Protocol summary

Summary
(1) Objectives: This study aimed to compare the effectiveness of Mindfulness based relapse prevention (MBRP)) on Impulsivity, Distress Tolerance and Relapse Prevention in Opiates dependent Patient at Qom. (2) Design: General plan of this study is consisted of experimental pre-test and post-test with follow-up period. (3) Setting and conduct: seventy subjects of opiates user who Beyond the period of detoxification and were able to complete the program were selected by convenient sampling and were randomly assigned in two groups (MBRP). Participants in two groups filled out Barratt Impulsiveness Scale-11scale, Simons JS, Gaher Distress Tolerance Scale questionnaire as pre-test and post- test and two month after intervention. The data were analyzed by SPSS-15 using the Multivariate Analysis of Covariance (MANCOVA). (4) Participants including major eligibility criteria: Inclusion criteria: Beyond the period of detoxification ; cycle degree; Age 20-40 years; at least once history of relapse; referred by a psychiatrist (diagnosis of drug dependence) based on DSM-IV; After more than a week of successful detoxification. Exclusion criteria: use Anti-psychotic drugs; having a long-term dependency on a substance simultaneously; the absence of more than two session; Get a history of other therapy during the past month. (5) Interventions: The intervention is consisted of 8 sessions (each session is 120 minutes) of Mindfulness based relapse prevention for the experimental group. (6) Main outcome measures: Main outcome measures variables in this research are Impulsivity, Distress Tolerance and Relapse Prevention.

General information

Acronym
Mindfulnees Based Relapse Prevention
IRCT registration information
IRCT registration number: IRCT2016010525870N1
Registration date: 2016-01-20, 1394/10/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-20, 1394/10/30
Registrant information
Name
Mehdi Yaghobi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 315554111
Email address
yaghobi-me@mail.kamus.ac.ir
Recruitment status
Recruitment complete
Funding source
govermental/Kashan University of Medical
Expected recruitment start date
2014-08-04, 1393/05/13
Expected recruitment end date
2015-09-04, 1394/06/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Mindfulness Based Relapse Prevention Model on Impulsivity, Distress Tolerance and Relapse Prevention in Opioid dependent Patient
Public title
Effect of Mindfulness Based Relapse Prevention Model on Impulsivity, Distress Tolerance and Relapse Prevention in Opioid dependent Patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Beyond the period of detoxification ; cycle degree; Age 20-40 years; at least once history of relapse; referred by a psychiatrist (diagnosis of drug dependence) based on DSM-IV; After more than a week of successful detoxification. Exclusion criteria: use Anti-psychotic drugs; having a long-term dependency on a substance simultaneously; the absence of more than two session; Get a history of other therapy during the past month
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
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 committee of Kashan University of Medical Sciences and Health Services
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
8715988141
Approval date
2015-06-05, 1394/03/15
Ethics committee reference number
IR.kAUMS.REC.1394.45

Health conditions studied

1

Description of health condition studied
Opioid dependency
ICD-10 code
F11
ICD-10 code description
F11 Mental and behavioural disorders due to use of opioids

Primary outcomes

1

Description
Impulsivity
Timepoint
before intervention, After intervention, 1 month after intervention
Method of measurement
Barratt Impulsiveness scale

2

Description
Distress Tolerance
Timepoint
Before intervention ٫After intervention٫ 1 month After intervention٫
Method of measurement
Simon JS ٫ Gaher Distress Tolerance scale

3

Description
relapse
Timepoint
Before intervention ٫After intervention٫ 1 month After intervention٫
Method of measurement
morphine kit

Secondary outcomes

empty

Intervention groups

1

Description
Mindfulness Based Relapse Prevention ٫ 8 session٫ 2 hours٫ intervention group
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Apadana Methadontherapy Institu
Full name of responsible person
Mosavi panah Hossein
Street address
Apadana Methadontherapy Institue٫Doctors spetialist bulding٫kamal almolk sq٫Kashan٫Iran.
City
kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Sciences and health service
Full name of responsible person
Dr Qolam Ali Hamidi
Street address
Vice chancellor for research of Kashan University of Medical Sciences and health service ٫pezeshk Blvd٫ 5 th of Qotobe Ravandi Blvd٫ Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Kashan University of Medical Sciences and health service
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences and health service
Full name of responsible person
Mehdi Yaghobi
Position
M.Sc Candidate in clinical psychology
Other areas of specialty/work
Street address
Depertment of Clinical Psychology ٫ school of Medicine٫ Kashan University of Medical Sciences and health service ٫pezeshk Blvd٫ 5 th of Qotobe Ravandi Blvd٫ Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
mehdiyaghobi13110@gmail.com;yaghobi-me@mail.kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences and health service
Full name of responsible person
Mehdi Yaghobi
Position
M.Sc clinical psychology
Other areas of specialty/work
Street address
Depertment of Clinical Psychology ٫ school of Medicine٫ Kashan University of Medical Sciences and health service ٫pezeshk Blvd٫ 5 th of Qotobe Ravandi Blvd٫ Kashan
City
Kashan
Postal code
Phone
+31 55540021
Fax
Email
mehdiyaghobi13110@gmail.com ; yaghobi-me@mail.kamus.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences and health service
Full name of responsible person
Mehdi Yaghobi
Position
M.Sc clinical psychology
Other areas of specialty/work
Street address
Depertment of Clinical Psychology ٫ school of Medicine٫ Kashan University of Medical Sciences and health service ٫pezeshk Blvd٫ 5 th of Qotobe Ravandi Blvd٫ Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
mehdiyaghobi13110@gmail.com ; yaghobi-me@mail.kamus.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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