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临床试验/NCT03730805
NCT03730805已完成不适用

The Adaptation and Evaluation of the WHO's ASSIST-linked Brief Intervention to Khat-Using Ethiopian University Students

University of Konstanz1 个研究点 分布在 1 个国家目标入组 307 人开始时间: 2018年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
307
试验地点
1
主要终点
khat use quantity (standard units)

研究概览

简要总结

The leaves of the khat tree (catha edulis) are traditionally chewed in the countries around the Horn of Africa. They contain the amphetamine-like alkaloid cathinone and their use can produce a Substance Use Disorder. The researchers intent to validate an Amharic and an Oromo version of the WHO's ASSIST-linked Brief Intervention among khat-using Ethiopian university students. In an RCT, khat using students of Jimma University with initial motivation to stop or cut down khat use will be randomised to either an intervention or a control group. In the intervention group, the WHO's ASSIST-linked BI will be delivered in a single session by trained local counsellors. In the control group, participants will receive a neuropsychological assessment (Raven's Standard Progressive Matrices, SPM; Raven, 1972). Khat use, the neuropsychological variables and psychiatric symptoms will be assessed before the intervention and two weeks after it. Additionally, the researchers will measure the participants resistance during the session. The control group will receive the intervention after the post test. In order to study state variables that influence brief intervention effectivity, e.g. by increasing or reducing resistance, the researchers randomise subjects in each study arm to several short pre-interventions that are based on Gollwitzer's empirically well established Mindset Theory of Action Phases (for summary: Gollwitzer & Keller, 2016). This means, before delivering the ASSIST-linked BI (intervention group) or before the SPM assessment (controlgroup) a specific psychological state will be induced by a brief writing task that theoretically should affect the openness to the intervention: (1) implemental mindset, (2) deliberative mindset, (3) no mindset induction. The researchers expect that khat use will be reduced more in the intervention condition compared to the control condition and that induced states influence the effectiveness of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • second year student or higher year student at Jimma University
  • khat use in the month prior to baseline
  • participant's wish to reduce or stop khat use

排除标准

  • severe substance use, except khat
  • inability to read and write Amharic or Oromo languages
  • ongoing acute episode of severe mental disorder
  • current suicidal ideation

结局指标

主要结局

khat use quantity (standard units)

时间窗: Change from T1 (Baseline at study entry) to T2 (two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group))

The researchers assess the khat units consumed in the two weeks prior to the assessment with Sobell \& Sobell's (1995) calender-based method, Timeline Follow Back.

days with khat use

时间窗: Change from T1 (Baseline at study entry) to T2 (two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group))

The researchers assess the days with khat use in the two weeks prior to the assessment with Sobell \& Sobell's (1995) calender-based method, Timeline Follow Back.

次要结局

  • Problem solving(Change from T1 (Baseline at study entry) to T2 (two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group)))
  • Working memory(Change from T1 (Baseline at study entry) to T2 (Two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group)))
  • Symptoms of depression and anxiety(Change from T1 (Baseline at study entry) to T2 (two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group)))
  • Symptoms of khat-induced psychosis(Change from T1 (Baseline at study entry) to T2 (two weeks after ASSIST-linked BI (intervention group) or two weeks after baseline assessment (control group)))
  • Resistance during intervention session(Immediately after the intervention session (ASSIST-linked BI) or control session (SPM assessment))

研究者

发起方
University of Konstanz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Odenwald

Managing Director, Outpatient Clinic for Psychotherapy

University of Konstanz

研究点 (1)

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