<?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>IRCT20260824070771N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-07</date_registration>
      <primary_sponsor>The Islamic Azad University, Roudehen Branch</primary_sponsor>
      <public_title>Psychological interventions for infertile women</public_title>
      <acronym></acronym>
      <scientific_title>: A Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Cognitive Therapy (MBCT) on Self-Esteem and Perceived Stress in Infertile Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92764</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After screening and obtaining written informed consent, 45 eligible participants were enrolled. Participants were randomly assigned to three groups (Acceptance and Commitment Therapy, Mindfulness-Based Cognitive Therapy, and control) using random block randomization with a block size of 15, ensuring equal allocation (15 per group). A computer-generated random number sequence (SPSS; Random Number Generator) was produced by an independent statistician not involved in recruitment or intervention delivery. Group allocation was concealed using sequentially numbered, opaque, sealed envelopes (SNOSE), which were opened only after baseline assessment was completed. Consequently, the outcome assessor and the intervention provider were blinded to the allocation sequence prior to assignment, ensuring allocation concealment, Blinding description: Participants will randomly assigned to the experimental and control groups using a lottery method. Due to the nature of the psychological interventions (MBCT and ACT), participants could not be blinded to the intervention; however, all assessments were conducted by an independent researcher who will blind to the group allocations (single-blind design).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Perceived Stress in Infertile Women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1:The Acceptance and Commitment Therapy (ACT) protocol will be administered by the researcher to the experimental group in 8 sessions of 90 minutes each, held once per week. Immediately upon completion of the sessions, a post-test will be conducted, and a three-month follow-up assessment will be carried out for all groups after the end of the interventions. Intervention 2: Intervention Group 2:The Mindfulness-Based Cognitive Therapy (MBCT) protocol will be administered by the researcher to the experimental group in 8 sessions of 90 minutes each, held once per week. Immediately upon completion of the sessions, a post-test will be conducted, and a three-month follow-up assessment will be carried out for all groups after the end of the interventions. Intervention 3: Control group:The control group will not receive any intervention.</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 the main results and outcomes are eligible for publication

When:
6 months after the publication of the results

To whom:
Researchers affiliated with academic and scientific institutions.

Conditions:
Only researchers within the same discipline

Where to obtain:
To my email address

How to obtain:
Please contact me via email

Comments:
No further explanation is provided</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Shahbazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Roudehen Branch, Islamic Azad University, Roudehen, Iran</address>
        <city>Roudehen Branch, Islamic Azad University, Roudehen, Iran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۹۷۳۱۸۸۹۸</zip>
        <telephone>+98 45 3381 9888</telephone>
        <email>fatemeh.shahbazi93@gmail.com</email>
        <affiliation>Roudehen Branch, Islamic Azad University, Roudehen, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Shahbazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Roudehen Branch, Islamic Azad University, Roudehen, Iran</address>
        <city>Roudehen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5618749761</zip>
        <telephone>0098 33819888</telephone>
        <email>fatemeh.shahbazi93@gmail.com</email>
        <affiliation>Roudehen Branch, Islamic Azad University, Roudehen, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 20–45 years
who had a medical record documenting infertility with their treating physician
had experienced infertility for at least one year
had a minimum educational level of junior high school
were in good psychiatric health
are willing to participate in the sessions</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Presence of severe psychiatric disorders (e.g., psychosis, bipolar disorder, active suicidal ideation) that prevent group participation.
Concurrent participation in any other structured psychological intervention or mindfulness-based training.
Initiation or significant adjustment of psychotropic medication dosage within the last 3 month
Current diagnosis of substance use disorder
Presence of severe cognitive impairment interfering with the ability to understand and perform therapeutic exercises.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility associated with anovulation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1:The Acceptance and Commitment Therapy (ACT) protocol will be administered by the researcher to the experimental group in 8 sessions of 90 minutes each, held once per week. Immediately upon completion of the sessions, a post-test will be conducted, and a three-month follow-up assessment will be carried out for all groups after the end of the interventions.</i_keyword>
      <i_keyword>Intervention Group 2:The Mindfulness-Based Cognitive Therapy (MBCT) protocol will be administered by the researcher to the experimental group in 8 sessions of 90 minutes each, held once per week. Immediately upon completion of the sessions, a post-test will be conducted, and a three-month follow-up assessment will be carried out for all groups after the end of the interventions.</i_keyword>
      <i_keyword>Control group:The control group will not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-esteem:Mean score on the Rosenberg Self-Esteem Scale (RSES; range 10–40about) after the intervention. Timepoint: pretest, posttest, and a three-month follow-up. Method of measurement: the Rosenberg Self-Esteem Scale (RSES).</prim_outcome>
      <prim_outcome>Perceived stress:Mean score on the Cohen Perceived Stress Scale (PSS; range 0–40about) after the intervention. Timepoint: pretest, posttest, and a three-month follow-up. Method of measurement: The Cohen Perceived Stress Scale (PSS).</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>The Islamic Azad University, Roudehen Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-09-15</approval_date>
        <contact_name>Research Ethics Working Group, Islamic Azad University, Roudehen Branch</contact_name>
        <contact_address>Paveh، Rudehen Roudehen Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
