CBT for Insomnia With Anxiety and Depression

Shanghai Mental Health Center

Status: Unknown

Conditions: Insomnia

Treatments: Behavioral: Plus Cognitive behavioral therapy of insomnia（CBT-I plus）; Behavioral: Cognitive behavioral therapy of insomnia（CBT-I）

Study type: Interventional

Funder types: Other

Identifiers

NCT04585282

Chengmei Yuan

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

intervention group

Experimental group

Description:

The study group was treated with intensive cognitive behavioral therapy for insomnia.

Treatment:

Behavioral: Plus Cognitive behavioral therapy of insomnia（CBT-I plus）

control group

Active Comparator group

Description:

The control group was treated with traditional cognitive behavioral therapy for insomnia.

Treatment:

Behavioral: Cognitive behavioral therapy of insomnia（CBT-I）