<?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>IRCT20201012049009N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-10</date_registration>
      <primary_sponsor>Research Branch of Tonekabon Islamic Azad University</primary_sponsor>
      <public_title>The effect of humor therapy and cognitive rehabilitation on mild cognitive impairment</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Humor Therapy and Cognitive Rehabilitation on Agitation, Apathy, Cognitive and Memory Function in Patients with Mild Cognitive Impairment (MCI)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51621</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomization process is performed www.randomization.com the site. In order to hide random allocation, random sequence sealed envelope is used. In this way, the sample size of 45 people, the envelope is prepared by the reception officer of the center and each of the random sequences created on a card is recorded and the cards are placed in the envelopes in order, in order to maintain the random sequence, the numbering is done on the external surface of the envelopes in the same order. Based on the order of entry of eligible participants into the study, one of the envelopes is opened and the assigned group of the participant is revealed and during this time the researcher and participants are not aware of the allocation of the experimental and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mild Cognitive Impairment (MCI).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:                                                                            Stages of humor training Educational content relied on the seven steps of fostering Paul McGui's sense of humor (2004). The program includes the effect of humor on life, examining the sense of humor of the members of the group from their point of view, theories about humor and discussion of ways of enhancing the spirit of humor, teaching humor skills, practicing jokes, benefits and types of humor, exposure to resistances and direct guidelines on how to use humor in the living environment and in times of crisis. At the end of each session, assignments were determined and each session started with discussions about the assignments performed.The humor skills training program was divided into meetings: the first session: familiarity with the rules of the group, discussing                                   of learning this skill as a positive defense mechanism and its impact on social interactions and physical health. The humor skills training program was divided into meetings: the first session, familiarity with the rules of the group, discussion of the concept and benefits of humor, the necessity of learning this skill as a positive defense mechanism and its impact on social interactions and physical health. Second session: Identifying the uniqueness of people's humor style, discussion, modeling and behavioral exercises such as funny imaginary dialogue with the other person and practicing it.Session 3: Practicing laughter, using the discussion method, activating the child inside and ten minutes of laughter without reason and expressing feelings.                       Session 4: The ability to play with words, to say jokes and riddles, to teach specific skills of humor, to use alternative. words as jokes. Session 5: Seeking satirical awares in everyday life, such as taking notes of any funny events among your or others' funny experiences, patterning and and ten minutes of laughing without reason and expressing feelings.Session 6: Learning to laugh at oneself, using the method of drawing your cartoon, laughing at the members together, practicing countering group inhibitions, and ten minutes of laughing without reason and expressing feelings. Session 7: The use of humor at the height of tension and discomfort, discussing the style of humor in stressful and fearful situations, teaching the patterns of humor application in these situations to the people of the group.Session 8: Summing up and exchanging experiences, applying the skills learned during this period and reviewing its effect. A summary of the training program and reviewing its effects on the group members and evaluating the program. Session 9: Post-test stage and re-implementation of questionnaires. Intervention 2: Intervention group: Session 1: Familiarity with group rules, discussion of learning these skills and cognitive rehabilitation exercises as strategies and techniques to improve memory and increase one's recall and its impact on one's daily life, as well as social interactions.Session 2: Teaching the basics about memory and recall, verbal repetition and continuous processing	 Session 3: Dual cognitive support: illustration and memory enhancement, errorless learning.	Session 4: Teaching Recall Strategies: Mnemonics, Cueing.	 Session 5: Continuation of Recall Strategies Training: Chunking, Loci Method, Spaced	Retrieval	Session 6: Specific interventions including face-name Recall: face accompaniment of face - names of familiar members of the group through their photographs.Session 7: Story Recall, List/Object Recall.Session 8: Procedural	Memory, practice and repetition with the aim of mastering the task.Session 9:Additional Support, Auxiliary programs and techniques including memory aids.Session 10: Adaptation to the individual's living environment, relaxation training. Intervention 3: Control group: Control group: 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>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 Because of the principle of confidentiality of participants' information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Fereidouni Valashejerdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Motahari street</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3143877766</zip>
        <telephone>+98 26 3443 1030</telephone>
        <email>zfereidouni@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Fereidouni Valashejerdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.98, Valfajr 4 alley, pirouzi Ave., Motahari street, Karaj. Iran</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3143877766</zip>
        <telephone>+98 26 3443 1030</telephone>
        <email>zfereidouni@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>elderly residents home
mild cognitive impairment
The ability to speak</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No psychiatric medications
No hearing problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1:                                                                            Stages of humor training Educational content relied on the seven steps of fostering Paul McGui's sense of humor (2004). The program includes the effect of humor on life, examining the sense of humor of the members of the group from their point of view, theories about humor and discussion of ways of enhancing the spirit of humor, teaching humor skills, practicing jokes, benefits and types of humor, exposure to resistances and direct guidelines on how to use humor in the living environment and in times of crisis. At the end of each session, assignments were determined and each session started with discussions about the assignments performed.The humor skills training program was divided into meetings: the first session: familiarity with the rules of the group, discussing                                   of learning this skill as a positive defense mechanism and its impact on social interactions and physical health. The humor skills training program was divided into meetings: the first session, familiarity with the rules of the group, discussion of the concept and benefits of humor, the necessity of learning this skill as a positive defense mechanism and its impact on social interactions and physical health. Second session: Identifying the uniqueness of people's humor style, discussion, modeling and behavioral exercises such as funny imaginary dialogue with the other person and practicing it.Session 3: Practicing laughter, using the discussion method, activating the child inside and ten minutes of laughter without reason and expressing feelings.                       Session 4: The ability to play with words, to say jokes and riddles, to teach specific skills of humor, to use alternative. words as jokes. Session 5: Seeking satirical awares in everyday life, such as taking notes of any funny events among your or others' funny experiences, patterning and and ten minutes of laughing without reason and expressing feelings.Session 6: Learning to laugh at oneself, using the method of drawing your cartoon, laughing at the members together, practicing countering group inhibitions, and ten minutes of laughing without reason and expressing feelings. Session 7: The use of humor at the height of tension and discomfort, discussing the style of humor in stressful and fearful situations, teaching the patterns of humor application in these situations to the people of the group.Session 8: Summing up and exchanging experiences, applying the skills learned during this period and reviewing its effect. A summary of the training program and reviewing its effects on the group members and evaluating the program. Session 9: Post-test stage and re-implementation of questionnaires</i_keyword>
      <i_keyword>Intervention group: Session 1: Familiarity with group rules, discussion of learning these skills and cognitive rehabilitation exercises as strategies and techniques to improve memory and increase one's recall and its impact on one's daily life, as well as social interactions.Session 2: Teaching the basics about memory and recall, verbal repetition and continuous processing	 Session 3: Dual cognitive support: illustration and memory enhancement, errorless learning.	Session 4: Teaching Recall Strategies: Mnemonics, Cueing.	 Session 5: Continuation of Recall Strategies Training: Chunking, Loci Method, Spaced	Retrieval	Session 6: Specific interventions including face-name Recall: face accompaniment of face - names of familiar members of the group through their photographs.Session 7: Story Recall, List/Object Recall.Session 8: Procedural	Memory, practice and repetition with the aim of mastering the task.Session 9:Additional Support, Auxiliary programs and techniques including memory aids.Session 10: Adaptation to the individual's living environment, relaxation training.</i_keyword>
      <i_keyword>Control group: Control group: do not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total number less than 24 in Montreal Cognitive Assessment-Basic (MoCA-Basic). Timepoint: Before the intervention, after the intervention, two months after the intervention. Method of measurement: Total  score in Montreal Cognitive Assessment-Basic (MoCA-Basic),.</prim_outcome>
      <prim_outcome>Total score in Cohen-Mansfield Agitation Inventory. Timepoint: Before the intervention, after the intervention, two months after the intervention. Method of measurement: Total score in Cohen-Mansfield Agitation Inventory.</prim_outcome>
      <prim_outcome>Total score in apathy Martin's inventory. Timepoint: Before the intervention, after the intervention, two months after the intervention. Method of measurement: Total score in apathy Martin's inventory.</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>Research Branch of Tonekabon Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-19</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Tonekabon</contact_name>
        <contact_address>No. 98, Valfajr 4, Pirouzi Alley, Motahari St. Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
