Insomnia DisorderNCT04616157
Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial
A study testing ICBT-I in people with Insomnia Disorder and Depressive Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary objective of this study is to test the feasibility and efficacy of Internet-delivered Cognitive Behavioral Therapy (CBT) for adolescents (13 - 17 years) with sleep problems (ICBT-I). All participants will receive ICBT-I for six weeks. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Insomnia Disorder, Depressive Disorder, Anxiety Disorders
- What is being tested?
- ICBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2018to 1 Jul 2020
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical levels of insomnia symptoms, as determined by ISI-a >10.
- Age between 13 and 17 years
- Ability to read and write Swedish
- Daily access to the internet through a computer or similar device
- Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
Who cannot join
- Diagnosed with autism spectrum disorder, psychosis or bipolar disorder
- Present risk of suicide
- Ongoing substance dependence
- Completed CBT for sleep disorders within the last 6 months (defined as at least 5 sessions of CBT
- Ongoing use of central nervous system stimulant medication
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to test the feasibility and efficacy of Internet-delivered Cognitive Behavioral Therapy (CBT) for adolescents (13 - 17 years) with sleep problems (ICBT-I). All participants will receive ICBT-I for six weeks. The investigators will also evaluate the effect of the intervention on comorbid psychiatric symptoms and function.
Read the detailed description
PARTICIPANT RECRUITMENT:
For recruitment, this pilot trial will be advertised at child and adolescent mental health services and primary care clinics, as well as through newspapers. The inclusion procedure will be carried out in two steps: 1) telephone interview and 2) face-to-face assessment.
Telephone interview: An initial telephone interview will be conducted with the adolescent/parent in order to broadly assess inclusion and exclusion criteria.
Face-to-face baseline diagnostic assessment: After the telephone screening, the adolescent along with his/her parents, are invited to a face-to-face assessment at the Child and Adolescent Mental Health clinic, including the diagnostic screening interview MINI-KID conducted with adolescents and parents jointly. Insomnia diagnoses will be established using DSM-IV criteria and levels of insomnia symptoms will be determined using ISI-a. If the ISI-a score is >10, the family will be invited to participate in the study, provided that the other inclusion criteria are fulfilled and no exclusion criteria prohibit participation. Following face-to-face assessment, participants will be provided with an information sheet and consent form.
DATA COLLECTION:
Baseline self-report measures: Participants included in the study after the face-to-face diagnostic assessment are asked to fill in self-report measures on the internet, provided via personal login and password. Participants will aslo be asked to fill in a sleep-wake diary and to wear an actigraph during seven consecutive days/nights.
Self-rating assessments during intervention: ISI-a is administered to adolescents every week during treatment.
Study participants are in regular contact (on a weekly basis) with experienced clinicians during the ICBT-I treatment. Clinicians that suspect any kind of adverse event during the assessment or treatment process will contact the parent via telephone as a first step of assessing the severity of the incident. Adverse events in this context are defined as an actual or potential situation that threatens the patient's well-being, e.g., suicide risk or an acute increase of symptoms. In the case of an adverse event, the clinician informs the study coordinator (LÅ) for a discussion of adequate action taking. If a continuation of the ICBT treatment is considered inappropriate with regard to the participants' best interest and well-being, the participant will be excluded from the study and parents/adolescents will be provided with proper referral information. Any adverse event will be reported in the planned publication of the pilot study.
Outcome measure reliability procedures: To ensure the reliability of the assessments conducted by study clinicians, all assessors will be trained by experienced instructors in the diagnostic screening instrument MINI-KID. All therapists that participate in the study will also be continuously trained in MINI-KID interviewing, assessment and diagnosing.
Post-treatment and follow-up measurement: Post-treatment measurement with actigraphy, sleep-wake diary and self-report measures will be conducted immediately after treatment (6 weeks after baseline). A follow-up measurement will be performed 6 months after treatment termination.
Referral of non-responders After the 6-month follow-up, all non-responders (defined as those participants who have not improved to a clinically meaningful degree according to ISI-a) will be referred to their local child-and adolescent psychiatric clinic for further treatment.
Statistical Analyses Outcomes will be described as significant changes in objective and subjective sleep and in clinician and self-rated measures of insomnia symptoms and comorbid symptoms, within-group effect sizes (Cohen's d), clinically significant improvement rates and remission rates. Analyses will involve t-tests as well as linear mixed-effects modeling. Randomness of missing data will be analyzed with logistic regression. Depending on the amount of missing data, multiple imputations will be employed to compensate for missing values.
- Being tested
- ICBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depressive Disorder, Anxiety Disorders, Chronic Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICBT-IBehavioural
Cognitive-behavioral therapy for insomnia
| Study group | Role | What they receive |
|---|---|---|
| ICBT-I | Experimental | The ICBT-I treatment program is a web-based intervention consisting of six chapters/sessions that adolescents go through during six consecutive weeks.The program starts with psychoeducation regarding sleep disorders and the rationale for a cognitive behavioral intervention. The main focus for the treatment is behavioral interventions, mainly sleep restriction and stimulus control. The intervention also addresses problem solving, maintenance of treatment gains, relapse prevention and relaxation techniques. Caregivers will not actively participate in the treatment. During the treatment phase participants will be in contact with a therapist through standardized forms in the program. Receives: Behavioral: ICBT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insomnia symptom severity
Insomnia Severity Index- adolescent version ISI is a seven-item measure that yields a quantitative index of sleep impairment and treatment outcome. Total scores range from 0 to 28, with higher scores indicating greater perceived insomnia severity. The instrument has been adapted to teenagers, ISI-a, and validated on Swedish teenagers.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Secondary outcomes (17)
Change in subjective total sleep time
Measured with Sleep Wake Diary (SWD). The SWD is a subjective measure of participants' sleeping and waking times, from which total sleep time expressed in minutes is derived.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in subjective sleep onset latency
Measured with Sleep Wake Diary (SWD). The SWD is a subjective measure of participants' sleeping and waking times from which latency until falling asleep, expressed in minutes, is obtained.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in subjective wake after sleep onset
Measured with Sleep Wake Diary (SWD). The SWD is a subjective measure of participants' sleeping and waking times in which time awake expressed in minutes after sleep onset is obtained.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in subjective sleep efficiency
Measured with Sleep Wake Diary (SWD). The SWD is a subjective measure of participants' sleeping and waking times, from which sleep efficency is computed as the quota between time sleeping/time spent in bed, expressed in percentage. A higher percentage denotes longer time asleep.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in objective sleep total sleep time
Measured with wrist worn actigraph units. The actigraph unit will be worn during 7 consecutive days/nights at all three measurement occasion, from which total sleep time expressed in minutes is obtained.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in objective sleep onset latency
Measured with wrist worn actigraph units. The actigraph unit will be worn during 7 consecutive days/nights at all three measurement occasions, from which time in minutes before falling asleep is obtained.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in objective wake after sleep onset
Measured with wrist worn actigraph units. The actigraph unit will be worn during 7 consecutive days/nights at all three measurement occasions from which time being awake after sleep onset is obtained.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in objective sleep efficiency
Measured with wrist worn actigraph units. The actigraph unit will be worn during 7 consecutive days/nights at all three measurement occasions, from which sleep efficency is computed as the quota between time sleeping/time spent in bed, expressed in percentage. A higher percentage denotes longer time asleep.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in symptoms of insomnia
Measured with Athens Insomnia Scale (AIS), a self-administered questionnaire consisting of eight items to measure symptoms of insomnia. Total scores range from 0 to 24. Higher scores indicate that responders more severe insomnia symptoms.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in symptoms of depression
Measured with Center for Epidemiological Studies Depression Scale for Children (CES-DC). CES-DS is a 20-item self-report depression inventory that is widely used in research and has been validated on children and adolescents. Scores range from 0 to 60, in which higher scores suggest a greater presence of depressive symptoms.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in symptoms of depression 2
Revised Children's Anxiety and Depression Scale Child and Parent version (RCADS-C/P). RCADS-C/P is a child and parent self-report measure of anxiety and depression related psychopathology. The 48 items of the RCADS measures five domains of anxiety: generalized anxiety, panic anxiety, separation anxiety, social anxiety and obsessive-compulsive anxiety, as well as symptoms of depression. For depression, values range from 0 to 30, with higher values denoting more depressive symptoms.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in symptoms of generalized anxiety
Measured with RCADS-C/P (see above). RCADS-C/P is a child and parent self-report measure of anxiety and depression related psychopathology. The 48 items of the RCADS measures five domains of anxiety: generalized anxiety, panic anxiety, separation anxiety, social anxiety and obsessive-compulsive anxiety, as well as symptoms of depression. For generalized anxiety, scores range from 0 to 18, with higher values denoting more severe symptoms of anxiety.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in difficulties in emotion regulation
Measured with Difficulties in Emotion Regulation Scale, short version (DERS-16), a self-rated questionnaire assessing difficulties to regulate emotion. DERS-16 can range from 16 to 80, with Higher scores reflect greater impairment.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in intensity of pain
A Visual Analogue Scale (VAS) will be used to measure intensity of participants' current and past pain.
The scale consists of a line where the ends are defined as extreme limits (0 = no pain; 10 = worst possible pain) of pain experience
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in daytime functioning
Measured with Functional Disability Inventory (FDI), a 15-item self-rated questionnaire to measure level of day-time functioning. Scores range from 0 (no disability) to 60 (severe disability).
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in daytime sleepiness 1
Measured with Pediatric Daytime Sleepiness Scale (PDSS), a self-report scale consisting of 8 items. Scores range from 0-32, with higher scores indicating more daytime sleepiness.
Measured: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in daytime sleepiness 2
Measured with the Karolinska Sleepiness Scale (KSS), a 9-point Likert scale, ranging from 1 to 9, with higher numbers denoting more sleepiness.
Measured: Change from before treatment to after (+6 weeks) and to 6 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 Nov 2020
- Study start1 Sep 2018
- Primary completion31 Dec 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive treatment
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Mats Lekander, Karolinska Institutet
- Investigators
- Mats Lekander, PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616157
- Sponsor's protocol ID
- 2017/2315-31/2
- Status last verified
- Oct 2020
- First submitted
- 5 Apr 2018
- Last updated
- 4 Nov 2020
- 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 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial
- ClinicalTrials.gov ID
- NCT04616157
- Acronym / sponsor ID
- 2017/2315-31/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 4 Nov 2020 (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 primary objective of this study is to test the feasibility and efficacy of Internet-delivered Cognitive Behavioral Therapy (CBT) for adolescents (13 - 17 years) with sleep problems (ICBT-I). All participants will receive ICBT-I for six weeks. The investigators will also evaluate the effect of the intervention on comorbid psychiatric symptoms and function.
Detailed description
PARTICIPANT RECRUITMENT:
For recruitment, this pilot trial will be advertised at child and adolescent mental health services and primary care clinics, as well as through newspapers. The inclusion procedure will be carried out in two steps: 1) telephone interview and 2) face-to-face assessment.
Telephone interview: An initial telephone interview will be conducted with the adolescent/parent in order to broadly assess inclusion and exclusion criteria.
Face-to-face baseline diagnostic assessment: After the telephone screening, the adolescent along with his/her parents, are invited to a face-to-face assessment at the Child and Adolescent Mental Health clinic, including the diagnostic screening interview MINI-KID conducted with adolescents and parents jointly. Insomnia diagnoses will be established using DSM-IV criteria and levels of insomnia symptoms will be determined using ISI-a. If the ISI-a score is >10, the family will be invited to participate in the study, provided that the other inclusion criteria are fulfilled and no exclusion criteria prohibit participation. Following face-to-face assessment, participants will be provided with an information sheet and consent form.
DATA COLLECTION:
Baseline self-report measures: Participants included in the study after the face-to-face diagnostic assessment are asked to fill in self-report measures on the internet, provided via personal login and password. Participants will aslo be asked to fill in a sleep-wake diary and to wear an actigraph during seven consecutive days/nights.
Self-rating assessments during intervention: ISI-a is administered to adolescents every week during treatment.
Study participants are in regular contact (on a weekly basis) with experienced clinicians during the ICBT-I treatment. Clinicians that suspect any kind of adverse event during the assessment or treatment process will contact the parent via telephone as a first step of assessing the severity of the incident. Adverse events in this context are defined as an actual or potential situation that threatens the patient's well-being, e.g., suicide risk or an acute increase of symptoms. In the case of an adverse event, the clinician informs the study coordinator (LÅ) for a discussion of adequate action taking. If a continuation of the ICBT treatment is considered inappropriate with regard to the participants' best interest and well-being, the participant will be excluded from the study and parents/adolescents will be provided with proper referral information. Any adverse event will be reported in the planned publication of the pilot study.
Outcome measure reliability procedures: To ensure the reliability of the assessments conducted by study clinicians, all assessors will be trained by experienced instructors in the diagnostic screening instrument MINI-KID. All therapists that participate in the study will also be continuously trained in MINI-KID interviewing, assessment and diagnosing.
Post-treatment and follow-up measurement: Post-treatment measurement with actigraphy, sleep-wake diary and self-report measures will be conducted immediately after treatment (6 weeks after baseline). A follow-up measurement will be performed 6 months after treatment termination.
Referral of non-responders After the 6-month follow-up, all non-responders (defined as those participants who have not improved to a clinically meaningful degree according to ISI-a) will be referred to their local child-and adolescent psychiatric clinic for further treatment.
Statistical Analyses Outcomes will be described as significant changes in objective and subjective sleep and in clinician and self-rated measures of insomnia symptoms and comorbid symptoms, within-group effect sizes (Cohen's d), clinically significant improvement rates and remission rates. Analyses will involve t-tests as well as linear mixed-effects modeling. Randomness of missing data will be analyzed with logistic regression. Depending on the amount of missing data, multiple imputations will be employed to compensate for missing values.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive treatment
| Arm | Type | Receives |
|---|---|---|
| ICBT-I | Experimental | Behavioral: ICBT-IThe ICBT-I treatment program is a web-based intervention consisting of six chapters/sessions that adolescents go through during six consecutive weeks.The program starts with psychoeducation regarding sleep disorders and the rationale for a cognitive behavioral intervention. The main focus for the treatment is behavioral interventions, mainly sleep restriction and stimulus control. The intervention also addresses problem solving, maintenance of treatment gains, relapse prevention and relaxation techniques. Caregivers will not actively participate in the treatment. During the treatment phase participants will be in contact with a therapist through standardized forms in the program. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinical levels of insomnia symptoms, as determined by ISI-a >10.
- Age between 13 and 17 years
- Ability to read and write Swedish
- Daily access to the internet through a computer or similar device
- Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
Key exclusion criteria (5 listed)
- Diagnosed with autism spectrum disorder, psychosis or bipolar disorder
- Present risk of suicide
- Ongoing substance dependence
- Completed CBT for sleep disorders within the last 6 months (defined as at least 5 sessions of CBT
- Ongoing use of central nervous system stimulant medication
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 |
|---|---|---|
| ICBT-ICognitive-behavioral therapy for insomnia | Behavioural | ICBT-I |
Primary outcome
Change in insomnia symptom severity
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Insomnia Severity Index- adolescent version ISI is a seven-item measure that yields a quantitative index of sleep impairment and treatment outcome. Total scores range from 0 to 28, with higher scores indicating greater perceived insomnia severity. The instrument has been adapted to teenagers, ISI-a, and validated on Swedish teenagers.
17 secondary outcomes
Change in subjective total sleep time
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in subjective sleep onset latency
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in subjective wake after sleep onset
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in subjective sleep efficiency
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in objective sleep total sleep time
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in objective sleep onset latency
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in objective wake after sleep onset
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in objective sleep efficiency
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in symptoms of insomnia
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in symptoms of depression
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in symptoms of depression 2
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in symptoms of generalized anxiety
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in difficulties in emotion regulation
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in intensity of pain
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in daytime functioning
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in daytime sleepiness 1
Time frame: Change from before treatment to after (+6 weeks) and to 6 month after treatment
Change in daytime sleepiness 2
Time frame: Change from before treatment to after (+6 weeks) and to 6 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 4 Nov 2020.
- 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.
Mats Lekander, PhD study chair
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 ICBT-I in people with Insomnia Disorder and Depressive Disorder, 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 5 inclusion and 5 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 4 Nov 2020. 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?
Change in insomnia symptom severity (time frame: Change from before treatment to after (+6 weeks) and to 6 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 4 Nov 2020.