CBT for Insomnia With Anxiety and Depression

Insomnia Clinical Trial

Official title:

A Randomized Controlled Study of Cognitive Behavioral Therapy for Insomnia With Anxiety and Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04585282
• Other study ID #: Chengmei Yuan
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: July 2020
• Source: Shanghai Mental Health Center
• Contact: Chengmei Yuan
• Phone: 86-13818132592
• Email: yuanchengmei[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Plus 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.
• Cognitive 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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of sleep efficiency	Sleep efficiency was measured by sleep diary; Sleep efficiency was measured by sleep diary	Change from Baseline Sleep efficiency at 8 weeks
Primary	Change of depressive symptoms	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 from Baseline Sleep efficiency at 8 weeks
Primary	Change of anxiety symptoms	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 from Baseline Sleep efficiency at 8 weeks