Clinical Trials Logo

Clinical Trial Summary

The overall purpose with this investigation was to increase access to cognitive behavioural therapy for insomnia (CBT-I) by examining CBT-I delivered through a smartphone application The first aim that will be addressed is to explore the efficacy of the smartphone delivered CBT-I on overall insomnia and on nighttime symptoms by comparing CBT-I to a waitlist control in a randomised controlled trial. The second aim is to investigate the effect smartphone delivered CBT-I compared to the waitlist on secondary outcomes related to insomnia, such as stress, anxiety, depression, quality of life and functional impairment. The third aim that will be addressed is to examine what patient characteristics that CBT delivered to a smartphone depend on to be effective with a treatment-moderator strategy. To investigate moderators, the following moderators will be assessed; age, gender, occupational status, level of education, initial insomnia severity, dysfunction, medication use, chronic pain, somatic/psychiatric co-morbidity, and proposed behavioral mediators of sleep restriction and stimulus control will also be employed as moderators. The fourth aim that will be addressed is to examine behavioural processes of sleep restriction and stimulus control as potential mediators of treatment outcome.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Sleep Initiation and Maintenance Disorders

NCT number NCT05065242
Study type Interventional
Source Karolinska Institutet
Contact Rikard Sunnhed, PhD
Phone 0046739 378193
Email [email protected]
Status Recruiting
Phase N/A
Start date August 20, 2021
Completion date May 20, 2022

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Recruiting NCT04661306 - The Better Sleep for Supporters With Insomnia Study N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Not yet recruiting NCT05000528 - Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia N/A
Completed NCT01784614 - A Study of LY2624803 in Japanese Participants With Transient Insomnia Phase 1
Completed NCT00365261 - Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer Phase 4
Completed NCT00380003 - Efficacy Study of EVT 201 to Treat Insomnia Phase 2
Completed NCT00183378 - Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease N/A
Completed NCT00946530 - Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease N/A
Completed NCT00097604 - Effects of Valerian on Sleep in Healthy Older Adults Phase 2
Completed NCT00630175 - Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia Phase 3
Completed NCT00044629 - Combined Behavioral/Pharmacological Therapy for Insomnia Phase 2
Completed NCT00079664 - Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults Phase 1
Completed NCT01154023 - Behavioral Intervention for Insomnia in Older Adults N/A
Recruiting NCT04417153 - Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes
Recruiting NCT04560595 - Remote Guided Caffeine Reduction N/A
Completed NCT03852966 - Better Sleep in Psychiatric Care - ADHD N/A
Terminated NCT00750919 - Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007) Phase 3
Recruiting NCT04550507 - Mind-Body Interventions to Mitigate Effects of Media Use on Sleep in Early Adolescents N/A
Not yet recruiting NCT04986904 - Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers N/A