Effectiveness of Dialectical Behavior Therapy on Emotion regulation strategies, Distress tolerance, Craving and Depression of patients receiving Methadone Maintain Therapy
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.