Back to resultsSmartphone-delivered CBT-I
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Cognitive behaviour therapy, Moderation, Mediation, Efficacy
Eligibility Criteria
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.
Sites / Locations
- Karolinska institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive Behavioural Therapy
Waitlist
Arm Description
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.
The waitlist serves as a passive control which will receive the same measures as the cognitive behaviour therapy group.
Outcomes
Primary Outcome Measures
Insomnia severity index
Global measure of insomnia severity, used for assessing change in insomnia severity from pretreatment to posttreatment.
Secondary Outcome Measures
Work and Social Adjustment Scale
Score: 0-40, with higher scores indicating worse outcome.
Sleep onset latency (SOL)
Wake time after sleep onset (WASO).
Early morning awakenings (EMA).
Total sleep time (TST).
Depression, anxiety and stress scale-21
Score: 0-63, with higher scores indicating worse outcome.
Brunnsviken Brief Quality of life index
Score: 0-96, with higher scores indicating better quality of life.
Bed and rise time variability
Time in bed (TIB)
Pre sleep arousal scale
Score: 16-80, with higher scores indicating worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05065242
Brief Title
Smartphone-delivered CBT-I
Official Title
Smartphone-delivered CBT for Insomnia, a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
November 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
Cognitive behaviour therapy, Moderation, Mediation, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
The waitlist serves as a passive control which will receive the same measures as the cognitive behaviour therapy group.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
Sleep restriction, Stimulus control, sleep hygiene and cognitive techniques to handle sleep disturbing thoughts.
Primary Outcome Measure Information:
Title
Insomnia severity index
Description
Global measure of insomnia severity, used for assessing change in insomnia severity from pretreatment to posttreatment.
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.
Secondary Outcome Measure Information:
Title
Work and Social Adjustment Scale
Description
Score: 0-40, with higher scores indicating worse outcome.
Time Frame
Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment
Title
Sleep onset latency (SOL)
Time Frame
Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Title
Wake time after sleep onset (WASO).
Time Frame
Pretreatment (week 0), post-treatment (week 6).
Title
Early morning awakenings (EMA).
Time Frame
Pretreatment (week 0), post-treatment (week 6).
Title
Total sleep time (TST).
Time Frame
Pretreatment (week 0), post-treatment (week 6).
Title
Depression, anxiety and stress scale-21
Description
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.
Title
Brunnsviken Brief Quality of life index
Description
Score: 0-96, with higher scores indicating better quality of life.
Time Frame
Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.
Title
Bed and rise time variability
Time Frame
Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Title
Time in bed (TIB)
Time Frame
Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Title
Pre sleep arousal scale
Description
Score: 16-80, 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) and follow-up at 3 month after treatment.
Other Pre-specified Outcome Measures:
Title
Credibility Expectancy Questionnaire.
Description
Score: 4 items, 1-9, 2 items 0-10, with higher scores indicating higher credibility and expectancy.
Time Frame
During the first treatment module (first week of treatment).
Title
Client Satisfaction Questionnaire.
Description
Score: 8-32, with higher scores indicating higher satisfaction.
Time Frame
Post-treatment (week 6)
Title
Activity and adherence with treatment protocol (self developed questionnaire assessing treatment activity and adherence relating to text, homework and therapist support).
Description
Score ranging from 1-5, with higher scores indicating higher activity and adherence.
Time Frame
Post-treatment (week 6)
Title
three items assessing sick-leave and other concomitant treatment (self developed questionns).
Description
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) and at 3-month follow-up.
Title
Adverse events (questionnaire from a previous similar study).
Time Frame
Post-treatment (week 6)
Title
Changes in suicide risk (Item 9 from the MADRS).
Description
Score: 0-6, with higher scores indicating a higher suicide risk.
Time Frame
Pretreatment (week 0), post-treatment (week 10) and follow-up at 6 month after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rikard Sunnhed, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska institute
City
Stockholm
State/Province
Stockholms Län
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Smartphone-delivered CBT-I
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