Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving

Addiction Opiate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05256485
• Other study ID #: RPC£0521190906
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: October 10, 2021

Study information

• Verified date: February 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 10, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Addiction Opiate
• Behavior, Addictive

Intervention

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.

Locations

Country	Name	City	State
Egypt	Sara Harby	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Sara Harby

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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