<?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>IRCT2012100411004N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-07-09</date_registration>
      <primary_sponsor>Vice chancellor for research, Hamadan university of medical sciences</primary_sponsor>
      <public_title>Treatment of sleep disorders in patients with non-psychotic depressed</public_title>
      <acronym></acronym>
      <scientific_title>Comparisons of healthy sleep education alone and combined with pharmacotherapy in the treatment of sleep disturbances in Non-psychotic depressed patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11367</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Depressive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Group 1: patients in group 1 will receive Lorazepam  1mg per night  for 4 week. Intervention 2: Group 2: patients in group 2 will receive sleep healthy education face to face training and pamphlets. Intervention 3: Group 3: patients in group 3 will receive sleep healthy education face to face training and pamphlets and Lorazepam  1mg per night for 4 week.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>           Sleep disturbances are nearly universal in psychiatric disorders, especially mood disorders. Research investigating associations between sleep and affective illness has largely focused on depression. This study evaluated the efficacy of lorazepam and Sleep hygiene education, alone or in combination on sleep in patients with non-psychotic depression. One hundred twenty patients with non-psychotic depression were randomly divided into 3 groups and either received Sleep hygiene education (n = 40), lorazepam (n = 40) and combined (n = 40) who were admitted to Farshchian hospital in Hamadan, Iran. The intervention lasted for 8 weeks. Pittsburgh Sleep Quality Index (PSQI) was used to measure of overall sleep quality. ANCOVA including and MANOVA were used to test intra-group and inter-group differences. Result showed that Sleep hygiene education, lorazepam and combined intervention were significant effect on sleep in patients with non-psychotic depression. There was no significant difference between Sleep hygiene educations and lorazepam. But found that intervention with a combination of Sleep hygiene educations and lorazepam had significant advantages over intervention with lorazepam or Sleep hygiene education alone (P</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>Farshid Shamsaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty,  Hamadan University of Medical Sciences, Shahid Fahmideh Bulv, Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65178</zip>
        <telephone>+98 81 1823 2193</telephone>
        <email>shamsaei68@yahoo.com</email>
        <affiliation>Hamadan university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farshid Shamsaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farshchian psychiatry hospital, Research center for behavioral disorders and substance abuse, Dibaj Ave.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 1827 1066</telephone>
        <email>shamsaei@umsha.ac.ir</email>
        <affiliation>Hamadan University of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Middle age group (35-60؛ No history of psychiatric disorders associated؛ No history of serious physical illness؛ Treated with SSRI antidepressants؛ The ability to read and write. Exclusion criteria included Electroconvulsive therapy؛ Having physical pain from chronic diseases؛ History of substance abuse.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F30, F31, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mood [affective] disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group 1: patients in group 1 will receive Lorazepam  1mg per night  for 4 week.</i_keyword>
      <i_keyword>Group 2: patients in group 2 will receive sleep healthy education face to face training and pamphlets.</i_keyword>
      <i_keyword>Group 3: patients in group 3 will receive sleep healthy education face to face training and pamphlets and Lorazepam  1mg per night for 4 week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep disorders. Timepoint: Before and 4 week after. Method of measurement: Sleep Disorders Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depressive level. Timepoint: Before and four weeks after. Method of measurement: Hamilton Depression Scale.</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>Vice chancellor for research, Hamadan university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-20</approval_date>
        <contact_name>Ethics Committee of Hamadan university of medical sciences</contact_name>
        <contact_address>Vice chancellor for research, Hamadan University of Medical Sciences, Shahid Fahmideh Bulv. Hamedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
