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NCT Number: NCT04136483

Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-I

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. Sleep Onset Latency (SOL)

    Time frame: Baseline, 6 weeks and 3 months

    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.

  2. Wake after sleep onset (WASO)

    Time frame: Baseline, 6 weeks and 3 months

    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.

  3. Total Sleep Time (TST)

    Time frame: Baseline, 6 weeks and 3 months

    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.

  4. Sleep Efficiency (SE)

    Time frame: Baseline, 6 weeks and 3 months

    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.

  5. Spences' Children Anxiety Scale (SCAS)

    Time frame: Baseline, 6 weeks and 3 months

    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.

  6. Center for Epidemiological Studies Depression Scale for Children (CES-DC)

    Time frame: Baseline, 6 weeks and 3 months

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Child and Adolescent Psychiatry, Stockholm
  • Karolinska University Hospital
  • Stockholm University

Registry information

Official study title

Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry: a Clinical Pilot Study

Acronym: 2012/871-31/1

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 23, 2019
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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