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

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05990699
• Other study ID #: IRB00013620/7/2023
• Status: Completed
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: October 22, 2023

Study information

• Verified date: October 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 22, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Able to read and write.

• Able to communicate and willing to participate in the study.

• Male patients only Exclusion Criteria

• Patients who are only alcoholics will be excluded.

• Diagnosed with SUDs with mental illness comorbidity.

Related Conditions & MeSH terms

• Recurrence
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Mindfulness-Based Relapse Prevention program
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.

Locations

Country	Name	City	State
Egypt	Faculty of Nursing	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Bowen S, Chawla N, Collins SE, Witkiewitz K, Hsu S, Grow J, Clifasefi S, Garner M, Douglass A, Larimer ME, Marlatt A. Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Subst Abus. 2009 Oct-Dec;30(4):295-305. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Five Factors Mindfulness Questionnaire (FFMQ)	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.	5 weeks
Primary	The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)	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.	5 weeks
Primary	Drug abstinence Self-Efficacy Scale (DASE)	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.	5 weeks