"Auricular Acupuncture and Cognitive Behavioral Therapy in the Context of Insomnia and Low Dose Dependence of Benzodiazepine-like Drugs and Other Sleep Medicine With Addiction Risk"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Insomnia
研究概览
简要总结
"Auricular acupuncture and cognitive behavioral therapy in the context of insomnia and low dose dependence of benzodiazepine-like drugs and other sleep medicine with addiction risk"
INTRODUCTION: Insomnia is a common health problem in Sweden, which increases with age and is more prevalent among women.
It is defined by unsatisfied sleep quality during more than a month's time. The main symptoms are difficulties falling- and/or maintaining sleep, involuntary awakenings during the night of early morning, day time sleepiness and decreased will for day time activity due to sleepiness. Insomnia is ranked to be the fifth most common cause of prescription of medicine at the outpatient clinics in general health care in Sweden. In 2008 a prevalence study was initiated in Sweden by the Swedish Council on Health Technology Assessment (SBU). The study showed that 24% of the Swedish population suffered from sleep disorders. Sleeping disorders can go on for many years and can therefore entail significant personal suffering.
Usually sleep medicine combined with general sleeping advices is the first-hand treatment for insomnia. However, according to SBU, first treatment should be non-pharmacological, for instance cognitive behavioral therapy (CBT). Despite this recommendation the prescribing of sleep medicine is still high.
There are studies that suggest auricular acupuncture (AA) to be an effective method to treat insomnia. However more evidence is needed to draw firm conclusions.
AIM: The aim of the study is to investigate if AA is as effective as CBT to treat insomnia for patients who have stopped using benzodiazepine-like sleep medicine.
METHOD: This is a randomized controlled study (RTC) including patients suffering from insomnia, with a low dose dependence of benzodiazepine-like drugs. The patients will be recruited from primary care and from an out-patient clinic specialized in sleeping disorders and also by add in the local news paper. The respondents will be randomized to one of two groups; group I will receive AA twice a week for 4 weeks; group II will receive CBT once a week for six weeks. After three months there will be a long-time follow up in order to investigate a potential long-term effect.
详细描述
INTRODUCTION During the 1960s benzodiazepines were introduced in the health care. The benzodiazepines replaced the barbiturates because of their low toxicity and their anxiety reducing effect. During the 1990s the benzodiazepines were replaced with benzodiazepine-like drugs to treat insomnia. In Swedish health care two out of three recipes of hypnotics are prescribed to women, more than 50% of these are prescribed to persons of age > 65. To minimize the risk of drug tolerance a short time use of benzodiazepine-like drugs are recommended, and only after careful consideration from the prescriber. The risk of developing addiction is increased for people with prior substance dependence issues, people suffering from other psychiatric of mental health issues and for people with a high-dose intake.
Insomnia is a common symptom for people who suffer from substance dependence, especially when the intake has ended. During this time, the withdrawal phase, risk for relapse is high. The protracted withdrawal phase can go on for 6-12 months. General symptoms during this time, except insomnia, are sensitivity to stress, emotional over- and under reactions and memory dysfunctions.
Insomnia and drug dependence Insomnia is a common health problem in Sweden, which increases with age and is more prevalent among women.
Insomnia is defined by unsatisfied sleep quality during more than a month's time. The main symptoms are difficulties falling- and/or maintaining sleep, involuntary awakenings during the night of early morning, day time sleepiness and decreased will for day time activity due to sleepiness.
Sleep quality is, according to the National Board of Health and Welfare, a measurement of life quality among the population. Insomnia is ranked to be the fifth most common cause of prescription of medicine at the outpatient clinics in general health care in Sweden. In 2008 a prevalence study was initiated in Sweden by the Swedish Council on Health Technology Assessment (SBU). The study showed that 24% of the Swedish population suffered from sleep disorders. Sleeping disorders can go on for many years and can therefore entail significant personal suffering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women (n=40)
- •18-75 years old with: (i) primary or secondary insomnia who have been treated every day for over six months with benzodiazepine-like drugs and developed a low dose drug dependence, and (ii) people suffering from insomnia who use benzodiazepine-like drugs ≥ three nights a week with no effect.
排除标准
- •high dose drug dependence,
- •generalized anxiety disorder (GAD),
- •patients diagnosed with diagnosed psychotic disorders,
- •personality disorders or serious somatic illness,
- •alcohol dependence/abuse,
- •anti psychotic medications,
- •pain reliving treatment with methadone- or methadone like drugs,
- •new onset depression,
- •patients who have initiated or changed their anti-depressant,anxiolytic or pregabalin medication during the last six months,
- •pregnancy.
结局指标
主要结局
Insomnia
时间窗: five months
Outcome will be measured by: i)actigraphy ii)evaluated questionary forms: Insomnia Severity Index (ISI) Hospital Anxiety Depression scale (HAD) Minimal Insomnia Symptom Scale (MISS) Ep-worth Sleepless scale (ESS) Dysfunctional Belief About Sleep (DBAS-16) Functional Outcome of Sleep Questionaire (FOSQ)
次要结局
- Quality of life(five months)