Insomnia
Conditions
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.
Interventions
BEHAVIORALPlus Cognitive behavioral therapy of insomnia（CBT-I plus）
Cbt-i plus program is an enhanced version of cbt-i program, which increases the response to depression and anxiety symptoms.
BEHAVIORALCognitive behavioral therapy of insomnia（CBT-I）
Cognitive behavioral therapy of insomnia is mainly aimed at correcting the bad behaviors and beliefs among the maintenance factors of insomnia, which is considered as the first-line treatment program of insomnia disorder. Cognitive behavioral therapy of insomnia mainly includes five important components: sleep restriction, secondary control, cognitive therapy, relaxation therapy and sleep hygiene.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The blind method of this study is evaluator blindness, that is, the evaluator does not know the grouping of subjects.
Intervention model description
In this study, patients were randomly assigned to study group and control group by random number table.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years, male and female 2. Meet the diagnostic criteria of DSM-5 for insomnia, the Pittsburgh Sleep Quality Index (PSQI) scale total score ≥10 3. May be accompanied by depression symptoms, but currently does not meet any depression disorders diagnostic criteria,14≤HAMD-17≤23 4. May be accompanied by anxiety symptoms, but currently does not meet any anxiety disorders diagnostic criteria ,14≤HAMA≤29 5. Have sufficient education and understanding to complete this study to be examined and evaluated 6. Voluntary participation in this clinical trial and signature of informed consent.
Exclusion criteria
1. DSM-5 other sleep problems, such as apnea syndrome, restless leg syndrome 2. Women who are pregnant, nursing or planning to become pregnant during the study 3. Insomnia caused by alcohol or substance abuse 4. Severe cognitive problems 5. 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 6. Patients with history of epilepsy or other serious somatic diseases 7. Persons receiving MECT treatment for nearly one month 8. Excluding those who have received systemic psychotherapy for more than 3 months in a row 9. The researchers believe that it is not suitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of sleep efficiency | Change from Baseline Sleep efficiency at 8 weeks | Sleep efficiency was measured by sleep diary Sleep efficiency was measured by sleep diary |
| Change of depressive symptoms | 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 | 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. |
Countries
China
Contacts
Primary ContactChengmei Yuan
Outcome results
None listed