<?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>IRCT20220706055395N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-19</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the Effectiveness of Solution-Focused Brief group Therapy  on reducing Anxiety and Depression.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effectiveness of Solution-Focused Brief Group Therapy (SFBT) on reducing Anxiety and Depression in Patients admitted to the Neuropsychiatric Department Compared to the Control Group.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64645</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Using the Lottery Method. In this Method, a Number or Code is prepared for each Patient admitted to the Psychiatric Ward. Then the Numbers are written on a piece of Paper. The pieces of Paper are placed in a Container and mixed well. Then a sample of 30 People is selected. The first 15 Numbers include control Group Patients and the next 15 numbers are intervention Group Patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: In the Experimental Group, the Intervention with Short-term Solution-oriented Treatment is carried out for six 45-minute Sessions (two Sessions per Week) in the Psychiatric Department of Kausar Hospital in a Group setting. In this Group, before and after the Implementation of the Intervention, In order to measure the level of Anxiety and Depression, the DASS-21 Anxiety-Depression Scale will be used. In order to perform the Intervention, Kim-Berg's Solution-oriented Short-term Group Therapy Protocol (SFBT) is used. The Principles of Solution-oriented Group Therapy include focusing on change and possibilities, setting Goals, focusing on People's Capabilities and Skills, creating Participation and Cooperation, using Humor and Creativity. The Intervention Group includes Patients with Anxiety and Depression Disorders admitted to the Psychiatric Department of the Hospital. Intervention 2: Control Group: Control group: no intervention is done in the Control Group. The level of Anxiety and Depression is evaluated on the first day of Hospitalization and after three Weeks. This Group is only under Medical Treatment during Hospitalization.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar Hospital., Amin Blvd</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519899951</zip>
        <telephone>+98 23 3142 2391</telephone>
        <email>abdollahi.mahsa631@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar Hospital., Amin Blvd</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519899951</zip>
        <telephone>+98 23 3142 2391</telephone>
        <email>abdollahi.mahsa631@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with Anxiety and Depression Disorders admitted to the Psychiatric Ward
Patients 18 to 60 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Psychotic or Mania Patients
Patients with Personality Disorders
Substance Abuse Patients
Mentally Retarded Patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
      <hc_keyword>Anxiety disorder due to known Physiological condition</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>In the Experimental Group, the Intervention with Short-term Solution-oriented Treatment is carried out for six 45-minute Sessions (two Sessions per Week) in the Psychiatric Department of Kausar Hospital in a Group setting. In this Group, before and after the Implementation of the Intervention, In order to measure the level of Anxiety and Depression, the DASS-21 Anxiety-Depression Scale will be used. In order to perform the Intervention, Kim-Berg's Solution-oriented Short-term Group Therapy Protocol (SFBT) is used. The Principles of Solution-oriented Group Therapy include focusing on change and possibilities, setting Goals, focusing on People's Capabilities and Skills, creating Participation and Cooperation, using Humor and Creativity. The Intervention Group includes Patients with Anxiety and Depression Disorders admitted to the Psychiatric Department of the Hospital.</i_keyword>
      <i_keyword>Control Group: Control group: no intervention is done in the Control Group. The level of Anxiety and Depression is evaluated on the first day of Hospitalization and after three Weeks. This Group is only under Medical Treatment during Hospitalization.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Percentage of People who Score higher than 21 in the Depression Subscale of the DASS-21 Questionnaire. Timepoint: Depression in the intervention Group is measured at the beginning of Hospitalization (before the intervention) and after the intervention (after three weeks). In the Control group, it is measured from the beginning of Hospitalization and after three Weeks. Method of measurement: Depression is measured by the Depression Subscale of the Depression- Anxiety- Stress Scale(DASS-21) Questionnaire.</prim_outcome>
      <prim_outcome>The Percentage of People who Score higher than 15 in the Anxiety-Stress Subscale of the DASS-21 Questionnaire. Timepoint: Anxiety in the intervention Group is measured at the beginning of Hospitalization (before the intervention) and after the intervention (after three weeks). In the Control group, it is measured from the beginning of Hospitalization and after three Weeks. Method of measurement: Anxiety is measured by the Anxiety Subscale of the DASS-21 qQuestionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>. Timepoint: . Method of measurement: .</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-24</approval_date>
        <contact_name>Ethics Committee of Semnan Islamic Azad University</contact_name>
        <contact_address>Kosar Hospital., Amin Blvd Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
