NCT06969053

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 5, 2025

Last Update Submit

May 19, 2025

Conditions

Chronic InsomniaAnxiety Disorders

Outcome Measures

Primary Outcomes (1)

  • The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks

    The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.

    Baseline, 6 weeks

Secondary Outcomes (11)

  • The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

    Baseline, 6 weeks, 3 months, 6 months, and 12 months

  • The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.

    Baseline, 6 weeks, 3 months, 6 months, and 12 months

  • The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

    Baseline, 6 weeks, 3 months, 6 months, and 12 months

  • The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

    Baseline, 6 weeks, 3 months, 6 months, and 12 months

  • The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.

    Baseline, 6 weeks, 3 months, 6 months, and 12 months.

  • +6 more secondary outcomes

Study Arms (2)

MIT + SHE

EXPERIMENTAL
Behavioral: Mindfulness Intervention Therapy plus Sleep Hygiene Education

SHE only

ACTIVE COMPARATOR
Behavioral: Sleep Hygiene Education

Interventions

Mindfulness Intervention Therapy plus Sleep Hygiene EducationBEHAVIORAL

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.

MIT + SHE
Sleep Hygiene EducationBEHAVIORAL

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.

SHE only

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 20350028BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

+86 13911127385wanghongxing@xwh.ccmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2025

First Posted

May 13, 2025

Study Start

November 1, 2024

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)