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Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving

16. februar 2022 opdateret af: Sara Harby

Comparing the Effect of Cognitive Behavioral Therapy, Mindfulness Based Relapse Prevention and Twelve-step Therapy in Patients With Opioid Craving

the study aim is to compare betwenn the effect of mindfulness based relapse prevention and other evidence based psychotherapy interventions regaring substance craving.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

45

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
      • Alexandria, Egypten, 03
        • Sara Harby

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

15 år til 50 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Adfærdsmæssigt: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy

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.
Aktiv komparator: mindfulness based relapse prevention

MBRP 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.
Adfærdsmæssigt: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy

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.
Aktiv komparator: twelve-step therapy
12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation
Adfærdsmæssigt: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
opioid craving scale
Tidsramme: 5 minutes
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Obsessive-Compulsive Drug use Scale
Tidsramme: 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
15 minutes
The desire for a drug questionnaire
Tidsramme: 15 minutes
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sara Harby

Efterforskere

  • Studiestol: Tarek K Molokhia, Phd, professor of neuropsychiatry
  • Studiestol: Osama A Elkholy, Phd, professor of neuropsychiatry
  • Studieleder: Ahmed M Abdelkreem, Phd, lecturer of neuropsychiatry
  • Ledende efterforsker: Sara A Harby, master, assistant lecturer of psychiatry

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. oktober 2019

Primær færdiggørelse (Faktiske)

30. juni 2021

Studieafslutning (Faktiske)

10. oktober 2021

Datoer for studieregistrering

Først indsendt

8. februar 2022

Først indsendt, der opfyldte QC-kriterier

16. februar 2022

Først opslået (Faktiske)

25. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RPC£0521190906

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