Last updated: August 13, 2023
Sponsor: Shanghai Mental Health Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Anxiety Disorders
Treatment
Cognitive Behavioral Therapy for Insomnia
Clinical Study ID
NCT05985512
ChengmeiYUAN
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged between 18 and 65 years, regardless of gender;
- Currently meeting the diagnostic criteria for insomnia disorder according to the FifthEdition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- Pittsburgh Sleep Quality Index (PSQI) total score ≥ 10;
- Sufficient level of education and comprehension to complete the required examinationsand assessments for this study;
- Voluntarily participating in this research and signing the informed consent form.
Exclusion
Exclusion Criteria:
- Currently diagnosed with other sleep disorders (sleep-related breathing disorders,periodic limb movement disorder, parasomnias, central disorders of hypersomnolence,circadian rhythm sleep-wake disorders, etc.);
- Currently diagnosed with organic brain diseases (epilepsy, cerebrovascular disease,etc.) or other organic diseases;
- Patients with a history of or currently diagnosed with bipolar and related disorders,obsessive-compulsive and related disorders, schizophrenia spectrum and other psychoticdisorders, trauma and stressor-related disorders, dissociative disorders, or eatingdisorders;
- Women who are pregnant, breastfeeding, or planning to become pregnant during the studyperiod;
- Insomnia caused by alcohol or substance abuse;
- High suicide risk, with HAMD-17 suicide factor score > 2;
- Inability to cooperate with near-infrared examinations and polysomnography due tophysical conditions such as head injury, etc.
Study Design
Total Participants: 216
Treatment Group(s): 1
Primary Treatment: Cognitive Behavioral Therapy for Insomnia
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
July 01, 2025
Connect with a study center
Shanghai Mental Health Center
Shanghai, Shanghai 200030
ChinaActive - Recruiting
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