Protocol summary

Study aim
Determining Effectiveness of Religious-Spiritual Group Training on Spiritual Health, Mental Health and Quality of Life in opioid dependent Patients
Design
In this research, 60 Opioid dependent Patient referring to Methadone Maintenance Therapy centers were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
This research is being held at the "Tavallodi Dobare" Methadone Maintenance Center in Qom. sixty subjects of opiate users who were able to complete the program were selected by convenient sampling and were randomly assigned in two groups. Participants in two groups filled out Quality Of Life Scale(SF36), GHQ Scale and spiritual Health Scale-48 questionnaire as pre-test, post- test and two months after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 20-40 years, at least middle school education, at least one history of relapse, referred by a psychiatrist (diagnosis of drug dependence) based on DSM-5. Exclusion criteria: using Anti-psychotic drugs, having a long-term dependency on a substance simultaneously, the absence of more than two session.
Intervention groups
Intervention group: 8 Religious-Spiritual Group Training sessions; 8 session; 2 hours. The control group will receive general information about the addiction and will receive no regular intervention..
Main outcome variables
Spiritual Health; Mental Health; Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160105025870N5
Registration date: 2018-05-14, 1397/02/24
Registration timing: retrospective

Last update: 2018-05-14, 1397/02/24
Update count: 0
Registration date
2018-05-14, 1397/02/24
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
Expected recruitment start date
2017-11-17, 1396/08/26
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-12-16, 1396/09/25
Actual recruitment end date
2018-01-20, 1396/10/30
Trial completion date
empty
Scientific title
Effect of Religious-Spiritual Group Training on Spiritual Health, Mental Health and Quality of Life in Opioid dependent Patients
Public title
Effect of Religious-Spiritual Group Training on Spiritual Health, Mental Health and Quality of Life in Opioid dependent Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 20-40 years referred by a psychiatrist (diagnosis of drug dependence) based on DSM-5 at least one history of relapse at least middle school education
Exclusion criteria:
Use Anti-psychotic drugs (approved by psychiatrist), having a long-term dependency on a substance simultaneously Long-term dependence on multiple substances simultaneously
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, after entering the participants to study, the subjects were divided into two groups of 30 people by block randomization. In this method, block size of 4 which contain codes A and B is used. The code A and B represent the intervention and control groups respectively. In each block, how to place the code is as follows: AABB, BBAA, ABAB, BABA, ABBA, BAAB. Blocks are randomly selected and individuals are assigned to the intervention or control groups according to the order of the block. After allocating all the cods of a block, that block is added to the previous blocks and another block is selected randomly. This process will be continued until completing the sample size.
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 Qom University of Medical Sciences
Street address
No. 83, alley 4 , 1.1 avenue, Safashahr street, Qom
City
Qom
Province
Ghoum
Postal code
3593
Approval date
2017-12-05, 1396/09/14
Ethics committee reference number
IR.MUQ.REC.1396.117

Health conditions studied

1

Description of health condition studied
Opiate dependence
ICD-10 code
F11
ICD-10 code description
Opioid related disorders

Primary outcomes

1

Description
Spiritual Health
Timepoint
Before intervention; After intervention; 2 months After intervention
Method of measurement
Spiritual Health scale-48

2

Description
Mental Health
Timepoint
Before intervention; After intervention; 2 months After intervention
Method of measurement
Mental Health scale (GHQ-28)

3

Description
Quality Of Life
Timepoint
Before intervention; After intervention; 2 months After intervention
Method of measurement
Quality Of Life scale (SF36)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 8 Religious-Spiritual Group Training sessions; 8 2-hour sessions
Category
Behavior

2

Description
Control group: The control group will receive general information about the addiction and will receive no regular intervention
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
"Tavalodi Dobareh" Methadon therapy Institue
Full name of responsible person
Mohammad AbdeKhoda
Street address
No. 2, alley 4 , Sadoghi street, Qom
City
Qom
Province
Ghoum
Postal code
3956
Phone
+98 25 3783 2370
Email
pharma_75@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
No. 83, alley 4 , 1.1 street, Safashahr Ave., Qom
City
Qom
Province
Ghoum
Postal code
3285886
Phone
+98 25 3612 2000
Email
pharma_75@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences
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
Qom University of Medical Sciences
Full name of responsible person
Samira Khani
Position
Ph.D. in Pharmacology, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
East Street No. 2, Moallem Blvd., School of Medicine328588
City
Qom
Province
Ghoum
Postal code
3285885
Phone
+98 25 3783 2370
Email
pharma_75@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Mehdi Yaghobi
Position
M.Sc in clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
East Street No. 2, Moallem Blvd., School of Medicine
City
Qom
Province
Ghoum
Postal code
3285885
Phone
+98 25 3783 2370
Email
mehdiyaghobi13110@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Mehdi Yaghobi
Position
M.Sc clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
East Street No. 2, Moallem Blvd., School of Medicine
City
Qom
Province
Ghoum
Postal code
3285885
Phone
+98 25 3783 2370
Email
mehdiyaghobi13110@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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