Effect of MIT for CI With Anxiety

NCT ID: NCT06969053

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-11-01

Brief Summary

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

Detailed Description

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Conditions

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Chronic Insomnia Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MIT + SHE

Group Type EXPERIMENTAL

Mindfulness Intervention Therapy plus Sleep Hygiene Education

Intervention Type BEHAVIORAL

Participants will receive a 6-week program combining Mindfulness Intervention Therapy (MIT) and Sleep Hygiene Education (SHE). MIT includes body scan, mindful breathing, breathing space exercises, mindful walking, sitting meditation, loving-kindness meditation, and development of a personalized mindfulness practice plan. Sessions are conducted daily for 50 minutes. SHE provides structured guidance on optimizing sleep schedules, bedroom environment, and reducing stimulants such as caffeine and alcohol.

SHE only

Group Type ACTIVE_COMPARATOR

Sleep Hygiene Education

Intervention Type BEHAVIORAL

Participants will receive Sleep Hygiene Education (SHE) alone for 6 weeks. SHE involves education on maintaining consistent sleep schedules, creating a sleep-conducive environment, reducing stimulant use (e.g., caffeine, alcohol), and promoting healthy daily routines to improve sleep quality.

Interventions

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Mindfulness Intervention Therapy plus Sleep Hygiene Education

Participants will receive a 6-week program combining Mindfulness Intervention Therapy (MIT) and Sleep Hygiene Education (SHE). MIT includes body scan, mindful breathing, breathing space exercises, mindful walking, sitting meditation, loving-kindness meditation, and development of a personalized mindfulness practice plan. Sessions are conducted daily for 50 minutes. SHE provides structured guidance on optimizing sleep schedules, bedroom environment, and reducing stimulants such as caffeine and alcohol.

Intervention Type BEHAVIORAL

Sleep Hygiene Education

Participants will receive Sleep Hygiene Education (SHE) alone for 6 weeks. SHE involves education on maintaining consistent sleep schedules, creating a sleep-conducive environment, reducing stimulant use (e.g., caffeine, alcohol), and promoting healthy daily routines to improve sleep quality.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongxing Wang, MD & PhD

Role: CONTACT

+86 13911127385

Facility Contacts

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Hongxing Wang, MD & PhD

Role: primary

+86 13911127385

References

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Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.

Reference Type BACKGROUND
PMID: 20350028 (View on PubMed)

Other Identifiers

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CI+CA-MIT

Identifier Type: -

Identifier Source: org_study_id

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