Mindfulness therapy for chronic insomnia with anxiety

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 randomized controlled trial investigates the effectiveness of Mindfulness Intervention Therapy (MIT) combined with Sleep Hygiene Education in treating patients suffering from Chronic Insomnia (CI) alongside anxiety symptoms. Participants will be assessed based on their insomnia and anxiety levels, and the study aims to determine if MIT can improve sleep quality and reduce anxiety. The trial includes individuals aged 8 years and older who meet specific diagnostic criteria for insomnia and anxiety. The study will compare outcomes between those receiving MIT and those receiving only Sleep Hygiene Education.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosed with Insomnia Disorder according to DSM-5 criteria.
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 anxiety symptoms, defined as Hamilton Anxiety Rating Scale (HAMA) score ≥ 14.

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 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.