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CBT for Insomnia With Anxiety and Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04585282
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Plus Cognitive behavioral therapy of insomnia(CBT-I plus) Behavioral: Cognitive behavioral therapy of insomnia(CBT-I) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this study, patients were randomly assigned to study group and control group by random number table.
Masking: Single (Investigator)
Masking Description: The blind method of this study is evaluator blindness, that is, the evaluator does not know the grouping of subjects.
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Cognitive Behavioral Therapy for Insomnia With Anxiety and Depression
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. Change of sleep efficiency [ Time Frame: Change from Baseline Sleep efficiency at 8 weeks ]

    Sleep efficiency was measured by sleep diary

    Sleep efficiency was measured by sleep diary


  2. Change of depressive symptoms [ Time Frame: 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.

  3. Change of anxiety symptoms [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585282


Contacts
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Contact: Chengmei Yuan 86-13818132592 yuanchengmei@yeah.net

Locations
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China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Chengmei Yuan    86-13818132592    yuanchengmei@yeah.net   
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
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Study Director: Chengmei Yuan Shanghai Mental Health Center
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT04585282    
Other Study ID Numbers: Chengmei Yuan
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders