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临床试验/NCT06174714
NCT06174714尚未招募不适用

Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders: a Pilot Study

Indonesia University0 个研究点目标入组 30 人开始时间: 2024年8月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Abstinence from Substance Use

研究概览

简要总结

Relapse in women was associated with depression, interpersonal stress, and relationship conflict with others when compared with men. The differences in gender profiles with substance use disorders (SUD) leads to the need for management strategies that are sensitive to each gender. This is a challenge to build a new module that can be applied continuously by collaborating CBT and several other psychosocial interventions, such as motivational enhancement therapy. The investigators compiled Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT). By implementing this module, it is hoped that it can provide short and long term effects and reduce the relapse rate in women with SUD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women aged 18-59 years old
  • diagnosed with substance use disorders based on DSM-V or ICD-10

排除标准

  • subjects with severe mental disorder or intellectual disability

结局指标

主要结局

Abstinence from Substance Use

时间窗: post-intervention (week 13)

Timeline Follow Back (TLFB): to assess daily use of addictive substances by writing yes/no for 28 days. This data will be collected weekly retrospectively to reduce the risk of recall bias.

Improvement in Motivation to Change

时间窗: pre-intervention (week 0), and post-intervention (week 13)

University of Rhode Island Change Assessment (URICA), measuring motivation to change with 4 domains: 1) pre-contemplation, 2) contemplation, 3) action, and 4) maintenance. A higher score indicates a better outcome.

Improvement in Substance Craving

时间窗: pre-intervention (week 0), and post-intervention (week 13)

Visual Analog Scale (VAS), measuring substance craving severity. Range 0 (no craving) - 100 (severe craving). A lower score indicates a better outcome.

Decrease in Addiction Severity

时间窗: pre-intervention (week 0), and post-intervention (week 13)

Addiction Severity Index (ASI), Indonesia version, measuring several domains: 1) Medical health (n= 11), 2) Employment/ support status (n= 24), 3 \& 4) Drug/ alcohol use (n= 35), 5) Illegal activity/ legal status (n= 32), 6) Family/ social relationships (n= 38) and 7) Psychiatric health (n= 23). Lesser score indicates better outcome.

次要结局

  • Improvement in Social Performance(pre-intervention (week 0), and post-intervention (week 13))
  • Improvement in Psychological Distress(pre-intervention (week 0), and post-intervention (week 13))
  • Improvement in Quality of Life(pre-intervention (week 0), and post-intervention (week 13))

研究者

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

Kristiana Siste

Dr. dr. Kristiana Siste, SpKJ(K) - Head of Department of Psychiatry, Faculty of Medicine, Indonesia University

Indonesia University

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