comparing the effectiveness of mindfulness-based relapse prevention group therapy with treatment as usual on shame, perfectionism and self-criticism among people with opioids use disorder
Determining the effictiveness of mindfulness-based relapse prevention group therapy on shame, perfectionism and self-criticism among people with opioids use disorder and comparing it with usual treatments
Design
This is a randomized clinical,controlled,parallel groups trial.30 participants will randomly assigned to study groups using a rondom sequence generation of quadrilateral block.
Settings and conduct
Iranian National Center for Addiction Studies. After going to this center and studying patients files, patients who meet criteria for the study, will be enrolled to the study after compeleting written informed consent.
Participants/Inclusion and exclusion criteria
inclusion criteria:
age: 20 to 45 years old
education: at least 8 grades
opioids use disorder based on DSM-5 criteria
informed consent for participating in research
maitenance therapy with methadone or buprenorphine more than 1 week and less than 24 weeks
exclusion criteria:
having psychotic syptoms
organic brain disorder
having suicide thoughts based on interiew
meeting critera for personality disorder
Intervention groups
Experiment group will recieve mindfulness- based relapse prevention group therapy within 8 sessions and usual teatments like methadone therapy, bupronorphine, or family therapy. contol group will recieve just usual treatments.
Main outcome variables
shame, perfectionism, self- criticism
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170702034844N5
Registration date:2020-04-28, 1399/02/09
Registration timing:retrospective
Last update:2020-04-28, 1399/02/09
Update count:0
Registration date
2020-04-28, 1399/02/09
Registrant information
Name
Alireza Noroozi
Name of organization / entity
Iranian National Center for Addiction Studies (INCAS)
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 1144
Email address
noroozi_a@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the effectiveness of mindfulness-based relapse prevention group therapy with treatment as usual on shame, perfectionism and self-criticism among people with opioids use disorder
Public title
effectiveness of mindfulness-based relapse prevention group therapy among people with opioids use disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age: 20 to 45 years old
education: at least 8 grades
opioids use disorder based on DSM-5 criteria
informed consent for participating in research
maitenance therapy with methadone or buprenorphine more than 1 week and less than 24 weeks
Exclusion criteria:
having psychotic syptoms
organic brain disorder
having suicide thoughts based on interiew
meeting critera for personality disorder
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
randomization: using a random sequence generation, a quadrilateral block is used with a random number table.
allocation: by a third-party supervisor who is a physician at the National Center fo Addictive Studies and coordinating the placement of each patient in each treatment group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of shahid beheshti university
Street address
faculty of cognitive sciences and brain, shahid beheshti university, daneshjoo blvd, Evin.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.SBU.REC.1399.008
Health conditions studied
1
Description of health condition studied
Opioids dependence
ICD-10 code
F11.2
ICD-10 code description
Opioid dependence
Primary outcomes
1
Description
Shame score other ad shamer scale
Timepoint
Before starting the treatment, after treatment, and 1 month after treatment.
Method of measurement
Using other as shamer scale
2
Description
scores in positive and negative perfectionism questionarre
Timepoint
Before starting the treatment, after treatment, and 1 month after treatment.
Method of measurement
Using positive and negative perfectionism questionarre.
3
Description
scores in self-criticism questionarre
Timepoint
Before starting the treatment, after treatment, and 1 month after treatment.
Method of measurement
Using self criticism questionarre.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group contains patients with opioid use disorder that aftermeeting interance critera will enter the group. At first, patients will fill the qustionarres of shame, positive and negative perfectionism, self- criticism, and addiction severity index.Then they reieve the mindfulness based relapse prevention intervention whithin 8 sessions. This programe is combined of mindfulness skills and cognitive behavioral therapy. This group will also recieve usual treatments like methadone or bupronorphine therapy or single psychotherapies. At the end of the intervention and 1 month after that, questionarres will be reapeted.
Category
Behavior
2
Description
Control group: This group contains patients with opioid use disorder that aftermeeting interance critera will enter the group. At first, patients will fill the qustionarres of shame, positive and negative perfectionism, self- criticism, and addiction severity index.This group will recieve usual treatments like methadone or bupronorphine therapy or single psychotherapies.At the end of the intervention of intervention group and after 1 month later, control group will fill the questionarres again.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian National Center for Addiction Studies
Full name of responsible person
Alireza Norouzi
Street address
No. 486, South Karegar Ave, Qazvin Square
City
Tehran
Province
Tehran
Postal code
1336616357
Phone
+98 21 5542 1155
Email
incas@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian National Center for Addiction Studies
Full name of responsible person
Dr. Alireza Noroozi
Street address
No 486, next to Farabi hospital, Qazvin sq, south kargar ave.
City
Tehran
Province
Tehran
Postal code
1336616357
Phone
+98 21 5542 1155
Email
incas@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian National Center for Addiction Studies
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Alireza Noroozi
Position
psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No 486, South kargar St, Qazvin Sq, Next to Farabi Hospital
City
Tehran
Province
Tehran
Postal code
1336616357
Phone
+98 21 5542 1155
Email
a_r_noroozi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Alireza Noroozi
Position
psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No 486, South karegar St, Qazvin Sq, Next to Farabi Hospital
City
Tehran
Province
Tehran
Postal code
1336616357
Phone
+98 21 5542 1155
Email
a_r_noroozi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Alireza Noroozi
Position
psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No 486, South Karegar St, Qazvin Sq, Next to Farabi Hospital
City
Tehran
Province
Tehran
Postal code
1336616357
Phone
+98 21 5542 1155
Email
a_r_noroozi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participants data file: The participants data without identifying information will be available after copmletion of the study.
Clinical study report: The clinical study report will be available after completion of the study.
When the data will become available and for how long
From August 2020
To whom data/document is available
Researchers of psychiatric disorders clinical studies.
Under which criteria data/document could be used
Using study data for systematic reviews and meta-analysis studies is permitted.
From where data/document is obtainable
Dr. Alireza Noroozi,Psychiatric clinic, Iranian National Center for Addiction Studies, No 486, south karegar St, Tehran, Iran.
Email: a_r_noroozi@yahoo.com
What processes are involved for a request to access data/document
The data request need to clearly define data needs. The study contact person will provide available data within 1 week after receiving the request.