<?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>IRCT20171031037145N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-22</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effects of mobile app cognitive rehabilitation on addiction</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of mobile application (Neuro-Rehab App)including working memory training and inhibitory control training in opioid craving impulse control, and cognitive function of patients with opioid use disorder undergoing methadone maintenance treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72383</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>Opioid related disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The neuro rehab application will be available to them for four weeks, and before that, how it works will be explained to them in a training session with two exercises of the application. And the participants will be advised to practice it for at least 60 to 90 minutes a week in order to get the most benefit. The application exercises, which are mainly based on strengthening working memory and inhibitory control, are adjusted to reduce their difficulty according to the performance of the participants. Intervention 2: Control group: They only receive methadone maintenance treatment.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information about the main outcome or similar can be shared.

When:
1 month

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
In order to facilitate further research

Where to obtain:
Correspondence with the person responsible for the research at the following address:Reza.emran66@gmail.com

How to obtain:
This process is done only by e-mail and a response will be given within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Emran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴) – Mashhad - Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٩١٧٧٨-٩٩١٩١</zip>
        <telephone>+98 51 3711 2721</telephone>
        <email>Reza.emran66@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farshad Sheybani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴)</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٩١٧٧٨-٩٩١٩١</zip>
        <telephone>+98 51 3711 2721</telephone>
        <email>sheibanifr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a smart phone
Undergoing methadone maintenance treatment
Eager to participate in this study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Age out of range 18 to 49 years
Having diseases such as Down syndrome
Gender other than male, female, or trans</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>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The neuro rehab application will be available to them for four weeks, and before that, how it works will be explained to them in a training session with two exercises of the application. And the participants will be advised to practice it for at least 60 to 90 minutes a week in order to get the most benefit. The application exercises, which are mainly based on strengthening working memory and inhibitory control, are adjusted to reduce their difficulty according to the performance of the participants.</i_keyword>
      <i_keyword>Control group: They only receive methadone maintenance treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Impulsivity. Timepoint: Before starting the study and after the end of the study. Method of measurement: Barrett impulsivity questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Comparison of the average latency of the correct response (average response time) in the attention game in the first week with the average speed of the correct response in the attention game in the fourth week. Timepoint: Percentage ratio of incorrect answers to all answers in the attention and concentration game of the Neuro-Rehab application. Method of measurement: The information about the amount and performance of the participants is recorded in the central server and the necessary comparisons of the performance are made by the server manager.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-24</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴) – Mashhad - Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
