<?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>IRCT20251222068410N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-29</date_registration>
      <primary_sponsor>Khorasan Institute of Higher Education</primary_sponsor>
      <public_title>Effectiveness of Mindfulness-Based Cognitive Therapy on Adjustment Disorder and Sleep Quality</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Mindfulness-Based Cognitive Therapy on Adjustment Disorder and Perceived Sleep Quality in Young Adults with Financial Difficulties</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/88250</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The study employed a quasi-experimental design with a pre-test–post-test and a control group. In this design, an experimental group and a control group were examined; both groups were assessed before and after the intervention, but only the experimental group received the mindfulness-based cognitive therapy. This design allows the researcher to measure and compare the effects of the intervention on the dependent variables (adjustment disorder and perceived sleep quality).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Adjustment Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in this group received Mindfulness-Based Cognitive Therapy (MBCT). The intervention consisted of 8 weekly group sessions, each lasting 60 minutes over a period of 2 months. The session content included: Teaching mindfulness concepts Meditation practices (such as breathing awareness, body scan, and mindfulness in daily activities)Identifying and restructuring dysfunctional thoughts Non-judgmental acceptance of inner experiences Performing home practice exercises. Intervention 2: Control group: Participants in this group did not receive any therapeutic or educational intervention during the study period and were placed on a waiting list. Assessments were conducted at the pre-test and post-test stages, similar to the intervention group.</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 shared data are limited to the pre-test and post-test questionnaire scores of the control group (ADNM-20, PSQI, and FSI). These data are provided in an anonymized format, and no identifying information of the participants is included. Other data (from the experimental group and participants’ personal information) contain identifying information and treatment outcomes, and will not be included in this sharing.

When:
The access period will begin 6 months after the publication of the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
The data may only be used for research purposes specified in the study protocol.
Each request for access must be reviewed and approved by the Ethics Committee and/or the Data Committee.

Where to obtain:
No. 82 Amuzgar Blvd, Mashhad, Razavi Khorasan Province, Iran, Postal Code 9189863113
Or
niloufartorabi1999@gmail.com

How to obtain:
The applicant must complete the request form for access to data and documents and submit it, along with the research protocol, ethics approval, and related documents, to the Data Committee.
Estimated time: 2–3 weeks for the applicant to prepare the required documents.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Farrokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>82 Amoozegar Blvd., Mashhad, Razavi Khorasan Province, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9189863113</zip>
        <telephone>+98 51 3502 8601</telephone>
        <email>Hossein.farrokhi110@gmail.com</email>
        <affiliation>Khorasan Institute of Higher Education</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Farrokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>82 Amoozegar Blvd., Mashhad, Razavi Khorasan Province, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9189863113</zip>
        <telephone>+98 51 3502 8601</telephone>
        <email>Hossein.farrokhi110@gmail.com</email>
        <affiliation>Khorasan Institute of Higher Education</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married men and women
Aged 20–40 years
With financial problems
Who are willing to participate in this study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Divorced
Receiving financial support to resolve financial problems
Absence from more than two sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adjustment disorders</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: Participants in this group received Mindfulness-Based Cognitive Therapy (MBCT). The intervention consisted of 8 weekly group sessions, each lasting 60 minutes over a period of 2 months. The session content included: Teaching mindfulness concepts Meditation practices (such as breathing awareness, body scan, and mindfulness in daily activities)Identifying and restructuring dysfunctional thoughts Non-judgmental acceptance of inner experiences Performing home practice exercises</i_keyword>
      <i_keyword>Control group: Participants in this group did not receive any therapeutic or educational intervention during the study period and were placed on a waiting list. Assessments were conducted at the pre-test and post-test stages, similar to the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduction in Adjustment Disorder score. Timepoint: Two months after the Mindfulness-Based Cognitive Therapy intervention. Method of measurement: Adjustment Disorder New Model – 20 (ADNM-20).</prim_outcome>
      <prim_outcome>A significant improvement in perceived sleep quality. Timepoint: Two months after the Mindfulness-Based Cognitive Therapy intervention. Method of measurement: Pittsburgh sleep quality index.</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>Khorasan Institute of Higher Education</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-12-04</approval_date>
        <contact_name>Research Ethics Committee of Ferdowsi University of Mashhad</contact_name>
        <contact_address>Ferdowsi University of Mashhad, Azadi Square, University Campus, Mashhad, Razavi Khorasan Province, Iran Postal Code: 9177948974 Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
