The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review.
Stefan G Hofmann, Alice T Sawyer, Ashley A Witt...
https://pubmed.ncbi.nlm.nih.gov/20350028/Actively Recruiting
Led by Xuanwu Hospital, Beijing · Updated on 2025-05-23
70
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are studying the effect of Mindfulness Intervention Therapy MIT on people aged 8 years and older who have Chronic Insomnia combined with anxiety symptoms. This trial aims to see how well MIT works in improving sleep quality and reducing anxiety compared to Sleep Hygiene Education SHE alone. The study is sponsored by Xuanwu Hospital, Beijing, and focuses on understanding treatment options for insomnia with anxiety. Participants will be randomly assigned to one of two groups one group will receive a 6-week program combining MIT and SHE, and the other will receive SHE alone for 6 weeks. The MIT program includes exercises such as body scan, mindful breathing, mindful walking, sitting meditation, loving-kindness meditation, and a personalized mindfulness practice plan, with daily 50-minute sessions. SHE offers guidance on healthy sleep habits like consistent sleep schedules and reducing stimulants like caffeine and alcohol. During the study, researchers will measure sleep quality changes using the Pittsburgh Sleep Quality Index PSQI from the start to 6 weeks. They will also assess other outcomes like insomnia severity, sleep efficiency, beliefs about sleep, mood, depression, anxiety, and life events over periods up to 24 months. Participants will be monitored through questionnaires and scales at multiple points baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months, ensuring comprehensive follow-up of treatment effects and safety.
CONDITIONS
Effect of MIT for CI With Anxiety
H
Hongxing Wang, MD & PhD
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Xuanwu Hospital, Beijing
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive either Mindfulness Intervention Therapy combined with Sleep Hygiene Education or Sleep Hygiene Education alone for 6 weeks. The therapy includes daily 50-minute sessions of mindfulness practices and structured guidance on improving sleep habits.
Daily sessions for 6 weeks
Duration - Up to 12 months after treatment
Participants are assessed at multiple time points after treatment to monitor changes in insomnia severity, sleep efficiency, mental health, and quality of life.
Visits at 6 weeks, 3 months, 6 months, and 12 months after treatment
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Stefan G Hofmann, Alice T Sawyer, Ashley A Witt...
https://pubmed.ncbi.nlm.nih.gov/20350028/Xuanwu Hospital, Beijing
Lead Sponsor