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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
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 3, 2019
    Last Updated
    October 22, 2019
    Sponsor
    Karolinska Institutet
    Collaborators
    Stockholm University, Child and Adolescent Psychiatry, Stockholm, Karolinska University Hospital
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    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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