Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving

NCT ID: NCT05256485

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2021-10-10

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).

Conditions

Addiction Opiate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

mindfulness based relapse prevention

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

twelve-step therapy

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sara Harby

OTHER

Sponsor Role: lead

Responsible Party

Sara Harby

assistant lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tarek K Molokhia, Phd

Role: STUDY_CHAIR

professor of neuropsychiatry

Osama A Elkholy, Phd

Role: STUDY_CHAIR

professor of neuropsychiatry

Ahmed M Abdelkreem, Phd

Role: STUDY_DIRECTOR

lecturer of neuropsychiatry

Sara A Harby, master

Role: PRINCIPAL_INVESTIGATOR

assistant lecturer of psychiatry

Locations

Sara Harby

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

RPC£0521190906

Identifier Type: -

Identifier Source: org_study_id