NCT05256485

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

February 8, 2022

Last Update Submit

February 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • opioid craving scale

    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

Secondary Outcomes (2)

  • The Obsessive-Compulsive Drug use Scale

    15 minutes

  • The desire for a drug questionnaire

    15 minutes

Study Arms (3)

cognitive behavioral therapy

ACTIVE COMPARATOR

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.

Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy

mindfulness based relapse prevention

ACTIVE COMPARATOR

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.

Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy

twelve-step therapy

ACTIVE COMPARATOR

12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation

Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy

Interventions

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.

cognitive behavioral therapymindfulness based relapse preventiontwelve-step therapy

Eligibility Criteria

Age15 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sara Harby

Alexandria, 03, Egypt

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tarek K Molokhia, Phd

    professor of neuropsychiatry

    STUDY CHAIR
  • Osama A Elkholy, Phd

    professor of neuropsychiatry

    STUDY CHAIR
  • Ahmed M Abdelkreem, Phd

    lecturer of neuropsychiatry

    STUDY DIRECTOR
  • Sara A Harby, master

    assistant lecturer of psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Standard cognitive behavioral therapy comprises approaches directed toward modifying dysfunctional thinking and behavior discussed through 8 sessions. mindfulness based relapse prevention is an 8-week therapy program based on: 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. This group therapy was facilitated by an ex-addict working in El Maamora hospital. 12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 25, 2022

Study Start

October 15, 2019

Primary Completion

June 30, 2021

Study Completion

October 10, 2021

Last Updated

February 25, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations