Insomnia Clinical Trial
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 31, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Stockholm Addiction eClinic (eStöd, Beroendecentrum Stockholm) | Stockholm | |
Sweden | Stockholm Centre for Dependency Disorders | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
Kaldo V, Jernelöv S, Blom K, Ljótsson B, Brodin M, Jörgensen M, Kraepelien M, Rück 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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.. | |
Secondary | 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) | |
Secondary | Daily alcohol diary | Total consumed standard units of alcohol per week, during day and before bedtime | Weeks 1 through 10 (max 15) | |
Secondary | 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.. | |
Secondary | 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.. | |
Secondary | 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.. | |
Secondary | 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.. |
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