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Efficacy Validation and Outreach of Digital Cognitive Behavioral Therapy for Insomnia

Efficacy Validation and Outreach of Digital Cognitive Behavioral Therapy for Insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079482
Enrollment
Unknown
Registered
2024-01-04
Start date
2024-01-06
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

Sleep Hygiene Education Group:Routine treatment + sleep hygiene education
The dCBTI Group:Routine treatment + dCBTI

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: a. meet the DSM-V-based diagnostic criteria for insomnia disorders; b. right-handed, aged 18-65 years; c. ISI> 14; d. Junior high school or above; e. MMSE= 24; f. PHQ-9=19; g. GAD-7=14.

Exclusion criteria

Exclusion criteria: a. Bipolar and related disorder, schizophrenia spectrum and other psychotic disorders, substance related and addictive disorders that met DSM-V diagnostic criteria in the past 6 months; b. the presence of seizures in the past 6 months; c. other currently untreated mental or physical diseases that are not stable; d. have been hospitalized in the past month for any reason; e. current severe suicidal ideation, suicidal behavior, or severe psychotic symptoms; f. Prior cognitive behavioral therapy for insomnia; g. Current psychotherapy or any other clinical trial; h. shift workers or flyers who frequently cross time zones; i. Pregnancy; j. no fixed residence; k. Undiagnosed AHI> 15 patients with OSAS; l. Other untreated medical conditions that affect sleep (e.g., restless legs syndrome, etc.) m. Patients who are using a variety of stimulation devices, such as cardiac pacemakers, brain depth stimulators, thalamic stimulators, vagus nerve stimulators, and transcranial magnetic stimulators.

Design outcomes

Primary

MeasureTime frame
Sleep Latency, SOL;Pittsburgh Sleep Quality Index, PQSI;Total sleep time, TST;Sleep efficiency, SE;Insomnia severity index scale;Epworth Sleeping Scale /ESS;Fatigue severity scale;PHQ-9 Depression Screening Scale;Generalized anxiety Scale / GAD-7;Sleep beliefs and Attitudes Questionnaire / DBAS-16;Mini-mental State Examination (MMSE);—

Secondary

MeasureTime frame
Night wake time;Night wake times;—

Countries

China

Contacts

Public ContactLv yudan

The First Hospital of Jilin University

lvyd@jlu.edu.cn+86 130 1913 5578

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026