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临床试验/NCT04517474
NCT04517474Unknown不适用

Evaluación de Una Herramienta E-Salud Para la reducción Del Consumo de Cannabis

Parc de Salut Mar2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年11月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
2
主要终点
Change in the number of days of self-reported cannabis use in the past 30 days (TLFB)

研究概览

简要总结

Cannabis is the most widely used psychoactive substance around the world after alcohol and tobacco. Although approximately one in ten users develop serious problems of dependency, only a small number attend outpatient addiction counseling centers. CANreduce is an adherence-focused guidance enhanced web-based self-help program with promising results in German and other languages. It also reaches those users who hesitate to approach such treatment centers and help them to reduce their cannabis use.

This study will test the effectiveness of the Spanish version of the enhanced web-based self-help intervention with psychological support, an enhanced web-based self-help intervention (without psychological support) and a waiting list control in reducing cannabis use in problematic users.

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 (Participant)

盲法说明

The masking technique will be partially single-blinded-in that participants in either of the two active treatment groups will not know which version they work with. The two versions are neutrally described as two differently optimized variants to prevent participants from having a preference of one over the other possibly resulting in a disappointment when being allocated to the unwished version. However, subjects will know whether they have been assigned to treatment-as-usual (TAU). Any blinding of research and study personnel is not warranted.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cannabis use of at least once a week 30 days prior to study entry
  • At least 18 years old
  • At least weekly internet access and a valid email address

排除标准

  • Participant reports current pharmacological psychiatric disease or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts
  • Use of other pharmacological and psychosocial treatments for cannabis use disorders
  • Inability to read or write in Spanish

结局指标

主要结局

Change in the number of days of self-reported cannabis use in the past 30 days (TLFB)

时间窗: Baseline, 6, 12 and 24 weeks.

Participants enter their cannabis consumption frequency into their consumption diary every week. More days of self-reported cannabis use indicate worse state

次要结局

  • Change in the scoring of the Cannabis Use Disorder Identification Test - Revised (CUDIT-R)(Baseline, 6, 12 and 24 weeks.)
  • Change in the scoring of the PROMIS Emotional Distress - Depression - Short Form 8b(Baseline, 6, 12 and 24 weeks.)
  • Change in the quantity of weekly standard joints (TLFB with predifined cannabis standard joints)(Baseline, 6, 12 and 24 weeks.)
  • Change in the scoring of the Severity Dependence Scale (SDS)(Baseline, 6, 12 and 24 weeks.)
  • Change in the scoring of the Alcohol Use Disorders Identification Test (AUDIT)(Baseline, 6, 12 and 24 weeks.)
  • Change in the scoring of the PROMIS Anxiety 8a - Adult v1.0(Baseline, 6, 12 and 24 weeks.)
  • Change in the scoring of the EQ-5D-5L(Baseline, 6, 12 and 24 weeks.)
  • Change in the number of days of weekly self-reported cannabis use Time Life Follow Back (TLFB)(Baseline, 6, 12 and 24 weeks.)

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Sponsor

研究点 (2)

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