<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210220050424N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-26</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effect of working memory rehabilitation on reducing craving</public_title>
      <acronym></acronym>
      <scientific_title>The effect of intervention based on working memory rehabilitation on reducing  craving  for drugs</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56308</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Addiction.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The data is analyzed as a group and there is no need to publish the data individually.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>seyyede Faeghe Alipour pouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 149, Ammar 5, Komeyl gharbi 7</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4715715934</zip>
        <telephone>+98 11 3239 3363</telephone>
        <email>Faeghe.ap1995@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faeghe Alipour pouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 149, Ammar 5, Komeyl gharbi 7, Salehin place</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4715715934</zip>
        <telephone>+98 11 3239 3363</telephone>
        <email>Faeghe.ap1995@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <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.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Opioid related disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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,.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-15</approval_date>
        <contact_name>Ethics committee of university of social welfare and rehabilitation sciences</contact_name>
        <contact_address>No 149, ammar 5 street, komeyl gharbi 7 street, salehin place, Babol Town, Mazandaran Province Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
