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

NCT ID: NCT04402619

Last Updated: 2022-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-13

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Alcohol Use Disorder Insomnia Sleep Disorder Dyssomnias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Online CBT

Ten modules with minimum therapist guidance

Group Type EXPERIMENTAL

Cognitive behavior therapy

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Sleep compression Sleep hygiene

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Philip Lindner

Head of Research and Development, Maria Ungdom Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip Lindner, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm)

Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

Stockholm Centre for Dependency Disorders

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Philip Lindner, PhD

Role: CONTACT

+46704522587

Facility Contacts

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Philip Lindner, PhD

Role: primary

+46704522587

Miriam Jakobson

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26091917 (View on PubMed)

Other Identifiers

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BCS Sömnskola

Identifier Type: -

Identifier Source: org_study_id

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