A Patient-Focused Approach to Insomnia Treatment for Women Veterans

由于现役军人组成的变化，女退伍军人的人数正在增加， 了解我们所服务的这一不断增长的患者群体的医疗保健需求至关重要。失眠 女性比男性更常见，美国平均患病率超过23%。 妇女失眠（定义为严重到足以造成痛苦或影响的睡眠障碍 功能），是一个重大的公共卫生问题，有助于丧失生产力，心理困扰， 医学发病率和死亡风险。在最近一篇关于退伍军人护理转型的论文中，Yano等人 al.包括“睡眠问题”作为“VA妇女未来健康研究议程”的一部分;然而， 对VA女性健康研究的系统性综述（2006年和2011年）没有发现任何先前的睡眠研究 女性退伍军人的疾病。2011年，我们完成了第一项关于睡眠问题的描述性研究， 接受退伍军人事务部保健服务的女退伍军人（HSRD PPO 09-282-1; PI：Martin）。我们发现， 失眠（54%的受访者）和可能影响治疗可接受性和交付的共病状况。 我们还发现，患有失眠症的女性退伍军人更喜欢非药物治疗而不是药物治疗， 他们最有可能获得这种治疗，如果它是以个人的形式提供（而不是团体）。 有越来越多的文献对治疗失眠的个人与共病条件，建议 失眠治疗可能会导致睡眠质量和其他方面有意义和持久的改善， 症状 这项研究是一项随机试验，比较一种新的治疗方法，接受行为 改变治疗冲动（ABC-I），它结合了认知行为疗法的行为成分 接受和承诺疗法（ACT）的组成部分，以提高依从性 CBT-I的行为建议目的是：1）比较辍学率和坚持率 ABC-I计划和结构相似的CBT-I计划之间的行为建议，2） 比较ABC-I在改善基线至治疗后的睡眠/觉醒模式方面的有效性， 相似结构的CBT-I程序，以及3）比较睡眠/觉醒改善的维持 治疗结束后3个月，两种治疗方案的模式。 将使用我们以前的试点研究中开发的方法来识别失眠女性。一个简短的调查 将邮寄给大约5,000名在6个月内接受医疗保健的女性退伍军人。 VA大洛杉矶医疗保健系统。所有返回调查表的妇女， 将通过电话联系失眠症患者并邀请其参加治疗研究。排除标准 仅限于严重或不稳定的医学/精神疾病，存在中度至重度睡眠呼吸暂停， 或参加治疗会话的障碍（例如，住得太远，没有交通工具）。ABC-我会 由受过训练的干预人员分5次一对一向患有失眠症的退伍军人提供（n=74）， 将与结构相似的CBT-I程序（n=74）进行比较。依从性和损耗将在 这两个条件。睡眠质量（自我报告和客观测量）、精神症状严重程度和 将在基线、治疗后和3个月随访时评估生活质量。将使用ANOVA进行检验 在坚持和磨损组之间的差异。等效性/非劣效性方法将用于 确定ABC-I的睡眠相关结局是否与CBT-I相当，使用意向治疗和 符合方案分析。以建议的样本量，我们将有足够的把握度来测试研究 假设

The number of women Veterans is increasing due to changes in the composition of the active duty military, and understanding the healthcare needs of this growing segment of the patients we serve is critical. Insomnia complaints are more common among women than men, with a mean prevalence of over 23% among US women. Insomnia (defined as sleep disturbance that is sufficiently severe to cause distress or impact functioning), is a significant public health concern that contributes to lost productivity, psychological distress, medical morbidity, and mortality risk. In a recent paper on transformation of care for women Veterans, Yano et al. included "sleep issues" as part of the "VA Women's Health Research Agenda for the Future"; however, systematic reviews of VA women's health research (2006 and 2011) did not identify any prior studies of sleep disorders among women Veterans. In 2011 we completed the first descriptive study of sleep problems among women Veterans who receive VA Healthcare (HSRD PPO 09-282-1; PI: Martin). We found high rates of insomnia (54% of respondents) and comorbid conditions that may impact treatment acceptability and delivery. We also found that women Veterans with insomnia preferred non-medication treatments over medications, and that they were most likely to access this treatment if it were delivered in individual format (rather than groups). There is a growing literature on treatment of insomnia among individuals with comorbid conditions, suggesting that insomnia treatment may lead to meaningful and durable improvements in sleep quality and other symptoms. The proposed study is a randomized trial to compare a novel treatment, Acceptance of the Behavioral Changes to treat Insomnia (ABC-I), which combines behavioral components of Cognitive-Behavioral Therapy for Insomnia (CBT-I), with components of Acceptance and Commitment Therapy (ACT) to improve adherence to the behavioral recommendations of CBT-I. The objectives are: 1) to compare dropout rates and adherence to behavioral recommendations between the ABC-I program and a similarly-structured CBT-I program, 2) to compare the effectiveness of the ABC-I in improving sleep/wake patterns from baseline to post-treatment to a similarly-structured CBT-I program, and 3) to compare the maintenance of improvements in sleep/wake patterns across the two treatment programs 3-months after the end of treatment. Women with insomnia will be identified using methods developed in our previous pilot study. A brief survey will be mailed to approximately 5,000 women Veterans who have received healthcare within 6 months from the VA Greater Los Angeles Healthcare System. All women who return the survey indicating symptoms of insomnia will be contacted by phone and invited to participate in the treatment study. Exclusion criteria will be limited to severe or unstable medical/psychiatric disorders, the presence of moderate-to-severe sleep apnea, or barriers to attending the treatment sessions (e.g., live too far away, no access to transportation). ABC-I will be provided in 5 one-on-one sessions to women Veterans with insomnia by a trained interventionist (n=74) and will be compared to a similarly-structured CBT-I program (n=74). Adherence and attrition will be measured in both conditions. Sleep quality (self-reported and objectively measured), psychiatric symptom severity and quality of life will be assessed at baseline, post-treatment and at 3-month follow-up. ANOVA will be used to test for differences between groups in adherence and attrition. Equivalency/noninferiority methods will be used to determine whether sleep-related outcomes for ABC-I are comparable to CBT-I, using both intent to treat and per protocol analyses. With the proposed sample size, we will have sufficient power to test the study hypotheses.