Smartphone-delivered CBT-I

  • STATUS
    Recruiting
  • End date
    Nov 20, 2022
  • participants needed
    90
  • sponsor
    Karolinska Institutet
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Updated on 19 April 2022
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depression
anxiety
behavior therapy
initial insomnia

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.

Details
Condition Sleep Initiation and Maintenance Disorders
Treatment Cognitive Behavioural Therapy
Clinical Study IdentifierNCT05065242
SponsorKarolinska Institutet
Last Modified on19 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Presence of insomnia more than three nights per week and for more than three months
Insomnia despite adequate opportunity to sleep
Insomnia severity typical for insomnia disorder, i.e. 11 points or more on the Insomnia Severity Index (ISI)
Nighttime insomnia symptoms, i.e., two points or more on at least one of the first three ISI questions
Daytime insomnia symptoms, i.e. two points or more on one or both of the ISI distress and impairment items (numbers 5 and 7)
Clinical insomnia symptoms from sleep diaries concerning three nighttime symptoms (difficulties with sleep initiation, difficulties with sleep maintenance, and early morning awakenings), i.e., thirty minutes or more on average on one or more of the symptoms
No current or past CBT-I treatment within the past 5 years
Time and opportunity to participate in treatment for six weeks
Time and opportunity to engage with the treatment content and execute homework assignments for six weeks
Access to a smart mobil telephone, email and internet

Exclusion Criteria

Severe depression, i.e., more than 30 points on MADRS-S
Suicidal risk, i.e., 4 points or more on item 9 on MADRS-S
A high intake of alcohol or caffeine
Insomnia due to shiftwork or other sleep-disturbing events (e.g., pregnancy, small children, or animals in the sleep environment)
Participants with a history of psychotic or bipolar disorder
If a somatic condition is reported, it is required that it is relatively stable and/or that the candidate is receiving treatment for the condition
When a candidate fulfills criteria for a psychiatric or somatic condition, it is required that insomnia is the disorder currently most distressing and disabling or that the insomnia remains despite treatment for the comorbid condition
Participants with the following primary sleep disorders will be excluded via the Duke Structured Interview for Sleep Disorders (DSISD): sleep apnea, restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, and parasomnias
If sleep medication is used, it is required that the use has been relatively stable during three months
If Selective Serotonin Reuptake Inhibitors (SSRI) use is reported, it is required that the onset of the medication was at least three months prior to the telephone interview
Participants who regularly consume sleep-disturbing medications
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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