<?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>IRCT20230524058277N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-01</date_registration>
      <primary_sponsor>Islamic Azad University of Sari</primary_sponsor>
      <public_title>Efficacy of Cognitive-Behavioral Therapy on the Infertility Stress, Marital self regulation, Marital burnout and Intolerance of uncertainty on Infertile women.</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Cognitive-Behavioral Therapy on the Infertility Stress, Marital self regulation, Marital burnout and Intolerance of uncertainty on Infertile women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70321</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: cognitive-behavioral therapy is a type of psychotherapy that is a mixture of cognitive therapy and behavioral therapy techniques, this approach is based on the assumption that false thoughts and beliefs are the foundation of problematic emotions and behaviors, and based on this, it is not the incidents and events that They make the person uncomfortable, but the way of thinking that is the result of his beliefs, schemas and attitude, which affects the way of information processing and causes emotions and reactions, causes him discomfort. . Major emphasis on changing the irreconcilable and replacement cognitions It is taken into account. The main emphasis is on changing irreconcilable cognitions and replacing them with efficient cognitions. This structured, collaborative, time-limited therapy emphasizes the role of homework, and holds the therapist responsible for accepting an active role in therapy sessions and outside of it. and is focused on the present time, in this treatment, two cognitive strategies such as discovering cognitive distortions and disturbing thoughts, cognitive reconstruction and strengthening of fruitful counter-narratives, and behavioral strategies such as modeling, confronting, and acting out role, muscle relaxation, training coping skills and increasing Self-control and self-efficacy are used. The first session: conducting the pre-test, establishing a therapeutic relationship, explaining the rules and structure of the sessions, creating a preliminary agreement on the goals and expectations of the treatment, getting to know the basic principles of cognitive-behavioral therapy, presenting homework. The second session: Getting to know the cognitive model- behavior includes identifying the chain of cognitive-behavioral events, presenting homework. The third session: reviewing assignments, recognizing situations, feelings, opinions and thoughts and specific actions (behavior), presenting homework. Fourth session: reviewing assignments, antecedents and consequences of behavior, situation Motivating, methods of reducing anxiety, presentation of homework. Fifth session: review of homework, identification of negative spontaneous thoughts, cognitive errors (especially regarding infertility), presentation of homework.The sixth session: review of assignments, training in visualization and diaphragmatic breathing and training in gradual muscle relaxation, presentation of homework. Seventh session: review of assignments, training in examining the evidence of thoughts (especially about thoughts related to infertility), training in examining the benefits and harms of thoughts (especially regarding thoughts related to infertility), presentation of homework. Eighth session: review of homework, training to control thoughts, emotions and behavior related to emotions, presentation of homework. Ninth session: review of homework, classification of techniques related to anxiety, training in ways to deal with Anxiety and intolerance of uncertainty, presentation of homework. Tenth session: reviewing assignments, teaching effective communication and discussing its effects. Creating the skill of transmitting and receiving clear, correct and effective thoughts, feelings and needs, especially in the marital relationship, presentation of homework. The 11th session: reviewing assignments, reviewing the assignments of the previous session, teaching problem-solving methods, especially regarding the problem of infertility and related issues such as the treatment process, teaching planning for health-promoting behaviors such as following a healthy diet, stress management, engaging in activities physical, presenting homework. twelfth session: reviewing homework, summarizing sessions, summarizing materials, receiving feedback from the client, appreciation and gratitude, post-exam implementation..</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:
All data is potentially shareable after de-identifying individuals

When:
The access period starts one month after the results are published.

To whom:
Researchers working in academic and scientific institutions and gynecology and obstetrics and infertility doctors

Conditions:
There are no special conditions for access.

Where to obtain:
Be in touch with the email address provided.
yeganeh_talebi_1998@yahoo.com

How to obtain:
After sending the request for obtaining the documents to the e-mail, the documents will be sent after 10 working days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hasanpour Alley, Moalem St., Sari, Mazandaran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4817849746</zip>
        <telephone>+98 11 3325 1204</telephone>
        <email>Yeganeh_talebi_1998@yahoo.com</email>
        <affiliation>Islamic Azad University of Sari</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahram Mirzaian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran Province,Sari, Farah Abad Road,</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816119318</zip>
        <telephone>+98 11 3325 9528</telephone>
        <email>bahrammirzaian@gmail.com</email>
        <affiliation>Islamic Azad University of Sari</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Getting a diagnosis of infertility by a gynecologist.
2. Age between 20 and 40 years
3. Not taking neuropsychiatric drugs during the last three months
4. Do not suffer from an incurable physical disease such as cancer, MS, Alzheimer's and the like.
5. Do not have a serious psychiatric illness such as psychotic or similar.
6. They should be literate up to the fifth grade.
7. Completion of the consent letter regarding participation in the research project.
8. Do not undergo treatment or other psychological interventions during the implementation of the research</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1. Getting a diagnosis of infertility by a gynecologist2. Age between 20 and 40 years3. Not taking neuropsychiatric drugs during the last three months4. Do not suffer from an incurable physical disease such as cancer, MS, Alzheimer's and the like.5. Do not have a serious psychiatric illness such as psychotic or similar.6. They should be literate up to the fifth grade.7. Completion of the consent letter regarding participation in the research project.8. Do not undergo treatment or other psychological interventions during the implementation of the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: cognitive-behavioral therapy is a type of psychotherapy that is a mixture of cognitive therapy and behavioral therapy techniques, this approach is based on the assumption that false thoughts and beliefs are the foundation of problematic emotions and behaviors, and based on this, it is not the incidents and events that They make the person uncomfortable, but the way of thinking that is the result of his beliefs, schemas and attitude, which affects the way of information processing and causes emotions and reactions, causes him discomfort. . Major emphasis on changing the irreconcilable and replacement cognitions It is taken into account. The main emphasis is on changing irreconcilable cognitions and replacing them with efficient cognitions. This structured, collaborative, time-limited therapy emphasizes the role of homework, and holds the therapist responsible for accepting an active role in therapy sessions and outside of it. and is focused on the present time, in this treatment, two cognitive strategies such as discovering cognitive distortions and disturbing thoughts, cognitive reconstruction and strengthening of fruitful counter-narratives, and behavioral strategies such as modeling, confronting, and acting out role, muscle relaxation, training coping skills and increasing Self-control and self-efficacy are used. The first session: conducting the pre-test, establishing a therapeutic relationship, explaining the rules and structure of the sessions, creating a preliminary agreement on the goals and expectations of the treatment, getting to know the basic principles of cognitive-behavioral therapy, presenting homework. The second session: Getting to know the cognitive model- behavior includes identifying the chain of cognitive-behavioral events, presenting homework. The third session: reviewing assignments, recognizing situations, feelings, opinions and thoughts and specific actions (behavior), presenting homework. Fourth session: reviewing assignments, antecedents and consequences of behavior, situation Motivating, methods of reducing anxiety, presentation of homework. Fifth session: review of homework, identification of negative spontaneous thoughts, cognitive errors (especially regarding infertility), presentation of homework.The sixth session: review of assignments, training in visualization and diaphragmatic breathing and training in gradual muscle relaxation, presentation of homework. Seventh session: review of assignments, training in examining the evidence of thoughts (especially about thoughts related to infertility), training in examining the benefits and harms of thoughts (especially regarding thoughts related to infertility), presentation of homework. Eighth session: review of homework, training to control thoughts, emotions and behavior related to emotions, presentation of homework. Ninth session: review of homework, classification of techniques related to anxiety, training in ways to deal with Anxiety and intolerance of uncertainty, presentation of homework. Tenth session: reviewing assignments, teaching effective communication and discussing its effects. Creating the skill of transmitting and receiving clear, correct and effective thoughts, feelings and needs, especially in the marital relationship, presentation of homework. The 11th session: reviewing assignments, reviewing the assignments of the previous session, teaching problem-solving methods, especially regarding the problem of infertility and related issues such as the treatment process, teaching planning for health-promoting behaviors such as following a healthy diet, stress management, engaging in activities physical, presenting homework. twelfth session: reviewing homework, summarizing sessions, summarizing materials, receiving feedback from the client, appreciation and gratitude, post-exam implementation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1. A decrease in the subject's score in the infertility stress questionnaire. Timepoint: The first treatment session, the twelfth session and 45 days after the last treatment session. Method of measurement: Infertility stress questionnaire4. Intolerance of uncertainty  questionnaire.</prim_outcome>
      <prim_outcome>2. A decrease in the subject's score in the  Marital burnout questionnaire. Timepoint: The first treatment session, the twelfth session and 45 days after the last treatment session. Method of measurement: 2. Marital burnout questionnaire.</prim_outcome>
      <prim_outcome>3. An increase in the subject's score in the Marital self-regulation questionnaire. Timepoint: The first treatment session, the twelfth session and 45 days after the last treatment session. Method of measurement: 3. Marital self-regulation questionnaire.</prim_outcome>
      <prim_outcome>A decrease in the subject's score in the Intolerance of uncertainty questionnaire. Timepoint: The first treatment session, the twelfth session and 45 days after the last treatment session. Method of measurement: 4. Reducing the subject's score in the Intolerance of uncertainty 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>Islamic Azad University of Sari</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-14</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University, Sari Branch</contact_name>
        <contact_address>km 7 Darya road, Sari, Mazandaran province Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
