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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online CBT | Experimental | Ten modules with minimum therapist guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavior therapy | Behavioral | The ten modules cover:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Condition Indicator | 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.. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Lindner, PhD | Contact | +46704522587 | philip.lindner@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Philip Lindner, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm) | Not yet recruiting | Stockholm | 18354 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26091917 | Background | 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. |
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Raw outcomes, with any other identifiable information, may be shared under the conditions described below.
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Requests for data will be accepted upon publication of trial, and for ten years after.
Signed data sharing agreement.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012893 | Sleep Wake Disorders |
| D020920 | Dyssomnias |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
|
| Daily sleep diary |
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 | 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) | 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) | 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) | 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) | Total score | Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline.. |
| Stockholm Centre for Dependency Disorders | Recruiting | Stockholm | Sweden |
|
| D020919 | Sleep Disorders, Intrinsic |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |