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

October 21, 2023 updated by: Ayman Mohamed El-Ashry, Alexandria University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 002
        • Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
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.
No Intervention: control group
patients with substance use disorder who will be under routine hospital care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Five Factors Mindfulness Questionnaire (FFMQ)
Time Frame: 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.
5 weeks
The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
Time Frame: 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.
5 weeks
Drug abstinence Self-Efficacy Scale (DASE)
Time Frame: 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.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2023

Primary Completion (Actual)

September 5, 2023

Study Completion (Actual)

October 22, 2023

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 21, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00013620/7/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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