Combining Cognitive-behavioral Therapy with Transcranial Alternating Current for Treating Insomnia
Evaluation of the Efficacy of Standard Cognitive Behavioural Therapy + Transcranial Alternating Current in the Treatment of Refractory Insomnia Disorder
This study is testing if combining cognitive-behavioral therapy with a brain stimulation technique can help people with stubborn insomnia get better sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06969040 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining cognitive-behavioral therapy for insomnia (CBTI) with transcranial alternating current stimulation (tACS) to treat patients with refractory insomnia. The research aims to explore how these two approaches interact to improve sleep quality and duration. By employing a randomized double-blind controlled trial design, the study will assess both the efficacy and safety of this combined treatment method. The goal is to provide clinical data that supports the use of CBTI and tACS together for patients who have not responded to traditional insomnia treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who meet the DSM-5 criteria for insomnia and have a Pittsburgh Sleep Quality Index score greater than 5.
Not a fit: Patients with severe physical or mental illnesses, sleep breathing disorders, or those currently undergoing psychological therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a more effective treatment option for patients suffering from refractory insomnia.
How similar studies have performed: While cognitive-behavioral therapy and tACS have shown effectiveness in treating chronic insomnia individually, this combined approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meets the diagnostic criteria for insomnia in DSM-5; 2. Pittsburgh Sleep Quality Index (PSQI) total score\>5 points; 3. Age ≥ 18 years old, with a junior high school education or above; 4. Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: 1. Individuals with severe physical or mental illnesses are at risk of suicide; 2. Clinically diagnosed or suspected sleep breathing disorders, restless leg syndrome, and sleep wake rhythm disorders, as well as workers on rotating shifts; 3. Pregnant and 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.