<?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>IRCT20260712070153N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-15</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of compassion on psychological components of women with depression</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effectiveness of compassion therapy on depression, functional flexibility, self-differentiation, and perceived social support in women with depression referring to psychological counseling centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91622</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The statistical population of this study includes all female patients with depressive disorder who will refer to the counseling and psychological services center for treatment within the specified time period for the study. In the sample selection stage, the available sampling method will be used. In such a way that people who are definitely diagnosed with depression by experts and based on the fifth edition of the classification of mental disorders using a structured checklist will be selected. After selecting the samples to a volume of 40 people based on the study's entry and exit criteria, the participants will be randomly assigned to two groups: "compassionate treatment" (intervention group) and "waiting list" (control group). Randomization will be performed using the random block method with variable sizes (4 and 6 people) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel software and then placed in opaque, sealed, and numbered envelopes so that the researcher and participants are not aware of the allocation sequence (allocation concealment). Opening the envelope and informing the group allocation will only be done when each participant enters the study. To ensure the equality of the baseline variables (such as anxiety level, age, and length of marriage), their distribution in the two groups will be examined during the statistical analysis stage.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Compassion-based therapy; Duration of each session: 90 minutes; Total number of sessions: 8 sessions; Sequence of sessions: twice a week; Therapeutic tools used: This intervention relies on the reconstruction of emotional regulation systems. The main tools include the following: Psychological training. Mindfulness exercises. Guided imagery exercises. Writing techniques, body-focusing exercises. Session content: First session: Pre-test; Psychological training about the structure of the brain and emotional systems; Explanation of the concept of compassion and its distinction from self-compassion and compassion. Second session: Identification of the "inner critic"; Examination of self-deprecating thought patterns and the harms caused by self-differentiation in women. Third session: Training in mindfulness exercises to observe negative thoughts; Introduction of the "soothing breathing" technique; Initial exercises to activate the relief system to reduce the severity of depressive symptoms. Fourth session: Training in compassionate imagery skills; Practice creating a "compassionate personality" to deal with self-blame and increase functional flexibility. Session five: Writing exercise; Using emotional discharge technique to process past painful experiences with a compassion-based approach. Session six: Examining barriers to compassion; Strengthening perceived social support through compassion exercises in interpersonal relationships. Session seven: Teaching strategies to deal with negative automatic thoughts using a compassion approach; Deep relaxation exercises and consolidating learned skills in daily life. Session eight: General summary; Reviewing mental health maintenance programs; Conducting a post-test and determining the time for a follow-up test to assess the durability of the intervention effects. Intervention 2: Control group: The control group will not receive any intervention during the research. However, to avoid factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization, they will be assured that they will receive self-compassion therapy at the next visit (after data collection).</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 Due to the lack of research work, lack of data related to the findings, and lack of writing an article, which is a requirement for publishing the data, I will publish the data as soon as the aforementioned issues are resolved.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Torfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 161, Rad St., between Holali and Eznavi, Kouy-e Enqelab</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6144936535</zip>
        <telephone>+98 61 3379 9217</telephone>
        <email>Maryamtorfi48@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Torfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 161, Rad St., between Holali and Eznavi, Kouy-e Enqelab</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6144936535</zip>
        <telephone>+98 61 3379 9217</telephone>
        <email>Maryamtorfi48@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 30 to 45 years
Scoring between 20 and 28 on the Beck Depression Inventory
Having a maximum of 2 years of history of depressive disorder
Undergoing medication for depression.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participation in other psychotherapy sessions 3 months before the study
Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Compassion-based therapy; Duration of each session: 90 minutes; Total number of sessions: 8 sessions; Sequence of sessions: twice a week; Therapeutic tools used: This intervention relies on the reconstruction of emotional regulation systems. The main tools include the following: Psychological training. Mindfulness exercises. Guided imagery exercises. Writing techniques, body-focusing exercises. Session content: First session: Pre-test; Psychological training about the structure of the brain and emotional systems; Explanation of the concept of compassion and its distinction from self-compassion and compassion. Second session: Identification of the "inner critic"; Examination of self-deprecating thought patterns and the harms caused by self-differentiation in women. Third session: Training in mindfulness exercises to observe negative thoughts; Introduction of the "soothing breathing" technique; Initial exercises to activate the relief system to reduce the severity of depressive symptoms. Fourth session: Training in compassionate imagery skills; Practice creating a "compassionate personality" to deal with self-blame and increase functional flexibility. Session five: Writing exercise; Using emotional discharge technique to process past painful experiences with a compassion-based approach. Session six: Examining barriers to compassion; Strengthening perceived social support through compassion exercises in interpersonal relationships. Session seven: Teaching strategies to deal with negative automatic thoughts using a compassion approach; Deep relaxation exercises and consolidating learned skills in daily life. Session eight: General summary; Reviewing mental health maintenance programs; Conducting a post-test and determining the time for a follow-up test to assess the durability of the intervention effects.</i_keyword>
      <i_keyword>Control group: The control group will not receive any intervention during the research. However, to avoid factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization, they will be assured that they will receive self-compassion therapy at the next visit (after data collection).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The method of measurement will be the Beck Depression Inventory (1961).</prim_outcome>
      <prim_outcome>Functional Flexibility. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The measurement method will be using the Connor and Davidson (2003) Functional Flexibility Questionnaire.</prim_outcome>
      <prim_outcome>Self-Differentiation. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The measurement method will be the Skowron and Friedlander (1998) differentiation questionnaire.</prim_outcome>
      <prim_outcome>Perceived Social Support. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The method of measurement will be Zimmet et al.'s (1988) multidimensional scale of perceived social support.</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>2026-06-30</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Ahvaz Branch</contact_name>
        <contact_address>Opposite Keshavarz Street, Farhang Shahr, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
