CBT for Insomnia With Anxiety and Depression

Not Applicable

• Conditions: Insomnia
• Interventions: Behavioral: Plus Cognitive behavioral therapy of insomnia（CBT-I plus）; Behavioral: Cognitive behavioral therapy of insomnia（CBT-I）

• Registration Number: NCT04585282
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-08-01
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-14
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19
• Primary Completion: 2022-04-30
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Plus Cognitive behavioral therapy of insomnia（CBT-I plus）	The study group was treated with intensive cognitive behavioral therapy for insomnia.
control group	Cognitive behavioral therapy of insomnia（CBT-I）	The control group was treated with traditional cognitive behavioral therapy for insomnia.

Primary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China