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- Essai clinique NCT05256485
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Alexandria, Egypte, 03
- Sara Harby
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
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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. |
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Comparateur actif: mindfulness based relapse prevention
MBRP training is based on a two-component process:
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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. |
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Comparateur actif: twelve-step therapy
12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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opioid craving scale
Délai: 5 minutes
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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).
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5 minutes
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Obsessive-Compulsive Drug use Scale
Délai: 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
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15 minutes
|
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The desire for a drug questionnaire
Délai: 15 minutes
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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
|
15 minutes
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Tarek K Molokhia, Phd, professor of neuropsychiatry
- Chaise d'étude: Osama A Elkholy, Phd, professor of neuropsychiatry
- Directeur d'études: Ahmed M Abdelkreem, Phd, lecturer of neuropsychiatry
- Chercheur principal: Sara A Harby, master, assistant lecturer of psychiatry
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RPC£0521190906
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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