Insomnia with anxiety and depression
Conditions
Interventions
Control group:The control group will receive a psychological education related to insomnia every day, which is randomized.
Intervenation group:The intervention group will complete the corresponding tasks every day according to the process of Smart CBT-I plus program.
Sponsors
Shanghai Mental Health Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old, male or female; 2. Currently meet the DSM-5 diagnostic criteria for insomnia disorder; 3. Insomnia Severity Index (ISI) scale: total score >=15 points; 4. With anxiety or depressive symptoms, 14 points< = HAMA< = 29 points, and/or 14< = HAMD-17< = 23 points; 5. Have sufficient education level and understanding ability to complete the required examination and evaluation of this study; 6. Have not taken sedatives, antidepressants, anxiolytics, or antipsychotics in the 2 weeks before enrollment, or have used relevant drugs in the 4 weeks before enrollment and the dose is stable; 7. Voluntarily participate in this clinical trial and sign the informed consent form of the subject.
Exclusion criteria
Exclusion criteria: 1. Other sleep problems in DSM-5, such as apnea syndrome, restless legs syndrome, etc.; 2. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period were excluded; 3. Insomnia problems caused by alcohol or substance abuse; 4. Severe cognitive problems; 5. Patients with previous or current diagnosis of bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stress-related disorders, separation disorders, eating disorders, etc.; 6. Excluding patients with significant negative suicide risk, HAMD-17 Clause 2 score >=2 points; 7. Exclude patients with a history of epilepsy or other serious physical diseases; 8. Those who have received MECT treatment in the past month are excluded; 9. Exclude those who have received systematic psychotherapy for more than 3 consecutive months and have not been effective; 10. Inability to tolerate this study setting; 11. Other conditions that are considered unsuitable by the investigator to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of ISI total score reduction rate between two groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of HAMA total score reduction rate between two groups;Comparison of HAMD total score reduction rate between two groups;Comparison of shortened sleep latency before and after intervention between two groups;Comparison of the increase in total sleep duration between the two groups before and after the intervention;Comparison between two groups of patients before and after the intervention of Pittsburg sleep Quality Index (PSQI) total score reduction rate and the change of each factor score;The improvement of sleep belief and attitude (DBAS-16 scale) before and after intervention was compared between the two groups.;Comparison of quality of life improvement (QOL-6 total score) before and after intervention between two groups; | — |
Countries
China
Contacts
Public ContactYuan Chengmei
Shanghai Mental Health Center
Outcome results
None listed