<?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>IRCT20260901070861N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-22</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the effect of self-focused therapies on improving mental health in patients with psychosomatic problems</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of self-care and self-compassion therapy on mood alexithymia, perceived stress, ego strength, and quality of life in psychosomatic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/93016</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The statistical population of this study includes all patients with psychosomatic disorders who refer to the psychology and counseling clinic and who will refer to the clinic within the specified time period for the study. In the sample selection stage, the available sampling method will be used. After selecting the samples to a volume of 45 people based on the study's entry and exit criteria, the participants will be randomly assigned to three groups: "self-treatment" (intervention group 1), "self-compassion treatment" (intervention group 2), 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). The envelope will be opened and the allocation group will be informed only when each participant enters the study. To ensure the equality of baseline variables (such as anxiety level and age), their distribution in the two groups will be examined during the statistical analysis stage.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Physical disorders of psychological origin.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Self-discipline; Duration of each session: 90 minutes; Total number of sessions: 14 sessions; Sequence of sessions: Twice a week; Therapeutic tools used: This intervention focuses on activating internal resources, rebuilding lifestyle, and emotional self-care. The main tools include: guided therapeutic dialogue, cognitive-behavioral training, body care exercises, stress management techniques, and rebuilding my strength. Session content: Session 1: Conducting a pre-test; Explaining the therapeutic logic; Getting to know the concepts of "self-discipline" and its role in improving the psychosomatic state. Session 2: Identifying basic needs; Examining the current lifestyle and its difference from the ideal self-discipline pattern. Session 3: Body awareness skills; Practicing identifying physical tensions. Session 4: Emotional analysis; Training in naming emotions and distinguishing between physical and mental feelings. Session 5: Assessing thoughts; Identifying dysfunctional beliefs that lead to ignoring one's own needs. Session 6: Breathing and relaxation techniques; Abdominal breathing training for managing perceived stress. Session 7: Managing stress in daily life; Identifying stress triggers and effective coping strategies. Session 8: Strengthening "my resilience"; Examining personal strengths and increasing self-esteem and self-efficacy. Session 9: Teaching assertiveness skills; Learning to say "no" and setting healthy boundaries in relationships to reduce psychological stress. Session 10: Managing negative emotions; Using writing techniques to express pent-up emotions. Session 11: Improving well-being; Planning for enjoyable and meaningful activities. Session 12: Pathology of barriers to self-care; Examining individual fears and resistance to lifestyle changes. Session 13: Consolidating skills; Reviewing methods for dealing with slippage and continuing exercises in critical situations. Session 14: Final summary; Presenting a plan for continuing self-care; Conducting a post-test and determining the timing of the follow-up test. Intervention 2: Intervention group 2: Compassion-focused 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 heavily on activating emotional regulation systems and internal resources of compassion. The main therapeutic tools include: guided therapeutic dialogue; mindfulness exercises; self-compassion imagery exercises; reciprocal compassion imagery exercises. Session content: Session 1: Pre-test; explanation of the logic of compassion-focused therapy and understanding the concepts of self-compassion and compassion for others in order to reduce psychosomatic tensions. Session 2: Identification of critical mental and behavioral patterns that the individual has towards himself; examination of the individual's way of thinking and behaving in the face of physical and psychological pain. Session 3: Training in compassionate imagery skills; practicing mindfulness to connect with oneself and using soothing breathing techniques to regulate physiological responses. Session 4: Using mindfulness techniques to focus on bodily experiences; teaching how to express emotional empathy towards personal suffering and repressed emotions. Session 5: Technique for writing a “compassionate letter”; enhancing the capacity for self-compassion by emotionally releasing past trauma and accepting shared humanity. Session 6: Pathology of obstacles and factors that create “fear of compassion”; examining internal fears and repulsions towards expressing kindness to oneself. Session 7: Teaching methods for dealing with resistance to compassion; strengthening self-compassion during times of peak stress and using relaxation techniques. Session 8: Summarizing the sessions, providing final suggestions for consolidating skills; administering the post-test and determining the timing for administering the follow-up test. Intervention 3: Control group: The control group will not receive any intervention during the research, but will receive the treatment intervention after data collection to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization.</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 personal issues—and given that publishing the data requires writing an article, a task that is time-consuming and demands precision—I will proceed with the publication as soon as these matters are resolved.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Opposite Keshavarz Street, Farhang Shahr, Golestan Highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134937333</zip>
        <telephone>+98 61 3334 8421</telephone>
        <email>sara.mousavi4146@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Opposite Keshavarz Street, Farhang Shahr, Golestan Highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134937333</zip>
        <telephone>+98 61 3334 8421</telephone>
        <email>sara.mousavi4146@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Confirmation of a psychosomatic diagnosis based on a clinical interview by an experienced psychologist or psychiatrist
Having an age range between 25 and 40 years</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Concurrent participation in other psychotherapy interventions or psychological training courses 3 months prior to the study
Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Body dysmorphic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Self-discipline; Duration of each session: 90 minutes; Total number of sessions: 14 sessions; Sequence of sessions: Twice a week; Therapeutic tools used: This intervention focuses on activating internal resources, rebuilding lifestyle, and emotional self-care. The main tools include: guided therapeutic dialogue, cognitive-behavioral training, body care exercises, stress management techniques, and rebuilding my strength. Session content: Session 1: Conducting a pre-test; Explaining the therapeutic logic; Getting to know the concepts of "self-discipline" and its role in improving the psychosomatic state. Session 2: Identifying basic needs; Examining the current lifestyle and its difference from the ideal self-discipline pattern. Session 3: Body awareness skills; Practicing identifying physical tensions. Session 4: Emotional analysis; Training in naming emotions and distinguishing between physical and mental feelings. Session 5: Assessing thoughts; Identifying dysfunctional beliefs that lead to ignoring one's own needs. Session 6: Breathing and relaxation techniques; Abdominal breathing training for managing perceived stress. Session 7: Managing stress in daily life; Identifying stress triggers and effective coping strategies. Session 8: Strengthening "my resilience"; Examining personal strengths and increasing self-esteem and self-efficacy. Session 9: Teaching assertiveness skills; Learning to say "no" and setting healthy boundaries in relationships to reduce psychological stress. Session 10: Managing negative emotions; Using writing techniques to express pent-up emotions. Session 11: Improving well-being; Planning for enjoyable and meaningful activities. Session 12: Pathology of barriers to self-care; Examining individual fears and resistance to lifestyle changes. Session 13: Consolidating skills; Reviewing methods for dealing with slippage and continuing exercises in critical situations. Session 14: Final summary; Presenting a plan for continuing self-care; Conducting a post-test and determining the timing of the follow-up test.</i_keyword>
      <i_keyword>Intervention group 2: Compassion-focused 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 heavily on activating emotional regulation systems and internal resources of compassion. The main therapeutic tools include: guided therapeutic dialogue; mindfulness exercises; self-compassion imagery exercises; reciprocal compassion imagery exercises. Session content: Session 1: Pre-test; explanation of the logic of compassion-focused therapy and understanding the concepts of self-compassion and compassion for others in order to reduce psychosomatic tensions. Session 2: Identification of critical mental and behavioral patterns that the individual has towards himself; examination of the individual's way of thinking and behaving in the face of physical and psychological pain. Session 3: Training in compassionate imagery skills; practicing mindfulness to connect with oneself and using soothing breathing techniques to regulate physiological responses. Session 4: Using mindfulness techniques to focus on bodily experiences; teaching how to express emotional empathy towards personal suffering and repressed emotions. Session 5: Technique for writing a “compassionate letter”; enhancing the capacity for self-compassion by emotionally releasing past trauma and accepting shared humanity. Session 6: Pathology of obstacles and factors that create “fear of compassion”; examining internal fears and repulsions towards expressing kindness to oneself. Session 7: Teaching methods for dealing with resistance to compassion; strengthening self-compassion during times of peak stress and using relaxation techniques. Session 8: Summarizing the sessions, providing final suggestions for consolidating skills; administering the post-test and determining the timing for administering the follow-up test.</i_keyword>
      <i_keyword>Control group: The control group will not receive any intervention during the research, but will receive the treatment intervention after data collection to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alexithymia. 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 Toronto Taylor Alexithymia Questionnaire (1989).</prim_outcome>
      <prim_outcome>Perceived Stress. 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 Cohen et al. (1983) Perceived Stress Scale.</prim_outcome>
      <prim_outcome>Ego Strength. 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 Mann-Flack and Narakmeh (2002) strength scale.</prim_outcome>
      <prim_outcome>Life Well-Being. 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 through the Bio-Benefit Questionnaire by Joharifard (2024).</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>2026-03-16</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of 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>
