Online Cognitive Behavior Therapy for Comorbid Sleep Problems in Alcohol Use Disorder

Not Applicable

• Conditions: Insomnia; Sleep Disorder; Dyssomnias; Alcohol Use Disorder
• Interventions: Behavioral: Cognitive behavior therapy

• Registration Number: NCT04402619
• Lead Sponsor: Karolinska Institutet

Brief Summary

The main goal is to study the effects of internet-delivered cognitive behavioural therapy with minimum guidance for comorbid sleep problems in alcohol use disorder, in routine addiction care.

Detailed Description

Alcohol use disorder (AUD) is highly prevalent and a major contributor to the global burden of disease. Insomnia symptoms are very common among individuals with AUD, including those in recovery, which may in turn promote alcohol relapse. Specialization and silo phenomena in healthcare organization, separating addiction from other types of psychiatric care, means that individuals with AUD and comorbid sleep problems often have difficulty accessing evidence-treatment for the latter. Offering online treatment for sleep problems to individuals enrolled in traditional routine addiction care is an attractive and pragmatic approach to offering parallel treatments covering the full clinical presentation, which has not yet been evaluated. This pilot and feasibility trial will recruit n=25 from patients in routine addiction care with comorbid sleep problems and AUD, who will complete an online, ten-module, CBT-based treatment program with minimum guidance for sleep problems, tailored for individuals with AUD.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-04-13
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-29
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

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

Inclusion Criteria

• Enrolled patient at Stockholm Center for Dependency Disorders
• Diagnosed alcohol use disorder
• Self-rated sleep problem

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Exclusion Criteria

• Addiction to sedative or hypnotic medication
• Psychoactive medication not yet 3-month stable in dose
• Bipolar disorder
• Psychotic disorder
• Suicidality
• Periodic Limb Movement Disorder (PLMD)
• Sleep apnea

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Online CBT	Cognitive behavior therapy	Ten modules with minimum therapist guidance

Primary Outcome Measures

Name	Time	Method
Two-item Sleep Condition Indicator	Weeks 1 through 10 (max 15)	Total score of the two-item SCI, assessing last-week symptoms. Administered on the treatment platform.

Secondary Outcome Measures

Name	Time	Method
Sleep Condition Indicator	Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..	Change in score on the full and regular SCI. Administered through the online survey tool connected to regular patient records system.
Daily sleep diary	Weeks 1 through 10 (max 15)	Derived measures: last-week average sleep efficiency, time to fall asleep, time awake at night, total sleep time.
Daily alcohol diary	Weeks 1 through 10 (max 15)	Total consumed standard units of alcohol per week, during day and before bedtime
Patient Health Questionnaire-9 (PHQ9)	Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..	Total score
Alcohol Use Disorders Identification Test (AUDIT)	Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..	Total score
Health-related quality of life (EQ5D)	Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..	Total score
Drug Use Disorders Identification Test (DUDIT)	Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..	Total score

Trial Locations

Locations (2)

Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm); 🇸🇪 Stockholm, Sweden

Stockholm Centre for Dependency Disorders; 🇸🇪 Stockholm, Sweden