Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving

16 februari 2022 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Faktisk)

45

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Alexandria, Egypten, 03
        • Sara Harby

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

15 år till 50 år (Barn, Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Manlig

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / 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.

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.

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

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
opioid craving scale
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The Obsessive-Compulsive Drug use Scale
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 oktober 2019

Primärt slutförande (Faktisk)

30 juni 2021

Avslutad studie (Faktisk)

10 oktober 2021

Studieregistreringsdatum

Först inskickad

8 februari 2022

Först inskickad som uppfyllde QC-kriterierna

16 februari 2022

Första postat (Faktisk)

25 februari 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 februari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 februari 2022

Senast verifierad

1 februari 2022

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • RPC£0521190906

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera