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

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mindfulness-Based Relapse Prevention program
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance Use Disorders focused on measuring Mindfulness, Relapse Prevention, Readiness for Change, Self-efficacy, substance use

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2023
Last Updated
October 21, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05990699
Brief Title
Effect of Mindfulness-Based Relapse Prevention Program on Readiness for Change and Self-efficacy Among Clients With Substance Use Disorders
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
September 5, 2023 (Actual)
Study Completion Date
October 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Mindfulness, Relapse Prevention, Readiness for Change, Self-efficacy, substance use

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
patients with substance use disorder who will be under routine hospital care.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Relapse Prevention program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Five Factors Mindfulness Questionnaire (FFMQ)
Description
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.
Time Frame
5 weeks
Title
The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
Description
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.
Time Frame
5 weeks
Title
Drug abstinence Self-Efficacy Scale (DASE)
Description
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.
Time Frame
5 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
male patients only to decrease confounding factors
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Nursing
City
Alexandria
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19904665
Citation
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: 10.1080/08897070903250084.
Results Reference
result

Learn more about this trial

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

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