Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry

NCT04136483 | Completed

• 1 other identifier: 2012-871-31-1
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Sleep Onset Latency (SOL)

  Baseline, 6 weeks and 3 months

• Wake after sleep onset (WASO)

  Baseline, 6 weeks and 3 months

• Total Sleep Time (TST)

  Baseline, 6 weeks and 3 months

• Sleep Efficiency (SE)

  Baseline, 6 weeks and 3 months

• Spences' Children Anxiety Scale (SCAS)

  Baseline, 6 weeks and 3 months

Study Arms (1)

CBT-I

EXPERIMENTAL

Behavioral: CBT-I

Interventions

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.

CBT-I

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm University: collaborator
• Child and Adolescent Psychiatry, Stockholm: collaborator
• Karolinska University Hospital: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Mats Lekander, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: October 23, 2019
• Study Start: April 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: January 30, 2018
• Last Updated: October 23, 2019

Record last verified: 2019-10