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

August 26, 2022 updated by: Philip Lindner, Karolinska Institutet

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Stockholm, Sweden, 18354
        • Not yet recruiting
        • Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm)
        • Contact:
      • Stockholm, Sweden
        • Recruiting
        • Stockholm Centre for Dependency Disorders
        • Contact:
        • Principal Investigator:
          • Philip Lindner, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online CBT
Ten modules with minimum therapist guidance
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
Other Names:
  • Sleep compression
  • Sleep hygiene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Two-item Sleep Condition Indicator
Time Frame: Weeks 1 through 10 (max 15)
Total score of the two-item SCI, assessing last-week symptoms. Administered on the treatment platform.
Weeks 1 through 10 (max 15)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Condition Indicator
Time Frame: Change 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.
Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Daily sleep diary
Time Frame: Weeks 1 through 10 (max 15)
Derived measures: last-week average sleep efficiency, time to fall asleep, time awake at night, total sleep time.
Weeks 1 through 10 (max 15)
Daily alcohol diary
Time Frame: Weeks 1 through 10 (max 15)
Total consumed standard units of alcohol per week, during day and before bedtime
Weeks 1 through 10 (max 15)
Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Total score
Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Drug Use Disorders Identification Test (DUDIT)
Time Frame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Total score
Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Patient Health Questionnaire-9 (PHQ9)
Time Frame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Total score
Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Health-related quality of life (EQ5D)
Time Frame: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Total score
Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Philip Lindner, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 26, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCS Sömnskola

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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