<?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>IRCT20230102057025N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-21</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effect of compassion-focused therapy on depression in people with childhood maltreatment</public_title>
      <acronym>CFT</acronym>
      <scientific_title>Comparison of the efficacy of compassion-focused therapy on depressive symptoms in individuals with severe and mild child maltreatment experience</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67835</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The study includes two groups with different characteristics that receive the same intervention, Blinding description: The statistical analyst is blind to research so data analysis can be done without bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Major Depressive Disorder. Condition 2: Major Depressive Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The participants include people who have obtained a moderate or higher depression score (14 and above) based on the Beck Depression Inventory-II and diagnostic interview. The questionnaires are completed before the start of the intervention and at least in one of the subscales of the childhood trauma questionnaire, they have scored average or higher. The content of group sessions is held in 8 sessions of 90 minutes once a week. The sessions are conducted with themes such as emotion regulation systems, characteristics of compassion and a compassionate person, reasoning, attention, visualization, compassionate feelings and behavior, and self-compassion, optimism, empathy, relaxation exercises, and positive self-induction are used. . At the end of the intervention, the participants will complete the questionnaires as a post-test. In the follow-up phase, after 2 months, the participants will complete the research questionnaires again. Intervention 2: Control group: Compassion-focused therapy: The participants include people who have obtained a moderate or higher depression score (14 and above) based on the Beck Depression Inventory-II and diagnostic interview and have not scored higher than mild in any of the subscales of the childhood trauma questionnaire. The content of group sessions is held in 8 sessions of 90 minutes once a week. The sessions are conducted with themes such as emotion regulation systems, characteristics of compassion and a compassionate person, reasoning, attention, visualization, compassionate feelings and behavior, and self-compassion, optimism, empathy, relaxation exercises, and positive self-induction are used. . At the end of the intervention, the participants will complete the questionnaires as a post-test. In the follow-up phase, after 2 months, the participants will complete the research questionnaires again.</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:
All data is potentially shareable after de-identifying individuals

When:
Start access after printing the results

To whom:
Researchers in academic institutions

Conditions:
There are no other conditions

Where to obtain:
Postal address: Zahra Asl Soleimani; Clinical psychology department, University of Social Welfare and Rehabilitation Sciences, Kodakyar Ave., Daneshjo Blvd., Evin, Tehran
Email: Z.soleimani1991@gmail.com

How to obtain:
The requester can have the data after the request email
be

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Asl Soleimani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Ave., Daneshjo Blvd., Evin, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 7173 2000</telephone>
        <email>webmaster@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Asl Soleimani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Ave., Daneshjo Blvd., Evin, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 7173 2000</telephone>
        <email>webmaster@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obtain a score of at least 14 on the Beck Depression Inventory-second edition (BDI-II)
Presence of minimal subclinical symptoms of depression based on the diagnostic interview (2-4 symptoms of major depression according to The Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition(DSM-5) that include at least one of the core symptoms)
The minimum ability to read and write</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A mild to moderate score on any of the Childhood Trauma Questionnaire (CTQ) subscales
Presence of psychotic symptoms based on diagnostic interview
receiving psychotherapy in the last 2 months
starting pharmacotherapy in the last 2 months
The presence of diagnostic criteria for personality disorders based on diagnostic interviews
Presence of severe suicidal ideation based on diagnostic interview
Suffering from substance, alcohol and drug related disorders based on individual report and diagnostic interview</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
      <hc_code>F33</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
      <hc_keyword>Major depressive disorder, recurrent</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: The participants include people who have obtained a moderate or higher depression score (14 and above) based on the Beck Depression Inventory-II and diagnostic interview. The questionnaires are completed before the start of the intervention and at least in one of the subscales of the childhood trauma questionnaire, they have scored average or higher. The content of group sessions is held in 8 sessions of 90 minutes once a week. The sessions are conducted with themes such as emotion regulation systems, characteristics of compassion and a compassionate person, reasoning, attention, visualization, compassionate feelings and behavior, and self-compassion, optimism, empathy, relaxation exercises, and positive self-induction are used. . At the end of the intervention, the participants will complete the questionnaires as a post-test. In the follow-up phase, after 2 months, the participants will complete the research questionnaires again.</i_keyword>
      <i_keyword>Control group: Compassion-focused therapy: The participants include people who have obtained a moderate or higher depression score (14 and above) based on the Beck Depression Inventory-II and diagnostic interview and have not scored higher than mild in any of the subscales of the childhood trauma questionnaire. The content of group sessions is held in 8 sessions of 90 minutes once a week. The sessions are conducted with themes such as emotion regulation systems, characteristics of compassion and a compassionate person, reasoning, attention, visualization, compassionate feelings and behavior, and self-compassion, optimism, empathy, relaxation exercises, and positive self-induction are used. . At the end of the intervention, the participants will complete the questionnaires as a post-test. In the follow-up phase, after 2 months, the participants will complete the research questionnaires again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of signs and symptoms in patients with depression. Timepoint: Before the intervention, last session, 2 months after the intervention. Method of measurement: Beck Depression Inventory–II.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognitive Emotion Regulation. Timepoint: Before the intervention, last session, 2 months after the intervention. Method of measurement: Cognitive Emotion Regulation Questionnaire- short form.</sec_outcome>
      <sec_outcome>Behavioral Emotion Regulation. Timepoint: Before the intervention, last session, 2 months after the intervention. Method of measurement: Behavioral Emotion Regulation Questionnaire.</sec_outcome>
      <sec_outcome>Interpersonal Emotion Regulation. Timepoint: Before the intervention, last session, 2 months after the intervention. Method of measurement: Interpersonal Emotion Regulation Questionnaire.</sec_outcome>
      <sec_outcome>Self-Compassion. Timepoint: Before the intervention, last session, 2 months after the intervention. Method of measurement: Self-Compassion Scale (short form).</sec_outcome>
      <sec_outcome>Fears of Compassion. Timepoint: Before the intervention, last session, 2 months after the intervention. Method of measurement: Fears of Compassion Scales.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-20</approval_date>
        <contact_name>Ethics committee of  University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Kodakyar Ave., Daneshjo Blvd.,Evin, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
