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The effect of the "lapse management" training on craving, relapse risk and abstinence self-efficacy of substances in people undergoing methadone maintenance treatment.

Protocol summary

Study aim
The effect of the "lapse management" training on craving, relapse risk and abstinence self-efficacy of substances in people undergoing methadone maintenance treatment.
Design
A randomized, double-blind, placebo-controlled clinical trial
Settings and conduct
The study population consisted of 76 addicts treated with methadone prescription drug referring to Imam Reza No.1- 4 addiction treatment centers in Birjand in 1396-97.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individual's willingness to participate in the study, male, age 18-50 years, referred to the center after the MMT course, during the last 6 months for treatment of addiction, literacy, hearing and speech impairment, access On the phone, no psychosis, no other treatments at the same time (other psychotherapies, NA, etc.). Exclusion criteria: Unwillingness to continue participating in the study, absenteeism, any serious health problems that prevent the person from continuing to participate in the study (hospitalization, etc.
Intervention groups
the "lapse management" protocol and the calendar slip self-assessment technique will be divided into 4 90-minute sessions in small groups of 2-3 (one session per week). Will be provided for the experimental group. In addition, the intervention group will receive follow-up and individual telephone counseling once a week for 4 weeks. The control group received no intervention. Only the landslide management package will be provided to the control group at the post-test stage for ethics compliance.
Main outcome variables
craving ؛ relapse risk ؛ abstinence self-efficacy of substances

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191014045108N2
Registration date: 2020-01-29, 1398/11/09
Registration timing: registered_while_recruiting

Last update: 2020-01-29, 1398/11/09
Update count: 0
Registration date
2020-01-29, 1398/11/09
Registrant information
Name
Hoda Khoshbakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3223 9917
Email address
hoda-khoshbakht@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-31, 1398/10/10
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the "lapse management" training on craving, relapse risk and abstinence self-efficacy of substances in people undergoing methadone maintenance treatment.
Public title
The effect of the "lapse management" training on craving, relapse risk and abstinence self-efficacy of substances in people undergoing methadone maintenance treatment.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Individual's willingness to participate in the study male age 18-50 years after MMT course have been referred to the center for treatment of addiction for the last 6 months literacy hearing and speech impairment access to Telephone absence of psychosis absence of other therapies at the same time (other psychotherapies, NA, etc.)
Exclusion criteria:
Unwillingness to continue participating in the study absenteeism any serious health problems that prevent the person from continuing to participate in the study (hospitalization, etc.)
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization : The method would be to randomly select a colored sphere from two in-box spheres
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the data analyzer is unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee ofBirjand University of Medical Sciences
Street address
No.48, Moalem5,West Moalem Ave
City
Birjand
Province
South Khorasan
Postal code
9717937715
Approval date
2019-11-27, 1398/09/06
Ethics committee reference number
IR.BUMS.REC.1398.266

Health conditions studied

1

Description of health condition studied
"Lapse Management" training
ICD-10 code
F11
ICD-10 code description
Opioid related disorders

Primary outcomes

1

Description
Craving Score in Tiffany's Drug Abuse Questionnaire
Timepoint
Before and after the intervention and 1 month after the intervention
Method of measurement
Tiffany's Drug Abuse Craving Questionnaire,

2

Description
Relapse Risk Scale on Ogai-Risk Relapse Risk Scale
Timepoint
Before and after the intervention and 1 month after the intervention
Method of measurement
Ogai-Risk Relapse Risk Scale

3

Description
abstinence self-efficacy of substances Scale in Martin Goleman abstinence self-efficacy of substances Questionnaire
Timepoint
Before and after the intervention and 1 month after the intervention
Method of measurement
Martin Goleman abstinence self-efficacy of substances Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The "Lapse Management" protocol and the calendar lapse self-assessment technique will be presented to the experimental group in 4 90-minute sessions in small groups of 2-3 (one session per week). In addition, the intervention group will receive once a week They will undergo follow-up and individual telephone counseling for 4 weeks
Category
Prevention

2

Description
Control group: There is no intervention for control group. Only the lapse management package will be provided to the control group in the post-test for ethics compliance.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Addiction Treatment Center No.1-4
Full name of responsible person
Ali Akbar Esmaeili
Street address
Taleghani 7-Taleghani Ave
City
Birjand
Province
South Khorasan
Postal code
9714811151
Phone
+98 56 3162 4531
Email
ERHL@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
dr.Tooba Kazemi
Street address
Vice Chancellor for Education and Research, Second Floor, Vice Chancellor for Research and Technology, Ghafari Ave.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Birjand University of Medical Sciences
Grant code / Reference number
456019
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Private
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
Birjand University of Medical Sciences
Full name of responsible person
Hoda Khoshbakht
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Moalem5, No 48
City
Birjand
Province
South Khorasan
Postal code
9717937715
Phone
+98 56 3223 9917
Email
hodakhoshbakht4@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hoda Khoshbakht
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Moalem5,No48
City
Birjand
Province
South Khorasan
Postal code
9717937715
Phone
+98 56 3223 9917
Email
hodakhoshbakht4@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hoda Khoshbakht
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 48,Moalem 5
City
Birjand
Province
South Khorasan
Postal code
9717937715
Phone
+98 56 3223 9917
Email
hodakhoshbakht4@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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