<?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>IRCT20220424054627N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-15</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>evaluating the effect of self-help intervention on mental health and quality of life</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of smartphone based self-help intervention on depression, anxiety, stress and quality of life in patients with Acute Coronary Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63167</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants in this study will be assigned to intervention or control group based on blocking randomization methods. For randomization, the sample size (64 persons) will be devided into 16 block. each block size will be 4 persons and 2 of them will be assigned to the control group and 2 of them will be assigned to intervention group. assigning participants in each block to intervention or control group will be based on random numbers generated by random allocation software. this random numbers sequence will be produced in a way that, 2 participants in each block assign to control group and 2 participant assign to intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute Coronary Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: intervention group will receive smartphone-based self-help intervention within 3 weeks. educational contents includes 6 main topics which will be sent to participants usnig whats app messenger. participants will  be asked to read these contents and use them in their routine life. generally, reading and using each topic requires 40-80 minutes in week and timing for reading and using educational contents will be based on participants preferences. educational contents will be sent to participants weekly and two topics each week. first topic incudes information about acute coronary syndrome and its possible effects on mental heal and quality of life, and also information about self-care such as physical activity, diet, prescibed medications and times to visit physician. in second topic, paticipants will receive information about coping with negative thoughts and tensions related to acute coronary syndrome. third topic will be about modification of Thought patterns and Cognitive thinking. fourth topic will focus on increasing participants resilience and coping skills. in fifth topic, information about sleep hygine and relaxing technics will be discussed. sixth topic includes information about importance of self-care and personal developement. Intervention 2: Control group: control group will receive only routine cares (such as physician visit, educations provided by physician and nurses). this group will not receive any education or intervention from the researchers.</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 After data collection and analysis, results will be presented to Shiraz University of Medical Sciences as final report of thesis and will be published as article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Molazem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh (P.B.U.H) School of Nursing and Midwifery, Namazi hospital, Namazi square.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۱۱۹ - ۷۱۹۳۶</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>molazem@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Molazem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh (P.B.U.H) School of Nursing and Midwifery, Namazi hospital, Namazi square.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۱۱۹ - ۷۱۹۳۶</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>molazem@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>acute coronary syndrome confirmed by cardiologist
passed at least 24 hours from hospitalization
willingness to participate in the study
age between 30 to 65 years
ability to read and write in persian
ability to use smartphone and accessibility to internet
not participated in psycological interventions in past 3 months</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute ischemic heart disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: intervention group will receive smartphone-based self-help intervention within 3 weeks. educational contents includes 6 main topics which will be sent to participants usnig whats app messenger. participants will  be asked to read these contents and use them in their routine life. generally, reading and using each topic requires 40-80 minutes in week and timing for reading and using educational contents will be based on participants preferences. educational contents will be sent to participants weekly and two topics each week. first topic incudes information about acute coronary syndrome and its possible effects on mental heal and quality of life, and also information about self-care such as physical activity, diet, prescibed medications and times to visit physician. in second topic, paticipants will receive information about coping with negative thoughts and tensions related to acute coronary syndrome. third topic will be about modification of Thought patterns and Cognitive thinking. fourth topic will focus on increasing participants resilience and coping skills. in fifth topic, information about sleep hygine and relaxing technics will be discussed. sixth topic includes information about importance of self-care and personal developement.</i_keyword>
      <i_keyword>Control group: control group will receive only routine cares (such as physician visit, educations provided by physician and nurses). this group will not receive any education or intervention from the researchers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life scores in Ferrans and Powers Quality of Life Index. Timepoint: before, immediately after and 3 weeks after interventions. Method of measurement: Ferrans and Powers Quality of Life Index.</prim_outcome>
      <prim_outcome>Depression scores based on Depression, anxiety and stress scale (DASS-21). Timepoint: before, immediately after and 3 weeks after interventions. Method of measurement: Depression, anxiety and stress scale (DASS-21).</prim_outcome>
      <prim_outcome>Anxiety scores based on depression, anxiety, stress scale (DASS-21). Timepoint: Before, immediately after and 3 weeks after interventions. Method of measurement: depression, anxiety, stress scale (DASS-21).</prim_outcome>
      <prim_outcome>Strss score based on depression, anxiety, stress scale (DASS-21). Timepoint: Before, immediately after and 3 weeks after interventions. Method of measurement: depression, anxiety, stress scale (DASS-21).</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-03</approval_date>
        <contact_name>Research Ethics Committees of Schools of Nursing and Midwifery, Management and Medical Information.</contact_name>
        <contact_address>Fatemeh (P.B.U.H) School of Nursing and Midwifery, Namazi hospital, Namazi square. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
