1. Home
  2. Approved trials
  3. » فارسی

Mindfulness-based cognitive therapy on reduction of psychological symptoms,craving beliefs and increase self-efficacy in opioid abusers

Protocol summary

Summary
The Efficacy of mindfulness-based cognitive therapy on reduction of psychological symptoms, craving beliefs and increase self-efficacy in opioid abusers 1) Objectives: the main aim of this study is the effectiveness of mindfulness-based cognitive therapy on reduction of psychological symptoms,craving beliefs and increase of self-efficacy in opioid abusers. 2) Design: the present study is a pilot design with intervention groups (examination group) and the control group. 3) Setting and conduct : First, all individuals willing to participate in this study are evaluated by a structured clinical interview (DSM-5) for axis I and II disorders. then , 40 opiate addicted (opium, heroin, tramadol and Similar substances) were randomly selected and will be replaced in experimental group ( n = 20 ) and control group ( n = 20). 4) Participants : the statistical population of this study was all people that refer to drug abuse center at shiraz university of medical sciences. Inclusion major criteria is included Being male , substance abuse and independency to Stimulants , having a minimum secondary education. also, exclusion major criteria is having mental retardation and psychotic disorders. 5) Intervention : intervention sessions for the experimental group are 8 sessions, each week a session (90 minutes), mindfulness-based cognitive therapy applied for the experimental group. 6) Main outcome measure (variables) : psychological symptoms,craving beliefs and increase self-efficacy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017081325160N7
Registration date: 2017-09-25, 1396/07/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-25, 1396/07/03
Registrant information
Name
Jamshid Ahmadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 3070
Email address
ahmadij@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Mindfulness-based cognitive therapy on reduction of psychological symptoms,craving beliefs and increase self-efficacy in opioid abusers
Public title
The Efficacy of mindfulness-based cognitive therapy on reduction of psychological symptoms,craving beliefs and increase self-efficacy in opioid abusers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion major eligibility criteria to study: Being male and having age between 20 to 45 years ; having a minimum secondary education ; substance abuse and independency to Stimulants ; having diagnostic criteria for the use of opioids to the initial diagnosis of a psychiatrist and the diagnosis of clinical psychologist based on the results of a structured clinical interview for axial disturbances (DSM-5) ; dependence on at least one opiate substance (opium, heroin, tramadol and Similar substances) based on clinical interviews ; passed at least one year of drug ; lack of participation in psychotherapy groups including NA in the last 6 months ; complete consent for participation in research. Exclusion major eligibility criteria of study: Having mental retardation ; psychotic disorders ; organic brain disorder ; having serious thoughts on suicide based on psychiatrist interviews ;having complete criteria for personality disorder in axis II based on the results of structured interviews of the disordered axis two ; employment in psychology or counseling ; receiving another psychological intervention at the same time or having a kinship or friendship with each member of the intervention group ; decisided to leave the group.
Age
From 20 years old to 45 years old
Gender
Male
Phase
2-3
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Science
Street address
Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Postal code
7194634786
Approval date
2017-06-11, 1396/03/21
Ethics committee reference number
IR.SUMS.REC.1396.58

Health conditions studied

1

Description of health condition studied
opioid abusers
ICD-10 code
F 11
ICD-10 code description
This block contains a wide variety of disorders that differ in severity and clinical form but that are all attributable to the use of one or more psychoactive substances, which may or may not have been medically prescribed. The third character of the code

Primary outcomes

1

Description
psychological symptoms
Timepoint
weekly to 2 months
Method of measurement
Clinical Interview for Focal I Disorders in DSM-IV-Clinical Version (SCID-I / CV)

Secondary outcomes

1

Description
craving beliefs
Timepoint
weekly to 2 months
Method of measurement
Addiction Severity Index (ASI) - Brief Symptom Inventory (BSI)

Intervention groups

1

Description
experimental group: The present study is a pilot design with two experimental group (mindfulness-based cognitive therapy) and the control group. in this study, the pilot project is pretest – posttest by using random assignment. Intervention is only on experimental group. The intervention is included the protocol of Cognitive therapy according to protocol of application of mindfullness in intervention of addiction and Addictive behaviours ( rebbecaeei, Williams, joli s. craft, 2012 ). The intervention sessions for the experimental group are 8 sessions, each week a session (90 minutes ), is applied cognitive-based cognitive therapy approach for the test group.
Category
Behavior

2

Description
in this study, control group does not receive no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ebne Sina Hospital
Full name of responsible person
Jamshid Ahmadi M.D
Street address
Ebne Sina Hospital, Hafeziye street
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Vice Chancellery for Research Affairs, Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Ahmadi M.D.
Position
Profesor
Other areas of specialty/work
Street address
Third floor, Neshat Complex, Daneshjoo Street
City
Shiraz
Postal code
Phone
+98 71 3646 1511
Fax
Email
jamshid_ahmadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Ahmadi M.D.
Position
professor
Other areas of specialty/work
Street address
Third floor, Neshat Complex, Daneshjoo Street
City
Shiraz
Postal code
Phone
+98 71 3646 1511
Fax
Email
jamshid_ahmadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Ahmadi
Position
professor
Other areas of specialty/work
Street address
Third floor, Neshat Complex, Daneshjoo Street
City
Shiraz
Postal code
Phone
+98 71 3646 1511
Fax
Email
ahmadij@sums.ac.ir
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
Loading...