<?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>IRCT20221205056720N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-06</date_registration>
      <primary_sponsor>The Islamia University of Bahwalpur</primary_sponsor>
      <public_title>Effectiveness of Cognitive Behavioral Therapy on Psychological Distress and its impact on Marital Adjustment and Quality of Life among Infertile Women.</public_title>
      <acronym>N/A</acronym>
      <scientific_title>Effectiveness of Cognitive Behavioral Therapy on Psychological Distress and its impact on Marital Adjustment and Quality of Life among Infertile Women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67356</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Total 40 participants will be the part of this study. Participants will be divided into two groups in which 20 participants will be the part of experimental group and whereas 20 participants will be the part of control group, Randomization description: In the random sampling process of infertile women in two groups of intervention and control, random allocation software for clinical trials will be used, Blinding description: N/A.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Infertility related Psychological distress. Condition 2: Marital Adjustment. Condition 3: Quality of Life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group will receive culturally adopted cognitive behavior therapy to decrease their psychological distress and to assess its impact on marital adjustment and quality of life.  Culturally adopted cognitive behavior therapy is a dialogue written exercises based therapy that is comprised on eight sessions . All subjects of experimental group will receive one session in a week that will be comprised on 120 minutes. After completing eight sessions of psycho therapy post assessment will be conducted to assess the effectiveness. Follow up will be taken after two months of post assessment. Intervention 2: Control group: This group will receive only placebo treatment that will be based on counselling and dialogues discussions between control group participants and therapist.</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:
The whole data will be shared by hiding subject's identity

When:
Data will be available  three months after recording the results

To whom:
Data will be available for researchers and students of social sciences

Conditions:
The use of documentation in all scientific and research measures is permitted . In order to submit a request for access to data they must be students and researchers of the relevant field

Where to obtain:
Data can be obtained by requesting through this given email that is written below. 
fa19e1pa001@iub.edu.pk

How to obtain:
Students and researchers who will be interested to reutilize the data or any documents will send an email with some important  details about the purpose of why they need data and it will be sent to them according to the need.

Comments:
N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sarwat Sultana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no 75 street no 10 Muslim town Bahawalpur</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>+92 62 2502025</telephone>
        <email>fa19e1pa001@iub.edu.pk</email>
        <affiliation>The Islamia University of Bahawalpur</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Professor Dr Masood Nadeem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baghdad ul Jadded Road Bahawalpur IUB town The Islamia University of Bahawalpur</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>+92 62 9255065</telephone>
        <email>sarwatsultana88@gmail.com</email>
        <affiliation>The Islamia University of Bahwalpur</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All diagnosed married infertile women belong to South Punjab Pakistan aged 20 to 40 years will be included in this study.
All women must be skilled in reading and writing.
Infertile women who had been trying to conceive for between 1 to 2 years will be included in this study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The infertile women above age of 40 years will be excluded from this study.
Women who can not read or write will excluded from sample of the study.
Infertile women who are not taking any infertility treatment will be excluded from this study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This group will receive culturally adopted cognitive behavior therapy to decrease their psychological distress and to assess its impact on marital adjustment and quality of life.  Culturally adopted cognitive behavior therapy is a dialogue written exercises based therapy that is comprised on eight sessions . All subjects of experimental group will receive one session in a week that will be comprised on 120 minutes. After completing eight sessions of psycho therapy post assessment will be conducted to assess the effectiveness. Follow up will be taken after two months of post assessment.</i_keyword>
      <i_keyword>Control group: This group will receive only placebo treatment that will be based on counselling and dialogues discussions between control group participants and therapist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>To assess the effectiveness of Culturally adapted Cognitive Behavioral Therapy to decrease the level of psychological distress of infertile women. Timepoint: Before the intervention, immediately after the intervention and 6 weeks after the intervention. Method of measurement: Depression Anxiety and Stress Scale.</prim_outcome>
      <prim_outcome>To assess the impact of applying Culturally adapted Cognitive Behavioral Therapy on marital adjustment among infertile women. Timepoint: Before the intervention, immediately after the intervention and 6 weeks after the intervention. Method of measurement: Dyadic Adjustment Scale.</prim_outcome>
      <prim_outcome>To assess the impact of applying Culturally adapted Cognitive Behavioral Therapy on Quality of llife among infertile women. Timepoint: Before the intervention, immediately after the intervention and 6 weeks after the intervention. Method of measurement: FertiQol Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>To assess the other demographic variables that cause psychological distress among infertile women. Timepoint: Before the intervention, immediately after the intervention and 6 weeks after the intervention. Method of measurement: Demographic sheet.</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>The Islamia University of Bahwalpur</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-06</approval_date>
        <contact_name>Ethics Committee of The Islamia University of Bahwalpur</contact_name>
        <contact_address>Baghdad ul Jadeed Road Bahwalpur Bahawalpur Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
