- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alexandria, Egipto, 03
- Sara Harby
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Comparador activo: 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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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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opioid craving scale
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Obsessive-Compulsive Drug use Scale
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Tarek K Molokhia, Phd, professor of neuropsychiatry
- Silla de estudio: Osama A Elkholy, Phd, professor of neuropsychiatry
- Director de estudio: Ahmed M Abdelkreem, Phd, lecturer of neuropsychiatry
- Investigador principal: Sara A Harby, master, assistant lecturer of psychiatry
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RPC£0521190906
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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