Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: CBT-I

• Registration Number: NCT04136483
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-04-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-01-30
• Study First Submitted: 2019-09-03
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-22
• Last Update Submitted: 2019-10-22
• Study First Posted: 2019-10-23
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBT-I	CBT-I	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline Insomnia Severity Index- adolescent version (ISI-a)	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 Outcome Measures

Name	Time	Method
Spences' Children Anxiety Scale (SCAS)	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.
Total Sleep Time (TST)	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.
Sleep Efficiency (SE)	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.
Sleep Onset Latency (SOL)	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.
Wake after sleep onset (WASO)	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.
Center for Epidemiological Studies Depression Scale for Children (CES-DC)	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.