Protocol summary

Study aim
Design
Settings and conduct
Participants/Inclusion and exclusion criteria
Intervention groups
Main outcome variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150413021727N2
Registration date: 2017-11-28, 1396/09/07
Registration timing: retrospective

Last update: 2017-11-28, 1396/09/07
Update count: 0
Registration date
2017-11-28, 1396/09/07
Registrant information
Name
Zahra Gholami
Name of organization / entity
Islamic Azad University of Torbat-e-Jam.
Country
Iran (Islamic Republic of)
Phone
+98 51 5251 0552
Email address
zahragholami014@gmail.com
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Torbat-e-Jam
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Mindfulness-Based Group Therapy in Relapse Prevention of Methamphetamine- Addicted Males
Public title
The Effect of Mindfulness-Based Group Therapy in Relapse Prevention of Methamphetamine-Addicted Males
Purpose
Treatment
Inclusion/Exclusion criteria
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Subjects will be assigned to experimental and control groups randomly: With the aid of Random Numbers Table.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Islamic Azad University of Torbat-e-Jam
Street address
7 km to Torbat-e-Jam, Mashhad road
City
Torbat-e-Jam
Postal code
Approval date
2017-07-11, 1396/04/20
Ethics committee reference number
11820701911029

Health conditions studied

1

Description of health condition studied
Substance dependence
ICD-10 code
Y49.7
ICD-10 code description
Psychostimulants with abuse potential

Primary outcomes

1

Description
Tendency towards taking drugs
Timepoint
Before and after the treatment
Method of measurement
Relaps Prediction Scale (RPS)

2

Description
Probability of taking drugs
Timepoint
Before and after the treatment
Method of measurement
Relaps Prediction Scale (RPS)

3

Description
Relapse
Timepoint
Before and after the treatment
Method of measurement
Relaps Prediction Scale (RPS)

4

Description
Depression
Timepoint
Before and after the treatment
Method of measurement
Beck Depression Inventory -2th ed. (BDI-11)

5

Description
Client Satisfaction
Timepoint
Before and after the treatment
Method of measurement
Client Satisfaction Questionnaire (CSQ)

6

Description
Clinical Global Impressions
Timepoint
Before and after the treatment
Method of measurement
Clinical Global Impressions (CGI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The Intervention group will attend mindfulness-based group therapy in relapse prevention sessions for 5 weeks (9 sessions of one hour). In general, the treatment plan for this group will be to at assess previous session homework, to le
Category
Behavior

2

Description
Control group:The control group simultaneously (9 one-hour sessions for 5 weeks) will continue Center’s usual care plan of the group
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Pooyandegan Hasti Addiction Treatment Center
Full name of responsible person
Kamran Tavassoli
Street address
Toos65, Mashhad.
City
Mashhad.

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University of Torbat-e-Jam
Full name of responsible person
Dr. Mohammad Hossein Bayyazi
Street address
7 km to Torbat-e-Jam, Mashhad road
City
Torbat-e-Jam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Islamic Azad University of Torbat-e-Jam
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
Islamic Azad University of Torbat-e-Jam
Full name of responsible person
Zahra Gholami
Position
Master of Clinical Psychology
Other areas of specialty/work
Street address
7 km to Torbat-e-jam, Mashhad road
City
Torbat-e-Jam
Postal code
Phone
+98 51 5251 0552
Fax
Email
zahragholami014@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shareh
Position
Prof. of Clinical Psychology
Other areas of specialty/work
Street address
Tohid Shahr Street, Sabzevar.
City
Sabzevar
Postal code
Phone
+98 51 4441 0106
Fax
Email
hsharreh@yahoo.com.au
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Torbat-e-Jam
Full name of responsible person
Zahra Gholami
Position
Master of Clinical Psychology
Other areas of specialty/work
Street address
7 km to Torbat-e-jam, Mashhad road
City
Torbat-e-Jam
Postal code
Phone
+98 51 5251 0552
Fax
Email
zahragholami014@gmail.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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