<?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>IRCT20250506065619N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-31</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing compassion-focused therapy intervention with mindfulness-based cognitive therapy</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effectiveness of Compassion-Focused Therapy and Mindefulness - Based Cognitive Therapy on Resilience, Emotion Regulation, Rumination, and Worry in Mothers of Children with Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83382</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method was simple random sampling and participants were randomly assigned to compassion-focused therapy (15 people), mindfulness-based cognitive therapy (15 people), and control (15 people) groups. We use the simple random allocation rule, which is one of the methods of limited randomization, and divide the subjects into 3 intervention control groups. Participants will be assigned to the control group (no intervention), compassion-focused therapy, and mindfulness-based cognitive therapy with the help of a random number table. For concealment, the method of sealed opaque envelopes with a random sequence is used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Worried.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group, compassion-focused therapy, is based on Gilbert's research. Each session includes a title and general content of the session, a description of the session, and assignments. This protocol will be implemented by a psychologist specializing in this field in 8 90-minute sessions, one session per week for three months. The first session is to establish initial group communication, review the structure of the sessions, familiarize yourself with the general principles and differentiate compassion from self-pity. The second session is to train mindfulness along with body scan and breathing exercises, familiarize yourself with brain systems based on compassion, and train empathy, train you to understand and appreciate how people feel and how to follow things with an empathetic attitude. The third session is to familiarize yourself with the characteristics of people who have compassion for others, cultivate a sense of warmth and kindness towards yourself, and develop an understanding that others also have flaws and problems. The fourth session, encouraging the subjects to self-recognize and examine their personality as a compassionate or non-compassionate person, according to the educational topics of identifying and applying compassionate mind-building exercises, the value of self-compassion, empathy and sympathy towards oneself and others, and teaching the physiotherapist metaphor) and teaching forgiveness. The fifth session, familiarizing and applying compassionate mind-building exercises, teaching accepting problems, accepting upcoming changes, and tolerating difficult and challenging situations, considering the variability of life and the fact that people face different challenges. The sixth session, practical practice of creating compassionate images, teaching styles and methods of expressing compassion and applying these methods in everyday life and for spouses, children, parents, friends, teachers, and acquaintances, teaching the development of valuable and transcendent emotions, the seventh session, teaching writing compassionate letters for oneself and others, teaching the method of recording and taking daily notes of real situations based on compassion and the individual's performance in that situation. Session 8: Training and practicing skills Review and practice of skills presented in previous sessions to help subjects cope with different life situations in different ways, and finally summarize and provide solutions for maintaining and applying this therapeutic method in daily life. Intervention 2: The second intervention group, mindfulness-based cognitive therapy, is to prepare a treatment plan and package from the mindfulness-based cognitive therapy treatment guide, based on Segal et al. Mindfulness will be implemented in 8 90-minute group counseling sessions, once a week for three months by a psychologist specializing in this field. The first session, setting a general policy by considering the aspect of confidentiality and personal life of individuals, inviting individuals to introduce themselves to each other, practicing eating raisins in a mindful manner, introducing the concept of automatic guidance, introducing this coping strategy to use when the current situation provokes disturbing emotions, practicing body check, homework, discussing and setting weekly meetings, distributing tapes and handouts from the first session. The second session, reviewing last week's homework, practicing body check, reviewing the exercise, practicing alternative thoughts and feelings, and teaching defocusing mental thoughts and assumptions by passing the hypothesis label over them, recording pleasant events, sitting meditation for 1 to 10 minutes, setting homework. Third session, practice seeing or hearing, introduction to the sitting meditation practice and the logic of its implementation, 30 to 40 minutes in the meditation state, strengthening the field of being-in-mind, review of the assignment, 3-minute breathing space practice and review, homework assignment. Fourth session, five-minute practice seeing or hearing, 40 minutes meditation, mindfulness of breathing, body, sound and thoughts review, mindfulness meditation practice, homework assignment. Fifth session, before any change, we must accept ourselves as we are and this requires allowing and granting permission for the presence of unpleasant emotions in consciousness, 40 minutes of sitting meditation review, review practice, review and review of the previous session's practice, homework assignment. Sixth session, training in paying attention to the mind and that thoughts are not facts, negative moods and thoughts limit our connection with experience; Understanding that thoughts are just thoughts, 40-minute seated meditation, mindfulness of breathing, body, sounds, and thoughts, review, homework review practice, preparing for the end of the course. Session 7, 40 minutes of seated meditation, awareness of breathing, body, sounds, and then thoughts, review exercises, activity planning, identifying and making a list of enjoyable and mastery-inducing activities, homework review, practice observing the connection between activity and mood. Session 8, review of previous material and summarization and post-test. Intervention 3: Control group: This group will not receive any intervention in the study.</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 Participant data is confidential and I do not intend to publish it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahya Motiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Classes, Hedayat Street, above Hedayat Square, Moshiri Alley</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1943613613</zip>
        <telephone>+98 21 2277 9063</telephone>
        <email>mahya.m161@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahya Motiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Classes, Hedayat Street, above Hedayat Square, Moshiri Alley</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1943613613</zip>
        <telephone>+98 21 2277 9063</telephone>
        <email>mahya.m161@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Possession of at least a diploma
Complete an informed consent agreement regarding participation in the research.
She has not taken any psychiatric medication in the past three months.
Age range between 25 and 50 years
The mother has a child with cancer.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having any significant psychological illness (such as personality disorder, major depression, obsessive-compulsive disorder, bipolar disorder, etc.)
Suffering from incurable physical illnesses such as cancer and the like</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R45.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Restlessness and agitation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group, compassion-focused therapy, is based on Gilbert's research. Each session includes a title and general content of the session, a description of the session, and assignments. This protocol will be implemented by a psychologist specializing in this field in 8 90-minute sessions, one session per week for three months. The first session is to establish initial group communication, review the structure of the sessions, familiarize yourself with the general principles and differentiate compassion from self-pity. The second session is to train mindfulness along with body scan and breathing exercises, familiarize yourself with brain systems based on compassion, and train empathy, train you to understand and appreciate how people feel and how to follow things with an empathetic attitude. The third session is to familiarize yourself with the characteristics of people who have compassion for others, cultivate a sense of warmth and kindness towards yourself, and develop an understanding that others also have flaws and problems. The fourth session, encouraging the subjects to self-recognize and examine their personality as a compassionate or non-compassionate person, according to the educational topics of identifying and applying compassionate mind-building exercises, the value of self-compassion, empathy and sympathy towards oneself and others, and teaching the physiotherapist metaphor) and teaching forgiveness. The fifth session, familiarizing and applying compassionate mind-building exercises, teaching accepting problems, accepting upcoming changes, and tolerating difficult and challenging situations, considering the variability of life and the fact that people face different challenges. The sixth session, practical practice of creating compassionate images, teaching styles and methods of expressing compassion and applying these methods in everyday life and for spouses, children, parents, friends, teachers, and acquaintances, teaching the development of valuable and transcendent emotions, the seventh session, teaching writing compassionate letters for oneself and others, teaching the method of recording and taking daily notes of real situations based on compassion and the individual's performance in that situation. Session 8: Training and practicing skills Review and practice of skills presented in previous sessions to help subjects cope with different life situations in different ways, and finally summarize and provide solutions for maintaining and applying this therapeutic method in daily life.</i_keyword>
      <i_keyword>The second intervention group, mindfulness-based cognitive therapy, is to prepare a treatment plan and package from the mindfulness-based cognitive therapy treatment guide, based on Segal et al. Mindfulness will be implemented in 8 90-minute group counseling sessions, once a week for three months by a psychologist specializing in this field. The first session, setting a general policy by considering the aspect of confidentiality and personal life of individuals, inviting individuals to introduce themselves to each other, practicing eating raisins in a mindful manner, introducing the concept of automatic guidance, introducing this coping strategy to use when the current situation provokes disturbing emotions, practicing body check, homework, discussing and setting weekly meetings, distributing tapes and handouts from the first session. The second session, reviewing last week's homework, practicing body check, reviewing the exercise, practicing alternative thoughts and feelings, and teaching defocusing mental thoughts and assumptions by passing the hypothesis label over them, recording pleasant events, sitting meditation for 1 to 10 minutes, setting homework. Third session, practice seeing or hearing, introduction to the sitting meditation practice and the logic of its implementation, 30 to 40 minutes in the meditation state, strengthening the field of being-in-mind, review of the assignment, 3-minute breathing space practice and review, homework assignment. Fourth session, five-minute practice seeing or hearing, 40 minutes meditation, mindfulness of breathing, body, sound and thoughts review, mindfulness meditation practice, homework assignment. Fifth session, before any change, we must accept ourselves as we are and this requires allowing and granting permission for the presence of unpleasant emotions in consciousness, 40 minutes of sitting meditation review, review practice, review and review of the previous session's practice, homework assignment. Sixth session, training in paying attention to the mind and that thoughts are not facts, negative moods and thoughts limit our connection with experience; Understanding that thoughts are just thoughts, 40-minute seated meditation, mindfulness of breathing, body, sounds, and thoughts, review, homework review practice, preparing for the end of the course. Session 7, 40 minutes of seated meditation, awareness of breathing, body, sounds, and then thoughts, review exercises, activity planning, identifying and making a list of enjoyable and mastery-inducing activities, homework review, practice observing the connection between activity and mood. Session 8, review of previous material and summarization and post-test.</i_keyword>
      <i_keyword>Control group: This group will not receive any intervention in the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience. Timepoint: Before intervention - One week after intervention - Three months after intervention. Method of measurement: The Connor and Davidson Resilience Questionnaire has 25 items that are scored on a Likert scale ranging from zero (completely false) to five (always true).</prim_outcome>
      <prim_outcome>Emotional regulation. Timepoint: Before intervention - One week after intervention - Three months after intervention. Method of measurement: The Emotion Regulation Questionnaire was designed and developed by Gross and John (2003) to measure emotion regulation. The Emotion Regulation Questionnaire has 10 questions and 2 components including emotional suppression and emotional reappraisal, and it measures emotion regulation based on a seven-point Likert scale with questions such as (When I want to feel more negative emotion, I change my thinking about that situation).</prim_outcome>
      <prim_outcome>Rumination. Timepoint: Before intervention - One week after intervention - Three months after intervention. Method of measurement: Hoeksma, in 1991, developed a self-test questionnaire that assessed four different styles of responding to negative people. The response styles questionnaire consists of two scales: the Intoxicating Responses Scale and the Sensory Distracting Responses Scale. The Intoxicating Responses Scale consists of 22 items, each of which respondents are asked to rate on a scale of never (1), sometimes (2), most of the time (3), and always (4).</prim_outcome>
      <prim_outcome>Worry. Timepoint: Before intervention - One week after intervention - Three months after intervention. Method of measurement: The Pennsylvania Worry Questionnaire (1990) is a 16-item scale developed by Meyer et al. (1990) and Molina and Brooke (1994) to measure a person's general tendency to worry. The 16 questions in the questionnaire were selected after factor analysis of 161 questions related to worry.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-16</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Sari</contact_name>
        <contact_address>Islamic Azad University of Sari Branch, Sea Road, Caspian Square Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
