Protocol summary

Summary
In this research the common Matrix Model will be compared with Dialectical and Spiritual Group Therapy for the treatment of individuals with Methamphetamine dependence. Convenience sampling is used to select individuals in this research. The criteria required to enter the research will be to have an age between 20 and 60, to have at least the 8th grade in education, to use stimulant drugs recently based on the stimulant dependence criteria in DSM-IV assessed by the psychiatrist or the clinical psychologist based on the SCID, and to have the patients’ acceptance for entering the study based on a written consent; the criteria required to exit the research is to have psychotic features, to have an organic brain disorder reported by the patient or his/her family, and to have serious suicidal thoughts reported by the psychiatric interview. Emotional Intelligence Questionnaire, Lovibond Anxiety, Depression and Stress Scale, and Addiction Intensity Scale are used to assess the results.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111523478N2
Registration date: 2017-02-04, 1395/11/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-04, 1395/11/16
Registrant information
Name
Mohammadreza Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 2001
Email address
mohammadimr@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-11-15, 1395/08/25
Expected recruitment end date
2017-01-14, 1395/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of effectiveness of the Matrix group therapy and Dialectical Behavior therapy with Spiritual therapy in addicted persons( methamphetamine
Public title
A comparison of effectiveness of the Matrix group therapy and Dialectical Behavior therapy with Spiritual therapy in addicted persons( methamphetamine
Purpose
Treatment
Inclusion/Exclusion criteria
The patients who entered the study met the following criteria: • Being between 20 to 60 years of age. • Minimum education: 8th grade(years). • Being diagnosed with “recent stimulant use” according to the stimulant dependence criteria in DSM-IV made by the psychiatrist or the clinical psychologist based on the SCID. • The patients’ acceptance to enter the study based on a written consent. The patients who dropped out of the study met the following criteria: • Having psychotic features. • Having an organic brain disorder reported by the patient or his/her family.
Age
From 20 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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 comittee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Postal code
Approval date
2016-10-30, 1395/08/09
Ethics committee reference number
IR.TUMS.VCR.REC.1395.889

Health conditions studied

1

Description of health condition studied
Addiction
ICD-10 code
F19
ICD-10 code description
Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances

Primary outcomes

1

Description
Stress
Timepoint
Before and after intervention
Method of measurement
Depression, anxiety and stress Scale(DASS-21)

2

Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Depression, anxiety and stress Scale(DASS-21)

3

Description
Depression
Timepoint
before and after intervention
Method of measurement
Depression, anxiety and stress Scale(DASS-21)

4

Description
Addiction Severity
Timepoint
Before and after intervention
Method of measurement
Addiction Severity Index

5

Description
Alcohol problems
Timepoint
Before and after intervention
Method of measurement
Structured Clinical Interview for DSM-IV

6

Description
Family problems
Timepoint
Before and after intervention
Method of measurement
Structured Clinical Interview for DSM-IV

7

Description
Psychiatric problems
Timepoint
Before and after intervention
Method of measurement
Structured Clinical Interview for DSM-IV

Secondary outcomes

1

Description
Job problems
Timepoint
Before and after intervention
Method of measurement
Structured Clinical Interview for DSM-IV

2

Description
Medical problems
Timepoint
Before and after intervention
Method of measurement
Structured Clinical Interview for DSM-IV

Intervention groups

1

Description
Matrix group therapy: intervention Matrix Model, a common method in treating individuals diagnosed with substance use and addictive disorders, has not been successful, many researchers have felt the necessity for a comprehensive treatment plan in this field. For this reason, this study attempts to compare the Matrix Model with the new methods of treatment such as Dialectical and Spiritual Group Therapy in individuals with Methamphetamine dependence.
Category
Treatment - Other

2

Description
Dialectical behavior therapy: in this study dialectical behavior therapy treatment focuse on four skills; 1: mindfulness 2: effective interpersonal relationships 3: emotion regulation 4: pain
Category
Behavior

3

Description
Spiritual groups therapy: the main component of spiritual Group Therapy is Morality, Spirituality and religion
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Dr. Mohammad Reza Mohammadi
Street address
Roozbeh hospital, South Kargar St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms. Esmat Karimi
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Psychiatric Research Center, Tehran University of Medical Sciences
Full name of responsible person
Zahed Abdollahi
Position
PhD
Other areas of specialty/work
Street address
Roozbeh hospital, South Kargar St.
City
Tehran
Postal code
Phone
+98 21 5542 1959
Fax
Email
zahed_abdolahi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Psychiatric Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Mohammadi
Position
Professor
Other areas of specialty/work
Street address
Roozbeh hospital, South Kargar St.
City
Tehran
Postal code
Phone
+98 21 5542 2001
Fax
Email
mohammadimr@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ameneh Ahmadi
Position
Researcher
Other areas of specialty/work
Street address
Roozbeh hospital, South Kargar St.
City
Tehran
Postal code
Phone
+98 21 5542 1959
Fax
Email
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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