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临床试验/NCT03363256
NCT03363256已完成不适用

Web-based Addiction Treatment: Cultural Adaptation With American Indians

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2018年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
Consecutive Weeks of Drug/Alcohol Abstinence

研究概览

简要总结

The purpose of the current study is to evaluate the preliminary efficacy of the Therapeutic Education System-Native Version (TES-NAV) (an efficacious web-delivered psychosocial intervention for substance use disorders adapted with American Indians/Alaska Natives [AI/AN]) to determine whether a future large-scale effectiveness trial is warranted. Specifically, a randomized controlled trial among urban AI/AN (N=80) attending outpatient addiction treatment services will be conducted to (1) estimate preliminary effect size of 12 weeks of TES-NAV on substance use disorder outcomes; (2) explore relevant moderators of TES-NAV outcomes; and (3) assess cultural factors that may correspond to variation in outcome.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years of age or older
  • •Identify as American Indian or Alaska Native
  • •Recent alcohol or drug use
  • •Within first 30 days of current outpatient treatment episode

排除标准

  • •Planned treatment episode of less than 3 months
  • •Insufficient ability to provide informed consent

研究组 & 干预措施

TAU+TES-NAV

Experimental

Standard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN

干预措施: TAU (Behavioral)

TAU+TES-NAV

Experimental

Standard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN

干预措施: TES-NAV (Behavioral)

TAU

Active Comparator

Standard outpatient addiction treatment

干预措施: TAU (Behavioral)

结局指标

主要结局

Consecutive Weeks of Drug/Alcohol Abstinence

时间窗: 12 weeks (following randomization)

Each week was categorized as abstinent if the urine screen was negative and the self-report indicated no drug use and no heavy drinking days and not abstinent if either urine screen or self-report indicated drug use or heavy drinking. If the urine screen was missing, TLFB self-report data was used.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aimee Campbell

Professor of Clinical Psychiatric Social Work

New York State Psychiatric Institute

研究点 (1)

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