Effect of MIT for CI With Anxiety
Recruiting · NCT06969053 · Interventional (participants receive a specific treatment) · Lead sponsor: Xuanwu Hospital, Beijing
View the official record on ClinicalTrials.gov →Interventions studied
Mindfulness Intervention Therapy plus Sleep Hygiene EducationSleep Hygiene Education
What this trial is about
This randomized controlled trial aims to investigate the efficacy of Mindfulness Intervention Therapy (MIT) in treating Chronic Insomnia (CI) comorbid with anxiety symptoms.
Who can take part
Age range
8 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Diagnosed with Insomnia Disorder according to DSM-5 criteria.
- Pittsburgh Sleep Quality Index (PSQI) total score \> 5.
- Age 8 years or older.
- Educational level of at least junior high school.
- Voluntarily agree to participate and provide written informed consent.
- Presence of anxiety symptoms, defined as Hamilton Anxiety Rating Scale (HAMA) score ≥ 14.
Exclusion criteria
- Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide.
- Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work.
- Pregnant or breastfeeding women.
- Currently undergoing any psychological therapy.
Where it is running
1 location listed.
- Xuanwu Hospital, Capital Medical University - Beijing, China