insomnia
Conditions
Interventions
Treatment Group:Subjects were treated with XBTI3.0 cognitive Behavioral therapy for insomnia
Sponsors
Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet The Diagnostic criteria for insomnia Disorders based on DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders-5); (2)18-65 years old; (3)ISI (Insomnia Severity Index) >14; (4)PHQ-9 (Patient Health Questionnaire-9, Depression Screening Scale) =19; (5)GAD-7 (General Anxiety Disorder 7) =14; (6)Volunteer to participate in this clinical trial, and the subject can understand the purpose of the trial, demonstrate adequate compliance with the trial protocol, and sign an informed consent.
Exclusion criteria
Exclusion criteria: (1) No informed consent is signed; (2) DSM-5 compliance (The Diagnostic and Statistical Manual of Mental) exists within 6 months prior to signing the informed consent Disorder 5, Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria for bipolar and related disorders, schizophrenia spectrum and other psychiatric disorders, substance-related and addictive disorders; (3) There are seizures within 6 months before signing the informed consent; (4) Other currently undiagnosed mental and physical diseases that are not yet stable; (5) Have been hospitalized in the past month for any reason; (6) Currently have serious suicidal thoughts, suicidal behavior or severe psychotic symptoms, and the PHQ-9 scale of the ninth score =2; (7) Previous experience of cognitive behavioral therapy for insomnia; (8) Participants who have participated in any other drug or medical device clinical trial within 3 months before signing the informed consent; (9) Shift workers or frequent cross-time zone fliers; (10) Women who are pregnant or have pregnancy intention in the past six months, or breastfeeding women; (11) No fixed residence; (12) Obstructive sleep apnea hypopnea syndrome screening scale (Stop Bang scale) =3 points; (13) Other undiagnosed diseases that affect sleep; (14) Patients who are using various stimulator devices, such as cardiac pacemakers, brain deep stimulators, thalamic stimulators, vagus nerve stimulators, and transcranial magnetic stimulators; (15) Use of drugs in the past month that significantly affect sleep; (16) Participants deemed inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scores on the Insomnia Severity Index (ISI) scale;Scores on the Sleep Beliefs and Attitudes Questionnaire (DBAS-16); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Scale (PSQI) score;Epworth Sleepiness Scale (ESS) score;PHQ-9 Depression Screening Scale (PHQ-9) score;Scores on the Generalized Anxiety Scale (GAD-7); | — |
Countries
China
Contacts
Public ContactJin Wang
Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
Outcome results
None listed