Investigating the effect of cognitive rehabilitation on executive functions and cravings in patients undergoing addiction treatment
Design
The clinical trial has a control group, with a pre-test - post-test design. The trial phase on 30 patients undergoing addiction treatment, spss software is used for data analysis.
Settings and conduct
The present study will be conducted on people suffering from addiction who were kept in compulsory addiction treatment centers in Semnan city. 30 people will be randomly selected and will be placed in two groups of 15 people, intervention and control. Cognitive rehabilitation intervention will be done in 14 sessions in the form of exercises on the intervention group, then the data obtained from the pre-test and post-test stages. The test will be analyzed by spss software
Participants/Inclusion and exclusion criteria
Entry requirements: people undergoing addiction treatment
Non-entry conditions: People with mental disorders
Intervention groups
Cognitive rehabilitation intervention (in the form of exercises) will be done to strengthen the executive functions of people with substance disorders who have been treated. The control group is the people undergoing addiction treatment who will not receive cognitive rehabilitation
Main outcome variables
Executive functions: creates purposeful behavior in humans
Craving: Strong desire to use drugs
General information
Reason for update
Acronym
AEFS
IRCT registration information
IRCT registration number:IRCT20230808059086N1
Registration date:2023-09-27, 1402/07/05
Registration timing:retrospective
Last update:2023-09-27, 1402/07/05
Update count:0
Registration date
2023-09-27, 1402/07/05
Registrant information
Name
Mahnaz Zargarani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3335 1017
Email address
mzargarani47@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-02, 1402/06/11
Expected recruitment end date
2023-09-12, 1402/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive rehabilitation on executive functions and cravings in patients undergoing addiction treatment
Public title
Investigating the effect of cognitive rehabilitation on addiction treatment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a history of drug use for at least one year or more
Passing more than a week of people's stay in the addiction treatment center
Age range of minimum 18 and maximum 55 years
Exclusion criteria:
Have mental disorders (psychosis, bipolar, acute depression).
Suffer from certain physical diseases
Age
From 18 years old to 55 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
Using random number tables (Morgan's table), 30 people were selected from the available population. The unit of randomization was individual. The number of 30 subjects were randomly assigned to two groups, then in the randomization stage of the experimental procedure, the subjects were placed in two control and intervention groups. The control and intervention groups were not known in advance, and after assigning people to two groups randomly, one group was selected as the intervention group and the other group as the control group. At this stage, concealment was done to prevent any predictions from the participants and the researcher.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study has two experimental and control groups, which is done only on the experimental rehabilitation intervention group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University, semnan branch
Street address
Eynak negah noo, moalem Square, semnan
City
Semnan
Province
Semnan
Postal code
3514713198
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.IAU.SEMNAN.REC.1402.034
Health conditions studied
1
Description of health condition studied
Drug addiction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Executive functions: are a set of cognitive processes that are necessary for the cognitive control of behavior, which include basic processes such as response inhibition, cognitive flexibility, and response inhibition.
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (after 14 sessions of cognitive rehabilitation intervention)
Method of measurement
Wisconsin card sorting tool, N BACK application, go no go assignment
2
Description
Craving: It is called a strong and uncontrollable desire in patients suffering from addiction to get the drug again
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (after 14 sessions of cognitive rehabilitation
Method of measurement
Instant consumption craving questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: NEAT cognitive rehabilitation intervention will take place on this group (15 people). The NEAT intervention will be presented to the study participants in the form of paper-based assignments. These tasks include finding the differences, finding lost objects, mazes, puzzles, vocabulary tables. The rehabilitation sessions are 14 sessions, which will be held during 7 weeks and 2 sessions each week with the aim of strengthening and improving the executive functions of the brain.
Category
Rehabilitation
2
Description
Control group: There is no intervention on the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Compulsory addiction treatment center semnan city
Full name of responsible person
Mahnaz Zargarani
Street address
Eynak negah noo, moalem Square, semnan
City
Semnan
Province
Semnan
Postal code
3514713198
Phone
+98 23 3335 1017
Email
Mzargarani47@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Karim Sohrabi
Street address
Eynak negah noo، moalem square, semnan
City
Semnan
Province
Semnan
Postal code
3514713198
Phone
+98 23 3335 1017
Email
Mzargarani47@gmail.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
5
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
Islamic Azad University
Full name of responsible person
Mahnaz Zargarani
Position
Collegian
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Eynak negah noo، moalem square, semnan
City
Semnan
Province
Semnan
Postal code
3514713198
Phone
0098 23 3335110
Email
Mzargarani47@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Zargarani
Position
Collegian
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Eynak negah noo، moalem square, semnan
City
Semnan
Province
Semnan
Postal code
3514713198
Phone
+98 23 3335 1017
Email
Mzargarani47@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Zargarani
Position
Collegian
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Eynak negah noo، moalem square, semnan
City
Semnan
Province
Semnan
Postal code
3514713198
Phone
+98 23 3335 1017
Email
Mzargarani47@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD