Effect of MIT for CI With Anxiety

Capital Medical University

Status: Enrolling

Conditions: Chronic Insomnia; Anxiety Disorders

Treatments: Behavioral: Mindfulness Intervention Therapy plus Sleep Hygiene Education; Behavioral: Sleep Hygiene Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06969053

CI+CA-MIT

Details and patient eligibility

About

This randomized controlled trial aims to investigate the efficacy of Mindfulness Intervention Therapy (MIT) in treating Chronic Insomnia (CI) comorbid with anxiety symptoms.

Enrollment: 70 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

MIT + SHE

Experimental group

Treatment:

Behavioral: Mindfulness Intervention Therapy plus Sleep Hygiene Education

SHE only

Active Comparator group

Treatment:

Behavioral: Sleep Hygiene Education