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Completed

NCT Number: NCT05256485

Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving

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

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Key information

Conditions

Addiction Opiate Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

15 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sara Harby

Alexandria, 03, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy

Behavioral

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 outcomes

  1. opioid craving scale

    Time frame: 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 outcomes

  1. The Obsessive-Compulsive Drug use Scale

    Time frame: 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

  2. The desire for a drug questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sara Harby

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2022
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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