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临床试验/NCT05256485
NCT05256485已完成不适用

Comparing the Effect of Cognitive Behavioral Therapy, Mindfulness Based Relapse Prevention and Twelve-step Therapy in Patients With Opioid Craving

Sara Harby1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年10月15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
发起方
入组人数
45
试验地点
1
主要终点
opioid craving scale

研究概览

简要总结

the study aim is to compare betwenn the effect of mindfulness based relapse prevention and other evidence based psychotherapy interventions regaring substance craving.

详细描述

In this prospective study, the population included opioid-dependent men (aged 18-50 years), some of them were admitted to El Maamora hospital and others were attendees in NA. To conduct this research, considering the drop-out rate, the list of 60 persons applying for treatment was prepared based on inclusion and exclusion criteria.

Then, three groups of 20 were randomly selected and placed in three intervention groups, group one received CBT, group two received MBRP, and group three received twelve-step therapy.

The subjects were assigned randomly to the treatment condition via a computer-generated random number with the aid of trained staff at the clinic blindly.

All participants completed the measurement scales immediately after detoxification (pre-test) and after the end of therapeutic sessions (post-test).

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
15 Years 至 50 Years(Child, Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Age: 15-50 years.
  • •Male gender.
  • •Patients meet DSM-5(3) criteria of opioid abuse.
  • •Had completed detoxification in a treatment center.
  • •Willing to give consent they will be randomly assigned to either CBT, MBRP, or twelve-step treatment group.
  • •Patients have dual diagnoses.
  • •Patients have poly-substance use disorder.

排除标准

  • •Participants with significant cognitive disorder.
  • •Participants with suicidal thoughts.
  • •Participants with any organic condition affecting stress response and so craving such as hypertension, respiratory or cardiovascular disorders.
  • •Participants taking any medications (e.g., antipsychotics in high doses) known to affect the stress response.
  • •Participants relapsed to drug abuse during therapy.

研究组 & 干预措施

cognitive behavioral therapy

Active Comparator

Standard CBT comprises an array of approaches directed toward modifying dysfunctional thinking and behavior. The two critical components are analysis of thoughts, feelings, and behaviors, as well as skills training for achieving active behavior and thought modification.

干预措施: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy (Behavioral)

mindfulness based relapse prevention

Active Comparator

MBRP training is based on a two-component process:

  1. Attention to present moment experience, even if it includes craving or negative emotion.
  2. An accepting attitude towards this experience letting it be exactly as it is, without judging it or reacting to it.

干预措施: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy (Behavioral)

twelve-step therapy

Active Comparator

12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation

干预措施: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy (Behavioral)

结局指标

主要结局

opioid craving scale

时间窗: 5 minutes

A visual analog scale, a modification of the Cocaine Craving Scale, is a 3-item scale used to measure the opioid craving and each item is ranging from 0 to 10 (0 means no craving at all and 10 means severe craving).

次要结局

  • The Obsessive-Compulsive Drug use Scale(15 minutes)
  • The desire for a drug questionnaire(15 minutes)

研究者

发起方
Sara Harby
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sara Harby

assistant lecturer

Alexandria University

研究点 (1)

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