Evaluation of the effectiveness of cognitive rehabilitation intervention on the improvement of cognitive deficits (working memory and selective attention) and quantitative electroencephalogram (QEEG) indices in men with heroin and methamphetamine use disorders
RehaCom package cognitive rehabilitation training can be effective in finding an effective treatment model to improve executive functions in substance abusers.The main purpose of this study is Evaluation of the effectiveness of cognitive rehabilitation intervention on the improvement of cognitive deficits (working memory and selective attention) and quantitative electroencephalogram (QEEG) indices in men with heroin and methamphetamine use disorders
Design
12 intervention sessions and duration of intervention sessions 6 weeks and 2 sessions per week with an interval of 3 days (each session = 60 minutes) are held individually for methamphetamine and heroin group participants.
Settings and conduct
Substance Abuse Clinic of Shiraz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Men with a minimum age of 20 years and a maximum of 50 year
- Having at least secondary education (cycle)
- Having diagnostic criteria for dependence on opiates (heroin) and stimulants (methamphetamine
Exclusion criteria:
- Having any psychiatric disorder except for drug-related disorders,
- Traumatic brain injuries (medium to severe) along with neurologic deficits or suffering from acute and unstable medical conditions
- having serious suicidal thoughts
- Receiving another medical or psychological intervention at the same time
Intervention groups
After initial and pre-test evaluation (completion of attention and memory tests and EEG recording), 12 sessions of RehaCom cognitive rehabilitation intervention are performed for both methamphetamine and heroin groups. Patients will be re-evaluated (follow up) two months after the end of the intervention.
Main outcome variables
cognitive deficits (working memory and selective attention) and quantitative electroencephalogram (QEEG) indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161026030510N4
Registration date:2022-01-07, 1400/10/17
Registration timing:registered_while_recruiting
Last update:2022-01-07, 1400/10/17
Update count:0
Registration date
2022-01-07, 1400/10/17
Registrant information
Name
Reza Arezoomandan
Name of organization / entity
Addiction Department, School of Behavioral Sciences and Mental Health (Institute of Tehran Psychiatr
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1658
Email address
arezoomandan.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-29, 1400/08/07
Expected recruitment end date
2021-12-28, 1400/10/07
Actual recruitment start date
2021-11-01, 1400/08/10
Actual recruitment end date
2022-01-30, 1400/11/10
Trial completion date
2022-07-20, 1401/04/29
Scientific title
Evaluation of the effectiveness of cognitive rehabilitation intervention on the improvement of cognitive deficits (working memory and selective attention) and quantitative electroencephalogram (QEEG) indices in men with heroin and methamphetamine use disorders
Public title
Evaluation of the effectiveness of cognitive rehabilitation intervention on the improvement of cognitive deficits (working memory and selective attention) and quantitative electroencephalogram (QEEG) indices in men with heroin and methamphetamine use disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
-Men with a minimum age of 20 years and a maximum of 50 year- Having at least secondary education (cycle) - Having diagnostic criteria for dependence on opiates (heroin) and stimulants (methamphetamine - Have lower than average scores on attention and memory tests based on initial assessment using RehaCom cognitive software screening modules - No participating in psychotherapy groups including NA in the last 6 months - Complete the informed consent form
Exclusion criteria:
- Having any psychiatric disorder except for drug-related disorders - Traumatic brain injuries (medium to severe) along with neurologic deficits or suffering from acute and unstable medical conditions - having serious suicidal thoughts - Receiving another medical or psychological intervention at the same time
Age
From 20 years old to 50 years old
Gender
Male
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
N/A
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences,Shahid Hemmat Highway; Next to Milad Tower
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
IR.IUMS.REC.1400.688
Health conditions studied
1
Description of health condition studied
Men with Heroin Disorder - Men with Methamphetamine Disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Selective Attention
Timepoint
Before and after the intervention
Method of measurement
Stroop test
2
Description
Quantitative Electroencephalogram (QEEG) Indices
Timepoint
Before and after the intervention
Method of measurement
QEEG 3840 -Neuroguide software
3
Description
working memory
Timepoint
Before and after the intervention
Method of measurement
Wechsler Memory Scale-Third Edition (WMS-III)
Secondary outcomes
empty
Intervention groups
1
Description
Methamphetamine (n=20) group is assessed by structured clinical interview (DSM-5) for Axis I and II disorders. They are then assessed (pre-test) through attention tests (Stroop test) and memory (Wechsler memory test). After the initial assessment (completion of attention and memory tests and EEG recording), 12 sessions of RehaCom cognitive rehabilitation intervention are performed. Also, patients will be re-evaluated ((post-test) two months after the end of the interventions (follow up).
Category
Rehabilitation
2
Description
The heroin group (n = 20) is assessed by structured clinical interview (DSM-5) for Axis I and II disorders. They are then assessed (pre-test) through attention tests (Stroop test) and memory (Wechsler memory test). After the initial assessment (completion of attention and memory tests and EEG recording), 12 sessions of RehaCom cognitive rehabilitation intervention are performed. Also, patients will be re-evaluated ((post-test) two months after the end of the interventions (follow up).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Substance Abuse Clinic of Shiraz University of Medical Sciences
Full name of responsible person
Reza arezoomandan
Street address
Zand St., in front of Phelestine St., the central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۳۳۶
Phone
+98 71 3212 2713
Fax
+98 71 3230 8200
Email
Arezoomandan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Abbas Motavlian
Street address
اتوبان همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
Adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Arezoomandan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Mansouri St, Faculty of Behavioral Sciences and Mental Health
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
Arezoomandan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Reza Arezoomandan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
خیابان منصوری، دانشکده علوم رفتاری و سلامت روان
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1555
Email
Arezoomandan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza arezoomandan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Mansouri St., Faculty of Behavioral Sciences and Mental Health
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1555
Email
arezoomandan.r@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Clinical and cognitive outcomes of patients after the intervention
When the data will become available and for how long
2022
To whom data/document is available
Researchers
Under which criteria data/document could be used
Researchers from all scientific centers
From where data/document is obtainable
Email
What processes are involved for a request to access data/document