Online Cognitive Behavior Therapy for Comorbid Sleep Problems in Alcohol Use Disorder
Primary Purpose
Alcohol Use Disorder, Insomnia, Sleep Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behavior therapy
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
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
Sites / Locations
- Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm)
- Stockholm Centre for Dependency DisordersRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Online CBT
Arm Description
Ten modules with minimum therapist guidance
Outcomes
Primary Outcome Measures
Two-item Sleep Condition Indicator
Total score of the two-item SCI, assessing last-week symptoms. Administered on the treatment platform.
Secondary Outcome Measures
Sleep Condition Indicator
Change in score on the full and regular SCI. Administered through the online survey tool connected to regular patient records system.
Daily sleep diary
Derived measures: last-week average sleep efficiency, time to fall asleep, time awake at night, total sleep time.
Daily alcohol diary
Total consumed standard units of alcohol per week, during day and before bedtime
Alcohol Use Disorders Identification Test (AUDIT)
Total score
Drug Use Disorders Identification Test (DUDIT)
Total score
Patient Health Questionnaire-9 (PHQ9)
Total score
Health-related quality of life (EQ5D)
Total score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04402619
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Insomnia, Sleep Disorder, Dyssomnias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Online CBT
Arm Type
Experimental
Arm Description
Ten modules with minimum therapist guidance
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy
Other Intervention Name(s)
Sleep compression, Sleep hygiene
Intervention Description
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
Primary Outcome Measure Information:
Title
Two-item Sleep Condition Indicator
Description
Total score of the two-item SCI, assessing last-week symptoms. Administered on the treatment platform.
Time Frame
Weeks 1 through 10 (max 15)
Secondary Outcome Measure Information:
Title
Sleep Condition Indicator
Description
Change in score on the full and regular SCI. Administered through the online survey tool connected to regular patient records system.
Time Frame
Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Title
Daily sleep diary
Description
Derived measures: last-week average sleep efficiency, time to fall asleep, time awake at night, total sleep time.
Time Frame
Weeks 1 through 10 (max 15)
Title
Daily alcohol diary
Description
Total consumed standard units of alcohol per week, during day and before bedtime
Time Frame
Weeks 1 through 10 (max 15)
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
Total score
Time Frame
Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Title
Drug Use Disorders Identification Test (DUDIT)
Description
Total score
Time Frame
Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Title
Patient Health Questionnaire-9 (PHQ9)
Description
Total score
Time Frame
Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Title
Health-related quality of life (EQ5D)
Description
Total score
Time Frame
Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Lindner, PhD
Phone
+46704522587
Email
philip.lindner@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Lindner, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm)
City
Stockholm
ZIP/Postal Code
18354
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Lindner, PhD
Phone
+46704522587
Email
philip.lindner@ki.se
Facility Name
Stockholm Centre for Dependency Disorders
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Jakobson
Email
miriam.jakobson@sll.se
First Name & Middle Initial & Last Name & Degree
Philip Lindner, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Raw outcomes, with any other identifiable information, may be shared under the conditions described below.
IPD Sharing Time Frame
Requests for data will be accepted upon publication of trial, and for ten years after.
IPD Sharing Access Criteria
Signed data sharing agreement.
Citations:
PubMed Identifier
26091917
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.
Results Reference
background
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Online Cognitive Behavior Therapy for Comorbid Sleep Problems in Alcohol Use Disorder
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