Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving

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

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

Study Overview

• Status: Completed
• Conditions: Addiction Opiate
• Intervention / Treatment: Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 03
    • Sara Harby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cognitive behavioral therapy; 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.	Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy; In cognitive-behavioral therapy, participants learned that thoughts and emotions contribute to behavior, and responses to thoughts and emotions can be controlled. in mindfulness-based relapse prevention, participants learned to focus on the present moment experience including craving with an attitude of acceptance and non-judging. In twelve-step therapy, participants learned principles of acceptance, gratitude, forgiveness, tolerance, patience, humility, and honesty together with participation in different healthy ways to enrich life.
Active Comparator: mindfulness based relapse prevention; MBRP training is based on a two-component process: Attention to present moment experience, even if it includes craving or negative emotion.; An accepting attitude towards this experience letting it be exactly as it is, without judging it or reacting to it.	Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy; In cognitive-behavioral therapy, participants learned that thoughts and emotions contribute to behavior, and responses to thoughts and emotions can be controlled. in mindfulness-based relapse prevention, participants learned to focus on the present moment experience including craving with an attitude of acceptance and non-judging. In twelve-step therapy, participants learned principles of acceptance, gratitude, forgiveness, tolerance, patience, humility, and honesty together with participation in different healthy ways to enrich life.
Active Comparator: twelve-step therapy; 12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation	Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy; In cognitive-behavioral therapy, participants learned that thoughts and emotions contribute to behavior, and responses to thoughts and emotions can be controlled. in mindfulness-based relapse prevention, participants learned to focus on the present moment experience including craving with an attitude of acceptance and non-judging. In twelve-step therapy, participants learned principles of acceptance, gratitude, forgiveness, tolerance, patience, humility, and honesty together with participation in different healthy ways to enrich life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid craving scale	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).	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Obsessive-Compulsive Drug use Scale	it measures craving in the previous ten days and includes 13 questions. Subjects should select from 5 graded options for each question based on their experiences during last week. The items were rated as follow:1) Never; 2) Rarely; 3) Sometimes; 4) Mostly and 5) Always	15 minutes
The desire for a drug questionnaire	it measures instant (now) craving, includes 14 questions and participants answer questions on a seven-step Likert-scale answer sheet based on what he/she feels or thinks at the moment. The items were rated as follows: 1) not at all; 2) mild; 3) mild to moderate; 4) moderate; 5) moderate to severe; 6) severe and 7) approximately complete	15 minutes

Collaborators and Investigators

• Sponsor: Sara Harby
• Investigators: Study Chair: Tarek K Molokhia, Phd, professor of neuropsychiatry; Study Chair: Osama A Elkholy, Phd, professor of neuropsychiatry; Study Director: Ahmed M Abdelkreem, Phd, lecturer of neuropsychiatry; Principal Investigator: Sara A Harby, master, assistant lecturer of psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): October 10, 2021

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive
• Other Study ID Numbers: RPC£0521190906

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