Clinical trial NCT06695000: Digital CBT-I for Chronic Insomnia
Official title: A Multi-Site, Randomized, Wait-List Controlled Trial to Assess the Effectiveness and Safety of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) in Patients with Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia Chronic
Insomnia Disorder
Lead sponsor: WELT corp
Sponsor class: INDUSTRY
First posted: 2024-11-19
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness and safety of a digital Cognitive Behavioral Therapy program for Insomnia (CBT-I) in individuals with chronic insomnia. Participants will be randomly assigned to either begin digital CBT-I immediately or join a wait-list.

Detailed description: This multi-site, randomized, wait-list controlled trial investigates the effectiveness and safety of a digital Cognitive Behavioral Therapy for Insomnia (CBT-I) program in treating chronic insomnia. Participants will be randomly assigned to start the digital CBT-I immediately or after a wait period. The digital CBT-I program, includes modules on sleep education, cognitive restructuring, stimulus control, sleep restriction, and relaxation techniques. Primary and secondary outcomes will measure insomnia severity, beliefs about sleep, daytime sleepiness, mood, quality of life, productivity, and sleep efficiency. Findings aim to assess the effectiveness of digital CBT-I in improving sleep and daily functioning among chronic insomnia patients in South Korea.

Eligibility criteria: Inclusion Criteria:

* Meets diagnostic criteria for insomnia disorder according to the International Classification of Diseases, 10th Revision (ICD-10), including: F51: Nonorganic sleep disorders; G47: Sleep disorders
* Has experienced insomnia symptoms for 3 months or longer.
* Scores 8 or higher on the Insomnia Severity Index (ISI).
* Oral and written fluency in Korean
* Owns a smartphone and is independently able to use apps on a smartphone.
* Voluntarily agrees to participate in this clinical study and provides signed informed consent.

Exclusion Criteria:

* Currently receiving non-pharmacological treatments for insomnia (e.g., CBT-I, light therapy, traditional medicine for sleep) within the past 3 months from screening.
* Diagnosed with other sleep disorders aside from insomnia and currently symptomatic, such as:

  * Obstructive sleep apnea (G47.30)
  * Sleep behavior disorders
  * Restless leg syndrome (G28.8)
  * Narcolepsy (G47.4)
* Has an active, ongoing physical illness that impedes daily functioning, such as:

  * Congestive heart failure
  * Chronic obstructive pulmonary disease (COPD)
  * Acute pain
  * Neurological disorders (e.g., cerebrovascular disease)
  * Neurodegenerative disorders (e.g., dementia, multiple sclerosis)
  * Unstable medical conditions or life expectancy of less than 6 months
* Adjustments in schedule or dosage of sleep medications, antidepressants, anticonvulsants, anxiolytics, or antipsychotics within the past 3 months, or use of PRN (as needed) prescribed sleep medications.
* Engaged in shift work.
* Pregnant individuals or those planning to become pregnant during the study period.
* Any condition that the investigator believes would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities

Primary outcomes:
measure: Change from Baseline in Insomnia Severity Index (ISI) Score at Post-Intervention
timeFrame: "From baseline (Visit 1) to post-intervention assessment at 6 weeks
Secondary outcomes:
measure: Change from Baseline in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) Score at Post-Intervention (6 Weeks)
timeFrame: From baseline to 6 weeks post-intervention
measure: Change from Baseline in Epworth Sleepiness Scale (ESS) Score at Post-Intervention (6 Weeks)
timeFrame: From baseline to 6 weeks post-intervention
measure: Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Post-Intervention (6 Weeks)
timeFrame: From baseline to 6 weeks post-intervention
measure: Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at Post-Intervention (6 Weeks)
timeFrame: From baseline to 6 weeks post-intervention
measure: Change from Baseline in Quality of Life (SF-36) Score at Post-Intervention (6 Weeks)
timeFrame: From baseline to 6 weeks post-intervention
measure: Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-SHP) Score at Post-Intervention (6 Weeks)
timeFrame: From baseline to 6 weeks post-intervention
measure: Change from Baseline in Sleep Efficiency at Post-Intervention (6 Weeks)
timeFrame: From baseline to 6 weeks post-intervention
measure: Change from Baseline in Sleep Onset Latency at Post-Intervention (6 Weeks)
timeFrame: From baseline to 6 weeks post-intervention
measure: Change from Baseline in Wake After Sleep Onset at Post-Intervention (6 Weeks)
timeFrame: From baseline to 6 weeks post-intervention
measure: Change from Baseline in Total Sleep Time at Post-Intervention (6 Weeks)
timeFrame: From baseline to 6 weeks post-intervention
Other outcomes:
measure: System Usability Scale (SUS) Score for Digital CBT-I at Post-Intervention (6 Weeks)
timeFrame: 6 weeks post-intervention
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Yongin-si
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
Study officials:
References: