized clinical trial was conducted from September 1, 2013, to August 31, 2015, in western Washington State among 106 perimenopausal or postmenopausal women aged 40 to 65 years with moderate insomnia symptoms (Insomnia Severity Index [ISI] score, ≥12) and 2 or more daily hot flashes. Blinded assessments were conducted at baseline, 8, and 24 weeks postrandomization. An intent-to-treat analysis was conducted.

INTERVENTIONS

Six CBT-I or MEC telephone sessions in 8 weeks. Participants submitted weekly electronic sleep diaries and received group-specific written educational materials. The CBT-I sessions included sleep restriction, stimulus control, sleep hygiene education, cognitive restructuring, and behavioral homework; MEC sessions provided information about menopause and women's health.

MAIN OUTCOMES AND MEASURES

Primary outcome was scores on the ISI (score range, 0-28; scores ≥15 indicate moderate to severe insomnia). Secondary outcome was scores on the Pittsburgh Sleep Quality Index (score range, 0-21; higher scores indicate worse sleep quality). Additional outcomes included sleep and hot flash diary variables and hot flash interference.

RESULTS

At 8 weeks, ISI scores had decreased 9.9 points among 53 women receiving CBT-I (mean [SD] age, 55.0 [3.5] years) and 4.7 points among 53 women receiving MEC (age, 54.7 [4.7] years), a mean between-group difference of 5.2 points (95% CI, -6.1 to -3.3; P < .001). Pittsburgh Sleep Quality Index scores decreased 4.0 points in women receiving CBT-I and 1.4 points in women receiving MEC, a mean between-group difference of 2.7 points (95% CI, -3.9 to -1.5; P < .001). Significant group differences were sustained at 24 weeks. At 8 and 24 weeks, 33 of 47 women (70%) and 37 of 44 (84%) in the CBT-I group, respectively, had ISI scores in the no-insomnia range compared with 10 of 41 (24%) and 16 of 37 (43%) in the MEC group, respectively. The CBT-I group also had greater improvements in diary-reported sleep latency, wake time, and sleep efficiency. There were no between-group differences in frequency of daily hot flashes, but hot flash interference was significantly decreased at 8 weeks for the CBT-I group (-15.7; 95% CI, -20.4 to -11.0) compared with the MEC group (-7.1; 95% CI, -14.6 to 0.4) (P = .03), differences that were maintained at 24 weeks for the CBT-I group (-22.8; 95% CI, -28.6 to -16.9) and MEC group (-11.6; 95% CI, -19.4 to -3.8) (P = .003).

CONCLUSIONS AND RELEVANCE

Telephone-based CBT-I improved sleep in perimenopausal and postmenopausal women with insomnia and hot flashes. Results support further development and testing of centralized CBT-I programs for treating menopausal insomnia.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01936441.


获取全文 10.1001/jamainternmed.2016.1795