Therapeutic effects of Well-Being Therapy for chronic insomnia with depression
Investigating on the Efficacy of Well-Being Therapy (WBT) for Chronic Insomnia (CI) With Depressive Symptoms
This study is testing if Well-Being Therapy can help people with chronic insomnia and depression feel better after six sessions of treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06968013 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial investigates the effects of Well-Being Therapy (WBT) on patients suffering from chronic insomnia accompanied by depressive symptoms. Chronic insomnia affects a significant portion of the adult population and is often linked with psychiatric issues, particularly depression. The study aims to evaluate the effectiveness of six sessions of WBT, which includes self-monitoring, cognitive restructuring, and homework assignments, as a non-pharmacological intervention. Participants will also receive education on sleep hygiene to enhance treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 8 years or older diagnosed with chronic insomnia and experiencing depressive symptoms.
Not a fit: Patients with severe physical illnesses, major psychiatric disorders, or those currently undergoing psychological therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-drug alternative for managing chronic insomnia and its associated depressive symptoms.
How similar studies have performed: Previous research has shown that Well-Being Therapy can effectively alleviate stress in populations with high allostatic load, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
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.