Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving

Not Applicable

Completed

• Conditions: Addiction Opiate
• Interventions: Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy

• Registration Number: NCT05256485
• Lead Sponsor: Sara Harby

Brief Summary

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

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 Timeline

• Study Start: 2019-10-15
• Primary Completion: 2021-06-30
• Study Completion: 2021-10-10
• Status Verified: 2022-02
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-16
• Last Update Submitted: 2022-02-16
• Study First Posted: 2022-02-25
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mindfulness based relapse prevention	cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy	MBRP training is based on a two-component process: 1. Attention to present moment experience, even if it includes craving or negative emotion. 2. An accepting attitude towards this experience letting it be exactly as it is, without judging it or reacting to it.
twelve-step therapy	cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy	12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation
cognitive behavioral therapy	cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step 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.

Primary Outcome Measures

Name	Time	Method
opioid craving scale	5 minutes	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).

Secondary Outcome Measures

Name	Time	Method
The Obsessive-Compulsive Drug use Scale	15 minutes	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
The desire for a drug questionnaire	15 minutes	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

Trial Locations

Locations (1)

Sara Harby; 🇪🇬 Alexandria, Egypt