Relaxation training and stimulus control for chronic insomnia
Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients With Hyperarousal and Maladaptive Sleep Patterns
This study is testing whether relaxation techniques and better sleep habits can help people with chronic insomnia sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06658171 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the effects of relaxation training and stimulus control on patients suffering from chronic insomnia. The approach includes techniques such as breathing exercises, muscle relaxation, and mindfulness meditation to reduce physical and psychological tension, thereby promoting better sleep. Additionally, stimulus control is employed to help patients break negative associations with their sleeping environment and foster positive sleep habits. The study will also incorporate sleep hygiene education to further support participants in improving their sleep quality.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who meet the diagnostic criteria for insomnia disorder and exhibit maladaptive sleep behaviors.
Not a fit: Patients with severe physical or mental disorders, sleep-related breathing disorders, or those currently undergoing psychological therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve sleep quality and overall well-being for patients with chronic insomnia.
How similar studies have performed: Previous studies have shown positive outcomes with similar relaxation and stimulus control approaches in treating insomnia, indicating a promising avenue for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meet the diagnostic criteria for insomnia disorder according to DSM-5. 2. Pittsburgh Sleep Quality Index (PSQI) total score \> 5. 3. Age ≥ 18 years, with at least a middle school education level. 4. Anxiety symptoms meeting HAMA ≥ 14. 5. "Self-developed 8-item questionnaire on maladaptive sleep behaviors" used to assess "maladaptive sleep behaviors." 6. Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: 1. Individuals with severe physical illnesses or severe mental disorders, at risk of suicide. 2. Clinically diagnosed or suspected sleep-related breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as shift workers. 3. Pregnant or lactating women. 4. Currently undergoing any psychological therapy.
Where this trial is running
Beijing
- Xuanwu Hospital, Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Hongxing Wang, MD & PhD
- Email: wanghongxing@xwh.ccmu.edu.cn
- Phone: +86 13911127385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.