- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Detailní popis
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).
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Alexandria, Egypt, 03
- Sara Harby
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: 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. |
Aktivní komparátor: 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. |
Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
opioid craving scale
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
The Obsessive-Compulsive Drug use Scale
Časové okno: 15 minutes
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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
Časové okno: 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
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15 minutes
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Tarek K Molokhia, Phd, professor of neuropsychiatry
- Studijní židle: Osama A Elkholy, Phd, professor of neuropsychiatry
- Ředitel studie: Ahmed M Abdelkreem, Phd, lecturer of neuropsychiatry
- Vrchní vyšetřovatel: Sara A Harby, master, assistant lecturer of psychiatry
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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