Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry

NCT ID: NCT04136483

Last Updated: 2019-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2018-01-30

Brief Summary

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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

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Conditions

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Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT-I

Group Type EXPERIMENTAL

CBT-I

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stockholm University

OTHER

Sponsor Role collaborator

Child and Adolescent Psychiatry, Stockholm

INDUSTRY

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Mats Lekander

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mats Lekander, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Other Identifiers

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2012-871-31-1

Identifier Type: -

Identifier Source: org_study_id

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