<?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>IRCT20230502058049N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-16</date_registration>
      <primary_sponsor>Shiraz University</primary_sponsor>
      <public_title>Effect of online group therapy of shame in depressed infertile women</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of online group acceptance and commitment-based shame therapy on depression, experience of shame, quality of life and marital adjustment in depressed infertile women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70058</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is a simple randomization that the participants will be placed in two treatment and control groups in a simple and individual way using a Random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Infertility. Condition 2: Major Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Shame-based acceptance and commitment treatment plan is designed in 11 sessions. Also, meetings are held online once a week and each meeting lasts for two hours. The first 3 sessions of this protocol include the assessment of shame and defect schemas, clinical symptoms such as depression, and shame-based coping behaviors. In the fourth session, practical training on changing the direction from avoidance to commitment is provided. In the fifth, sixth, and seventh session, the practice of seeing thirty seconds, defining and clarifying values, and dissociative techniques are discussed, respectively. Next, confrontation and self-compassion exercises form the content of the eighth to tenth sessions. Finally, the 11th session deals with relapse prevention training and terminating the treatment. It should be noted that before the intervention and after the intervention, the baseline assessment is done. Intervention 2: Control group: It is a group in which the people are defined as the waiting group and no intervention is done for them in order to control the test error.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to compliance with ethical standards</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdi Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.14, First Floor, Shiraz University,Islamic Republic Boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194684759</zip>
        <telephone>+98 21 4448 5228</telephone>
        <email>dr.mahdiimani@gmail.com</email>
        <affiliation>Shiraz University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Najmeh Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit13, No. 21, Shahid Islamian Street, Ashrafi Esfahani Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1469619884</zip>
        <telephone>+98 21 4448 5228</telephone>
        <email>n-amiri@shirazu.ac.ir</email>
        <affiliation>Shiraz university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infertile women with symptoms of depression
Infertile women who experience shame
The length of waiting (infertility) is more than one year
The duration of marriage is more than 2 years
Age range from 20 to 40 years
Education at least diploma</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Specific disorders such as psychotic and personality disorders
Substance dependence disorder
Suicidal thoughts or attempts during the current period of depression
Having a history of a previous pregnancy or childbirth
Women who are currently undergoing medication or psychotherapy due to depression and anxiety disorders or were undergoing psychotherapy in the last 3 months.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
      <hc_code>F32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility</hc_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Shame-based acceptance and commitment treatment plan is designed in 11 sessions. Also, meetings are held online once a week and each meeting lasts for two hours. The first 3 sessions of this protocol include the assessment of shame and defect schemas, clinical symptoms such as depression, and shame-based coping behaviors. In the fourth session, practical training on changing the direction from avoidance to commitment is provided. In the fifth, sixth, and seventh session, the practice of seeing thirty seconds, defining and clarifying values, and dissociative techniques are discussed, respectively. Next, confrontation and self-compassion exercises form the content of the eighth to tenth sessions. Finally, the 11th session deals with relapse prevention training and terminating the treatment. It should be noted that before the intervention and after the intervention, the baseline assessment is done.</i_keyword>
      <i_keyword>Control group: It is a group in which the people are defined as the waiting group and no intervention is done for them in order to control the test error.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Beck Depression Inventory Score. Timepoint: Before starting the treatment (Pre-test) and After treatment (Post-test). Method of measurement: Beck Depression Inventory.</prim_outcome>
      <prim_outcome>Young Shame and Defect Schema Questionnaire Score. Timepoint: Before starting the treatment (Pre-test) and After treatment (Post-test). Method of measurement: Young Shame and Defect Schema Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality Of Life Questionnaire Score. Timepoint: Before starting the treatment (Pre-test) and After treatment (Post-test). Method of measurement: Quality Of Life Questionnaire.</sec_outcome>
      <sec_outcome>Marital Adjustment Questionnaire Score. Timepoint: Before starting the treatment (Pre-test) and After treatment (Post-test). Method of measurement: Marital Adjustment 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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-18</approval_date>
        <contact_name>Ethics Committee of Faculty of Educational Sciences and Psychology of Shiraz University</contact_name>
        <contact_address>Ground floor, Faculty of Educational Sciences and Psychology, Eram Campus, Eram Dormitory, Eram Square Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
