<?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>IRCT20211118053093N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-04</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the role of acceptance and commitment therapy    in patients with substance use disorder</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the role of acceptance and commitment therapy  on reducing internalized stigma in patients with substance use disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60089</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants do not know which group they are in.
The data analyser does not know which group it is analysing.
The number of people in the intervention and treatment groups is the same (we have 10 patients in each group for the treatment group). The duration for both intervention and control groups is 12 hours for three weeks.The number of sessions is equal, so the patient is blind to the type of treatment.Data analysis is given only data and does not know what treatment was done for either group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Substance use disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: It consists of four groups of ten. Subjects receive their treatment in groups for three weeks including 12 hours in total (two two-hour sessions a week) and after one week after the end of the treatment, they will be asked again. ACT sessions consist of 5 cases including willingness and values and committed action and efficiency and two non-specific objectives including stigma and shame.How to run meetings is as follows:Session 1 achieves the basic goals of the patient and familiarizes himself with his past efforts to accomplish the goal.  Session 2: Logic training of behavioral activation and initial regulation of functional behavioral goal. Session 3 Continue extracting the patient's experience to strengthen the cognition of "controlling a problem" and introducing desire as an alternative and introducing the concept of depressive thoughts.Session 4 The 4th session is to know your mind is not your friend and identifying the simple behavioral goal.Session 5 assesses the patient's ability to pass on depressing thoughts and feelings.Session 6 introduces self-conceptualized distinction against the observer himself.Session 7 showing the importance of values and understanding the references and continuing the practice of mindfulness.Session 8 is a help for the patient who continuously recognizes the areas of life that do not conform to one's values.Session 9The finding the relationship between goals, activities.Session 10 Continues to emphasize the components that are related to the clients' issues.Session 11 Training to the patient to be a therapist himself.Session 12show  the progress achieved and the continuous goals of the patient. Intervention 2: Control group: The subjects receive their treatment in groups for three weeks including 12 hours in total (two two-hour sessions a week) and after one week after the end of the treatment, they are asked again to complete the internalized stigma questionnaire and quality of life questionnaire.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Razeghian Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>13th Km Shiraz-Isfahan, Ostad Mehrari Hospital</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71441-13331÷</zip>
        <telephone>+98 71 3226 5702</telephone>
        <email>leilarazeghian1366@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Razeghian Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>13th Km Shiraz-Isfahan, Ostad Mehrari Hospital</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71441-13331</zip>
        <telephone>+98 71 3260 5702</telephone>
        <email>leilarazeghian1366@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-50 year
Diagnosis of substance use disorder
Informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Medical disease
Cognitive problems
Psychiatric disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F19.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other psychoactive substance abuse</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: It consists of four groups of ten. Subjects receive their treatment in groups for three weeks including 12 hours in total (two two-hour sessions a week) and after one week after the end of the treatment, they will be asked again. ACT sessions consist of 5 cases including willingness and values and committed action and efficiency and two non-specific objectives including stigma and shame.How to run meetings is as follows:Session 1 achieves the basic goals of the patient and familiarizes himself with his past efforts to accomplish the goal.  Session 2: Logic training of behavioral activation and initial regulation of functional behavioral goal. Session 3 Continue extracting the patient's experience to strengthen the cognition of "controlling a problem" and introducing desire as an alternative and introducing the concept of depressive thoughts.Session 4 The 4th session is to know your mind is not your friend and identifying the simple behavioral goal.Session 5 assesses the patient's ability to pass on depressing thoughts and feelings.Session 6 introduces self-conceptualized distinction against the observer himself.Session 7 showing the importance of values and understanding the references and continuing the practice of mindfulness.Session 8 is a help for the patient who continuously recognizes the areas of life that do not conform to one's values.Session 9The finding the relationship between goals, activities.Session 10 Continues to emphasize the components that are related to the clients' issues.Session 11 Training to the patient to be a therapist himself.Session 12show  the progress achieved and the continuous goals of the patient.</i_keyword>
      <i_keyword>Control group: The subjects receive their treatment in groups for three weeks including 12 hours in total (two two-hour sessions a week) and after one week after the end of the treatment, they are asked again to complete the internalized stigma questionnaire and quality of life questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Internalized stigma score. Timepoint: Before the study and one week after the intervention. Method of measurement: Internalized Stigma Questionnaire  that includes 28 Likert questions.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life score. Timepoint: Before the intervention and one week after the intervention. Method of measurement: World Health Organization Quality of Life Questionnaire.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-09</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>13 km shiraz-isfahan highway, Ostad Mehrari Hospital Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
