Qi Gong as a Method of Craving Reduction in Severe Addict Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 186
- 试验地点
- 6
- 主要终点
- Variation of craving intensity
研究概览
简要总结
Craving arises in response to an affective tone that is associated with perceptual representations of a sensory object, rather than directly in response to the object.
The investigators presume that qi gong functions to decouple pleasant and unpleasant experience from habitual reactions by removing the affective bias that fuels such emotional reactivity. Qi gong training may specifically target the associated learning process with an emphasis on the critical link between affect and craving in an addictive loop.
详细描述
The treatment of severe addiction to alcohol and one other or more psychoactive substances sometimes requires hospitalization for complex withdrawal. The medical term " sevrage complexe " is used in this file for hospitalization of patients with multiple addictions or with multiple comorbidities. In the french regulation the duration of hospitalization for " sevrage complexe " is at least 13 days.
The acute period of the first week is sufficient for physical weaning. A period relay for maintaining abstinence beyond the acute phase is a difficult stage. During this period the psychological craving related to the absence of the product causes dysphoria, stress, emotivity and increased difficulty in managing psychological aggression. The risk of relapse is then maximal and favored by many insults of everyday life.
Qi gong is classified by US National Library of Medicine as a mind-body therapy (MBT). It's an ancient traditional Chinese health practice believed to have special healing and recovery power. Today millions of people practice qi gong in China and around the world to treat various diseases. Qi gong is an ecole of breath, relaxation, guided imagery and inward attention. Practice of qi gong is believed to help cleanse the body of toxins, restore energy balance, reduce stress and anxiety. The Baduanjin qigong is one of the most common form of Chinese qi gong.
When going through withdrawal, craving is a psychological urge to administer a discontinued medication or recreational drug. Craving episodes may be triggered by seeing objects or experiencing moments that are associated with the drug or usage of it, and this phenomenon is termed post-acute withdrawal syndrome.
The main goal of our study is to demonstrate a reduction of craving during alcohol and coaddictions withdrawal. This demonstration is of first importance: first for the well-being of the patient during the first weeks after withdrawal, second for drug savings, and third abstinence rate because many authors consider that craving intensity is correlated with relapses risk.
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
- Single (Outcomes Assessor)
盲法说明
Primary outcome (VAS scale) will be presented to the patient and reported by a study nurse blinded of the randomization arm of the patient.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Qi Gong
Qi gong sessions added to usual well defined medical and psychological support
干预措施: Qi Gong sessions (Other)
Control
Usual well defined medical and psychological support
结局指标
主要结局
Variation of craving intensity
时间窗: Change in VAS from baseline to 9 weeks treatment
Variation of craving intensity on a Vvisual aAnalogic sScale (VAS) between baseline and the end of the treatment. The intensity is measured by "not at all" (score of 0) and "craving as bad as it could be" or "the most I've ever felt " (maximum score of 10), self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents his craving intensity. The score is determined by measuring the distance on the 10-cm line between the "no craving" anchor and the patient's mark.
次要结局
- Evolution over time of total alcohol consumption measured by Carbohydrate-Deficient Transferrin (CDT) marker(at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline)
- Evolution over time of total alcohol consumption measured by Mean Globular Volume (MGV) marker(at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline)
- Difference in treatment retention(3 weeks and 9 weeks post-baseline)
- Psycological qualitative evaluation(1 day, 2 days, 3 days, 4 days, 5 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks and 9 weeks post-baseline)
- Evolution over time of total alcohol consumption measured by GGT biomarker(at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline)
- Evolution over time of craving intensity(0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline)
- Evolution over time of total alcohol consumption(0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline)
- Evoluation over time of anxiety(0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline)
- Evolution over time of depression(0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline)