Chronic Insomnia Clinical Trial
Official title:
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia ：A Randomized Controlled Trial
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).
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). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03171519 -
Effects of Exercise and Acupuncture on Chronic Insomnia
|
N/A | |
| Completed |
NCT02515006 -
Impact of Homeopathy for Persistent Insomnia in Patients With Cancer
|
N/A | |
| Recruiting |
NCT05247697 -
Mirtazapine for Chronic Insomnia in Older Adults
|
Phase 1 | |
| Active, not recruiting |
NCT04350866 -
Enhancing Access to Insomnia Care in VA PCMHI Clinics
|
||
| Active, not recruiting |
NCT04366284 -
Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
|
N/A | |
| Recruiting |
NCT04761796 -
Sleep Time and Insomnia Factors Among Professional Flight Members
|
||
| Completed |
NCT02688569 -
Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study
|
N/A | |
| Completed |
NCT02236845 -
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
|
N/A | |
| Completed |
NCT01949389 -
Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
|
N/A | |
| Completed |
NCT00414102 -
Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.
|
Phase 4 | |
| Completed |
NCT00671294 -
Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.
|
Phase 3 | |
| Completed |
NCT02392000 -
Mobile Sleep Intervention for OEF, OIF and OND Veterans
|
N/A | |
| Recruiting |
NCT04471168 -
Interest of Auriculotherapy in the Management of Chronic Insomnia
|
N/A | |
| Completed |
NCT02774642 -
Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)
|
N/A | |
| Completed |
NCT02290405 -
Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
|
||
| Recruiting |
NCT05618002 -
Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
|
||
| Completed |
NCT01995838 -
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia
|
Phase 2 | |
| Recruiting |
NCT05457790 -
Feasibility and Preliminary Efficacy of Acceptance and Commitment Therapy (ACT) for Sleep Disturbances in Adults With Sickle Cell Disease (SCD)
|
N/A | |
| Active, not recruiting |
NCT02272712 -
The Effectiveness of Online Treatment for Insomnia in Cancer Survivors
|
N/A | |
| Completed |
NCT00915135 -
Efficacy and Safety of Ramelteon on Chronic Insomnia
|
Phase 2 |