<?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>IRCT20170816035739N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-18</date_registration>
      <primary_sponsor>Research deputy of Shahroud University of Medical Science</primary_sponsor>
      <public_title>Evaluate the effectiveness of positive cognitive-behavioral counseling on domestic violence</public_title>
      <acronym></acronym>
      <scientific_title>Effect of cognitive-behavioral empowerment group counseling on the degree and severity of domestic violence in violent women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26922</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Because we would like two study groups have the same sample size, we will use block randomization. Blocking is used to create the number of samples in the number of samples assigned to each of the studied groups. In this research, four random blocks are used. In a way that , after sampling, according to the order of eligible participants entrance to study, the designated group of the participant will become apparent, and just allocated person knows it and the researcher and sampler will never understand which sample will enter to the intervening group, Blinding description: In this study, we will use central randomization to hide. We will have a allocator who holds the list of blocks. The samplers will sample according to the criteria for entering the study and after the consent of the participant in the research, with the responsible person for assignment, he /she writes the name and surname, the name of the sample center, and gives only one number and a code to the individual. This code and number should be written on the questionnaire. In this way, the arrangement of groups A and B is not recognizable and blindness is also observed for references, both for sampler and analizer.Intervention is predominantly part of the health education package, with the attention that the participants have already mentioned, training to increase the health of women. Therefore, the probability that the intervention group will be informed about the exact content of the training is prevented and that the control group is also given the education of women's health.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Domestic violence.</hc_freetext>
      <i_freetext>Intervention 1: "control group:" 8 sessions, weekly, 90-min, in selected health centers, focused on selfcare in Middle aged women. Intervention 2: The intervention group: will be placed under 8 sessions of 90 minutes, an educational intervention based on cognitive-behavioral group counseling. The contents of this course will include such topics as (recognizing and changing irrational beliefs to rational beliefs, some aspects of life skills, expressing Existence and positivism, etc.) and will be performed in a different intervention group (women's health education). And immediately after the intervention, three and six months later, both groups will be evaluated.Positive Cognitive Counseling: An Approach Based on Strengths. There is a broad philosophical view according to which all individuals are capable, that is, within themselves and their social systems, abilities, resources, resources and facilities. Strengths when triggered and brought to life by experiences, perceptions and new skills bring passages that reduce pain and suffering, resolve conflicts and concerns, and more effectively adapt to stressful factors of life. The outcome and outcome of this approach is a better understanding of mental health and quality of life and an increase in social and interpersonal functions.</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 Because of the confidentiality of the information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeynab Ameri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Arab Asadi alley, Ghaffari Avenue.</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098233617797865</zip>
        <telephone>+98 23 3237 0325</telephone>
        <email>Ameri.z@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh TaherKhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central building of Shahroud University of Medical Sciences, 7 Tir square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098233614773947</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>taherkhani@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age from 15 to 49
experience with domestic violence during the past six months
ability to speak Persian
being married
being Iranian
not being in the pregnancy or postpartum period (up to 6 Month after childbirth)</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>A physical or mental illness that limits the collaboration in the research project
Women who have a disturbance in consciousness.</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>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"control group:" 8 sessions, weekly, 90-min, in selected health centers, focused on selfcare in Middle aged women.</i_keyword>
      <i_keyword>The intervention group: will be placed under 8 sessions of 90 minutes, an educational intervention based on cognitive-behavioral group counseling. The contents of this course will include such topics as (recognizing and changing irrational beliefs to rational beliefs, some aspects of life skills, expressing Existence and positivism, etc.) and will be performed in a different intervention group (women's health education). And immediately after the intervention, three and six months later, both groups will be evaluated.Positive Cognitive Counseling: An Approach Based on Strengths. There is a broad philosophical view according to which all individuals are capable, that is, within themselves and their social systems, abilities, resources, resources and facilities. Strengths when triggered and brought to life by experiences, perceptions and new skills bring passages that reduce pain and suffering, resolve conflicts and concerns, and more effectively adapt to stressful factors of life. The outcome and outcome of this approach is a better understanding of mental health and quality of life and an increase in social and interpersonal functions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The incidence of domestic violence. Timepoint: Before intervention,Immediately after the intervention, three and six months after the intervention. Method of measurement: questionnaire(CTS2).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before intervention, Immediately after the intervention, three and six months after the intervention. Method of measurement: questionnaire(sf36).</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>Research deputy of Shahroud University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-13</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Central building of Shahroud University of Medical Sciences, Hafte Tir square Shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
