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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Online Cognitive Behavior Therapy in Routine Addiction Care for Comorbid Sleep Problems in Alcohol Use Disorder

Conditions
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Dyssomnias, Alcohol Use Disorder, Insomnia, Sleep Disorder

Intervention / Treatment
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* Behavioral: Cognitive behavior therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled patient at Stockholm Center for Dependency Disorders Diagnosed alcohol use disorder Self-rated sleep problem 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online CBT<br>Ten modules with minimum therapist guidance | Behavioral: Cognitive behavior therapy<br>* The ten modules cover: Psychoeducation about sleep, sleep problems, and associations with alcohol How to keep and use a sleep diary Sleep hygiene Sleep compression Cognitive restructuring Emotional regulation Preparing for the future<br>* Other names: Sleep hygiene;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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