Smartphone-delivered CBT-I

Not Applicable

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Behavioral: Cognitive Behavioural Therapy

• Registration Number: NCT05065242
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-08-20
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-04
• Primary Completion: 2022-09-29
• Study Completion: 2022-11-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioural Therapy	Cognitive Behavioural Therapy	Cognitive Behavior Therapy involves the use of stimulus control and sleep restriction in order to reverse maladaptive sleep habits (time in bed, napping, bedtime variability, rise time variability) proposed to maintain insomnia. It also involves the practice of sleep hygiene principles and to a lesser extent some cognitive exercises. focused on handling sleep disturbing thought activities.

Primary Outcome Measures

Name	Time	Method
Insomnia severity index	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.

Secondary Outcome Measures

Name	Time	Method
Pre sleep arousal scale	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.
Sleep onset latency (SOL)	Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Wake time after sleep onset (WASO).	Pretreatment (week 0), post-treatment (week 6).
Early morning awakenings (EMA).	Pretreatment (week 0), post-treatment (week 6).
Bed and rise time variability	Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Time in bed (TIB)	Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Work and Social Adjustment Scale	Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment	Score: 0-40, with higher scores indicating worse outcome.
Total sleep time (TST).	Pretreatment (week 0), post-treatment (week 6).
Depression, anxiety and stress scale-21	Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.	Score: 0-63, with higher scores indicating worse outcome.
Brunnsviken Brief Quality of life index	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.

Trial Locations

Locations (1)

Karolinska institute; 🇸🇪 Stockholm, Stockholms Län, Sweden