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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04402619
Other study ID # BCS Sömnskola
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 13, 2020
Est. completion date December 31, 2023

Study information

Verified date August 2022
Source Karolinska Institutet
Contact Philip Lindner, PhD
Phone +46704522587
Email philip.lindner@ki.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Cognitive 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

Locations

Country Name City State
Sweden Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm) Stockholm
Sweden Stockholm Centre for Dependency Disorders Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Kaldo V, Jernelöv S, Blom K, Ljótsson B, Brodin M, Jörgensen M, Kraepelien M, Rück 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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..
Secondary 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)
Secondary Daily alcohol diary Total consumed standard units of alcohol per week, during day and before bedtime Weeks 1 through 10 (max 15)
Secondary 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..
Secondary 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..
Secondary 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..
Secondary 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..
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