<?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>IRCT20210811052149N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-09</date_registration>
      <primary_sponsor>Shiraz University</primary_sponsor>
      <public_title>Effectiveness of Social Cognition and Interaction Training (SCIT) Based Group Therapy in Schizophrenic and Bipolar Disorder Patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effectiveness of Social Cognition and Interaction Training (SCIT) Based Group Therapy on Social Cognition and Functioning in Schizophrenic and Bipolar Disorder Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58342</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: For each intervention group (each bipolar group and Schizophrenia group) 30 subjects will be chosen from available candidates using convenience sampling method. Subjects will be split randomly between two groups, control and intervention groups, each group containing 15 persons. For randomizing the splitting process; initially, an integer code between 01 and 30 will be assigned to each person, then we move and stop our finger randomly and blindfolded on a RAND Corporation random number table, we move on that chosen row to find the corresponding random number and consider the last two digits of the random number. A successful random number is generated if the number is between 01 and 30. The process will continue till 15 random integers in the desired interval is made. 15 selected codes are in the intervention group and the rest are in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Schizophrenia. Condition 2: Bipolar disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: are consisted of 15  patients who will have group therapy for 18 sessions of 45 to 60 minutes long. Group-therapy sessions will be held 4 times a week. Participants will continue their treatment as usual (TAU).This group therapy consists of 3 phase (Introduction and Emotions, Figuring Out Situations &amp; Integration). Each session has a main topic and target which will be trained by discussing more elaborate subtopics and by practicing various pieces of training. In this therapy Various aids such as paper, PowerPoint slideshows and SCIT video vignettes and varied tasks are used.In the first part, the basic emotions, the relationship between emotions and social situations, and the recognition of emotions according to facial expressions are discussed. The goal of the second part of treatment is to learn and use social cognitive methods to avoid the pitfalls of jumping to conclusions related to social situations. These strategies include generating  multiple attributions for negative events, distinguishing social facts from social guesses, tolerating ambiguity in social situations, etc. In the third part, the integration of the skills learned up to this stage and the application of these skills in the lives of patients are discussed. At this stage, patients are encouraged to bring in problematic situations from their daily lives; the group then analyzes the situations and finds behavioral strategies to take steps to reduce interpersonal distress based on the skills they have learned during this treatment. Intervention 2: Control group: consisted of 15 subjects that will not receive any extra treatment and continue their treatment as usual. They will join pre-test, post-test and follow-up before, after and 3 months later than the intervention respectively.</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:
Data (without participant personal information) as questionnaire’s raw scores, basic consent form, and general protocols is available for fellow researchers via email application, 6 months after publication of first paper.

When:
Accessible 6 months after publication of paper.

To whom:
For whom the data is useful and usable.

Conditions:
using in the fields of psychology, psychiatry, and severe mental illness treatment

Where to obtain:
Sending email to the researchers

How to obtain:
Requests for information will be reviewed by researchers and information will be sent if relevant to mental health research.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shima Dehghanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>12th unit, 6th floor, Mehrayin Building, 62nd Ave, Pasdaran Blvd., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7184976914</zip>
        <telephone>+98 71 3842 9289</telephone>
        <email>sh.dehghanzadeh183@gmail.com</email>
        <affiliation>Shiraz University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Changiz Rahimi Taghanaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology, Educational Science and Psychology Faculty, Shiraz University, Eram Sq., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194684759</zip>
        <telephone>+98 71 3627 6708</telephone>
        <email>crahimi2016@hotmail.com</email>
        <affiliation>Shiraz University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>known-case of Schizophrenia Disorder
known-case of Bipolar Disorder
Be at least 18 years old
Ability to understand experimental assignments
Ability to see and hear normally</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of current or past developmental disorders
severe head trauma
a history of substance abuse in the past 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
      <hc_code>F31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
      <hc_keyword>Bipolar disorder</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: are consisted of 15  patients who will have group therapy for 18 sessions of 45 to 60 minutes long. Group-therapy sessions will be held 4 times a week. Participants will continue their treatment as usual (TAU).This group therapy consists of 3 phase (Introduction and Emotions, Figuring Out Situations &amp; Integration). Each session has a main topic and target which will be trained by discussing more elaborate subtopics and by practicing various pieces of training. In this therapy Various aids such as paper, PowerPoint slideshows and SCIT video vignettes and varied tasks are used.In the first part, the basic emotions, the relationship between emotions and social situations, and the recognition of emotions according to facial expressions are discussed. The goal of the second part of treatment is to learn and use social cognitive methods to avoid the pitfalls of jumping to conclusions related to social situations. These strategies include generating  multiple attributions for negative events, distinguishing social facts from social guesses, tolerating ambiguity in social situations, etc. In the third part, the integration of the skills learned up to this stage and the application of these skills in the lives of patients are discussed. At this stage, patients are encouraged to bring in problematic situations from their daily lives; the group then analyzes the situations and finds behavioral strategies to take steps to reduce interpersonal distress based on the skills they have learned during this treatment.</i_keyword>
      <i_keyword>Control group: consisted of 15 subjects that will not receive any extra treatment and continue their treatment as usual. They will join pre-test, post-test and follow-up before, after and 3 months later than the intervention respectively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social cognition. Timepoint: Before intervention, after intervention &amp; 3 months after in follow-up. Method of measurement: The Hinting Task, and The Penn Emotion Recognition Task (ER-40).</prim_outcome>
      <prim_outcome>Social function. Timepoint: Before intervention, after intervention &amp; 3 months after in follow-up. Method of measurement: short form of Social Functioning Scale (SFS), and Nurses’ Observation Scale for Inpatient Evaluation (NOSIE).</prim_outcome>
      <prim_outcome>Clinical symptoms. Timepoint: Before &amp; after intervention. Method of measurement: The Positive and Negative Syndrome Scale (PANSS).</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>Shiraz University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-28</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>7th Floor,  Administration Building of Shiraz University of Medical Sciences,  Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
