Objectives: the study aims to evaluate effectiveness of emotion regulation therapy on craving and emotion dysregulation in patients with substance use disorders. Design: this is a controlled clinical trial with pretest and post- test stages. Setting and conduct: Using convenient sampling, 30 patients admitted to the Noor hospital of Isfahan were assigned in Methadone therapy or experimental group (Methadone therapy and emotion regulation therapy) randomly. Difficulties in emotion regulation scale, marital adjustment questionnaire and craving beliefs questionnaire will administer in pre and post treatment in both groups. Major Inclusion and Exclusion criteria: inclusion criteria: having a diagnosis of substance use disorder diagnosis criteria psychiatrist; not receiving psychological treatment for at least a month before the study; having at least 18 years and a maximum of 60 years; having at least third-level education in guided school and agreement to participate in research according to informed consent. Exclusion criteria: having psychotic symptoms; having full criteria for psychiatric disorders in axis I; having serious suicidal thoughts; having symptoms of borderline personality disorder and antisocial personality disorder. Intervention: the experimental group will receive eight weekly treatments. Main outcome measures: difficulties in emotion regulation, marital adjustment and craving beliefs.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201505157227N2
Registration date:2015-07-31, 1394/05/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-31, 1394/05/09
Registrant information
Name
Fatemeh Zargar
Name of organization / entity
Tehran Psychiatric Institute, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 8748
Email address
f.zargar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of emotion regulation therapy on craving and emotion dysregulation in patients with substance use disorders.
Public title
A randomized clinical trial of effect of emotion regulation therapy on craving and emotion dysregulation in patients with substance use disorders.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:having a diagnosis of substance use disorder diagnosis criteria psychiatrist;not receiving psychological treatment for at least a month before the study; at least 18 years and a maximum of 60 years; at least third-level education in guided school; patients agreed to participate in research According to informed consent.
Exclusion criteria: having psychotic symptoms; having full criteria for psychiatric axis I disorders; thoughts of suicide are serious about the possibility of drug and makes it impossible to maintain it; having symptoms of borderline personality disorder and antisocial personality disorder.
Age
From 18 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Azad University, Khorasgan branch
Street address
Isfahan
City
Isfahan
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
2382/701/د/92
Health conditions studied
1
Description of health condition studied
Mental and behavioural disorders due to use of opioids
ICD-10 code
F-11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
Marital adjustment
Timepoint
pre-test and 2 months after starting intervention
Method of measurement
Spanier marital adjustment
2
Description
Craving
Timepoint
pre-test and 2 months after starting intervention
Method of measurement
Craving beliefs questionnaire
3
Description
Emotion dysregulation
Timepoint
pre-test and 2 months after starting intervention
Method of measurement
difficulties in emotion regulation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Methadone therapy combined to emotion regulation therapy
Category
Behavior
2
Description
Control group: Methadone therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor hospital
Full name of responsible person
Nasim Bagheri
Street address
Noor hospital, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
investigator
Full name of responsible person
Nasim Bagheri
Street address
700, Hossein Abad, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
investigator
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
Kashan university in medical sciences
Full name of responsible person
Fatemeh Zargar
Position
Ph.D. in clinical psychology, assistant profesor
Other areas of specialty/work
Street address
Kashan university in medical sciences
City
Kashan
Postal code
Phone
+98 31 3625 8748
Fax
Email
fatemehzargar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan university in medical sciences
Full name of responsible person
Fatemeh Zargar
Position
ph.D. in clinical psychology/assistant profesor
Other areas of specialty/work
Street address
Kashan university in medical sciences
City
Kashan
Postal code
Phone
+98 31 3625 8748
Fax
Email
fatemehzargar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan university in medical sciences
Full name of responsible person
fatemeh Zargar
Position
Ph.D. in clinical psychology, assistant profesor
Other areas of specialty/work
Street address
Kashan university in medical sciences
City
Kashan
Postal code
Phone
+98 31 3625 8748
Fax
Email
fatemehzargar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)