Combining Cognitive-behavioral Therapy with Transcranial Alternating Current for Treating Insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.