Protocol summary

Summary
Regarding the high number of drug users and the high incidence of recurrent phenomenon on the one hand and the need to increase prevention programs for drug users on the other hand, the researchers aimed to study the effects of group education on self efficacy and tempting tendencies in people leaving drug addiction in Gorgan 5th Azar treatment training center. This is a non-randomized clinical trial. The research plan was taken in two groups (experimental and control groups); containing two pre test and post test stages. First, the control group filled two questionnaires of carving tendency and self sufficiency. They filled the questionnaires again after one month. Then, members of the experimental group are selected. They filled two questionnaires of carving tendency and self sufficiency. Afterwards, a training group program including 8 sessions is hold (each session 1.5 hours; two sessions per week). One month later, after completion of the group training sessions, questionnaires were completed again by the experimental group.

General information

Acronym
not used
IRCT registration information
IRCT registration number: IRCT2015091323683N2
Registration date: 2017-02-20, 1395/12/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Naiemeh Seyedfatemi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 1880
Email address
seyedfatemi.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Group Education on Self efficacy and Craving Tendencie in Drug Abuser Treatment Center
Public title
The Effect of Group Education on Self efficacy and Craving Tendencie in Drug Abuser Treatment Center
Purpose
Supportive
Inclusion/Exclusion criteria
Input criteria: The age of 18-65 years old; ability to read and write; experiences of taking different drugs; both male and female genders without known physical disease; passing a maximum time of one month from their referring to the center. Output criteria: Existence of a sudden stress factor; being absent in more than three meeting sessions; attending the rehabilitation and abstinence based session.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
not used

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences, School of Nursing and Midwifery
Street address
Street Martyr Yassami, Vanak Square, Valiasr Street
City
Tehran
Postal code
1996713883
Approval date
2015-11-07, 1394/08/16
Ethics committee reference number
IR.IUMS.REC.1394.9211196201

Health conditions studied

1

Description of health condition studied
Relationship of Group Education on Self Efficacy and Craving Tendencie in Drug Abusers Treatment center
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Primary Outcom 1: Self Efficacy
Timepoint
A pre test, Immediately after the 8 session of post test training
Method of measurement
DAASE Index

2

Description
Primary Outcom 2: Craving Tendencie
Timepoint
A pre test, one month later than usual care clinics, post test
Method of measurement
Craving Beliefs Questionnaire CBQ

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: In these sessions, in addition to discussing the symptoms and problems caused by drugs in the, the explanations about the warning signs of relapse, identification of stressful and dangerous situations, ways to overcome interpersonal conflicts, social pressures to cope with temptation based on mindfulness, using the favorable consumers’ experience, and correction of undesirable factors were also discussed. The sessions also address the reinforcement of the coping skills, strengthening the control of painful emotions such as anxiety and anger, and the basic tasks in supportive methods.
Category
Other

2

Description
Itervention 2: In the control group, only common clinical program runs. After the completion of training courses, training manual given to this group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fifth of Azar Medical, Addiction Training Center
Full name of responsible person
Fateme Sheikhnejad
Street address
Street Fifth of Azar
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Science, Vice Chancellor for Rrcearch
Full name of responsible person
Dr Seyed Javad Mosavi
Street address
Iran University of Medical Science, Shahid Hemat Highway,Tehran, IRAN
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Science, Vice Chancellor for Rrcearch
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
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Mrs. Doctor Naima Seyedfatemi
Position
Doctor, Head of Graduate
Other areas of specialty/work
Street address
Street Martyr Yassami, Vanak Square, Valiasr Street
City
Tehran
Postal code
88201978
Phone
+98 2102188201880
Fax
Email
nseydfatemi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Fateme Sheikhnejad
Position
Msc Student
Other areas of specialty/work
Street address
Street Martyr Yassami, Vanak Square, Valiasr Street
City
Tehran
Postal code
491686636
Phone
+98 17 3254 2144
Fax
Email
fsheikhnejad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Fateme Sheikhnejad
Position
Msc Student
Other areas of specialty/work
Street address
Street Martyr Yassami, Vanak Square, Valiasr Street
City
Tehran
Postal code
4916816636
Phone
+98 17 3254 2144
Fax
Email
fsheikhnejad@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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