NCT04402619

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

April 14, 2020

Last Update Submit

August 26, 2022

Conditions

Alcohol Use DisorderInsomniaSleep DisorderDyssomnias

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Sleep Condition Indicator

    Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..

  • Daily sleep diary

    Weeks 1 through 10 (max 15)

  • Daily alcohol diary

    Weeks 1 through 10 (max 15)

  • Alcohol Use Disorders Identification Test (AUDIT)

    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)

    Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..

  • +2 more secondary outcomes

Study Arms (1)

Online CBT

EXPERIMENTAL

Ten modules with minimum therapist guidance

Behavioral: Cognitive behavior therapy

Interventions

Cognitive behavior therapyBEHAVIORAL

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

Also known as: Sleep compression, Sleep hygiene
Online CBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled patient at Stockholm Center for Dependency Disorders
  • Diagnosed alcohol use disorder
  • Self-rated sleep problem

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm)

Stockholm, 18354, Sweden

NOT YET RECRUITING

Stockholm Centre for Dependency Disorders

Stockholm, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26091917BACKGROUND

MeSH Terms

Conditions

AlcoholismSleep Initiation and Maintenance DisordersSleep Wake DisordersDyssomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersSleep Disorders, IntrinsicNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Philip Lindner, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Lindner, PhD

CONTACT

+46704522587philip.lindner@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research and Development, Maria Ungdom Clinic

Study Record Dates

First Submitted

April 14, 2020

First Posted

May 27, 2020

Study Start

April 13, 2020

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Raw outcomes, with any other identifiable information, may be shared under the conditions described below.

Time Frame
Requests for data will be accepted upon publication of trial, and for ten years after.
Access Criteria
Signed data sharing agreement.

Locations

SE(2)