Acceptance and Commitment Therapy for Chronic Insomnia in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Change in the score of Insomnia Severity Index (ISI)
研究概览
简要总结
Insomnia is a frequent complaint and is associated with impairments in physical and psychological health. Although Cognitive-Behavioral Therapy (CBT) demonstrates effective results for insomnia, there are those who do not respond to this type of intervention or present difficulties in adherence. Acceptance and Commitment Therapy (ACT) presents itself as a potentially useful intervention for the treatment of insomnia, for which, instead of focusing on controlling the symptoms, the respective approach focuses on accepting the feelings and thoughts associated, through value-based actions. The aim of this study is to evaluate the effectiveness of ACT for chronic insomnia in adults. Participants will be 150 adults aged between 18 and 59 years, diagnosed with chronic insomnia who will be randomly assigned to the ACT, CBT and wait list (WL) groups. For both groups (ACT and CBT), the intervention will be performed in six group and weekly sessions. Assessments of sleep patterns, insomnia, depression, anxiety, psychological flexibility, acceptance of sleep, beliefs about sleep, personality traits will be performed in the pre-treatment, post-treatment and six-month follow-up. After the intervention is completed, participants will respond to an inventory of compliance and satisfaction. Treatment effects will assessed using the fixed effects of group variables (ACT vs. CBT-I and ACT vs. waitlist) and their interaction with time (pre-test vs. post-test and pretest vs. six-month follow-up). Estimated pairwise contrasts to examine changes across time within groups will be used. Variables will analyzed using generalized mixed models (GMM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic insomnia
排除标准
- •Neurological degenerative disease
- •Psychotic disorder
- •sleep apnea, restless legs or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)
- •cognitive impairments
- •unavailability in attending the sessions.
研究组 & 干预措施
ACT for Insomnia
干预措施: Acceptance and Commitment Therapy for Insomnia (Behavioral)
CBT for Insomnia
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
Wait List
结局指标
主要结局
Change in the score of Insomnia Severity Index (ISI)
时间窗: baseline, 7 weeks and 24 weeks after treatment commencement.
Change in the total score of Insomnia Severity Index (ISI)
次要结局
- Treatment response - categorical variable(baseline, 7 weeks and 24 weeks after treatment commencement.)
- Increase in Total Sleep Time (TST)(baseline, 7 weeks and 24 weeks after treatment commencement.)
- Reduction in Wake After Sleep Onset (WASO)(baseline, 7 weeks and 24 weeks after treatment commencement.)
- Change in the Acceptance and Action Questionnaire-II (AAQ-II)(baseline, 7 weeks and 24 weeks after treatment commencement.)
- Change in the Sleep Problem Acceptance Questionnaire (SPAQ)(baseline, 7 weeks and 24 weeks after treatment commencement.)
- Increase in Sleep Efficiency (SE)(baseline, 7 weeks and 24 weeks after treatment commencement.)
- Change in the Hospital Anxiety and Depression Scale (HADS)(baseline, 7 weeks and 24 weeks after treatment commencement.)
- Remission - categorical variable(baseline, 7 weeks and 24 weeks after treatment commencement.)
- Reduction in Sleep Onset Latency (SOL)(baseline, 7 weeks and 24 weeks after treatment commencement.)
- Change in the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)(baseline, 7 weeks and 24 weeks after treatment commencement.)