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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402619
• Other study ID #: BCS Sömnskola
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Disease
• Dyssomnias
• Insomnia
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

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..