Present study is aimed to design and study the efficacy of a developed package for neurocognitive rehabilitation of addicted people particularly opioid and stimulants dependents as a supplementary therapeutic service. This investigation is going to be conducted as a randomized controlled single blind trial with 120 patients at a residential treatment center who meet our inclusion crite¬ria (age 20-40, ability to read and speak in Farsi, meet DSV-IV-TR criteria for opiate dependence, to give writ¬ten informed consent). Our exclusion criteria are suffering from serious chronic mental disease, demonstration of withdrawal symptoms at the end of first 2-weeks admission, or a his¬tory of a suicide attempt during last month. Participants will be randomly classified into two groups; intervention (n=60) or control group (n=60). Participants in the intervention group are scheduled for 32 one-hour group sessions four times a week and those in control group receive painting session as a placebo beside their standard treatment. To assess the efficacy of implementing of the developed package, assessments will be conducted at baseline, midterm, at the end of study and follow-up period (1, 3 and 6 month). These assessments are both related to cognitive functions such as memory and attention and treatment outcomes such as the results of urine tests and treatment commitment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090123849N1
Registration date:2015-11-27, 1394/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-27, 1394/09/06
Registrant information
Name
Tara Rezapour
Name of organization / entity
Institute for Cognitive Science Studies
Country
Iran (Islamic Republic of)
Phone
+98 912 618 5031
Email address
rezapour_t@iricss.org
Recruitment status
Recruitment complete
Funding source
Cognitive Science and Technologies Council (CSTS)
Expected recruitment start date
2015-10-25, 1394/08/03
Expected recruitment end date
2016-01-25, 1394/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing a Neuro Cognitive Rehabilitation Package for Drug Addicted Patients (NECOREDA) and Studying is Efficiency: Randomized Clinical Trial
Public title
Neurocognitive Rehabilitation Program for Disease of Addiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 20 -40 years old; ability to read and speak in Farsi; meet DSM-IV-TR criteria for opiate dependence; have voluntary and informed consent.
Exclusion criteria:
suffer from serious chronic mental disease; history of suicide during last month; demonstrate withdrawal symptoms at the end of first two weeks of admission.
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Postal code
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
USWR.REC.1393.161
Health conditions studied
1
Description of health condition studied
Opiate Dependence
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
Improvement of cognitive performance
Timepoint
Baseline, Midterm, Final, follow- up(1,3,6 month)
Method of measurement
Cognitive Assessment Battery
Secondary outcomes
1
Description
Change in adiction treatment outcomes
Timepoint
At the end of intervention and follow- up (1,3,6 month)
Method of measurement
Subjective reports, Urine tests
Intervention groups
1
Description
Intervention:
Intervention group receive neurocognitive rehabilitation with developed package during 2 months. Cognitive rehabilitation sessions are 32 one-hour group sessions that hold 4 times a week.
Category
Rehabilitation
2
Description
Control :
Control group receive placebo intervention that is painting during 2 months. Painting sessions are 32 one-hour group sessions that hold 4 times a week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian National Center for Addiction Studies
Full name of responsible person
Tara Rezapour
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cognitive Science and Technologies Council (CSTS)
Full name of responsible person
Dr.Majid Nili (Research Group)
Street address
No 35, Presidency Building, Alvand St, Argentina Sq
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cognitive Science and Technologies Council (CSTS)
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
Translational Neuroscience Program, Institute for Cognitive Science Studies, Tehran, Iran
Full name of responsible person
Tara Rezapour
Position
PhD Student
Other areas of specialty/work
Street address
Pardis New City (15 KMs North East of Tehran), 4th Phase, Safir Omid Blvd. Pazhouheshkadeh Blvd.
City
Pardis
Postal code
Phone
+98 21 5540 0034
Fax
Email
tara_rezapour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Translational Neuroscience Program, Institute for Cognitive Science Studies,
Full name of responsible person
Hamed Ekhtiari
Position
Faculty member
Other areas of specialty/work
Street address
Pardis
City
Pardis
Postal code
Phone
+98 21 5540 0034
Fax
Email
h.ekhtiari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Translational Neuroscience Program, Institute for Cognitive Science Studies, Tehran, Iran
Full name of responsible person
Tara Rezapour
Position
PhD Student
Other areas of specialty/work
Street address
Pardis New City (15 KMs North East of Tehran), 4th Phase, Safir Omid Blvd. Pazhouheshkadeh Blvd.
City
Pardis
Postal code
Phone
+98 21 7629 1130
Fax
Email
Tara_rezapour@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)