Online Cognitive Behavior Therapy in Routine Addiction Care for Comorbid Sleep Problems in Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Two-item Sleep Condition Indicator
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled patient at Stockholm Center for Dependency Disorders
- •Diagnosed alcohol use disorder
- •Self-rated sleep problem
排除标准
- •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
结局指标
主要结局
Two-item Sleep Condition Indicator
时间窗: Weeks 1 through 10 (max 15)
Total score of the two-item SCI, assessing last-week symptoms. Administered on the treatment platform.
次要结局
- 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))
- Patient Health Questionnaire-9 (PHQ9)(Change from baseline (pre-treatment), post-treatment (primary endpoint, 10-15 weeks after baseline), and follow-up three months after baseline..)
- 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..)
- Health-related quality of life (EQ5D)(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..)
研究者
Philip Lindner
Head of Research and Development, Maria Ungdom Clinic
Karolinska Institutet