<?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>IRCT20241008063298N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-11</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dignity therapy on internal stigma, dignity and hope of depressed patients in the inpatient and outpatient departments of 505 Aja Hospital.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of dignity therapy on internal stigma, dignity and hope of depressed patients in the inpatient and outpatient departments of 505 Aja Hospital in 1403.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79497</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Health service research, Randomization description: The researcher will use the random block method (6 blocks of 4) with the aim of randomizing and allocating samples in two control and intervention groups. Depressed outpatients and inpatients will be randomly selected separately. The intervention group will consist of 60% outpatients and 40% inpatients, and the control group will be the same ratio, Blinding description: The researcher distributes the questionnaires among the studied samples and the study participants do not know whether they are in the control or intervention group. So the study is a blind one.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Major Depressive Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dignity therapy is a non-pharmacological psychological intervention in which the patient is guided by interviewing the therapist with questions from the Dignity Therapy protocol. The questions of the dignity treatment protocol are in accordance with the specific wishes and needs of patients. These interviews are recorded and edited within 3 to 5 days and become a coherent narrative. Editing includes removing colloquial phrases, correcting the chronological order, removing unnecessary content. Another meeting is arranged to read and correct it, and after the patient approves the final version, a printed version is given to the patient to give to her family or friends. Intervention 2: Control group: The pre-test including the demographic information form, questionnaires of human dignity, internal stigma and hope will be provided to the control group, and after two weeks, the post-test will be administered to the control group. And they are asked to complete the questionnaires mentioned. During this period, the control group will not receive any other intervention, apart from the treatment and routine care of the hospital. Then the data collection for the test group will also be done.</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:
Just part of the data, such as information related to the main outcome or similar, can be shared.

When:
The access period starts 6 months after the results are published

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
All postgraduate students of medical sciences and researchers and professors of medical sciences universities of the country

Where to obtain:
Adress: Dr. Zahra Farsi- Vice President of Research- Additional Education- Faculty of Nursing- Aja University of Medical Sciences. Contact number: 02177500929 Email address: zahrafarsi@gmail.com
Address: Nursing Faculty of the Islamic Republic of Iran Army- end of Kaj St- Shariati St- Tehran
Postal code: 6717855379 E-mail: https://mail.ajaums.ac.ir/ Website of Aja Nursing School: https://nursing.ajaums.ac.ir/

How to obtain:
It takes about 1 month to access information through the faculty

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Tat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Army University of Medical Sciences, Etemadzadeh Street, Fatemi Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33883171338</zip>
        <telephone>+98 21 3622 2374</telephone>
        <email>zahratat98@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Tat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Army University of Medical Sciences, Etemadzadeh Street, Fatemi Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3383171338</zip>
        <telephone>+98 21 3622 2374</telephone>
        <email>zahratat98@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Depressed patients in the inpatient and outpatient departments of 505 Aja Hospital.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, severe without psychotic features</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Dignity therapy is a non-pharmacological psychological intervention in which the patient is guided by interviewing the therapist with questions from the Dignity Therapy protocol. The questions of the dignity treatment protocol are in accordance with the specific wishes and needs of patients. These interviews are recorded and edited within 3 to 5 days and become a coherent narrative. Editing includes removing colloquial phrases, correcting the chronological order, removing unnecessary content. Another meeting is arranged to read and correct it, and after the patient approves the final version, a printed version is given to the patient to give to her family or friends.</i_keyword>
      <i_keyword>Control group: The pre-test including the demographic information form, questionnaires of human dignity, internal stigma and hope will be provided to the control group, and after two weeks, the post-test will be administered to the control group. And they are asked to complete the questionnaires mentioned. During this period, the control group will not receive any other intervention, apart from the treatment and routine care of the hospital. Then the data collection for the test group will also be done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Human dignity measurement questionnaire is a 25-item scale to measure human dignity. This questionnaire will be scored based on a 5-point Likert scale. The score of this questionnaire varies between 25 and 125, and according to the way the questionnaire is expressed, a lower score means more dignity and a higher score means less dignity. Timepoint: Human dignity is measured at the beginning of the intervention and then 14 days after dignity treatment. Method of measurement: Human Dignity Questionnaire.</prim_outcome>
      <prim_outcome>Internalized Stigma of Mental Illness Index (ISMI) is a 29-item self-report instrument. The answers are in the form of four Likert options from completely agree to completely disagree. The way of scoring the questions is that in the first 4 sub scales, I completely agree with a score of 4, I agree with a score of 3, I disagree with a score of 2, and I completely disagree with a score of 1, and in the last sub scale (resistance to stigma), scoring is reversed. That is, I completely agree with a score of 1, I agree with a score of 2, I disagree with a score of 3, and I completely disagree with a score of 4. Overall, a higher score indicates a more intense internal stigma. Timepoint: The measurement of Internal Stigma is at the beginning and then 14 days after dignity therapy. Method of measurement: Internalized Stigma Index of Mental Illness (ISMI).</prim_outcome>
      <prim_outcome>The hope questionnaire of Schneider and colleagues has 12 questions and its purpose is to measure the level of hope in people. This questionnaire is designed for people 15 years old and above. To get the score of the questionnaire, the scores of each question are added together. A higher score indicates a higher life expectancy of the respondent, and a lower score indicates a lower life expectancy. Timepoint: Hope Measurement is done at the beginning and then 14 days after dignity therapy. Method of measurement: The Hope Questionnaire of Schneider (ADHS).</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-02</approval_date>
        <contact_name>Ethics Committee of Aja University of Medical Sciences</contact_name>
        <contact_address>13th floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran St., between South Flamak and Zarafshan, Quds town (west), Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
