CBT for Insomnia With Anxiety and Depression

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

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.

Study Overview

• Status: Unknown
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Plus Cognitive behavioral therapy of insomnia（CBT-I plus）; Behavioral: Cognitive behavioral therapy of insomnia（CBT-I）

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center
      • Contact: Chengmei Yuan; Phone Number: 86-13818132592; Email: yuanchengmei@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; The study group was treated with intensive cognitive behavioral therapy for insomnia.	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.
Active Comparator: control group; The control group was treated with traditional cognitive behavioral therapy for insomnia.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Study Director: Chengmei Yuan, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: Chengmei Yuan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No