A Randomized Controlled Study of Cognitive Behavioral Therapy for Insomnia With Anxiety and Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- Shanghai Mental Health Center
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Change of depressive symptoms
- Last Updated
- 5 years ago
Overview
Brief Summary
Objective to explore whether cbt-i plus is more effective and feasible for patients with insomnia complicated with anxiety and depression than the traditional cognitive behavioral therapy for insomnia.
Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.
Detailed Description
The purpose of this study was to explore the treatment of cognitive behavioral enhancement of insomnia (cbt-i plus), which was randomly divided into cbt-i plus intervention group (Study Group) and cbt-i intervention group (control group). The study group used the unified cognitive behavioral therapy manual for insomnia (cbt-i plus) for one-to-one individual treatment intervention, once a week, 45-50 minutes each time, a total of 8 times; the control group used the unified cognitive behavioral therapy manual for insomnia (cbt-i) for one-on-one treatment intervention, once a week, 45-50 minutes each time, a total of 8 times. The related indexes were evaluated at baseline, 2 weeks, 4 weeks and 8 weeks after enrollment, and were followed up at 12 weeks and 24 weeks after enrollment. Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years, male and female
- •Meet the diagnostic criteria of DSM-5 for insomnia, the Pittsburgh Sleep Quality Index (PSQI) scale total score ≥10
- •May be accompanied by depression symptoms, but currently does not meet any depression disorders diagnostic criteria,14≤HAMD-17≤23
- •May be accompanied by anxiety symptoms, but currently does not meet any anxiety disorders diagnostic criteria ,14≤HAMA≤29
- •Have sufficient education and understanding to complete this study to be examined and evaluated
- •Voluntary participation in this clinical trial and signature of informed consent.
Exclusion Criteria
- •DSM-5 other sleep problems, such as apnea syndrome, restless leg syndrome
- •Women who are pregnant, nursing or planning to become pregnant during the study
- •Insomnia caused by alcohol or substance abuse
- •Severe cognitive problems
- •Patients who were previously or currently diagnosed as bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stress related disorders, separation disorders, eating disorders
- •Patients with history of epilepsy or other serious somatic diseases
- •Persons receiving MECT treatment for nearly one month
- •Excluding those who have received systemic psychotherapy for more than 3 months in a row
- •The researchers believe that it is not suitable to participate in this clinical study.
Outcomes
Primary Outcomes
Change of depressive symptoms
Time Frame: Change from Baseline Sleep efficiency at 8 weeks
The measurement tool is Hamilton Depression Scale-17 items,the minimum score of the scale was 0 and the maximum score was 52. The higher the score was, the more serious the depression was.
Change of anxiety symptoms
Time Frame: Change from Baseline Sleep efficiency at 8 weeks
The measurement tool is Hamilton Anxiety Scale, the minimum score of the scale was 0 and the maximum score was 56. The higher the score was, the more serious the anxiety was.
Change of sleep efficiency
Time Frame: Change from Baseline Sleep efficiency at 8 weeks
Sleep efficiency was measured by sleep diary Sleep efficiency was measured by sleep diary