NCT06658158招募中不适用
Effects of Cognitive Correction and Stimulus Control in Chronic Insomnia Patients With Sleep Cognitive Distortions 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
This study aims to validate the effect of cognitive correction and stimulus control on correcting sleep cognitive distortions and improving maladaptive sleep behaviors.
详细描述
Cognitive correction aims to identify and change patients' erroneous beliefs and attitudes about sleep, which may include exaggerated sleep needs, excessive worry about the consequences of insomnia, and unrealistic expectations about bedtime. Stimulus control, on the other hand, focuses on modifying patients' behaviors in bed, linking the bed with a rapid onset of sleep, and reducing the negative association between the bed and insomnia.
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
- •Meets the diagnostic criteria for insomnia disorder according to DSM-5;
- •PSQI total score > 5;
- •Age ≥ 18 years, with at least a junior high school education;
- •Sleep cognitive distortions assessed using the DBAS-16;
- •"Maladaptive Sleep Behavior Questionnaire - 8 items" used to assess "maladaptive sleep behaviors";
- •Willing to participate in the study and sign an informed consent form.
排除标准
- •Presence of severe physical illness or serious mental disorders, or at risk for suicide;
- •Clinically diagnosed or suspected sleep-related breathing disorders, restless legs syndrome, and circadian rhythm sleep-wake disorders; shift workers;
- •Pregnant or lactating women;
- •Currently undergoing any form of 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 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 PSQI total scores from baseline to 3 months, 6 months, and 12 months.(Baseline, 3 months, 6 months, 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 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
Effect of Cognitive Stimulating Interventions on Cognitive Self-Efficacy and Sense of Happiness Among Older AdultsSelf- EfficacyNCT05802043Alexandria University80
Unknown
不适用
Cognitive Control Training as an Adjunct to Behavioral Activation Therapy in the Treatment of DepressionDepressionNCT01694719Boston University26
已完成
不适用
Compensatory Cognitive Training For SchizophreniaSchizophreniaNCT04040998Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan46
已完成
不适用
tDCS-enhanced Working Memory Training in Subjective Cognitive DeclineSubjective Cognitive DeclineNCT03236454University Hospital Tuebingen30
Unknown
不适用
Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental IllnessMood DisordersSchizophreniaSchizoaffective DisorderNCT04551027Shalvata Mental Health Center60