Randomized Controlled Trial to Evaluate the Efficacy of Hypnosis and Learning Self-exercises for Outpatients With Moderate to Severe Alcohol Addiction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- The patient's ability to control alcohol consumption during outpatient follow-up in a CSAPA
研究概览
简要总结
Many patients are considering the use of so-called "hypnosis" treatments in the field of addictions. However, these techniques lack sufficient levels of evidence with regard to the standards required by Evidence-Based Medicine.
In other domains, however, hypnosis has demonstrated an interesting level of evidence, particularly in pain management.
The investigators will focus on the "Techniques for Activating Consciousness" (TAC), which represent an optimized therapeutic approach derived from hypnotic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adult patients consulting for an alcohol-related addiction problem at the CSAPA of Versailles (sites in Versailles, Trappes, Rambouillet) or at the Centre Hospitalier des 4 Villes (day hospital or CSAPA in Sèvres)
- •Patients must meet at least 4 of the 11 DSM-5 criteria (Annex 2), corresponding to moderate to severe addiction
- •Patients must be affiliated with the French social security system
排除标准
- •Refusal to participate
- •Decompensated psychiatric pathology contraindicating therapy:
- •Presence at inclusion of delusional, dissociative, and/or persecutory symptoms
- •Presence at inclusion of hypomanic or manic decompensation
- •Severe cognitive impairment, evidenced by inability to perform the clock-drawing test (draw the clock face, place the numbers, and set the hands to 11:10)
- •Adults legally protected under French law (deprivation of liberty, legal safeguard, guardianship, curatorship)
- •Inability to understand French
研究组 & 干预措施
Control
TAC intervention
干预措施: TAC intervention (Behavioral)
结局指标
主要结局
The patient's ability to control alcohol consumption during outpatient follow-up in a CSAPA
时间窗: 6 months
The main outcome measure will be the number of weeks to achieve the targeted goal between T0 (first consultation when the objective is set) and M6 (cumulative time).
次要结局
- Controlling addictive behavior in both groups(12 months)
- Evaluation criteria for the TAC group(12 months)
研究者
Dr Claire FARINA
Investigator Coordonnator
Versailles Hospital