<?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>IRCT20090304001742N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-10</date_registration>
      <primary_sponsor>Larestan University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Structured Group Reminiscence Therapy on Depression and Anxiety of Elderly Women Smoking Hookah</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Structured Group Reminiscence Therapy on Depression and Anxiety of Elderly Women Smoking Hookah Referred to Larestan Community Health Centers, 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49241</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Due to the fact that the final sample size is 24 people, the randomized blocks method will be used to allocate people equally to the intervention and control groups.
Assisting the researcher By referring to the health centers of the selected community, at first, individuals enter the study through available sampling and according to the inclusion and exclusion criteria. The researcher will design 4 blocks of 6 (with 6 cells) according to the final sample size, which is 24 people. Then, people are referred in order and using random block method, they are placed in each of the block cells. It will pre-mark each cell with the letters A and B, and according to the pre-arranged contract, the people in house A will receive the intervention and the people in house B will become members of the control group. Finally, 12 people in the intervention group and 12 people in the control group will be randomly assigned.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Elderly women consuming hookah.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receiving 8 sessions of structured group reminiscence therapy. In this program, twelve topics are discussed in 12 sessions (one to one and a half hours). In each of these sessions, stimuli are used to recall memories related to the topic of the session, which, depending on the topic of the session, may include photos, work tools, childhood toys, and so on. The protocol in this study will be implemented by the researchers themselves.In the present study, some sessions will be merged and the protocol will be reduced to 8 sessions (integration of sessions 1 and 2, 4 and 5, 9 and 10, 11 and 12).In order to record the course of changes in grades, participants will be asked to complete the questionnaires one month after the intervention in the pre-test stage, immediately after the intervention. Intervention 2: Control group: They do not receive any intervention.</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:
It can be shared by unidentifiable participants

When:
Access begins a year after the publication of results

To whom:
People who are working in the academic and scientific institutions

Conditions:
It needs the agreement of Larestan University of Medical Sciences

Where to obtain:
Dr. Mohammad Rafi Bazrafshan, Associate Professor, Larestan University of Medical Sciences, e-mail address: mrbazr@sums.ac.ir, Contact Phone: 07152247110, Mobile Number: 09173821959

How to obtain:
Written and formal request to the vice chancellor for research of Larestan University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad-Rafi Bazrafshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>New City, North Ghadir Blvd., Karmandan St., Behind Larestan Grand Bazaar, Sina Building (Larestan University of Medical Sciences)</address>
        <city>Larestan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7431889629</zip>
        <telephone>+98 71 5225 5512</telephone>
        <email>mrbazr@sums.ac.ir</email>
        <affiliation>Larestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad-Rafi Bazrafshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>New City, North Ghadir Blvd., Karmandan St., Behind Larestan Grand Bazaar, Sina Building (Larestan University of Medical Sciences)</address>
        <city>Larestan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7431889629</zip>
        <telephone>+98 71 5225 5512</telephone>
        <email>mrbazr@sums.ac.ir</email>
        <affiliation>Larestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Samples tend to be voluntary to participate in research.
Candidates must be at least 60 years old.
Candidates have acceptable listening and speaking skills.
Candidates with acute psychosis do not have chronic and debilitating diseases and cognitive disorders such as dementia.
Depression and anxiety are not the result of physical problems such as hypothyroidism.
Candidates do not have a history of using psychiatric medications due to psychological problems.
Candidates did not receive treatment that impaired mental ability, memory, or thinking.
Candidates should be familiar with Persian language.
Before the intervention, the candidates obtained a score of 5 to 11 from the Elderly Depression Questionnaire, a score of 32 to 64 from the state Anxiety Test, and a score of 32 to 62 from the trait Anxiety Test.
Candidates should have a moderate level of cognitive status (obtaining a minimum score of 21 in the Mini-Mental State Examination test).
Candidates should not be in other treatment groups.
Candidates have a history of hookah use for at least 1 year.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Occurrence of any severe social, familial crisis during the study (such as the grief of family members in the last 6 months)
Hospitalization or acute and chronic illness that interferes with research.
Cognitive disorders and physical disabilities that seriously hinder participation in group therapy sessions.
Taking psychiatric pills due to psychological problems during the study
Symptoms and signs of crisis at the time of expression and review of life events during the study
Absence from meetings more than once
Alcohol or drug abuse
Lack of willingness of samples to continue participating in research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z72.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tobacco use</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Receiving 8 sessions of structured group reminiscence therapy. In this program, twelve topics are discussed in 12 sessions (one to one and a half hours). In each of these sessions, stimuli are used to recall memories related to the topic of the session, which, depending on the topic of the session, may include photos, work tools, childhood toys, and so on. The protocol in this study will be implemented by the researchers themselves.In the present study, some sessions will be merged and the protocol will be reduced to 8 sessions (integration of sessions 1 and 2, 4 and 5, 9 and 10, 11 and 12).In order to record the course of changes in grades, participants will be asked to complete the questionnaires one month after the intervention in the pre-test stage, immediately after the intervention.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>A score of 5 to 8 indicates mild depression, 9 to 11 indicates moderate depression, and 12 to 15 indicates severe depression. Timepoint: Before the intervention, immediately and one month after the intervention. Method of measurement: Elderly Depression Questionnaire.</prim_outcome>
      <prim_outcome>The scores on either of the trait and state anxiety scales can range from 20 to 80. state Anxiety: Rating 20 - 31 Mild Anxiety, Score 32 - 42 Medium to Low Anxiety, Rating 43 - 53 Medium to High Anxiety, Rating 54 - 64 Relatively Severe, Rating 65 - 75 Severe and Rating 76 and Up indicate High Anxiety It is severe. For trait Anxiety: Rating 20 - 31 Mild Anxiety, Rating 32 - 42 Medium to Low Anxiety, Rating 43 - 52 Medium to High Anxiety, Rating 53 - 62 Relatively Severe Anxiety, Rating 63 - 72 Severe Anxiety, Rating 73 and Up Very Anxiety Shows extreme. Timepoint: Before the intervention, immediately and one month after the intervention. Method of measurement: Spiel Berger Anxiety Questionnaire.</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>Larestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-27</approval_date>
        <contact_name>Ethics committee of Larestan University of Medical Sciences</contact_name>
        <contact_address>Fars, Larestan, New City, North Ghadir Blvd., Karmandan St., Behind Larestan Grand Bazaar, Sina Building (Larestan University of Medical Sciences) Larestan Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
