<?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>IRCT20231204060264N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-11</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of family-centered neuropsychological training interventions on reducing stress, marital incompatibility, drug craving and cognitive-emotional regulation of married drug-dependent clients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of family-centered neuropsychological training interventions on reducing stress, marital incompatibility, drug craving and cognitive-emotional regulation of married drug-dependent clients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74187</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Other design features: Designing a treatment protocol and package that is a combination of four treatments, Randomization description: Available sampling method was used.
Randomization method: simple randomization
Randomization unit: cluster
Randomization tool: table of random numbers
In the first step, using available sampling, first the hospital was selected, then in the next step, married drug-dependent patients admitted to the neuropsychiatric department of the hospital were selected, and after the necessary explanations about the objectives of the research and the stages of the research, and obtaining consent With the knowledge of the participants, they were randomly assigned to the experimental and control groups using a table of random numbers, Blinding description: The participants were blinded. They will know that they have participated in a study, but they will not know how to receive or not receive the treatment package of the other group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Addicted to drugs.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Family-centered neuropsychological therapy training for ten sessions. Intervention 2: Control group: They will undergo the usual medical care and will not participate in the researcher's training sessions.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hanieh Goli Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Blvd., Taleghani 1st, Shahid Ramzanpur Alley, Ghasemian House</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818953653</zip>
        <telephone>+98 11 3327 0044</telephone>
        <email>hani_ebi80@yahoo.com</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hanieh Goli Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4818953653, Shaid Ramzanpour Ave, Taleghani Aval st, Emam Reza Blvd, Sari Town</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818953653</zip>
        <telephone>+98 11 3327 0044</telephone>
        <email>Hani_ebi80@yahoo.com</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having the diagnostic criteria of substance dependence based on DSM-5
The person suffering from addiction must be at least 18 years old and at most 40 years old
The education level of the person suffering from addiction should be at least elementary
The person is not taking antipsychotic drugs (such as haloperidol) and does not have bipolar or dissociative disorder</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Taking psychiatric drugs
Not cooperating with the therapist
Not doing the main tasks</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Family-centered neuropsychological therapy training for ten sessions</i_keyword>
      <i_keyword>Control group: They will undergo the usual medical care and will not participate in the researcher's training sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress: means the sum of scores that the respondents will get from answering questions 1 to 14 of Everly and Girdano's (1980) questionnaire. Timepoint: The beginning of the study (before the start of the intervention) and after the end of the intervention and 90 days after the end of the intervention. Method of measurement: Standard stress questionnaire.</prim_outcome>
      <prim_outcome>Marital incompatibility: refers to the sum of scores that respondents will get from answering questions 1 to 32 of Spanier's (1976) questionnaire. Timepoint: The beginning of the study (before the start of the intervention) and after the end of the intervention and 90 days after the end of the intervention. Method of measurement: Marital incompatibility standard questionnaire.</prim_outcome>
      <prim_outcome>Craving for drug use: it means the sum of scores that respondents will get from answering questions 1 to 14 of Franken, Hendricks, and VandenBernick (2002) questionnaire. Timepoint: The beginning of the study (before the start of the intervention) and after the end of the intervention and 90 days after the end of the intervention. Method of measurement: Standard substance craving questionnaire.</prim_outcome>
      <prim_outcome>Cognitive regulation of emotion: it means the sum of the scores that the respondents will get from answering questions 1 to 36 of the Granfsky, Kraij and Spinhoven (2001) questionnaire. Timepoint: The beginning of the study (before the start of the intervention) and after the end of the intervention and 90 days after the end of the intervention. Method of measurement: Standard questionnaire of cognitive emotion regulation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stress: means the sum of scores that the respondents will get from answering questions 1 to 14 of Everly and Girdano's (1980) questionnaire. Timepoint: After the completion of the intervention and 90 days after the completion of the intervention. Method of measurement: Standard stress questionnaire.</sec_outcome>
      <sec_outcome>Marital incompatibility: refers to the sum of scores that respondents will get from answering questions 1 to 32 of Spanier's (1976) questionnaire. Timepoint: After the completion of the intervention and 90 days after the completion of the intervention. Method of measurement: Marital incompatibility standard questionnaire.</sec_outcome>
      <sec_outcome>Craving for drug use: it means the sum of scores that respondents will get from answering questions 1 to 14 of Franken, Hendricks, and VandenBernick (2002) questionnaire. Timepoint: After the completion of the intervention and 90 days after the completion of the intervention. Method of measurement: Standard substance craving questionnaire.</sec_outcome>
      <sec_outcome>Cognitive regulation of emotion: it means the sum of the scores that the respondents will get from answering questions 1 to 36 of the Granfsky, Kraij and Spinhoven (2001) questionnaire. Timepoint: After the completion of the intervention and 90 days after the completion of the intervention. Method of measurement: Standard questionnaire of cognitive emotion regulation.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>0</sec_id>
        <issuing_authority>000</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-18</approval_date>
        <contact_name>Ethics Committee of Tehran University</contact_name>
        <contact_address>Shahid Chamran Highway - Jalal Al Ahmad St. - opposite Koi Nasr, Dr. Kardan St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
