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Recruiting NCT06969053

Effect of MIT for CI With Anxiety

No phase Interventional Chronic Insomnia Anxiety Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness Intervention Therapy plus Sleep Hygiene Education, Sleep Hygiene Education.
Who it may be relevant to
Registry conditions: Chronic Insomnia, Anxiety Disorders. Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Behavioral 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 al
  • 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.

Primary outcome measures

  • The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks [Time frame: Baseline, 6 weeks]
Secondary outcome measures (11)
  • The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months.]
  • The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Xuanwu Hospital, Capital Medical University — Beijing

Publications

  • 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 20350028

Identifiers

NCT: NCT06969053 · CI+CA-MIT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗