NCT02059083撤回1 期
Biofeedback for Adolescent Cannabis Use Disorder
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Change in Perceived Stress Scale
研究概览
简要总结
The aims of this study are: 1) to estimate the effect size of HRV biofeedback for stress in adolescents undergoing cognitive behavioral therapy (CBT) for cannabis use disorder (primary outcome: Perceived Stress Scale) and 2) to estimate the effect size of HRV biofeedback for cannabis use in adolescents undergoing CBT for cannabis use disorder (primary outcome: number of days used cannabis in the past 30 days).
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
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be between the ages of 13 and 19 years, with a parent or legal guardian available to complete parental assessments, if the participant is a minor
- •meet Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-V) criteria for cannabis use disorder by clinical interview;
- •be medically healthy;
- •be willing to participate in the study intervention and assessments;
- •plan to live locally for at least 4 months;
- •be able to read English well enough to complete study questionnaires;
- •have self-reported cannabis use in the past 28 days;
- •have a Perceived Stress Scale score > 20.
排除标准
- •current or past psychosis;
- •bipolar I or II disorder;
- •the need to take psychotropic medications at any time during the study;
- •pregnancy;
- •psychiatric or substance use disorder that cannot be managed with outpatient care (e.g. alcohol withdrawal, severe major depressive disorder, significant suicidal ideation); and
- •medications known to affect HRV (e.g. albuterol, pseudoephedrine, beta adrenergic blockers).
结局指标
主要结局
Change in Perceived Stress Scale
时间窗: baseline and 16 weeks
次要结局
- Change in the number of days used marijuana in the past 28 days(baseline and 16 weeks)
研究者
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