<?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>IRCT20220328054360N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-18</date_registration>
      <primary_sponsor>Khomein School of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of cognitive-behavioral therapy and motivational interviewing on the symptoms of anxiety sensitivity, depression and self-esteem in divorced women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of cognitive-behavioral therapy and motivational interviewing on the symptoms of anxiety sensitivity, depression and self-esteem in divorced women covered by comprehensive health service centers in Khomein city.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62650</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: The research sample includes 60 divorced women (20 to 50 years old) who have the criteria to enter the intervention and are selected by systematic random sampling and Then there is a random assignment of 20 participants to each group and the implementation of interventions.
 Randomly (table of random numbers) are divided into three experimental groups (two experimental groups) and a control group (20 people in each group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depressive disorder. Condition 2: anxiety sensitivity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive-behavioral therapy: A type of psychotherapy that helps patients understand the thoughts and feelings that affect behaviors. Cognitive-behavioral therapy is based on the book of applied cognitive-behavioral group therapy written by Najmeh Hamid and consists of 12 sessions of 75 minutes. The experimental group undergoes cognitive-behavioral therapy interventions. , Mendelssohn, Mark and Arbaf (1986), and the results are analyzed using multivariate analysis of covariance. Intervention 2: Intervention group: Motivational interviewing is a patient-centered method that uses to examine and resolve ambiguities in order to increase people's inner motivation to change behavior. Motivational interviewing is based on the practical guide of group motivational interviewing written by Dr. Ali Navidian and Dr. Hamid Poursharifi in 5 sessions of 75 minutes The research tool is the Rosenberg Self-Esteem Questionnaire (1965) and the results are analyzed using multivariate analysis of covariance. Intervention 3: Control group: In this study, except for CBT therapeutic interventions for the experimental group and motivational interview therapeutic intervention for the comparison group, no other intervention is performed. In addition, for the control group (control) only the mentioned questionnaires (depression, self-esteem, anxiety sensitivity) are distributed and collected as pre-test and post-test. In the control group, no intervention is performed.</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:
Only part of the data such as the original outcome information

When:
6 months after printing the results

To whom:
For researchers working in academic and scientific institutions as well as applications in other industries

Conditions:
Use of documents and other data analysis only by observing the principles formulated in scientific and ethical laws

Where to obtain:
Email address or website

How to obtain:
Request and request documents or files through this site and email address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Bayatasghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Markazi Province - Khomein County - Quds Boulevard - Deputy Minister of Health</address>
        <city>khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3881858591</zip>
        <telephone>+98 86 4622 9237</telephone>
        <email>abolfazl86khomein@yahoo.com</email>
        <affiliation>Khomein School of Medical ScieKhomein School of Medical Sciencesnces</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Bayatasghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Markazi Province - Khomein County - Quds Boulevard - Deputy Minister of Health</address>
        <city>khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3881858591</zip>
        <telephone>+98 86 4622 9327</telephone>
        <email>abolfazl86khomein@yahoo.com</email>
        <affiliation>Khomein School of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The borderline score in the Rosenberg Self-Esteem Questionnaire is 10 questions, 30 and below
The borderline score in the Anxiety Sensitivity Questionnaire is 25 and higher
The borderline score in the Anxiety Sensitivity Questionnaire is 25
Absence of psychotic and paranoid disorders in the subjects
Receiving voluntary and informed consent
At least 6 months have passed since their divorce
Age gap between 20 to 50 years
Have at least a diploma</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absence for more than two sessions
Lack of interest of people to continue education</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.9</hc_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, unspecified</hc_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cognitive-behavioral therapy: A type of psychotherapy that helps patients understand the thoughts and feelings that affect behaviors. Cognitive-behavioral therapy is based on the book of applied cognitive-behavioral group therapy written by Najmeh Hamid and consists of 12 sessions of 75 minutes. The experimental group undergoes cognitive-behavioral therapy interventions. , Mendelssohn, Mark and Arbaf (1986), and the results are analyzed using multivariate analysis of covariance.</i_keyword>
      <i_keyword>Intervention group: Motivational interviewing is a patient-centered method that uses to examine and resolve ambiguities in order to increase people's inner motivation to change behavior. Motivational interviewing is based on the practical guide of group motivational interviewing written by Dr. Ali Navidian and Dr. Hamid Poursharifi in 5 sessions of 75 minutes The research tool is the Rosenberg Self-Esteem Questionnaire (1965) and the results are analyzed using multivariate analysis of covariance.</i_keyword>
      <i_keyword>Control group: In this study, except for CBT therapeutic interventions for the experimental group and motivational interview therapeutic intervention for the comparison group, no other intervention is performed. In addition, for the control group (control) only the mentioned questionnaires (depression, self-esteem, anxiety sensitivity) are distributed and collected as pre-test and post-test. In the control group, no intervention is performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome is the "Depression Score in the Beck Questionnaire".For this purpose, achieving the differential rate of depression between the two depressed and healthy groups, number 17, is determined, which is the appropriate number of differentiation between this group. Timepoint: Experimental groups undergo motivational interview therapy for 5 sessions of 75 minutes and cognitive-behavioral therapy for 12 sessions of 75 minutes from May 1401, one session per week until the end of July. Method of measurement: The research instrument is Aaron Beck, Beckward, Mendelson, Mark and Arbaf (1986) Depression Scale Questionnaire.</prim_outcome>
      <prim_outcome>The primary outcome is the anxiety sensitivity score obtained in the Anxiety Sensitivity Questionnaire. In this questionnaire, the highest score that a person can get is 80 and the lowest score is 16. A high score close to 80 will mean that the person has a high anxiety sensitivity, and a low score on this test will mean that the person is experiencing a low anxiety sensitivity. The borderline score is 25 or higher. Timepoint: Experimental groups undergo motivational interview therapy for 5 sessions of 75 minutes and cognitive-behavioral therapy for 12 sessions of 75 minutes from May 1401, one session per week until the end of July. Method of measurement: Research tool Anxiety Sensitivity Questionnaire: is a self-report questionnaire that has 16 items. This questionnaire was developed by Reese and Patterson (1985).</prim_outcome>
      <prim_outcome>The primary outcome is the self-esteem score obtained on the Rosenberg Self-Esteem Questionnaire. This scale contains 10 general terms that measure life satisfaction and feeling good about oneself. Timepoint: Experimental groups undergo motivational interview therapy for 5 sessions of 75 minutes and cognitive-behavioral therapy for 12 sessions of 75 minutes from May 1401, one session per week until the end of July. Method of measurement: The research tool is the Rosenberg Self-Esteem Scale Questionnaire, which consists of 10 items that are answered based on the Likert scale of four degrees from strongly agree to strongly disagree.</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>khomein Medical Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-20</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University - Kerman Branch</contact_name>
        <contact_address>Kerman, Valiasr Blvd., Islamic Azad University, Kerman Branch Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
