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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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