Clinical trial NCT06969053: Effect of MIT for CI With Anxiety
Official title: Evaluation of Mindfulness Intervention Therapy in Treating Chronic Insomnia (CI) With Comorbid Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Insomnia
Anxiety Disorders
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: 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.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months.
measure: The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: 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
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References:
citation: 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.