Protocol summary

Summary
Relapse is the most important challenges in addiction treatment. Purpose of this study was to assess the effectiveness of relapse prevention program during the detoxification stage. This study a randomized clinical trial was conducted among 70 male addicts who referred to treatment addiction centers in Hamadan in both experimental and control groups. Drug detoxification Stage, Voluntarily to leave the drugs, and willingness to cooperate were considered as inclusion criteria, in addition, absent in two education sessions or treatment were considered as exclusion criteria. The educational intervention with activates learning approach included ten weekly teaching (individual education for each of participants) units (45–60 min each) by a psychologist. Training sessions included: pattern addiction, drug abuse side effect, craving beliefs control, knowledge about relapse symptoms, coping skills such as (stress management, problem solving skills, assertiveness skills training and refusal skills against drug use). Cross-tabulation, t-test, correlation and regression by using SPSS statistical package, version 16 was used for the statistical analysis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013092314736N1
Registration date: 2013-10-05, 1392/07/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-10-05, 1392/07/13
Registrant information
Name
Farzad Jalilian
Name of organization / entity
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 468 5499
Email address
jalilian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan Unversity of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and Implementing Intervention Program to Relapse Prevention among Addicts Referred to Addiction Centers in Hamadan
Public title
Designing and Implementing Intervention Program to Relapse Prevention among Addicts
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: volunteers reffered to leave the drugs, and willingness to cooperate. Exclusion criteria: absent in two education sessions or treatment.
Age
No age limit
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
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
Approval date
2011-10-07, 1390/07/15
Ethics committee reference number
1356

Health conditions studied

1

Description of health condition studied
Prevention among Addicts Referred to Addiction Centers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Relapse
Timepoint
Starting the intervention and three months post-intervention
Method of measurement
Morphine test

Secondary outcomes

1

Description
Behavioral intention
Timepoint
Before and three months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Training program for participants in the intervention group training ten sessions were held for 45 to 60 minutes. Session 1: Physiology of Addiction Session 2: Complications and consequences of drug use (individual, family and community) Session 3: wrong beliefs associated with drug use and awareness of the symptoms of relapse Session 4: Relapse, Complications and Symptoms Session 5 and 6: training life skills (stress management skills - resist pressure skills) Session 7 and 8: training life skills (, problem solving skills - Self-Presentation skills) Session 9 and 10: training life skills (coping with anxiety skills - communicating skills)
Category
Prevention

2

Description
In the control group: No Action
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Meher Poyan Addiction Center
Full name of responsible person
Davood Alipour
Street address
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Full name of responsible person
Dr Mohammad Ahmad Panah
Street address
Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
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
Hamadan University of Medical Sciences
Full name of responsible person
Farzad Jalilian
Position
PhD candidate
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 31 7726 3623
Fax
Email
f_jalilian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farzad Jalilian
Position
PhD candidate in Health Education
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 31 7726 3623
Fax
Email
f_jalilian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Farzad Jalilian
Position
PhD student in in Health Education and Health Promotion
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
00
Fax
Email
f_jalilian@yahoo.com
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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