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CBT for Insomnia With Anxiety and Depression

Primary Purpose

Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Plus Cognitive behavioral therapy of insomnia（CBT-I plus）
Cognitive behavioral therapy of insomnia（CBT-I）
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of sleep efficiency
Sleep efficiency was measured by sleep diary Sleep efficiency was measured by sleep diary
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 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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2020
Last Updated
October 15, 2020
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT04585282
Brief Title
CBT for Insomnia With Anxiety and Depression
Official Title
A Randomized Controlled Study of Cognitive Behavioral Therapy for Insomnia With Anxiety and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study, patients were randomly assigned to study group and control group by random number table.
Masking
Investigator
Masking Description
The blind method of this study is evaluator blindness, that is, the evaluator does not know the grouping of subjects.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
The study group was treated with intensive cognitive behavioral therapy for insomnia.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The control group was treated with traditional cognitive behavioral therapy for insomnia.
Intervention Type
Behavioral
Intervention Name(s)
Plus Cognitive behavioral therapy of insomnia（CBT-I plus）
Intervention Description
Cbt-i plus program is an enhanced version of cbt-i program, which increases the response to depression and anxiety symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy of insomnia（CBT-I）
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of sleep efficiency
Description
Sleep efficiency was measured by sleep diary Sleep efficiency was measured by sleep diary
Time Frame
Change from Baseline Sleep efficiency at 8 weeks
Title
Change of depressive symptoms
Description
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.
Time Frame
Change from Baseline Sleep efficiency at 8 weeks
Title
Change of anxiety symptoms
Description
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.
Time Frame
Change from Baseline Sleep efficiency at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years, male and female Meet the diagnostic criteria of DSM-5 for insomnia, the Pittsburgh Sleep Quality Index (PSQI) scale total score ≥10 May be accompanied by depression symptoms, but currently does not meet any depression disorders diagnostic criteria,14≤HAMD-17≤23 May be accompanied by anxiety symptoms, but currently does not meet any anxiety disorders diagnostic criteria ,14≤HAMA≤29 Have sufficient education and understanding to complete this study to be examined and evaluated Voluntary participation in this clinical trial and signature of informed consent. Exclusion Criteria: DSM-5 other sleep problems, such as apnea syndrome, restless leg syndrome Women who are pregnant, nursing or planning to become pregnant during the study Insomnia caused by alcohol or substance abuse Severe cognitive problems 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 Patients with history of epilepsy or other serious somatic diseases Persons receiving MECT treatment for nearly one month Excluding those who have received systemic psychotherapy for more than 3 months in a row The researchers believe that it is not suitable to participate in this clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengmei Yuan
Phone
86-13818132592
Email
yuanchengmei@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chengmei Yuan
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengmei Yuan
Phone
86-13818132592
Email
yuanchengmei@yeah.net

12. IPD Sharing Statement

Plan to Share IPD
No

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CBT for Insomnia With Anxiety and Depression

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