| NCT ID | NCT06968013 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Chronic Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-10-01 |
Trial Parameters
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Brief Summary
This randomized controlled trial aims to explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosed with Insomnia Disorder according to DSM-5 criteria, with a duration of at least 3 months. 2. Pittsburgh Sleep Quality Index (PSQI) total score \> 5. 3. Age 8 years or older. 4. Educational level of at least junior high school. 5. Voluntarily agree to participate and provide written informed consent. 6. Presence of depressive symptoms, defined as Hamilton Depression Scale (HAMD) score ≥ 16. Exclusion Criteria: 1. Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide. 2. Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work. 3. Pregnant or breastfeeding women. 4. Currently undergoing any psychological therapy.
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