Mindfulness therapy for chronic insomnia with anxiety

Evaluation of Mindfulness Intervention Therapy in Treating Chronic Insomnia (CI) With Comorbid Anxiety

This study is testing whether a mindfulness therapy combined with sleep tips can help people aged 8 and older with chronic insomnia and anxiety sleep better and feel less anxious.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 8 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06969053 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 8 years or older diagnosed with insomnia and experiencing anxiety 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 intervention could significantly improve sleep quality and reduce anxiety symptoms in patients with chronic insomnia.

How similar studies have performed: Other studies have shown promising results using mindfulness-based interventions for insomnia and anxiety, suggesting this approach may be effective.

Eligibility criteria

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 this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Hongxing Wang, MD & PhD

Conditions: Chronic Insomnia, Anxiety Disorders