<?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>IRCT20260530069576N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-01</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Examining the Effectiveness of Emotion Efficacy Therapy on Emotional Memory, Emotion Regulation Strategies, Rumination, and Relapse Tendency in Individuals with Substance Use Disorder Under Methadone Maintenance Treatment</public_title>
      <acronym></acronym>
      <scientific_title>Examining the Effectiveness of Emotion Efficacy Therapy on Emotional Memory, Emotion Regulation Strategies, Rumination, and Relapse Tendency in Individuals with Substance Use Disorder Under Methadone Maintenance Treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90479</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method is simple (lottery). The names of all eligible and volunteer participants are written on identical separate pieces of paper. A person external to the research, who has no role in patient enrollment or assessment, randomly draws the names from a container, Blinding description: In this study, a single-blind (assessor-blind) method is used. Participants and the therapist cannot be blinded to the type of intervention due to the nature of group psychotherapy and skills training, which makes it impossible to conceal the treatment type from these two groups. However, the assessor responsible for data collection (a clinical psychologist) is completely blinded to group allocation (intervention or control). The assessor has no role in the treatment process and is unaware of the type of intervention received by each participant prior to conducting the post-test. Additionally, the statistical data analyst is also blinded to group allocation, as data are provided using numeric codes without any mention of group names. Thus, bias in outcome measurement and data analysis is minimized.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Substance Use Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:. Intervention 2: Control group:.</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:
داده‌های فردی شرکت‌کنندگان به صورت غیرقابل شناسایی (بدون نام و با کد عددی) شامل: نمرات پیش‌آزمون و پس‌آزمون متغیرهای حافظه هیجانی (آزمون حافظه هیجانی)، راهبردهای تنظیم هیجان (پرسشنامه ERQ)، نشخوار فکری (مقیاس RRS) و گرایش به عود (پرسشنامه RPS) به همراه اطلاعات دموگرافیک (سن، جنسیت، وضعیت تأهل، تحصیلات، مدت مصرف، مدت درمان با متادون). فایل راهنمای متغیرها و پروتکل مطالعه نیز ارائه خواهد شد.

عنوان و جزیی

When:
Starting six months after publication of the main results (after manuscript acceptance and print) and continuing for 5 years.

To whom:
Researchers affiliated with recognized academic or research institutions (universities, research centers, teaching hospitals). Requests from industry (private companies) will be considered on a case-by-case basis if the proposed use aligns with research ethics.

Conditions:
Data may be used solely for legitimate and ethical research purposes such as meta-analysis, independent replication, verification of results, or secondary analyses related to substance use disorder, emotion regulation, and emotion efficacy therapies. Commercial use or any attempt to re-identify participants is prohibited. Requests must include a scientific proposal and approval from the requester's institutional ethics committee.

Where to obtain:
Nassim Rezaei (corresponding researcher / MSc student) via email: Nassim.rre@gmail.com
Alternatively, the principal investigator, Dr. Nasrin Jaberghaderi, can be contacted at: n_jg2004@yahoo.com
Postal address: Department of Clinical Psychology, Faculty of Medicine, Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard, Kermanshah, Iran.

How to obtain:
Requester sends a written request including a scientific proposal, approval from their institutional ethics committee, and a clear description of the intended use to the above emails.
The request will be reviewed by the principal investigator and researcher within 2 weeks.
If approved, the requester must sign a data use agreement (committing to no re-identification and no commercial use).
After receiving the signed agreement, a download link for the de-identified data (Excel or CSV format) along with a data dictionary will be provided within 1 week.
The entire process typically takes less than 1 month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nassim Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sepidar</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۱۷۷۷۷۴۶۹۰</zip>
        <telephone>+98 21 0000 0000</telephone>
        <email>Re.nasim@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nassim Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sepidar-mehrgan4</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6177111111</zip>
        <telephone>00980000000000</telephone>
        <email>nassim.rre@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to read, write, and attend sessions
Having informed consent to participate in the research and completing the informed consent form
Not having severe mental illnesses including schizophrenia spectrum disorders, bipolar type I, and severe personality disorders (assessed via clinical interview)
Meeting diagnostic criteria for substance use disorder
Being aged 25 to 45 years
Not receiving any psychological treatment
Being treated with methadone</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F19.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other psychoactive substance dependence</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:</i_keyword>
      <i_keyword>Control group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional Memory. Timepoint: Pre-test (before the intervention) and post-test (immediately after completion of treatment sessions). Method of measurement: Emotional Memory Task.</prim_outcome>
      <prim_outcome>Emotion Regulation Strategies. Timepoint: Pre-test (before the intervention) and post-test (immediately after completion of treatment sessions). Method of measurement: Emotion Regulation Questionnaire.</prim_outcome>
      <prim_outcome>Rumination. Timepoint: Pre-test (before the intervention) and post-test (immediately after completion of treatment sessions). Method of measurement: Ruminative Responses Scale.</prim_outcome>
      <prim_outcome>Relapse Tendency. Timepoint: Pre-test (before the intervention) and post-test (immediately after completion of treatment sessions). Method of measurement: Relapse Prediction 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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-01</approval_date>
        <contact_name>کمیته اخلاق در پژوهش دانشکده پزشکی دانشگاه علوم پزشکی کرمانشاه</contact_name>
        <contact_address>Taq-e Bostan Boulevard, Kermanshah University of Medical Sciences, Faculty of Medicine, Second Floor, Ethics Committee Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
