Protocol summary

Study aim
The effect of working memory rehabilitation treatment with methadone on drug craving in people with a history of opium use and its derivatives.
Design
A clinical trial with a control group, randomized by sampling method available on 50 patients. SPSS software is used for randomization.
Settings and conduct
At the Addiction Treatment Center, after placing the subjects in the desired groups, each subject was first repeated by the WHO Questionnaire of Periodicity and Consumption and Quality of Life and the severity of substance dependence and three subtests of mental control. The figures will be evaluated forward and reverse and the learning of Wechsler memory associations will be measured and their craving will be measured. Immediately after the evaluation of the first session, working memory training will be performed. The number of sessions is 10 and it takes place twice a week, which will cover a total of 5 weeks. In each training session, the person performs working memory exercises.
Participants/Inclusion and exclusion criteria
A history of at least 12 months of opioid use disorder based on DSM-5 diagnostic criteria prior to treatment. • Age 18 to 50 years. • Male gender. • Cycle education.
Intervention groups
Cognitive rehabilitation treatment
Main outcome variables
Craving rate; The degree of dependence on substance use; Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210220050424N1
Registration date: 2021-05-26, 1400/03/05
Registration timing: prospective

Last update: 2021-05-26, 1400/03/05
Update count: 0
Registration date
2021-05-26, 1400/03/05
Registrant information
Name
Seyyede faeghe Alipoor poori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3239 3363
Email address
faeghe.ap1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-30, 1400/03/09
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intervention based on working memory rehabilitation on reducing craving for drugs
Public title
The effect of working memory rehabilitation on reducing craving
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects should have a history of methadone use of at least one year. Subjects must have at least a degree in the cycle. Subjects should be eager to attend and attend meetings.
Exclusion criteria:
Subjects have illness and psychotic symptoms. Subjects are less than 18 years old and more than 50 years old. Subjects should be absent for more than two sessions.
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
This is how the research is randomized: The first step is to create a random sequence. In this research, simple randomization will be used. Randomization based on a single sequence of random allocations is called simple randomization. The randomization unit in this study is individual. There are various randomization tools for this type of randomization, which in this research uses a table of random numbers. Random number table is a set of numbers that are generated without a pattern and with a specific order and in a completely random way and have become a table. Here's how to make a random sequence: First, read the numbers We specify that two are from above. Numbers can be considered for different groups. Here, even numbers obtained from this table are assigned to the control group and odd numbers to the intervention group. Then we place our fingers on one of the numbers in the table and act according to the described process (ie we move upwards 2) and record the numbers and assign them to the control or intervention group according to their individuality or evenness. Let's. The next step, called concealment, refers to the method used to execute random sequences on subjects so that the assigned group is not known before the individual is assigned To hide in this study, opaque sealed envelopes or random sequences will be used. In this method, a random sequence is performed, which is done here by a table of random numbers. Then, based on the sample size (50 people), a number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the envelope lids are glued and placed in a box, respectively. At the beginning of the registration of the subjects, according to the order of entry of the eligible participants into the study, one of the envelopes was opened in order and the assigned group of the participant was revealed.
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 university of social welfare and rehabilitation sciences
Street address
No 149, ammar 5 street, komeyl gharbi 7 street, salehin place, Babol Town, Mazandaran Province
City
Babol
Province
Mazandaran
Postal code
۴۷۱۵۷۱۵۹۳۴
Approval date
2021-05-15, 1400/02/25
Ethics committee reference number
IR.USWR.REC.1400.013

Health conditions studied

1

Description of health condition studied
Addiction
ICD-10 code
F11
ICD-10 code description
Opioid related disorders

Primary outcomes

1

Description
The primary outcome can be a craving score in craving questionnaires
Timepoint
For the experimental group for 5 weeks and two sessions per week and for the control group, the post-test is performed 5 weeks after the pre-test.
Method of measurement
Craving Questionnaire, Periodic Craving Questionnaire,

2

Description
The primary consequence may be the improvement in quality of life following the rehabilitation of working memory.
Timepoint
For the experimental group for 5 weeks and two sessions per week and for the control group, the post-test is performed 5 weeks after the pre-test.
Method of measurement
World Health Organization Quality of Life Questionnaire, Revised Wechsler Memory Scale

3

Description
The primary consequence may be a reduction in the severity of substance dependence.
Timepoint
For the experimental group for 5 weeks and two sessions per week and for the control group, the post-test is performed 5 weeks after the pre-test.
Method of measurement
substance dependence severity scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Working memory rehabilitation treatment, After placing the subjects in the target groups, each of the subjects was first repeated the questionnaires by means of periodic cravings and cravings questionnaires and quality of life of the World Health Organization and the severity of substance dependence and three sub-tests of mental control. Forward and reverse and learning Wechsler memory associations will be evaluated and their craving will be measured. Immediately after the evaluation of the first session, working memory training is done. The number of sessions is 10 sessions and it takes place twice a week for a total of 5 weeks. In each training session, the person performs working memory exercises. The person will have freedom of action in the order of presenting the exercises, but he must do all the exercises completely in each session. The amount of time for each exercise is 3 to 4 minutes. Each training session is 1 hour for each subject, taking into account the rest time. The program is step-by-step and adaptive, so that in each effort, process and difficulty of the program, each individual's capacity and ability is matched separately. In fact, the degree of difficulty in each exercise is classified from 1 to 9, and the person can choose the desired degree of difficulty at the beginning of each exercise and start training from that degree, but after starting the exercise, the degree of difficulty Auto goes higher and allows you to use the maximum working memory capacity for more practice. The software provides the user with the amount of points earned as feedback from the exercise And for each correct attempt, 20 points are added to the total points, and for each error attempt, 10 points are deducted, and if you get 100 points, the difficulty level of the training is one degree. increase. This training program is designed in such a way that in each part, by providing appropriate visual and auditory feedback and recording the scores and execution time of each stage, the person is guided step by step and helps to improve his working memory.
Category
Rehabilitation

2

Description
Control group: Control group members; First, they were assessed by the World Health Organization's periodic cravings and cravings and quality of life questionnaires and the severity of substance dependence and three subtests of mental control, repetition of forward and reverse digits and learning Wechsler memory associations and the amount of craving. They will be measured and pre-tested, after 5 weeks without any intervention, they will be measured again by the same instruments and the post-test will be performed.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
rahe sabz center
Full name of responsible person
Dr.Ahmad Bagherpoor
Street address
Shahid Soleymani square
City
Babol
Province
Mazandaran
Postal code
4715715934
Phone
+98 11 3239 3363
Email
Faeghe.ap1995@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khanke
Street address
Daneshjoo Blvd, Evin, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
pr@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
1
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
University of social welfare and rehabilitation sciences
Full name of responsible person
seyyede Faeghe Alipour pouri
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 149, Ammar 5, Komeyl gharbi 7
City
Babol
Province
Mazandaran
Postal code
4715715934
Phone
+98 11 3239 3363
Email
Faeghe.ap1995@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Faeghe Alipour pouri
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 149, Ammar 5, Komeyl gharbi 7, Salehin place
City
Babol
Province
Mazandaran
Postal code
4715715934
Phone
+98 11 3239 3363
Email
Faeghe.ap1995@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Faeghe Alipour pouri
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 149, Ammar 5 Ave, Komeyl gharbi 7 Ave, Salehin palace
City
Babol
Province
Mazandaran
Postal code
4715715934
Phone
+98 11 3239 3363
Email
Faeghe.ap1995@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
The data is analyzed as a group and there is no need to publish the data individually.
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
It is not necessary to share data separately because they are analyzed in groups. Group data analysis can be shared.
When the data will become available and for how long
Access period starts 6 months after printing
To whom data/document is available
Researchers in academic institutions after completing and publishing the dissertation
Under which criteria data/document could be used
Only if you are trustworthy and follow moral principles
From where data/document is obtainable
ایمیل : faeghe.ap1995@gmail.com
What processes are involved for a request to access data/document
After completing the work and defending the dissertation and publishing the article, they can contact the researcher by email.
Comments
Loading...