Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry (2012/871-31/1)
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CBT-I
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBT-I
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04136483
First Posted
September 3, 2019
Last Updated
October 22, 2019
Sponsor
Karolinska Institutet
Collaborators
Stockholm University, Child and Adolescent Psychiatry, Stockholm, Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04136483
Brief Title
Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry
Acronym
2012/871-31/1
Official Title
Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry: a Clinical Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
January 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Stockholm University, Child and Adolescent Psychiatry, Stockholm, Karolinska University Hospital
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-I
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
CBT-I
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Insomnia Severity Index- adolescent version (ISI-a)
Description
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.
Time Frame
6 weeks and 3 months
Secondary Outcome Measure Information:
Title
Sleep Onset Latency (SOL)
Description
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.
Time Frame
Baseline, 6 weeks and 3 months
Title
Wake after sleep onset (WASO)
Description
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.
Time Frame
Baseline, 6 weeks and 3 months
Title
Total Sleep Time (TST)
Description
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.
Time Frame
Baseline, 6 weeks and 3 months
Title
Sleep Efficiency (SE)
Description
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.
Time Frame
Baseline, 6 weeks and 3 months
Title
Spences' Children Anxiety Scale (SCAS)
Description
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.
Time Frame
Baseline, 6 weeks and 3 months
Title
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Description
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.
Time Frame
Baseline, 6 weeks and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats Lekander, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry
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