<?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>IRCT20170812035647N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-16</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of support groups on relocation stress syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of participating in support groups on relocation stress syndrome( RSS)  in residents of nursing homes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31631</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting the prototype, individuals will be assigned to the intervention and control groups based on the case number and using the random number table, Blinding description: To collect data from a research collaborator using unknowing type groups
Also, the statistics specialist and participants in the research will also be unaware.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Anxiety Disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Desired tools included researcher-made demographic questionnaire and geriatric depression scale(GDS), geriatric anxiety scale(GAS) And the shortened form of UCLA (ULS) University of California, Los Angeles ، will be completed at the beginning of the study  for both groups. The support groups will hold for 6 sessions and each session for 1 hour and 2 times a week.The first session will focus on the familiarization and expression of goals. At the next sessions, according to the goals, the researcher will initially provide the group members with information on each of the topics discussed, including depression, anxiety and loneliness.Then the people in the group will share their experiences and individual ways of dealing with it ,In the meantime, the researcher addresses the problems raised during the meeting, while the elderly are discussing and discussing emotional support among each other, to provide scientific and practical solutions And uses the experience of a successful counterpart in relation to the subject. After 4 weeks from the last support group meeting, the questionnaires are completed again. At the end, the tools for the control group will be completed and the results will be compared. Intervention 2: Control group: Depression, anxiety and loneliness questionnaires will be completed before the beginning of the study for the control group. During the study, the group will not receive intervention. After the end of the intervention in the intervention group, the questionnaires will be completed again for the control group and then the results will be compared.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Sahar Ghaderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing Midwifery ,Tehran University of Medical Sciences,Nosrat St. Tohid sq. Tehran I.IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21066922700</telephone>
        <email>Saharghaderi90@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh Sahar Ghaderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing Midwifery ,Tehran University of Medical Sciences,Nosrat St. Tohid sq. Tehran I.IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21066922700</telephone>
        <email>Saharghaderi90@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The elderly living in a nursing home whose length of stay at that center is at most 1 year
There is no recognized cognitive impairment (such as Alzheimer's, dementia, delirium, etc.)
Being able to communicate verbally and eye contact
There is no history of mood disorders based on expert diagnosis</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue participating in the study
Non-attendance at support group meetings in 2 sessions
Beginning of the cognitive disorder during the study
In one year, an important incident (such as divorce, death of loved ones, financial bankruptcy ...) has occurred in life</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.0</hc_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, mild</hc_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Desired tools included researcher-made demographic questionnaire and geriatric depression scale(GDS), geriatric anxiety scale(GAS) And the shortened form of UCLA (ULS) University of California, Los Angeles ، will be completed at the beginning of the study  for both groups. The support groups will hold for 6 sessions and each session for 1 hour and 2 times a week.The first session will focus on the familiarization and expression of goals. At the next sessions, according to the goals, the researcher will initially provide the group members with information on each of the topics discussed, including depression, anxiety and loneliness.Then the people in the group will share their experiences and individual ways of dealing with it ,In the meantime, the researcher addresses the problems raised during the meeting, while the elderly are discussing and discussing emotional support among each other, to provide scientific and practical solutions And uses the experience of a successful counterpart in relation to the subject. After 4 weeks from the last support group meeting, the questionnaires are completed again. At the end, the tools for the control group will be completed and the results will be compared.</i_keyword>
      <i_keyword>Control group: Depression, anxiety and loneliness questionnaires will be completed before the beginning of the study for the control group. During the study, the group will not receive intervention. After the end of the intervention in the intervention group, the questionnaires will be completed again for the control group and then the results will be compared.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: Geriatric depression scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: Geriatric anxiety scale.</prim_outcome>
      <prim_outcome>Loneliness. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: University of California at Los Angeles loneliness 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-03</approval_date>
        <contact_name>•Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Nursing Midwifery ,Tehran University of Medical Sciences,Nosrat st. Tohid sq. Tehran I.IRAN 141973317 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
