Clinical trial NCT05256485: 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
Overall status: COMPLETED
Phase: NA
Conditions: Addiction Opiate
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 45
Sex: MALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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:

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.

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.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: opioid craving scale
timeFrame: 5 minutes
Secondary outcomes:
measure: The Obsessive-Compulsive Drug use Scale
timeFrame: 15 minutes
measure: The desire for a drug questionnaire
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Sara Harby
Study officials:
affiliation: professor of neuropsychiatry
name: Tarek K Molokhia, Phd
role: STUDY_CHAIR
affiliation: professor of neuropsychiatry
name: Osama A Elkholy, Phd
role: STUDY_CHAIR
affiliation: lecturer of neuropsychiatry
name: Ahmed M Abdelkreem, Phd
role: STUDY_DIRECTOR
affiliation: assistant lecturer of psychiatry
name: Sara A Harby, master
role: PRINCIPAL_INVESTIGATOR
References: