Clinical trial NCT06339853: Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
Official title: A Single-arm Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients

Detailed description: The investigators intend to conduct a single-arm clinical trial. Following voluntary consent during the screening visit, participants will undergo screening procedures. The screening process will proceed step by step, evaluating selection/exclusion criteria through assessments such as the Mini International Neuropsychiatric Interview (MINI), Columbia Suicide Severity Rating Scale (C-SSRS), etc. Participants who meet the selection criteria and do not meet the exclusion criteria will use the DTx app for 8 weeks. Surveys conducted after app installation (Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale (GAD-7), and a sleep environment questionnaire) will serve as the baseline.

During the clinical trial period, sleep diaries and compliance (lesson completion rate) (applicable only to the experimental group) will be collected through the app. Sleep diaries will be used to evaluate sleep metrics such as sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset (WASO), etc.

For the experimental group, assessments as per the protocol will be conducted at baseline (Visit 1), and safety (adverse events) evaluation and termination of app usage will occur at 9 weeks (Visit 2).

Eligibility criteria: Inclusion Criteria:

1. Individuals aged 19 to 65 years old
2. DSM-5 insomnia disorder patient
3. ISI ≥11
4. Capable of using mobile device and application

Exclusion Criteria:

1. currently on non-pharmacological treatment for insomnia (ex. CBT-I, light therapy, oriental therapy for insomnia)
2. sleep disorders diagnosis other than insomnia (ex. Obstructive sleep apnea, sleep behavior problem, restless leg syndrome)
3. progressive and active medical conditions
4. received continuous psychotherapy such as CBT, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months
5. major psychiatric illness as assessed through MINI
6. suicide risk as assessed through C-SSRS
7. having occupational risk due to sleep restriction
8. shift workers
9. PHQ-9 of 20 or above
10. Individuals who have actually slept less than an average of 5 hours per night over the past month
11. Pregnant women or individuals planning pregnancy during the clinical trial period

Primary outcomes:
measure: Change from baseline to week 9 (post-treatment) of ISI
timeFrame: 9 weeks
Secondary outcomes:
measure: Secondary Outcome - Changes from baseline to week 9 of SE
timeFrame: 9 weeks
measure: Changes from baseline to week 9 of SOL.
timeFrame: 9 weeks
measure: Changes from baseline to week 9 of WASO.
timeFrame: 9 weeks
measure: Changes from baseline to week 9 of PHQ-9.
timeFrame: 9 weeks
measure: Changes from baseline to week 9 of GAD-7.
timeFrame: 9 weeks
measure: Changes from baseline to week 9 of compliance.
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Seoul,
country: Korea, Republic of
facility: Department of Psychiatry, Severance Hospital
Study officials:
References: