<?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>IRCT20190917044802N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-14</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of acceptance and commitment therapy on stigma and family functioning of patients with mental disorders</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of acceptance and commitment therapy on stigma and family functioning of patients with mental disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72344</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 60 cards are placed in a sealed envelope. 30 cards will be labeled A (intervention group) and 30 cards will be labeled B (control group). Then, the members of the families participating in the study are asked to take one of the cards. People who take card A will be in the intervention group and people who take card B will be in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mental disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:For the intervention test group, the educational program will be implemented in the form of 6 sessions of 60 minutes each session and two days a week for 3 weeks. Lectures, group discussions, questions and answers, and brainstorming methods are used in the training sessions by a psychologist who has already completed the training course. In this research, the general treatment guide based on acceptance and commitment will be used. Acceptance and commitment therapy is a psychotherapy technique that promotes acceptance of negative thoughts, feelings, and events. In fact, this psychotherapy technique encourages a person to consciously participate in activities. The training sessions include the first session of familiarization and training regarding treatment based on acceptance and commitment, the second session of creating flexible patterns of behavior through value-oriented encounter, the third session of moving towards a valuable life with an accepting and observant self, the fourth session of ways to respond to thoughts Disturbing and stressful, the fifth session is self-awareness and self-control behaviors, the sixth session is setting goals based on values and taking effective measures to achieve those goals and stay on the path of values. Intervention 2: Control group: The control group will not receive the training intervention, but they will be given the training package.</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:
After completing the study and publishing the results, researchers can send their request to the responsible author to use the results of this study

When:
After completing the study and publishing the results

To whom:
After completing the study and publishing the results, researchers can send their request to the responsible author to use the results of this study

Conditions:
After completing the study and publishing the results, researchers can send their request to the responsible author to use the results of this study

Where to obtain:
corresponding author: Mostafa Bijani

How to obtain:
After completing the study and publishing the results, researchers can send their request to the responsible author to use the results of this study

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa  Bijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran .</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461686688</zip>
        <telephone>071-53350994-6</telephone>
        <email>bizhani_mostafa@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa Bijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran .</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461686688</zip>
        <telephone>071-53350994-6</telephone>
        <email>bizhani_mostafa@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Having at least one year of experience caring for patients with mental disorders</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of family members for more than two sessions in training sessions
Unwillingness to continue participating in the study for any reason</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified mental disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:For the intervention test group, the educational program will be implemented in the form of 6 sessions of 60 minutes each session and two days a week for 3 weeks. Lectures, group discussions, questions and answers, and brainstorming methods are used in the training sessions by a psychologist who has already completed the training course. In this research, the general treatment guide based on acceptance and commitment will be used. Acceptance and commitment therapy is a psychotherapy technique that promotes acceptance of negative thoughts, feelings, and events. In fact, this psychotherapy technique encourages a person to consciously participate in activities. The training sessions include the first session of familiarization and training regarding treatment based on acceptance and commitment, the second session of creating flexible patterns of behavior through value-oriented encounter, the third session of moving towards a valuable life with an accepting and observant self, the fourth session of ways to respond to thoughts Disturbing and stressful, the fifth session is self-awareness and self-control behaviors, the sixth session is setting goals based on values and taking effective measures to achieve those goals and stay on the path of values.</i_keyword>
      <i_keyword>Control group: The control group will not receive the training intervention, but they will be given the training package</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stigma. Timepoint: Before, immediately and one month after the educational intervention. Method of measurement: Shamsaei et al.'s stigma questionnaire.</prim_outcome>
      <prim_outcome>Family functioning. Timepoint: Before, immediately and one month after the educational intervention. Method of measurement: Epstein et al.'s family function assessment 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>Fasa University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-30</approval_date>
        <contact_name>Ethics committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
