<?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>IRCT20200402046920N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-09</date_registration>
      <primary_sponsor>Tanta university</primary_sponsor>
      <public_title>Effect of an Emotion Regulation Training intervention  on Social Functioning of Patients with Psychiatric Disorders</public_title>
      <acronym></acronym>
      <scientific_title>Effect of an Emotion Regulation Training intervention on Social Functioning of Patients with Psychiatric Disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46890</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: •	The control and study group will be assigned using simple randomization , by picking their codes up from a pool. The first two-selected codes will be assigned for the control group and the second two for the study group. The process was repeated till the required number obtained.</study_design>
      <phase>N/A</phase>
      <hc_freetext>emotional disturbance( problems in identification ,understanding,and expression of emotion ).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:•	The intervention  group  divided into subgroups. Each subgroup ranged between 4 to 6 patients. •	 The emotion regulation training program will conducted through 10 training sessions with a series of 12 training exercise , each lasting from (60-90) minutes; 3 times per week for a period of 4 weeks.                                                                                                                Session 1: The first and second exercise intended to help the subjects to recognize emotion •	Understanding emotional words: expressing emotion by using emotion word cards (e.g., happy)•	Learning emotional words: matching emotional word cards and emotional face cards.Session 2: the third and fourth exercises intended to help the subjects to identify emotion •	Finding emotional words: choosing emotional word cards from emotional face cards that represent different emotions.•	Identifying emotion by context: choose emotional word cards from a short film cartoon that represent certain emotions.Stage two: Emotion expression training : The aim of this stage was to help the patient to express emotions. This stage comprised four exercises that was conduct into three sessions.Session 3: The fifth and sixth exercise intended to help the subjects to express emotions  •	Making facial expression: the patients expressed emotions by emotional face cards.•	Facial expression relay: Identifying one’s facial expression and passing it to the next person. This procedure was applied on all emotional face cards where each patient in the group will draw different facial expressions            Session 4:- the seventh exercise  was performed to help the patients to express emotion by using image. •	Storytelling and watching a film and expressing emotion: The researcher asked the patients to write or draw their feelings after emotional storytelling and watching a film cartoon.           Session 5: -The eighth exercise in this session was to help the patients to express emotion by using sentence. •	Expressing emotion using written instructions: Each patient by turn was   pick a card with a written instruction of certain emotional expression in a group.Stage three: Emotion application training.   The aim of this stage was to help the patient to share their feelings, understand complex emotion and emotional inference. This stage comprised three exercises that conducted into two sessions.Session 6: - the nineth exercise was  applied to help the patients to share their feelings:•	Emotional mask:  making emotional mask by drawing one’s feeling on a mask then wearing each emotional mask and expressing their feelings.            Session 7: - the tenth and eleventh exercises were used to help the patients to understand complex emotion and emotion inference:•	 Making facial expressions by context: expressing feelings using written emotional sentences.•	 Exercising emotional inference: making up a story with emotional sentence cards.Stage four: Emotional control training. This stage conducted into 2 sessions ; the aim of this stage is to help the patient to develop self -awareness and cope with negative emotions. The researcher used the following learning strategies during the program: modeling, role play/ behavioral rehearsal, getting participant’s feedback (e.g. providing corrective feedback) and positive reinforcement (e.g. praising a client’s efforts). Intervention 2: Control group:  will receive the routine care that provided in the hospital.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Souzan Harfush</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Elgeish street, Faculty of nursing ,Tanta ,Egypt</address>
        <city>Tanta</city>
        <country1>Egypt</country1>
        <zip>31111</zip>
        <telephone>+20 40 3331841</telephone>
        <email>suzan.ahmed@nursing.tanta.edu.eg</email>
        <affiliation>Tanta university , Faculty of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Souzan Harfush</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Elgeish street, Faculty of nursing ,Tanta ,Egypt</address>
        <city>Tanta</city>
        <country1>Egypt</country1>
        <zip>31111</zip>
        <telephone>+20 40 3331841</telephone>
        <email>suzan.ahmed@nursing.tanta.edu.eg</email>
        <affiliation>Tanta university , Faculty of Nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Egypt</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Able to communicate relevantly
Agree to participate in the study
Diagnosis according to DSM-5 criteria for the psychiatric disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any evidence of organic brain disease, mental retardation, and or substance  use disorder
Acute stage of illness.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:•	The intervention  group  divided into subgroups. Each subgroup ranged between 4 to 6 patients. •	 The emotion regulation training program will conducted through 10 training sessions with a series of 12 training exercise , each lasting from (60-90) minutes; 3 times per week for a period of 4 weeks.                                                                                                                Session 1: The first and second exercise intended to help the subjects to recognize emotion •	Understanding emotional words: expressing emotion by using emotion word cards (e.g., happy)•	Learning emotional words: matching emotional word cards and emotional face cards.Session 2: the third and fourth exercises intended to help the subjects to identify emotion •	Finding emotional words: choosing emotional word cards from emotional face cards that represent different emotions.•	Identifying emotion by context: choose emotional word cards from a short film cartoon that represent certain emotions.Stage two: Emotion expression training : The aim of this stage was to help the patient to express emotions. This stage comprised four exercises that was conduct into three sessions.Session 3: The fifth and sixth exercise intended to help the subjects to express emotions  •	Making facial expression: the patients expressed emotions by emotional face cards.•	Facial expression relay: Identifying one’s facial expression and passing it to the next person. This procedure was applied on all emotional face cards where each patient in the group will draw different facial expressions            Session 4:- the seventh exercise  was performed to help the patients to express emotion by using image. •	Storytelling and watching a film and expressing emotion: The researcher asked the patients to write or draw their feelings after emotional storytelling and watching a film cartoon.           Session 5: -The eighth exercise in this session was to help the patients to express emotion by using sentence. •	Expressing emotion using written instructions: Each patient by turn was   pick a card with a written instruction of certain emotional expression in a group.Stage three: Emotion application training.   The aim of this stage was to help the patient to share their feelings, understand complex emotion and emotional inference. This stage comprised three exercises that conducted into two sessions.Session 6: - the nineth exercise was  applied to help the patients to share their feelings:•	Emotional mask:  making emotional mask by drawing one’s feeling on a mask then wearing each emotional mask and expressing their feelings.            Session 7: - the tenth and eleventh exercises were used to help the patients to understand complex emotion and emotion inference:•	 Making facial expressions by context: expressing feelings using written emotional sentences.•	 Exercising emotional inference: making up a story with emotional sentence cards.Stage four: Emotional control training. This stage conducted into 2 sessions ; the aim of this stage is to help the patient to develop self -awareness and cope with negative emotions. The researcher used the following learning strategies during the program: modeling, role play/ behavioral rehearsal, getting participant’s feedback (e.g. providing corrective feedback) and positive reinforcement (e.g. praising a client’s efforts).</i_keyword>
      <i_keyword>Control group:  will receive the routine care that provided in the hospital</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social functioning. Timepoint: before intervention ,immediately  after intervention, and three months later. Method of measurement: using social functioning scale.</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>Tanta university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-18</approval_date>
        <contact_name>Ethics committe of faculty of medicine  ,tanta university</contact_name>
        <contact_address>Algeish street ,tanta,Algharibia, Egypt,faculty of medicine Tanta Algharbia Egypt</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
