<?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>IRCT2017061834608N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-10</date_registration>
      <primary_sponsor>Vice chancellor for research, Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of cognitive behavioral group intervention on insomnia, bedtime procrastination and negative affect.</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of cognitive behavioral group intervention on insomnia, bedtime procrastination and negative affect in student.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26407</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>INSOMNIA.</hc_freetext>
      <i_freetext>Intervention 1: The implementation of the cognitive-behavioral group therapy for insomnia using the Edinger-Carney protocol in 8 sessions of 90 minutes on the experimental group includes the following sessions: &#13;
1. First and second sessions: Measures and therapeutic preparations (psycho-education) a. assessing the nature of sleeplessness and the suitability of the patient for cognitive-behavioral therapy, b. Review sleep baseline report.  &#13;
2. Third and fourth sessions: Performing behavioral therapy component. a. Describe the logic of treatment and sleep training plan, b. Working on sleep rules, c. Calculating the initial time prescribed for bedding, d. assign homework. &#13;
3. Fifth and sixth sessions: using cognitive therapy strategies. a. review and comment on the results of a sleep report, b. explaining cognitive logic to the patient, c. discussing constructive worries. C. discussing the method of the memo of thoughts, d. assign homework. &#13;
4.  Seventh and eighth sessions: principles of relapse prevention and problem-solving techniques.  a. recommendations for adjusting the time spent in bed, b. reviewing and reinforcing compliance with treatment, c. resolving the difficulty of behavioral components, d. resolving the difficulty of cognitive components, e. terminating the treatment. Intervention 2: There is no treatment for the control group at the same time as working on the experimental group.&#13;
But at the end of the work on experimental group, the same treatment will be performed on the control group.</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>Zolfaghar Hosnavy Dehshams</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beheshti Hospital, Gate the Ark, Sadi Crossroad, Zanjan.</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3353 4500</telephone>
        <email>zolfaghar.hosnavy@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zolfaghar Hosnavy Dehshams</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beheshti Hospital, Gate the Ark, Sadi Crossroad, Zanjan.</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3353 4500</telephone>
        <email>Zolfaghar.hosnavy@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion major conditions:  sleep quality score higher than 15;  less than 45 in test score of SCL-25; volunteered to participate in the plan satisfied Exclusion major conditions:  sleep quality score below 15; score higher than 45 on tests of mental disorder symptoms SCL-25.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G47.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of initiating and maintaining sleep</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The implementation of the cognitive-behavioral group therapy for insomnia using the Edinger-Carney protocol in 8 sessions of 90 minutes on the experimental group includes the following sessions: &#13;
1. First and second sessions: Measures and therapeutic preparations (psycho-education) a. assessing the nature of sleeplessness and the suitability of the patient for cognitive-behavioral therapy, b. Review sleep baseline report.  &#13;
2. Third and fourth sessions: Performing behavioral therapy component. a. Describe the logic of treatment and sleep training plan, b. Working on sleep rules, c. Calculating the initial time prescribed for bedding, d. assign homework. &#13;
3. Fifth and sixth sessions: using cognitive therapy strategies. a. review and comment on the results of a sleep report, b. explaining cognitive logic to the patient, c. discussing constructive worries. C. discussing the method of the memo of thoughts, d. assign homework. &#13;
4.  Seventh and eighth sessions: principles of relapse prevention and problem-solving techniques.  a. recommendations for adjusting the time spent in bed, b. reviewing and reinforcing compliance with treatment, c. resolving the difficulty of behavioral components, d. resolving the difficulty of cognitive components, e. terminating the treatment</i_keyword>
      <i_keyword>There is no treatment for the control group at the same time as working on the experimental group.&#13;
But at the end of the work on experimental group, the same treatment will be performed on the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Insomnia. Timepoint: Pre test, Post test and one month Follow up. Method of measurement: Insomnia severity index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Negative affect. Timepoint: Pre test, Post test and one month Follow up. Method of measurement: Positive and Negative Affect Scale.</sec_outcome>
      <sec_outcome>Bedtime procrastination. Timepoint: Pretest, Posttest and one month Follow up. Method of measurement: Bedtime Procrastination 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, Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-27</approval_date>
        <contact_name>Zanjan University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Zanjan University Of Medical Sience, Azadi Blvd, Zanjan Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
