Protocol summary

Summary
Aim: The main aim of the present research is to find the effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on craving, rumination and relapse prevention for heroin abusers treating with methadone. The present study was a clinical trial including pre and post-tests as well as two months follow-up phases. All subjects were selected from a main population which referred to a treatment Center in the city of Arak. From those, 36 patients with heroin abusers treating with methadone and without acute mental disorder were randomly selected and divided into two the two control (N= 20) and experimental groups (N= 16). All subjects were requested to fill in The Obsessive Compulsive Drug Use Scale (OCDUS) and Ruminative response scale (RRS) in the pre and post-tests as well as in the follow-up phases. Then, The MBCT program were coduvted for the experimental group (eight sessions) while the control group has not received it.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015061522749N1
Registration date: 2015-06-29, 1394/04/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-29, 1394/04/08
Registrant information
Name
Ali Haghnazari
Name of organization / entity
Baqiyatallah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6219
Email address
ali91haghnazari@gmail.com
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Science
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness based cognitive therapy on craving, rumination and relapse prevention for heroin abusers treating with methadone
Public title
The effectiveness of mindfulness on addiction
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: heroin abuser; treating with methadone exclusion criteria: acute mental disorder
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: 36
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
Baqiyatallah University of Medical Science
Street address
Sheykh bahayi st, Molla sadra st, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-04-28, 1394/02/08
Ethics committee reference number
IR.BMSU.REC.1394.72

Health conditions studied

1

Description of health condition studied
addiction
ICD-10 code
f55
ICD-10 code description
abuse of non-dependence-producing substances

Primary outcomes

1

Description
Craving and Rumination
Timepoint
befor, after and 2 months follow up
Method of measurement
Craving and Rumination Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: don't received any intervention
Category
N/A

2

Description
Experimental group: Mindfulness Based Cognitive Therapy (MBCT)
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Methadone maintenance therapy center
Full name of responsible person
Ali Haghnazari
Street address
Baqiyatallah University of Medical Science
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Science
Full name of responsible person
Mrs Dr Naderi
Street address
Sheykh bahayi st, Molla sadra st, 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
Baqiyatallah 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
Baqiyatallah University of Medical Science
Full name of responsible person
Ali Haghnazari
Position
student
Other areas of specialty/work
Street address
Sheykh bahayi st, Molla sadra st, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8894 6219
Fax
Email
ali91haghnazari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Science
Full name of responsible person
Ali Haghnazari
Position
Master of Science
Other areas of specialty/work
Street address
Sheykh bahayi st, Molla sadra st, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8894 6219
Fax
Email
ali91hagnazari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiyatallah University of Medical Science
Full name of responsible person
Ali Haghnazari
Position
Other areas of specialty/work
Street address
Sheykh bahayi st, Molla sadra st, Tehran, Iran
City
Postal code
Phone
+98 21 8894 6219
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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