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The Effectiveness of Mindfulness Therapy on Self-regulation, Affective control and Perceived Stress in Methamphetamine Addicts

Protocol summary

Summary
The purpose of this study is survey for the effectiveness of Mindfulness therapy on self-regulation, affective control and perceived stress among Methamphetamine addicts. Inclusion criteria are being male, being in the age range of 20 to 39 years, and being educated. Exclusion criteria are suffering from psychotic disorders, bipolar or dissociation disorders, or a severe somatic disease. The sample of this study is made of 90 addicts who will be placed in three groups: 30 addicts in experimental group, 30 addicts in the first control group and also, 30 addicts in the second control group. In the pre-test, it will use all of questionnaires. Then, it will administer Mindfulness intervention for experimental group for 12 sessions during the six months. And during this study, control groups won’t have any interventions. Finally, it will use post-test to be aware of the effectiveness of independent variable on dependent variables. Therefore, it seems that by using Mindfulness therapy on Methamphetamine addicts, their self-regulation and affective control will be increased, and their perceived stress will be decreased.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121925603N1
Registration date: 2016-03-18, 1394/12/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-03-18, 1394/12/28
Registrant information
Name
Kolsum Tayyebi
Name of organization / entity
Qom University of Medical Science and Health
Country
Iran (Islamic Republic of)
Phone
+98 25 3783 6396
Email address
psyk13t@yahoo.com
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Mindfulness Therapy on Self-regulation, Affective control and Perceived Stress in Methamphetamine Addicts
Public title
The Effectiveness of Mindfulness Therapy on the Methamphetamine Addicts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being male; being in the age range of 20 to 39 years; being educated. Exclusion criteria: suffering from psychotic disorders; bipolar or dissociation disorders; or a severe somatic disease.
Age
From 20 years old to 39 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Number 83, Alley 4, Avenue 1, Safa Shar Street
City
Qom
Postal code
Approval date
2015-12-20, 1394/09/29
Ethics committee reference number
IR.MUQ.REC.1394.122

Health conditions studied

1

Description of health condition studied
Methamphetamine
ICD-10 code
T43.6
ICD-10 code description
Psychostimulants with abuse potential

2

Description of health condition studied
Addiction
ICD-10 code
F15
ICD-10 code description
Mental and behavioural disorders due to use of other stimulants, including caffeine

Primary outcomes

1

Description
increasing the affective control
Timepoint
7 days
Method of measurement
questionnare

2

Description
increasing the self-regulation
Timepoint
7 days
Method of measurement
questionnare

3

Description
decreasing the perceived stress
Timepoint
7 days
Method of measurement
questionnare

Secondary outcomes

empty

Intervention groups

1

Description
This study is analytical-interventional which it use pre-test & post-test design with the three groups. The interventional group is a group that receive Mindfulness therapy.
Category
Behavior

2

Description
Another control group is a group that people are present like intervention group but they just discuss about social issues to be clear changes is related to being with psychotherapist or is as a result of Mindfulness therapy.
Category
Behavior

3

Description
Control group is a group that don’t receive any intervention, just taking part for filling in the questionnaires sections.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Quitting Addiction Centers
Full name of responsible person
Kolsum Tayyebi
Street address
Qom University of Medical Science
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Science
Full name of responsible person
Dr. Maleki
Street address
Qom University of Medical science, Saheli Street
City
Qom
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 Science
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
Qom University of Medical science and Health services
Full name of responsible person
Valiollah Akbari
Position
Psychiatrist
Other areas of specialty/work
Street address
Qom University of Medical science and Health Services, Shahid Lavasani St.
City
Qom
Postal code
Phone
+98 25 3772 6290
Fax
Email
Voakbari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical science and Health Services
Full name of responsible person
Kolsum Tayyebi
Position
M.A. in clinical psychology
Other areas of specialty/work
Street address
Qom University of Medical science and Health Services, Shahid Lavasani Street
City
Qom
Postal code
3713649373
Phone
+98 25 3783 6396
Fax
Email
psyk13t@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Science and Health Services
Full name of responsible person
Kolsum Tayyebi
Position
M.A. in Clinical Psychology
Other areas of specialty/work
Street address
Qom University of Medical Science and Health Services, Shahid Lavasani Street
City
Qom
Postal code
3713649373
Phone
+98 25 3772 6290
Fax
Email
psyk13t@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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