Alcohol Use DisorderNCT04402619
Online Cognitive Behavior Therapy for Comorbid Sleep Problems in Alcohol Use Disorder
A study testing Cognitive behavior therapy in people with Alcohol Use Disorder and Insomnia, run by Karolinska Institutet at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Insomnia, Sleep Disorder
- What is being tested?
- Cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesSweden
- Study dates
- 13 Apr 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled patient at Stockholm Center for Dependency Disorders
- Diagnosed alcohol use disorder
- Self-rated sleep problem
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm)
Stockholm, 18354
Philip Lindner, PhD, +46704522587, philip.lindner@ki.se
- Recruiting
Stockholm Centre for Dependency Disorders
Stockholm
Miriam Jakobson, miriam.jakobson@sll.se
Philip Lindner, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use Disorder, Insomnia, Sleep Disorder, Dyssomnias
- Being tested
- Cognitive behavior therapy
- Medical subject headings
- Alcoholism, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Dyssomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapyBehavioural
Also called Sleep compression, Sleep hygiene
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
| Study group | Role | What they receive |
|---|---|---|
| Online CBT | Experimental | Ten modules with minimum therapist guidance Receives: Behavioral: Cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-item Sleep Condition Indicator
Total score of the two-item SCI, assessing last-week symptoms. Administered on the treatment platform.
Measured: Weeks 1 through 10 (max 15)
Secondary outcomes (7)
Sleep Condition Indicator
Change in score on the full and regular SCI. Administered through the online survey tool connected to regular patient records system.
Measured: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Daily sleep diary
Derived measures: last-week average sleep efficiency, time to fall asleep, time awake at night, total sleep time.
Measured: Weeks 1 through 10 (max 15)
Daily alcohol diary
Total consumed standard units of alcohol per week, during day and before bedtime
Measured: Weeks 1 through 10 (max 15)
Alcohol Use Disorders Identification Test (AUDIT)
Total score
Measured: 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)
Total score
Measured: 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)
Total score
Measured: 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)
Total score
Measured: Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start13 Apr 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Lindner, Karolinska Institutet
- Investigators
- Philip Lindner, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402619
- Sponsor's protocol ID
- BCS Sömnskola
- Status last verified
- Aug 2022
- First submitted
- 14 Apr 2020
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw outcomes, with any other identifiable information, may be shared under the conditions described below.
Publications
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.
PubMed 26091917
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cognitive Behavior Therapy in Routine Addiction Care for Comorbid Sleep Problems in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04402619
- Acronym / sponsor ID
- BCS Sömnskola
- Conditions
- Alcohol Use Disorder, Insomnia, Sleep Disorder, Dyssomnias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online CBT | Experimental | Behavioral: Cognitive behavior therapyTen modules with minimum therapist guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled patient at Stockholm Center for Dependency Disorders
- Diagnosed alcohol use disorder
- Self-rated sleep problem
Key exclusion criteria (7 listed)
- Addiction to sedative or hypnotic medication
- Psychoactive medication not yet 3-month stable in dose
- Bipolar disorder
- Psychotic disorder
- Suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavior therapyAlso: Sleep compression, Sleep hygieneThe 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 | Behavioural | Online CBT |
Primary outcome
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.
7 secondary outcomes
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..
Daily sleep diary
Time frame: Weeks 1 through 10 (max 15)
Daily alcohol diary
Time frame: 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..
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..
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..
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..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Background: PubMed 26091917Kaldo 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.
- Individual participant dataSharing planned: Yes. Raw outcomes, with any other identifiable information, may be shared under the conditions described below.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Lindner, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy in people with Alcohol Use Disorder and Insomnia, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Lindner, PhD (+46704522587, philip.lindner@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-item Sleep Condition Indicator (time frame: Weeks 1 through 10 (max 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.