NCT06658171招募中不适用
Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients With Hyperarousal and Maladaptive Sleep Patterns
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks.
研究概览
简要总结
The study aims to validate the effect of relaxation training and stimulus control on reducing hyperarousal states and improving maladaptive sleep behaviors.
详细描述
Relaxation training typically includes techniques such as breathing exercises, muscle relaxation, and mindfulness meditation to help patients reduce levels of physical and psychological tension, promote relaxation, and create favorable conditions for sleep onset. Stimulus control aims to break the negative association between the bed and insomnia, and rebuild a positive association between the bed and sleep.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for insomnia disorder according to DSM-
- •Pittsburgh Sleep Quality Index (PSQI) total score >
- •Age ≥ 18 years, with at least a middle school education level.
- •Anxiety symptoms meeting HAMA ≥
- •"Self-developed 8-item questionnaire on maladaptive sleep behaviors" used to assess "maladaptive sleep behaviors."
- •Voluntarily participate in this study and sign an informed consent form.
排除标准
- •Individuals with severe physical illnesses or severe mental disorders, at risk of suicide.
- •Clinically diagnosed or suspected sleep-related breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as shift workers.
- •Pregnant or lactating women.
- •Currently undergoing any psychological therapy.
结局指标
主要结局
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks.
时间窗: Baseline, 6 weeks
The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.
次要结局
- The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months.(Baseline, 3 months, 6 months, and 12 months)
- The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months.)
- The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Progressive Relaxation Exercises and Sleep, Anxiety and Stress in Risky PregnantsHealth Care Seeking BehaviorNCT05508542Cukurova University30
已完成
不适用
Virginia Commonwealth University Stress Reduction StudyStressNCT04190030Virginia Commonwealth University72
已完成
不适用
The Effect of Exercise and Music on Sleep, Quality of Life and Emotional State in Children With EpilepsyEpilepsy in ChildrenNCT06300814TC Erciyes University45
Enrolling By Invitation
不适用
The Effect of Progressive Relaxation Exercises on Bariatric Surgery PeriodObesity, MorbidBariatric Surgery CandidatePostoperative PainAnxietyNCT05591898Başakşehir Çam & Sakura City Hospital72
尚未招募
不适用
Progressive Relaxation Exercises on Anxiety LevelsExercises TherapyTotal Knee Replacement SurgeryAnxietyNCT06676202Erzi̇ncan Binali Yildirim Uni̇versi̇tesi̇66