<?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>IRCT2013091414499N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-12-07</date_registration>
      <primary_sponsor>Research and Technology Deputy Office of University of Social Welfare and Rehabilitation Sciences</primary_sponsor>
      <public_title>The effects of living skills training on  treatment of the patients with Schizophrenia.</public_title>
      <acronym></acronym>
      <scientific_title>Randomized controlled trial of Social and Independent Living Skills Training on function and quality of life for Schizophrenic Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-11-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14119</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Eligible patients will be randomly allocated into two intervention and control groups. There is equal allocation of participants between arms. Eligible participants will be assigned by stratified balanced block randomization method with allocation concealment.   The allocation lists will be generated independently by the trial statistician.                                                                                                This is a single blind study because patients are not blind to their treatment group.                                                    &#13;
The assessors will not be selected from among the trainers or therapists.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention for control group (occupational therapy):&#13;
The control group will receive psychosocial services including group therapy (group discussion), leisure activities, arts and structured activities. Like the intervention group, the patients in the control group will attend occupational therapy sessions three times per week at outpatient centers and five times per week at inpatient centers, for 90 to 120 minutes per session. Intervention 2: The treatment for the intervention group is the independent and social living skills package. These skills include medication and symptom management, leisure management and basic conversational skills. Also family members of the intervention group will participate, as a generalization agent, in separate sessions (four sessions) where they will be provided with information concerning learned skills as well as problem solving and home assignment. Moreover, the family will be contacted by phone (once a month) during the follow-up period (transition of skills to the home). Interventions will be conducted three times per week at outpatient centers and five times per week at inpatient centers, for 90 to 120 minutes per session.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ashraf Karbalaee Nouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar Dead-end, Daneshjoo Blvd, Evin.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0037</telephone>
        <email>nouri@uswr.ac.irashraf1345@yahoo.com</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Ali Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar Dead-end, Daneshjoo Blvd, Evin.</address>
        <city>TEHRAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0123</telephone>
        <email>alihosse@gmail.com</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria&#13;
 &#13;
1	Informed willingness and consent of the patient for participation in the study.&#13;
&#13;
2	Being Diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental&#13;
Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria; however, after the active&#13;
phase of illness.&#13;
&#13;
3	Scoring between 40 and 70 on Global Assessment of Functioning (GAF).&#13;
&#13;
4	Having been hospitalized at least for one time.&#13;
&#13;
5	Ranging between 18 to 55 years old.&#13;
&#13;
6	Living in the vicinity of the therapy center.&#13;
&#13;
7	Being literate.&#13;
&#13;
8	Living with family.&#13;
&#13;
&#13;
&#13;
&#13;
&#13;
&#13;
&#13;
&#13;
&#13;
&#13;
Exclusion Criteria&#13;
&#13;
1	Any known current drug dependence or abuse and mental retardation.&#13;
&#13;
2	Seizure disorder requiring medication.&#13;
&#13;
3	Serious psychotic disorders other than schizophrenia.&#13;
&#13;
4	Clinically significant physical or neurological disorder.&#13;
5	Risk of harming himself/herself and others.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>f20-f21-f2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia, schizotypal and delusional disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention for control group (occupational therapy):&#13;
The control group will receive psychosocial services including group therapy (group discussion), leisure activities, arts and structured activities. Like the intervention group, the patients in the control group will attend occupational therapy sessions three times per week at outpatient centers and five times per week at inpatient centers, for 90 to 120 minutes per session.</i_keyword>
      <i_keyword>The treatment for the intervention group is the independent and social living skills package. These skills include medication and symptom management, leisure management and basic conversational skills. Also family members of the intervention group will participate, as a generalization agent, in separate sessions (four sessions) where they will be provided with information concerning learned skills as well as problem solving and home assignment. Moreover, the family will be contacted by phone (once a month) during the follow-up period (transition of skills to the home). Interventions will be conducted three times per week at outpatient centers and five times per week at inpatient centers, for 90 to 120 minutes per session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of Psychopathology. Timepoint: Before intervention, upon completion of intervention, and 6 months after completion  of intervention. Method of measurement: Positive and Negative Syndrome Scale (PANSS).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention, upon completion of intervention, and 6 months after completion of intervention. Method of measurement: WHO-Quality of Life Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Global Function. Timepoint: before intervention, upon completion of intervention, and 6 months after completion of intervention. Method of measurement: Global Assessment of Functioning.</sec_outcome>
      <sec_outcome>Patient Satisfaction. Timepoint: Before intervention, upon completion of intervention, and 6 months after completion of intervention. Method of measurement: Client Satisfaction Questionnaire.</sec_outcome>
      <sec_outcome>Drug Compliance. Timepoint: Before Intervention, upon completion of intervention, and 6 months after completion of intervention. Method of measurement: Drug Compliance Questionnaire.</sec_outcome>
      <sec_outcome>Family Burden. Timepoint: Before intervention, upon completion of intervention, and 6 months after completion of intervention. Method of measurement: Experience of Caregiving Inventory.</sec_outcome>
      <sec_outcome>Family Quality of Life. Timepoint: before intervention,upon completion of intervention, and 6 months after completion of intervention. Method of measurement: WHO-Quality of Life.</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>Research and Technology Deputy Office of University of Social Welfare and Rehabilitation Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-08</approval_date>
        <contact_name>Ethics Committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koodakyar Dead-end, Daneshjoo Blvd, Evin. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
