Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry (2012/871-31/1)

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: CBT-I

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: CBT-I

Behavioral: CBT-I; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Baseline, 6 weeks and 3 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital; Stockholm University; Child and Adolescent Psychiatry, Stockholm
• Investigators: Principal Investigator: Mats Lekander, Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2015
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): January 30, 2018

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (ACTUAL): October 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2012-871-31-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No