Effect of MIT for CI With Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorXuanwu Hospital, Beijing
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness Intervention Therapy plus Sleep Hygiene Education
BehavioralParticipants 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.
Sleep Hygiene Education
BehavioralParticipants 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: MIT + SHEExperimental treatment 1 intervention
Group B: SHE onlyActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 6 weeksSecondary outcomes
1
The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The ISI reporting insomnia symptoms severity consists of 7-items on a 5-point Likert scale, and the total score ranges from 0 to 28 with higher scores indicating more severe insomnia.
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months2
The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months3
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.
The DBAS assessing sleep related cognitions in 16 items rated on a 10-point Likert scale, and the total score ranges from 0 to 160 with higher scores indicating more intensive dysfunctional beliefs.
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months4
The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The SHAPS assessing anhedonia consists of 14 items, and the total score ranges from 14 to 56 with higher scores indicating more serious the anhedonia.
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov