Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
180 participants
INTERVENTIONAL
2020-08-01
2022-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transdiagnostic CBT-I on Comorbid Depression and Insomnia
NCT05630261
The Impact of CBT-i on CPAP Therapy Use and Drop Outs in OSAS Patients With Insomnia.
NCT04306835
CBT-I as Early Intervention of Mood Disorders
NCT03000894
Smartphone-delivered CBT-I
NCT05065242
Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Mental Illness
NCT04598425
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
intervention group
The study group was treated with intensive cognitive behavioral therapy for insomnia.
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.
control group
The control group was treated with traditional cognitive behavioral therapy for insomnia.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Mental Health Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chengmei Yuan
Role: STUDY_DIRECTOR
Shanghai Mental Health Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Chengmei Yuan
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.