Investigating on the Efficacy of Well-Being Therapy (WBT) for Chronic Insomnia (CI) With Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 6 Weeks
研究概览
简要总结
This randomized controlled trial aims to explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms.
详细描述
According to DSM-IV criteria, approximately 6%-10% of the adult population in industrialized countries suffer from chronic insomnia (CI), characterized by difficulties in initiating or maintaining sleep accompanied by daytime symptoms persisting for at least four weeks. Chronic insomnia often leads to various psychiatric symptoms, with depressive symptoms being among the most common. For patients with CI and comorbid depressive symptoms, the most common treatment involves the use of antidepressant medications. However, while depressive symptoms may improve, insomnia symptoms often persist.
Among non-pharmacological interventions aimed at promoting psychological well-being, Well-Being Therapy (WBT) stands out as a brief and innovative psychotherapeutic approach. WBT is a structured, manualized, short-term therapy that incorporates self-monitoring of well-being episodes through the use of a diary, cognitive restructuring of interfering thoughts and behaviors, and homework assignments.
Previous research has demonstrated the effectiveness of WBT in alleviating stress in populations experiencing 'allostatic load.' This study seeks to evaluate the therapeutic effects of six WBT sessions on individuals with CI and comorbid depressive symptoms.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Insomnia Disorder according to DSM-5 criteria, with a duration of at least 3 months.
- •Pittsburgh Sleep Quality Index (PSQI) total score >
- •Age 8 years or older.
- •Educational level of at least junior high school.
- •Voluntarily agree to participate and provide written informed consent.
- •Presence of depressive symptoms, defined as Hamilton Depression Scale (HAMD) score ≥ 16.
排除标准
- •Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide.
- •Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work.
- •Pregnant or breastfeeding women.
- •Currently undergoing any psychological therapy.
研究组 & 干预措施
WBT-CI
干预措施: Well-Being Therapy (Behavioral)
SHE-CI
干预措施: Sleep Hygiene Education (Behavioral)
结局指标
主要结局
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 6 Weeks
时间窗: Baseline and Week 6
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire designed to evaluate sleep quality over a one-month period. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored on a scale of 0 to 3, and the total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
次要结局
- Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores at 3, 6, and 12 Months(Baseline, 3 months, 6 months, and 12 months)
- Change from Baseline in Hamilton Depression Scale-17 (HAMD-17) Scores(Baseline, Week 6, 3 months, 6 months, and 12 months)
- Change from Baseline in Beck Depression Inventory-II (BDI-II) Scores(Baseline, Week 6, 3 months, 6 months, and 12 months)
- Change from Baseline in Beck Anxiety Inventory (BAI) Scores(Baseline, Week 6, 3 months, 6 months, and 12 months)
- Change from Baseline in Patient Health Questionnaire-4 (PHQ-4) Scores(Baseline, Week 6, 3 months, 6 months, and 12 months)
- Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores(Baseline, Week 6, 3 months, 6 months, and 12 months)
- Change from Snaith-Hamilton Pleasure Scale (SHAPS) Scores(Baseline, Week 6, 3 months, 6 months, and 12 months)
- Change from Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) Scores(Baseline, Week 6, 3 months, 6 months, and 12 months)
- Change from Insomnia Severity Index (ISI) Scores(Baseline, Week 6, 3 months, 6 months, and 12 months)
- Change in Self-rated Sleep Severity (0-10 Numeric Rating Scale)(Baseline, Week 6, 3 months, 6 months, and 12 months)
- Frequency and Severity of Adverse Events(Throughout study duration up to 12 months)