Clinical trial NCT04402619: Online Cognitive Behavior Therapy for Comorbid Sleep Problems in Alcohol Use Disorder
Official title: Online Cognitive Behavior Therapy in Routine Addiction Care for Comorbid Sleep Problems in Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Insomnia
Sleep Disorder
Dyssomnias
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Two-item Sleep Condition Indicator
timeFrame: Weeks 1 through 10 (max 15)
Secondary outcomes:
measure: Sleep Condition Indicator
timeFrame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
measure: Daily sleep diary
timeFrame: Weeks 1 through 10 (max 15)
measure: Daily alcohol diary
timeFrame: Weeks 1 through 10 (max 15)
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
measure: Patient Health Questionnaire-9 (PHQ9)
timeFrame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
measure: Health-related quality of life (EQ5D)
timeFrame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm)
city: Stockholm
country: Sweden
facility: Stockholm Centre for Dependency Disorders
Study officials:
affiliation: Karolinska Institutet
name: Philip Lindner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaldo V, Jernelov S, Blom K, Ljotsson B, Brodin M, Jorgensen M, Kraepelien M, Ruck C, Lindefors N. Guided internet cognitive behavioral therapy for insomnia compared to a control treatment - A randomized trial. Behav Res Ther. 2015 Aug;71:90-100. doi: 10.1016/j.brat.2015.06.001. Epub 2015 Jun 3.