<?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>IRCT2016042527584N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-08</date_registration>
      <primary_sponsor>Islamic Azad University, Sari branch</primary_sponsor>
      <public_title>Effect of  Mindfulness based on Acceptance  and Commitment on mental health of the Elderly</public_title>
      <acronym></acronym>
      <scientific_title>Effect of  Mindfulness based on Acceptance  and Commitment on Quality of Life and Death Depression and Internalized Shame in the elderly at Behshahr city.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2005-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22569</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Depression.</hc_freetext>
      <i_freetext>Intervention 1: The pre-test, first, done by questionnaire on death depression, life quality and internal shame of the elderly. The control group didn’t receive any training and are placed in a waiting list after the pre-test. For the experiment group, the acceptance-based mindfulness protocol was executed. The execution was held in 8 sessions, per week 2 sessions and each session for 60 minutes in group and on the basis of Flaxman instruction. The population of the study are all the eldery women in the behzisti Complex at the city of Behshahr, Mazandaran, Iran.  &#13;
Acceptance-based mindfulness is one of the interventions of the third wave in psychotherapy. Concepts of thought, feeling and behavior, and then about fundamental principles of intervention purposes and importance of assignments and exercises were explained at the first meeting of the members with each other and with the therapist. Experiencing avoidance and exercising disappointment and fundamental belief of the old people about changing were explained at the second meeting. The acceptance and practices and examples of it were presented at the third meeting.the fourth to sixth meetings were held on backing to the present time and mindful attention and assuming his own contextual understanding, and measuring the values and committed action and its exercises and examples.the seventh and eighth meetings were just reviewing the content of previous sessions, group discussions on problems which managers had at the pre-sessions; and the feedback and the effectiveness were discussed. Intervention 2: No intervention was done for the control group, and they lived in the center as before.</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>Hasan Abdollahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behshahr Payame Noor University</address>
        <city>Behshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3457 4939</telephone>
        <email>abdollahzadeh2002@yahoo.com</email>
        <affiliation>Behshahr Payame Noor University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hasan Abdollahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behshahr Payame Noor University</address>
        <city>Behshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3457 4939</telephone>
        <email>abdollahzadeh2002@yahoo.com</email>
        <affiliation>Behshahr Payame Noor University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria for entering the research are: being female; the minimum age 65 years and maximum 75 years; the minimum education is graduation of middle school and residence of nursing homes (the behzisti Complex at Behshahr); and exclusion criteria: mental illness or special physical disorder, educational disorder, educational experience similar to intervention, such as meditation and relaxation before or during the study.</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Depressive episode, unspecified</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>The pre-test, first, done by questionnaire on death depression, life quality and internal shame of the elderly. The control group didn’t receive any training and are placed in a waiting list after the pre-test. For the experiment group, the acceptance-based mindfulness protocol was executed. The execution was held in 8 sessions, per week 2 sessions and each session for 60 minutes in group and on the basis of Flaxman instruction. The population of the study are all the eldery women in the behzisti Complex at the city of Behshahr, Mazandaran, Iran.  &#13;
Acceptance-based mindfulness is one of the interventions of the third wave in psychotherapy. Concepts of thought, feeling and behavior, and then about fundamental principles of intervention purposes and importance of assignments and exercises were explained at the first meeting of the members with each other and with the therapist. Experiencing avoidance and exercising disappointment and fundamental belief of the old people about changing were explained at the second meeting. The acceptance and practices and examples of it were presented at the third meeting.the fourth to sixth meetings were held on backing to the present time and mindful attention and assuming his own contextual understanding, and measuring the values and committed action and its exercises and examples.the seventh and eighth meetings were just reviewing the content of previous sessions, group discussions on problems which managers had at the pre-sessions; and the feedback and the effectiveness were discussed.</i_keyword>
      <i_keyword>No intervention was done for the control group, and they lived in the center as before.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Death Depression and Internalized Shame. Timepoint: 4 months after intervention. Method of measurement: Thempler depression test,  WHO quality of life questionaire, Kock internalized shame test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: 4 months after intervention. Method of measurement: WHO quality of life questionaire.</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>Islamic Azad University, Sari branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-23</approval_date>
        <contact_name>Islamic Azad University, Sari branch</contact_name>
        <contact_address>Islamic Azad University, Sari branch Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
