<?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>IRCT20170411033378N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-11</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effective of   spiritual group therapy on  anxiety and  hope in patients with type 2 diabetes</public_title>
      <acronym>DM</acronym>
      <scientific_title>The effective of   spiritual group therapy on  anxiety and  hope in patients with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42327</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Samples will be  selected by available method with considering  inclusion criteria, then divided into two intervention and control groups by randomized allocation. Random allocation will be by permuted block randomization. It is individual randomization. First, a random list is generated using R software in which the intervention group (A) and the control group (B) are based on blocks such as ABAB. And AABB, ABBA and ... are randomly generated based on the number of samples. Then these lists are put into an envelope and one of the envelopes is randomly selected by referring patients and then individuals are assigned to group A Or B are allocated. Due to the educational intervention and having the control and experimental group there is no possibility of blinding the participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes, Spiritual Health, Anxiety, Hope.</hc_freetext>
      <i_freetext>Intervention group: Group counseling based on spiritual health  in 8 sessions  80-minute, using  a spirituality package provided by the researcher..</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:
The whole data will be published after the unidentifiable individuals are shared. which will be published as the final report and artical.

When:
Start of access period 6 months after printing results

To whom:
Researchers working in academic and scientific institutions and people in the industry can apply for them.

Conditions:
Anyone who would like to use cited articles is possible by email.

Where to obtain:
Applicants can  email their request for receving the relevent  documents and data to sadeghianefat@gmail.com or send  it to  postal address Hamadan; Shahid Fahmideh Street, Front of Mardom park;  Faculty of  Nursing and Midwifery; Psychiatric Nursing Department, Dr Effat Sadeghian; Postal code: 38698-65178; or Call: 38380535-081 and Fax: 38380447-081.

How to obtain:
Applicants can  email their request for receving the relevent  documents and data to sadeghianefat@gmail.com or send  it to  postal address Hamadan; Shahid Fahmideh Street, Front of Mardom park;  Faculty of  Nursing and Midwifery; Psychiatric Nursing Department, Dr Effat Sadeghian; Postal code: 38698-65178; or Call: 38380535-081 and Fax: 38380447-081. The response will be sent to the Applicants at least one week after reviewing the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Efat Sadeghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>In Front Of People's Park, Shahid Fahmideh Boulevard, Hamadan University of Medical Sciences, Hamadan, Iran</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3838 0535</telephone>
        <email>Sadeghianefat@gmail.com</email>
        <affiliation>Hamadan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Efat Sadeghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan, Mahdye Street-Shahid Fahmedeh Bolvar-Hamadan University of Medical Sciences</address>
        <city>Hamdan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65178-38698</zip>
        <telephone>+98 81 3838 0150</telephone>
        <email>Sadeghianefat@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of type 2 diabetes based on medical records
At least 20 years of age
Literacy of reading and writing
Has not taken any psychiatric medication  in the  three months recent
Not attending psychotherapy sessions in the past 6 months
Speaking Persian language
Having Islam religion
Consent to participate in the research
No psychiatric disorder according to medical record
Not having a serious physical illness other than diabetes
Lack of crisis experience in the  three months recent</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absent more than 2 sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group counseling based on spiritual health  in 8 sessions  80-minute, using  a spirituality package provided by the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score of the Cattell Anxiety Scale                                                                                      Hope Score of the Snyder Hope Scale. Timepoint: Measurement of anxiety before intervention, immediately after intervention and one month after intervention                                                                                                               Measurement of hope before intervention, immediately after intervention and one month after intervention. Method of measurement: Cattell Anxiety Scale                                                                                Snyder Hope Scale.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-15</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>In front of People's Park, Shahid Fahmideh Boulevard, Hamadan University of Medical Sciences, Hamadan, Iran Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
