<?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>IRCT20170826035896N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-20</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Cognitive-Behavioral Group Counseling on Premenopausal Women's Anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of cognitive-behavioral group counseling on premenopausal women's anxiety</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26988</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Quadruple random blocks, consisted of replaced parts named A and B, have already been generated by R software and each of these blocks of size 4 is placed in a separate envelope. The envelopes are provided to one of the colleagues other than researcher. Then the co-worker unlocks the design of one of the envelopesrandomly, and according to the insertion, the four patients, who are referring sequentially, are allocated according to the sequence of the four blocks to each of the groups A or B, and then he selects a different envelope for the next reference, Blinding description: In this study, the analyst and the participant are not aware of the type of intervention in each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group 1 consists of 15 people .On intervention group 1 educational and therapy interventions were performedbased on the cognitive-behavioral therapy (cbt). These interventions were taught to women separately during 7 sessions of 2 hours in each intervention group. Educational interventions were developed step by step and in the short run with significant and practical changes. Educational methods in intervention groups are performed based on the first cognitive model and behavioral models, familiarity with treatment methods for intervention group, exposure and prevention of response, evaluation and confrontation with avoidance, acceptance and commitment, educating the relief-making and diaphragmatic breathing, cognitive assessments, considering theworries and distinguishing between efficient worry and challenging worry, the challenge by inefficient self-thinkingand acquaintance with distorted self-thinking, and self-perfection and skill-building, especially problem-solving skills. Also, a set of necessary tools, in addition to cognitive and behavioral techniques, are in the form of post-testand pre-test, evaluation worksheets, homework and self-help worksheets, and educational summary leaflet. Intervention 2: the intervention group 2 consists of 12 people .On intervention group 2 educational and therapy interventions were performedbased on the cognitive-behavioral therapy (cbt). These interventions were taught to women separately during 7 sessions of 2 hours in each intervention group. Educational interventions were developed step by step and in the short run with significant and practical changes. Educational methods in intervention groups are performed based on the first cognitive model and behavioral models, familiarity with treatment methods for intervention group, exposure and prevention of response, evaluation and confrontation with avoidance, acceptance and commitment, educating the relief-making and diaphragmatic breathing, cognitive assessments, considering theworries and distinguishing between efficient worry and challenging worry, the challenge by inefficient self-thinkingand acquaintance with distorted self-thinking, and self-perfection and skill-building, especially problem-solving skills. Also, a set of necessary tools, in addition to cognitive and behavioral techniques, are in the form of post-testand pre-test, evaluation worksheets, homework and self-help worksheets, and educational leaflet summaries. Intervention 3: Control group: The control group is consisted of 15 people. At first, they just filled out a pre-test in a single session, and after a two-month period, they again did the same test as post-test, and no intervention was conducted during the two sessions.</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>Bahareh Ameri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Musa Kazem Health Center, Kargar blvd</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۴۷-۷۳۹۴۷</zip>
        <telephone>+98 23 3233 3275</telephone>
        <email>ameri.bahareh91@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Mottaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, Hafte-Tir Square,Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۴۷-۷۳۹۴۷</zip>
        <telephone>+98 32395054</telephone>
        <email>zhrmotaghi@yahoo.com</email>
        <affiliation>Shahrood University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 45-60 years
The emergence of menopause symptoms or complete menopause
Having diploma degree
Passing at least 6 months from the onset of anxiety symptoms
The presence of cognitive symptoms in addition to the physiological excitations</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women outside the age range
Consuming psychiatric medications
Not having enough education
Occurrence of Psychoticsigns and symptoms
Having hysterectomy surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Organic anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group 1 consists of 15 people .On intervention group 1 educational and therapy interventions were performedbased on the cognitive-behavioral therapy (cbt). These interventions were taught to women separately during 7 sessions of 2 hours in each intervention group. Educational interventions were developed step by step and in the short run with significant and practical changes. Educational methods in intervention groups are performed based on the first cognitive model and behavioral models, familiarity with treatment methods for intervention group, exposure and prevention of response, evaluation and confrontation with avoidance, acceptance and commitment, educating the relief-making and diaphragmatic breathing, cognitive assessments, considering theworries and distinguishing between efficient worry and challenging worry, the challenge by inefficient self-thinkingand acquaintance with distorted self-thinking, and self-perfection and skill-building, especially problem-solving skills. Also, a set of necessary tools, in addition to cognitive and behavioral techniques, are in the form of post-testand pre-test, evaluation worksheets, homework and self-help worksheets, and educational summary leaflet.</i_keyword>
      <i_keyword>the intervention group 2 consists of 12 people .On intervention group 2 educational and therapy interventions were performedbased on the cognitive-behavioral therapy (cbt). These interventions were taught to women separately during 7 sessions of 2 hours in each intervention group. Educational interventions were developed step by step and in the short run with significant and practical changes. Educational methods in intervention groups are performed based on the first cognitive model and behavioral models, familiarity with treatment methods for intervention group, exposure and prevention of response, evaluation and confrontation with avoidance, acceptance and commitment, educating the relief-making and diaphragmatic breathing, cognitive assessments, considering theworries and distinguishing between efficient worry and challenging worry, the challenge by inefficient self-thinkingand acquaintance with distorted self-thinking, and self-perfection and skill-building, especially problem-solving skills. Also, a set of necessary tools, in addition to cognitive and behavioral techniques, are in the form of post-testand pre-test, evaluation worksheets, homework and self-help worksheets, and educational leaflet summaries.</i_keyword>
      <i_keyword>Control group: The control group is consisted of 15 people. At first, they just filled out a pre-test in a single session, and after a two-month period, they again did the same test as post-test, and no intervention was conducted during the two sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before intervention, after the intervention, 2 months and 6 months after the intervention. Method of measurement: By Hamilton's Anxiety Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical symptoms of menopause. Timepoint: Before and after intervention. Method of measurement: Copermanen 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-19</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>7 Tir Square,Shahroud Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
