<?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>IRCT20230627058600N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-09</date_registration>
      <primary_sponsor>Semnan Islamic Azad University</primary_sponsor>
      <public_title>Investigating the effectiveness of Unified transdiagnostic treatment on emotion regulation؛distress tolerance, ؛experiential avoidance ؛persistence</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of Unified transdiagnostic treatment on emotion regulation؛distress tolerance, ؛experiential avoidance ؛persistence on treatment in methadone maintenance</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70994</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: These people are randomly placed in two experimental and control groups. After the pre-test, the experimental group will be treated and the control group will receive the usual treatments of the clinic. At the end of the intervention, the post-test will be performed on both experimental and control groups.
In this research, the tap or line method is used for randomization to determine the intervention and control groups. This method is very simple and the researcher's opinion will not be involved in it.

نماد «مورد تأیید انجمن».</study_design>
      <phase>N/A</phase>
      <hc_freetext>Emotion regulation, emotional disturbance, distress tolerance, persistence on treatment, experiential avoidance.</hc_freetext>
      <i_freetext>Intervention group: The research sample consists of 40 of these people who meet the criteria for entering the study and are selected by available sampling method; These people are randomly placed in two experimental and control groups. After the pre-test, the experimental group will be treated and the control group will receive the usual treatments of the clinic..</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:
Part of the data

When:
Year 1403

To whom:
The results of this research can be used by other researchers, service providers and psychological treatment specialists in various organizations and institutions, including addiction treatment centers and psychological clinics.

Conditions:
Researchers and students

Where to obtain:
Zahra Mokhtari
zahra.m1369@yahoo.com

How to obtain:
two months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Mokhtari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>At the end of Army Highway, Qamar Bani Hashem Quay, Block 10, Unit 23</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1698613361</zip>
        <telephone>+98 31 4542 2861</telephone>
        <email>zahra.m1369@yahoo.com</email>
        <affiliation>Semnan Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Mokhtari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>At the end of Army Highway, Qamar Bani Hashem Quay, Block 10, Unit 23</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1698613361</zip>
        <telephone>+98 31 4542 2861</telephone>
        <email>zahra.m1369@yahoo.com</email>
        <affiliation>Semnan Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being under maintenance treatment with methadone- Suffering from emotional problems based on questionnaires and interviews- Consent to participate in the research- Patients who take psychiatric drugs must be confirmed by the relevant psychiatrist that it is possible to keep the amount and type of drug constant during the research and that there are no risks for the patient.- Not having a personality disorder based on the interview- Absence of concurrent drug use based on urine test- Absence of acute psychiatric problems, including bipolar disorder and psychosis based on the interview</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>68 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Receiving any type of psychotherapy or medication at the same time for the desired emotional problems- History of receiving integrated metadiagnostic treatment- Two consecutive positive morphine urine tests within two weeks- Absence of more than a week- The person's unwillingness to continue the treatment process- Changes in the amount and type of psychiatric drugs during the research due to the worsening of the patient's symptoms or the presence of risks such as suicide, which should increase or change the amount and type of drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The research sample consists of 40 of these people who meet the criteria for entering the study and are selected by available sampling method; These people are randomly placed in two experimental and control groups. After the pre-test, the experimental group will be treated and the control group will receive the usual treatments of the clinic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score DASS-21. Timepoint: The measurement of DASS-21 is done on two occasions including before the intervention and at the end of the intervention. Method of measurement: DASS 21 question questionnaire.</prim_outcome>
      <prim_outcome>Experiential avoidance score in BEAQ questionnaire. Timepoint: before the beginning of the intervention and at the end of the interventionنماد «مورد تأیید انجمن». Method of measurement: Experiential avoidance questionnaire-short form.</prim_outcome>
      <prim_outcome>DTS questionnaire score. Timepoint: Before the start of the intervention and the end of the intervention. Method of measurement: DTS Distress Tolerance Questionnaire.</prim_outcome>
      <prim_outcome>DERS questionnaire score. Timepoint: Before the start of the intervention and the end of the intervention. Method of measurement: DERS emotion dysregulation questionnaire.</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>Semnan Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-02</approval_date>
        <contact_name>Ethics Committee of Semnan Azad University</contact_name>
        <contact_address>At the end of Army Highway, Qamar Bani Hashem, Block 10, Unit 23 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
