Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving
Comparing the Effect of Cognitive Behavioral Therapy, Mindfulness Based Relapse Prevention and Twelve-step Therapy in Patients With Opioid Craving
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2021
CompletedFirst Submitted
Initial submission to the registry
February 8, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedFebruary 25, 2022
February 1, 2022
1.7 years
February 8, 2022
February 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
The Obsessive-Compulsive Drug use Scale
15 minutes
The desire for a drug questionnaire
15 minutes
Study Arms (3)
cognitive behavioral therapy
ACTIVE COMPARATORStandard 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.
mindfulness based relapse prevention
ACTIVE COMPARATORMBRP 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.
twelve-step therapy
ACTIVE COMPARATOR12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sara Harbylead
Study Sites (1)
Sara Harby
Alexandria, 03, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tarek K Molokhia, Phd
professor of neuropsychiatry
- STUDY CHAIR
Osama A Elkholy, Phd
professor of neuropsychiatry
- STUDY DIRECTOR
Ahmed M Abdelkreem, Phd
lecturer of neuropsychiatry
- PRINCIPAL INVESTIGATOR
Sara A Harby, master
assistant lecturer of psychiatry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- assistant lecturer
Study Record Dates
First Submitted
February 8, 2022
First Posted
February 25, 2022
Study Start
October 15, 2019
Primary Completion
June 30, 2021
Study Completion
October 10, 2021
Last Updated
February 25, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share