Protocol summary

Study aim
The purpose of present study is effectiveness of dialectical behavior therapy in emotional regulation strategies, distress tolerance, craving and depression for individuals under treatment with methadone.
Design
In this research, 40 eligible patients with opiate dependence diagnosis according to DSM-IV criteria are enrolled and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
40 eligible patients with opiate dependence diagnosis referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria are being masculine; recent opiates dependency (opium, heroin); negative morphine test and Exclusion Criteria are Unwillingness to participate in the study; having severe psychotic disorders; having antisocial personality disorder
Intervention groups
The first group will receive dialectical behavior therapy- skills training (DBT-ST) for 12 weeks. The second group will receive methadone maintenance treatment (MMT) for 12 weeks.
Main outcome variables
Distress tolerance is evaluated with Distress tolerance Scale (DTS); craving is evaluated with Obsessive Compulsive Drug Use Scale (OCDUS) and depression is evaluated with Beck Depression Inventory (BDI-II) Before the intervention, after the intervention, and three months after the intervention. Emotion Regulation Strategies also is evaluated with Cognitive Emotion Regulation Questionaire (CERQ-P), after the intervention, and three months after the intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170314033079N3
Registration date: 2017-12-17, 1396/09/26
Registration timing: retrospective

Last update: 2017-12-17, 1396/09/26
Update count: 0
Registration date
2017-12-17, 1396/09/26
Registrant information
Name
Morad Rasouli-Azad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 989355392455
Email address
rasouliazad-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Dialectical Behavior Therapy on Emotion regulation strategies, Distress tolerance, Craving and Depression of patients receiving Methadone Maintain Therapy
Public title
Effectiveness of Dialectical Behavior Therapy in methadone maintenance treatment patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being masculine Recent opiates dependency (opium, heroin) Negative morphine test Education at least third grade middle school
Exclusion criteria:
Unwillingness to participate in the study Positive morphine test in at least three weeks (relapse) Absence more than 4 session Having severe psychotic disorders Having antisocial personality disorder
Age
No age limit
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
Random assignment will be done by the use of computer-generated random numbers.
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 Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.KAUMS.REC.1396.36

Health conditions studied

1

Description of health condition studied
Mental and behavioural disorders due to use of opioids
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids

Primary outcomes

1

Description
Distress tolerance
Timepoint
Before the intervention, after the intervention, and three months after the intervention.
Method of measurement
Distress tolerance Scale (DTS)

2

Description
Craving
Timepoint
Before the intervention, after the intervention, and three months after the intervention.
Method of measurement
Obsessive Compulsive Drug Use Scale (OCDUS)

3

Description
Depression
Timepoint
Before the intervention, after the intervention, and three months after the intervention.
Method of measurement
Beck Depression Inventory (BDI-II)

4

Description
Positive Affect
Timepoint
Before the intervention, after the intervention, and three months after the intervention.
Method of measurement
Positive Affect Negative Affect Scale (PANAS)

5

Description
Negative Affect
Timepoint
Before the intervention, after the intervention, and three months after the intervention.
Method of measurement
Positive Affect Negative Affect Scale (PANAS)

Secondary outcomes

1

Description
Emotion Regulation Strategies
Timepoint
Before the intervention, after the intervention, and three months after the intervention.
Method of measurement
Cognitive Emotion Regulation Questionaire (CERQ-P)

2

Description
Emotion Regulation
Timepoint
Before the intervention, after the intervention, and three months after the intervention.
Method of measurement
Emotion Regulation Questionaire

3

Description
defficulity in Emotion Regulation
Timepoint
Before the intervention, after the intervention, and three months after the intervention.
Method of measurement
Defficulities in Emotion Regulation Scale (DERS)

Intervention groups

1

Description
Intervention group: Dialectical Behavior Therapy- Skills Training (DBT-ST)
Category
Behavior

2

Description
Control group: Methadone maintenance treatment (MMT)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gholabchi Clinic
Full name of responsible person
Morad Rasouli-Azad
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 6769
Email
rasouliazad-m@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 2999
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zeinab Rezaei
Position
MA student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 2999
Fax
Email
Zeinab.rezaie90@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morad Rasouli-Azad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
Email
mrasoliazad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morad Rasouli-Azad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
Email
rasouliazad-m@kaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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