Insomnia2012/871-31/1NCT04136483
Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry
A study testing CBT-I in people with Insomnia, run by Karolinska Institutet.
Trial summary
The study is a clinical pilot study that examine the preliminary effect of cognitive-behavioral therapy for insomnia (CBT-I) in adolescents with comorbid psychiatric disorders. Participants (n=25) are recruited from three psychiatric clinics (n=19) and one pediatric pain clinic (n=6). Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Insomnia
- What is being tested?
- CBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 30 Jan 2018
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- be between 13-17 years old
- meet criteria for insomnia disorder (primary or secondary insomnia) according to DSM-IV-TR
- have insomnia symptoms at a clinical level, as defined as more than 10 points on the ISI-a
- adequate Swedish language skills
Who cannot join
- severe psychiatric disorder that is contraindicative of the treatment (i.e., bipolar disorder, psychotic disorder)
- autistic disorder
- severe suicidality (defined as ≥17 points on MINI-kid suicide subscale)
- alcohol or drug dependence
- psychotropic medication
- previous (> 5 sessions) or ongoing CBT-treatment for insomnia
About this study
Official title: Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry: a Clinical Pilot Study
The study is a clinical pilot study that examine the preliminary effect of cognitive-behavioral therapy for insomnia (CBT-I) in adolescents with comorbid psychiatric disorders. Participants (n=25) are recruited from three psychiatric clinics (n=19) and one pediatric pain clinic (n=6). After diagnostic assessment, participants that fulfil inclusion criteria are offered the CBT-I intervention. Pre-post and 3-months follow-up assessments include subjective measures of insomnia symptom severity, sleep parameters (collected through sleep-wake diaries), symptoms of depression and anxiety and daytime functioning.
- Conditions
- Insomnia
- Being tested
- CBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
The theoretical framework is cognitive-behavioral therapy that includes sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive interventions and relaxation. The intervention has been adapted to adolescents by reducing the amount of psychoeducational information and the interventions related to changing cognitions. It involves six weekly face-to-face individual sessions with a therapist, supported by a participant workbook that contains information, work- sheets, and at-home tasks. Clinical psychologists or graduate clinical psychologists in training delivered the intervention sessions under supervision by the first author. Parents/care-givers were given information about the components, but did not take active part of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | Not described Receives: Behavioral: CBT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Insomnia Severity Index- adolescent version (ISI-a)
The Insomnia Severity Index, ISI -adolescent version18 was used before, after at three months follow-up to measure insomnia symptom severity. ISI-a is an adaptation to adolescents of the Insomnia Severity Index32,36. ISI-a 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.
Measured: 6 weeks and 3 months
Secondary outcomes (6)
Sleep Onset Latency (SOL)
Subjective sleep onset latency was measured using a sleep-wake diary (SWD) before, after and at three-months follow-up. Participants filled in the SWD during seven consecutive days/nights at all time points.
Measured: Baseline, 6 weeks and 3 months
Wake after sleep onset (WASO)
Subjective wake after sleep onset was measured using a sleep-wake diary (SWD) before, after and at three-months follow-up. Participants filled in the SWD during seven consecutive days/nights at all time points.
Measured: Baseline, 6 weeks and 3 months
Total Sleep Time (TST)
Subjective total sleep time was measured using a sleep-wake diary (SWD) before, after and at three-months follow-up. Participants filled in the SWD during seven consecutive days/nights at all time points.
Measured: Baseline, 6 weeks and 3 months
Sleep Efficiency (SE)
Subjective sleep efficiency was measured using a sleep-wake diary (SWD) before, after and at three-months follow-up. Participants filled in the SWD during seven consecutive days/nights at all time points.
Measured: Baseline, 6 weeks and 3 months
Spences' Children Anxiety Scale (SCAS)
Spences Children's Anxiety Scale - SCAS 37 was used before, after and at three months follow-up to measure level of anxiety symptoms. SCAS is a child self-report measure of anxiety related psychopathology, measuring five domains of anxiety: generalized anxiety, panic anxiety, separation anxiety, social anxiety and obsessive-compulsive anxiety.Scores range from 0 to 114 and higher scores indicate more severe symptoms of anxiety.
Measured: Baseline, 6 weeks and 3 months
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Center for Epidemiological Studies Depression Scale for Children (CES-DC)38 was used before, after and at three months follow-up to measure depressive symptoms. CES-DC is a 20-item self-report depression inventory.Scores range from 0 to 60, with higher scores indicating more severe depressive symptomatology.
Measured: Baseline, 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Apr 2015
- Primary completion31 Dec 2017
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm University, Child and Adolescent Psychiatry, Stockholm, Karolinska University Hospital
- Responsible party
- Principal investigator, Mats Lekander, Karolinska Institutet
- Investigators
- Mats Lekander, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136483
- Sponsor's protocol ID
- 2012-871-31-1
- Acronym
- 2012/871-31/1
- Status last verified
- Oct 2019
- First submitted
- 3 Sep 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry: a Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT04136483
- Acronym / sponsor ID
- 2012/871-31/1 / 2012-871-31-1
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm University, Child and Adolescent Psychiatry, Stockholm, Karolinska University Hospital
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 23 Oct 2019 (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 study is a clinical pilot study that examine the preliminary effect of cognitive-behavioral therapy for insomnia (CBT-I) in adolescents with comorbid psychiatric disorders. Participants (n=25) are recruited from three psychiatric clinics (n=19) and one pediatric pain clinic (n=6). After diagnostic assessment, participants that fulfil inclusion criteria are offered the CBT-I intervention. Pre-post and 3-months follow-up assessments include subjective measures of insomnia symptom severity, sleep parameters (collected through sleep-wake diaries), symptoms of depression and anxiety and daytime functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: CBT-I |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- be between 13-17 years old
- meet criteria for insomnia disorder (primary or secondary insomnia) according to DSM-IV-TR
- have insomnia symptoms at a clinical level, as defined as more than 10 points on the ISI-a
- adequate Swedish language skills
Key exclusion criteria (6 listed)
- severe psychiatric disorder that is contraindicative of the treatment (i.e., bipolar disorder, psychotic disorder)
- autistic disorder
- severe suicidality (defined as ≥17 points on MINI-kid suicide subscale)
- alcohol or drug dependence
- psychotropic 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 |
|---|---|---|
| CBT-IThe theoretical framework is cognitive-behavioral therapy that includes sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive interventions and relaxation. The intervention has been adapted to adolescents by reducing the amount of psychoeducational information and the interventions related to changing cognitions. It involves six weekly face-to-face individual sessions with a therapist, supported by a participant workbook that contains information, work- sheets, and at-home tasks. Clinical psychologists or graduate clinical psychologists in training delivered the intervention sessions under supervision by the first author. Parents/care-givers were given information about the components, but did not take active part of the intervention. | Behavioural | CBT-I |
Primary outcome
Change from Baseline Insomnia Severity Index- adolescent version (ISI-a)
Time frame: 6 weeks and 3 months
The Insomnia Severity Index, ISI -adolescent version18 was used before, after at three months follow-up to measure insomnia symptom severity. ISI-a is an adaptation to adolescents of the Insomnia Severity Index32,36. ISI-a 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.
6 secondary outcomes
Sleep Onset Latency (SOL)
Time frame: Baseline, 6 weeks and 3 months
Wake after sleep onset (WASO)
Time frame: Baseline, 6 weeks and 3 months
Total Sleep Time (TST)
Time frame: Baseline, 6 weeks and 3 months
Sleep Efficiency (SE)
Time frame: Baseline, 6 weeks and 3 months
Spences' Children Anxiety Scale (SCAS)
Time frame: Baseline, 6 weeks and 3 months
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Time frame: Baseline, 6 weeks and 3 months
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 23 Oct 2019.
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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, Professor principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I in people with Insomnia, run by Karolinska Institutet.
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 4 inclusion and 6 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 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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 from Baseline Insomnia Severity Index- adolescent version (ISI-a) (time frame: 6 weeks and 3 months). 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 23 Oct 2019.