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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04402619
Enrollment
25
Registered
2020-05-27
Start date
2020-04-13
Completion date
2023-12-31
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Dyssomnias, Insomnia, Sleep Disorder

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.

Interventions

BEHAVIORALCognitive behavior therapy

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

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Two-item Sleep Condition IndicatorWeeks 1 through 10 (max 15)Total score of the two-item SCI, assessing last-week symptoms. Administered on the treatment platform.

Secondary

MeasureTime frameDescription
Daily sleep diaryWeeks 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 diaryWeeks 1 through 10 (max 15)Total consumed standard units of alcohol per week, during day and before bedtime
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
Sleep Condition IndicatorChange 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.
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
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

Countries

Sweden

Contacts

Primary ContactPhilip Lindner, PhD
philip.lindner@ki.se+46704522587

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026