Karolinska institute
Stockholm, Stockholm County, Sweden
NCT Number: NCT05065242
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Stockholm, Stockholm County, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sleep restriction, Stimulus control, sleep hygiene and cognitive techniques to handle sleep disturbing thoughts.
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6) and follow-up at 3 month after treatment.
Global measure of insomnia severity, used for assessing change in insomnia severity from pretreatment to posttreatment.
Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment
Score: 0-40, with higher scores indicating worse outcome.
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Time frame: Pretreatment (week 0), post-treatment (week 6).
Time frame: Pretreatment (week 0), post-treatment (week 6).
Time frame: Pretreatment (week 0), post-treatment (week 6).
Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.
Score: 0-63, with higher scores indicating worse outcome.
Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.
Score: 0-96, with higher scores indicating better quality of life.
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6) and follow-up at 3 month after treatment.
Score: 16-80, with higher scores indicating worse outcome.
Time frame: During the first treatment module (first week of treatment).
Score: 4 items, 1-9, 2 items 0-10, with higher scores indicating higher credibility and expectancy.
Time frame: Post-treatment (week 6)
Score: 8-32, with higher scores indicating higher satisfaction.
Time frame: Post-treatment (week 6)
Score ranging from 1-5, with higher scores indicating higher activity and adherence.
Time frame: Post-treatment (week 6) and at 3-month follow-up.
Item one assessing number of days on sick-leave. Item two assessing whether participants have sought other healthcare options. Item three assessing whether participants have received other treatments for their sleeping issues during the specified time frames.
Time frame: Post-treatment (week 6)
Time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6 month after treatment.
Score: 0-6, with higher scores indicating a higher suicide risk.
Karolinska Institutet
Other
Smartphone-delivered CBT for Insomnia, a Randomised Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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