Sleep Initiation and Maintenance DisordersNCT05065242
Smartphone-delivered CBT-I
A study testing Cognitive Behavioural Therapy in people with Sleep Initiation and Maintenance Disorders, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- 20 Aug 2021to 20 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone-delivered CBT for Insomnia, a Randomised Controlled Trial
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.
Read more
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.
- Being tested
- Cognitive Behavioural Therapy
- Keywords
- Cognitive behaviour therapy, Moderation, Mediation, Efficacy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Negotiating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
Sleep restriction, Stimulus control, sleep hygiene and cognitive techniques to handle sleep disturbing thoughts.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy | Experimental | 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. Receives: Behavioral: Cognitive Behavioural Therapy |
| Waitlist | No intervention | The waitlist serves as a passive control which will receive the same measures as the cognitive behaviour therapy group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity index
Global measure of insomnia severity, used for assessing change in insomnia severity from pretreatment to posttreatment.
Measured: 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 outcomes (10)
Work and Social Adjustment Scale
Score: 0-40, with higher scores indicating worse outcome.
Measured: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment
Sleep onset latency (SOL)
Measured: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Wake time after sleep onset (WASO).
Measured: Pretreatment (week 0), post-treatment (week 6).
Early morning awakenings (EMA).
Measured: Pretreatment (week 0), post-treatment (week 6).
Total sleep time (TST).
Measured: Pretreatment (week 0), post-treatment (week 6).
Depression, anxiety and stress scale-21
Score: 0-63, with higher scores indicating worse outcome.
Measured: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.
Brunnsviken Brief Quality of life index
Score: 0-96, with higher scores indicating better quality of life.
Measured: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.
Bed and rise time variability
Measured: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Time in bed (TIB)
Measured: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Pre sleep arousal scale
Score: 16-80, with higher scores indicating worse outcome.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start20 Aug 2021
- Primary completion29 Sep 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikard Sunnhed, Karolinska Institutet
- Investigators
- Rikard Sunnhed, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065242
- Sponsor's protocol ID
- CBT-I - L2S
- Status last verified
- Mar 2023
- First submitted
- 9 Sep 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-delivered CBT for Insomnia, a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05065242
- Acronym / sponsor ID
- CBT-I - L2S
- Keywords
- Cognitive behaviour therapy, Moderation, Mediation, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy | Experimental | Behavioral: Cognitive Behavioural TherapyCognitive 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. |
| Waitlist | No intervention | –The waitlist serves as a passive control which will receive the same measures as the cognitive behaviour therapy group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural TherapySleep restriction, Stimulus control, sleep hygiene and cognitive techniques to handle sleep disturbing thoughts. | Behavioural | Cognitive Behavioural Therapy |
Primary outcome
Insomnia severity index
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.
10 secondary outcomes
Work and Social Adjustment Scale
Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment
Sleep onset latency (SOL)
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Wake time after sleep onset (WASO).
Time frame: Pretreatment (week 0), post-treatment (week 6).
Early morning awakenings (EMA).
Time frame: Pretreatment (week 0), post-treatment (week 6).
Total sleep time (TST).
Time frame: Pretreatment (week 0), post-treatment (week 6).
Depression, anxiety and stress scale-21
Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.
Brunnsviken Brief Quality of life index
Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.
Bed and rise time variability
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Time in bed (TIB)
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Pre sleep arousal scale
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikard Sunnhed, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy in people with Sleep Initiation and Maintenance Disorders, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity index (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.