Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia ：A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Insomnia
- Sponsor
- Peking University First Hospital
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Insomnia Severity Index (ISI)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This randomized, open, parallel controlled study aims to explore the clinical effectiveness of smartphone-based digital Cognitive behavioural therapy for insomnia（dCBT-I）. Patients who diagnosed chronic insomnia disorder and proficient in using mobile phone intended to receive CBT-I. Participants will be random allocation into Group dCBT-I and Group Sleep Education. Primary outcome is the insomnia severity as measured using the Insomnia Severity Index (ISI).
Detailed Description
This is a single-center, randomized, open, parallel controlled study. Patients who had no CBTI treatment before for chronic insomnia will be recruited and followed for 6 weeks. Participants will be random allocation into Group dCBT-I and Group Sleep Education, and then explore the clinical effectiveness of smartphone-based digital CBT-I therapy. We will collect the baseline information: population characteristics, including age, sex, education, employment, living and residential status, demographic data, smoking and alcohol consumption, body mass index (BMI); medical history and medication status and adverse reactions during treatment. Primary outcome is the Insomnia Severity Index (ISI). Secondary outcomes include an online sleep diary measured information regarding: time in bed(TIB), total sleep time (TST), sleep efficiency (SE), total wake time(TWT); bracelet measured information regarding: total sleep time (TST), sleep latency(SL), sleep efficiency (SE), the times of wake from sleep(TWS), sleep quality score setting by bracelet; the 16-item Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16); Fatigue Severity Scale(FSS); Health-related Quality of Life (SF-12); Generalized Anxiety Disorder Scale-7 (GAD-7); Patient Health Questionnaire-9 (PHQ-9).
Investigators
Jing MA
Dr.
Peking University First Hospital
Eligibility Criteria
Inclusion Criteria
- •Participants who meet proposed ICSD-3 and DSM-5 criterias for persistent Insomnia Disorder. (a) a current complaint of poor sleep (diffculty initiating and/or maintaining sleep, early morning wakening, or non-restorative sleep); with (b) signifcant daytime effects in 1 of 6 domains (fatigue, daytime sleepiness, cognitive impairment \[e.g., concentration problems\], mood disturbance, impaired occupational or academic functioning \[e.g., poor productivity\], impaired interpersonal/ social functioning); and (c) affecting them 3 nights per week for 3 months.
- •Insomnia Severity Index (ISI) ≥14;
- •If a comorbid sleep or psychiatric disorder is present, treatment of this condition should be stable at the time of entry in the study. There is no requirement of insomnia medications.
- •Can use APP/ Wechat applet skillfully, can freely communicate, read and fill the electronic questionnaire, well understanding.
- •Sign informed consent
Exclusion Criteria
- •The presence of shift work, head injury, acute suicidality, current mania, schizophrenia or elevated substance use.
- •With documented severe physical diseases impairing sleep: such as craniocerebral disease, cancer pain, unstable angina or uncontrolled heart failure, etc.
- •Current or past CBT-I
- •Epworth Sleepiness Scale (ESS) ≥12
- •Without informed consent or not signed
Outcomes
Primary Outcomes
Insomnia Severity Index (ISI)
Time Frame: V2 and V4 visit ( 6, 18 weeks after recruitment).
The ISI is a 6-item self-report measure of impairment in daytime functioning due to inadequate sleep. The ISI shows adequate internal consistency, appropriate test-retest reliability, and sensitivity to change with treatment. Scores can range from 0 to 28, with higher scores indicating more impairment. Scores higher than 14 are thought to be indicative of the presence of clinical insomnia and change in scores of 8.4 have been found to reflect moderate improvement in clinical samples.
Secondary Outcomes
- Sleep characters recorded by smart bracelet(baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.)
- Health-related Quality of Life (SF-12)(baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.)
- Insomnia Severity Index (ISI) at V3 and V5 visit(V3 and V5 visit ( 10, 30 weeks after recruitment).)
- Dysfunctional Beliefs and Attitudes about sleep scale (DBAS-16)(baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.)
- Generalized Anxiety Disorder Scale-7 (GAD-7)(baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.)
- Insomnia Severity Index (ISI) improvement(6, 10,18, 30 weeks after recruitment.)
- Sleep characters recorded by online sleep diary(baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.)
- Fatigue Severity Scale(FSS)(baseline, and 6, 10,18, 30 weeks after recruitment. Some participants 52 weeks after recruitment decided by themselves.)
- Patient Health Questionnaire-9 (PHQ-9)(baseline, and 6, 10,18, 30 weeks after recruitment.)