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Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving

Primary Purpose

Addiction Opiate

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy
Sponsored by
Sara Harby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction Opiate

Eligibility Criteria

15 Years - 50 Years (Child, Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Sara Harby

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

cognitive behavioral therapy

mindfulness based relapse prevention

twelve-step therapy

Arm Description

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.

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.

12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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

Full Information

First Posted
February 8, 2022
Last Updated
February 16, 2022
Sponsor
Sara Harby
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1. Study Identification

Unique Protocol Identification Number
NCT05256485
Brief Title
Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving
Official Title
Comparing the Effect of Cognitive Behavioral Therapy, Mindfulness Based Relapse Prevention and Twelve-step Therapy in Patients With Opioid Craving
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
October 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Harby

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction Opiate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Standard cognitive behavioral therapy comprises approaches directed toward modifying dysfunctional thinking and behavior discussed through 8 sessions. mindfulness based relapse prevention is an 8-week therapy program based on: 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. This group therapy was facilitated by an ex-addict working in El Maamora hospital. 12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cognitive behavioral therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
mindfulness based relapse prevention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
twelve-step therapy
Arm Type
Active Comparator
Arm Description
12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
opioid craving scale
Description
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).
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
The Obsessive-Compulsive Drug use Scale
Description
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
Time Frame
15 minutes
Title
The desire for a drug questionnaire
Description
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
Time Frame
15 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek K Molokhia, Phd
Organizational Affiliation
professor of neuropsychiatry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Osama A Elkholy, Phd
Organizational Affiliation
professor of neuropsychiatry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed M Abdelkreem, Phd
Organizational Affiliation
lecturer of neuropsychiatry
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sara A Harby, master
Organizational Affiliation
assistant lecturer of psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sara Harby
City
Alexandria
ZIP/Postal Code
03
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving

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