CBT for Insomnia With Anxiety and Depression

NCT04585282 | Unknown

• 1 other identifier: Chengmei Yuan
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

intervention group

EXPERIMENTAL

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

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

control group

ACTIVE COMPARATOR

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

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

Interventions

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

Cbt-i plus program is an enhanced version of cbt-i program, which increases the response to depression and anxiety symptoms.

intervention group

Cognitive behavioral therapy of insomnia（CBT-I） BEHAVIORAL

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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Chengmei Yuan

  Shanghai Mental Health Center

  STUDY DIRECTOR

Central Study Contacts

Chengmei Yuan

CONTACT

86-13818132592; yuanchengmei@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The blind method of this study is evaluator blindness, that is, the evaluator does not know the grouping of subjects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study, patients were randomly assigned to study group and control group by random number table.

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: October 14, 2020
• Study Start: August 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: July 31, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)