跳至主要内容
临床试验/NCT05990699
NCT05990699已完成不适用

Effect of Mindfulness-Based Relapse Prevention Program on Readiness for Change and Self-efficacy Among Clients With Substance Use Disorders: A Randomized Control Trial

Alexandria University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月5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
100
试验地点
1
主要终点
The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)

研究概览

简要总结

The treatment process of substance addiction is applied principally by psychiatrists, psychologists, and psychiatric mental health nurses. In this respect, psychiatric mental health nurses have a crucial role to play. As they are the one who is in touch with the patients for 24 hours, psychiatric nurses can enhance the treatment process a lot through the application of a mindfulness-based relapse prevention program.

As drug abuse is such a devastating affliction, further knowledge about specific traits that may increase the chances of a successful recovery would be greatly beneficial to enhance treatment and decrease relapse rate. Accordingly, this study will be conducted to determine the effect of mindfulness-based relapse prevention program on readiness for change, and efficacy among clients with substance use disorder.

AIMS OF THE STUDY

The aim of this study is to:

Examine the effect of the Mindfulness-Based Relapse Prevention Program on readiness for change and self-efficacy among clients with substance use disorder during the rehabilitation phase.

RESEARCH HYPOTHESIS Clients with substance use disorder who attend Mindfulness-Based Relapse Prevention program sessions exhibit higher levels of readiness for change and self-efficacy compared to those who receive conventional hospital treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

性别
Male
接受健康志愿者
否

入选标准

  • •Able to read and write.
  • •Able to communicate and willing to participate in the study.
  • •Male patients only

排除标准

  • •Patients who are only alcoholics will be excluded.
  • •Diagnosed with SUDs with mental illness comorbidity.

研究组 & 干预措施

Intervention group

Experimental

patients will under routine hospital care as well as MBRP. This program consists of eight sessions spanning across four weeks, each focusing on specific techniques and skills to aid in substance use disorder treatment. The first session emphasizes the correlation between the "unconscious pilot" and substance use, incorporating a "corporeal examination" technique to promote intentional concentration. The second session focuses on mindfulness to identify stimuli and observe accompanying sentiments, thoughts, and feelings. The third session introduces the "ABSTEMIOUS space" technique, urging patients to pause, observe their experiences, concentrate on breathing, broaden cognizance, and choose judicious responses in trying or hazardous situations. The remaining sessions address coping mechanisms for relapse risks, taking pragmatic action in high-risk situations, integrating healthy activities into life, and sustaining mindfulness practice through the development of a support network.

干预措施: Mindfulness-Based Relapse Prevention program (Behavioral)

control group

No Intervention

patients with substance use disorder who will be under routine hospital care.

结局指标

主要结局

The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)

时间窗: 5 weeks

This scale was developed by Miller and Tonigan (1996) to assess readiness for change in alcohol and substance abuse clients (version 8D) (Miller \& Tonigan., 1996). It is composed of 19-items, which are rated on a five-point Likert scale. The responses ranged from 1 (No, strongly disagree) to 5 (Yes, strongly agree). The scale includes statements belonging to three factors of readiness for change which are Recognition, Ambivalence, and Taking Steps. The nineteen items have a total score ranging from 19 to 95, with higher scores indicating higher levels of recognition, ambivalence and taking steps.

Five Factors Mindfulness Questionnaire (FFMQ)

时间窗: 5 weeks

This scale was developed by Baer et al (2006) to measure elements of mindfulness (104). It is composed of 39-items, which are rated on a five point likert scale. The responses ranging from 1 (never or very rarely true) to 5 (very often or always true). The scale is divided into five subscales which are observing (notice or attend to internal and external phenomena), describing (label observed phenomena such as thoughts and emotions), acting with awareness (engage with full awareness in current experience or activity), non-judging of inner experience (nonjudgmental awareness of current experience without evaluation) and non reactivity to inner experience (notice internal phenomena without reacting). . Higher scores of the subscales represent greater observing, describing, awareness, non- judgment and non reactivity.

Drug abstinence Self-Efficacy Scale (DASE)

时间窗: 5 weeks

DASE scale is a modified version of Alcohol Abstinence Self- Efficacy scale. It was modified by Hiller et al (2000). It is composed of 20-items, which are rated on a five-point Likert scale ranging from 1 (not at all) to 5 (extremely). The scale encompasses four subscales, five items each that examine cues related to: negative affect, social interactions \& positive states, physical \& other concerns and finally Cravings \& urges. For each item, respondents are requested to respond to how "tempted" they would be to use drugs in each situation. The same 20 items are presented to the subjects for a second time but this time they are requested to indicate how "confident" they are that they would not use drugs in that situation (abstinence self-efficacy). The twenty items are summed to obtain a total score that ranges from 20 to 100 with higher scores reflecting greater self-efficacy for each temptation and confidence separately.

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

Ayman Mohamed El-Ashry

Lecturer at psychiatric and mental health nursing, faculty of nursing

Alexandria University

研究点 (1)

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