investigate the effect of teaching of dialectical behavioral therapy skills (DBT-ST) on cognitive functions in patients undergoing methadone maintenance therapy.
Design
The present study is a semi experimental design with pretest-posttest with control group. First, the researcher will refer to the addiction treatment clinics by conducting clinical interviews with the people who will have the criteria for entering the study, and then the participants will be randomly assigned using a random number table. The two groups will be treated and controlled.
Settings and conduct
40 patients will be selected in the study with a diagnosis of dependence on eligible opioids and referred to Omid Clinic, Kashan, Teachers' Square, Iran. Double-blind clinical trial parallel.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age range from 18 to 45 years
Detection of opioid dependence (opium, sap and heroin)
Treated at least one month of MMT
consent to participate in study
Level of at least third degree education (cycle)
Exit criteria:
Positive morphine test during initial assessment and post-test
The presence of a phase of mania or current depression
The presence of psychoactive or micropsychotic courses in patients
There is a history of head injury that has led to anesthesia
Four absentee sessions for each patient during treatment
Intervention groups
The first group will receive training for dialectical behavioral therapy (DBT-ST) for 12 weeks. The second group will be treated with methadone for 12 weeks
Main outcome variables
Risk Decision Making using Gambling Assignment (IGT), Attention with Continuous Performance Task (CPT), Cognitive Flexibility Using Wisconsin Card Classification (WCST), Planning using London Tower Execution (TOL), Problem Solving Using the Wisconsin Card Classification (WCST), psychological symptoms using the Dass-42 questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180721040541N1
Registration date:2018-09-26, 1397/07/04
Registration timing:prospective
Last update:2018-09-26, 1397/07/04
Update count:0
Registration date
2018-09-26, 1397/07/04
Registrant information
Name
kiamars khezrian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
khezrian-k@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2018-12-11, 1397/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of the Effect of Dialectical Behavior Therapy – Skills Training (DBT-ST) on Cognitive Function in Methadone Maintenance Treatment Patients.
Public title
The Effect of Dialectical Behavior Therapy – Skills Training (DBT-ST) on Cognitive Function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 45 years
Detection of opioid dependence (opium, sap and heroin)
Treatment for at least one month with methadone
Participant consent
Level of at least third degree education (cycle)
Exclusion criteria:
Positive morphine test during initial assessment and post-test
The presence of a phase of mania or current depression
The presence of psychoactive or micropsychotic courses in patients
There is a history of head injury that has led to anesthesia
Four absentee sessions for each patient during treatment
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with random numbers, simple randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individual and group data are not coded as code and analytical and evaluation results are not known from the titles of individuals and groups.
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
2018-06-20, 1397/03/30
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.016
Health conditions studied
1
Description of health condition studied
Mental and behavioral disorders due to the use of opioids
ICD-10 code
F11
ICD-10 code description
Mental and behavioral disorders due to the use of opioids