<?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>IRCT20230513058161N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-19</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effects of affective expectations on anhedonia among patients suffering from major depression disorder</public_title>
      <acronym></acronym>
      <scientific_title>The effects of affective expectations on affective experience and anhedonia among anhedonic patients suffering from major depression disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70082</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets and write "intervention" on one and "control" on the other. Then, upon each patient's visit, he/she is asked to pick one of the sheets randomly, and based on this, the patient is assigned to the intervention or control group. It is continued in the same way for other patients, Blinding description: The general design of the experiment is explained to the participants, but the subject does not know which group will be placed in. In this way, the general objectives of the research are explained to the subjects before the implementation of the research: In this research, we intend to investigate the symptom of anhedonia in major depressive disorder using psychological interventions. However, subjects are not told which of the experimental or control groups they have been placed in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Major Depression Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: induction of positive expectations. Individuals in this group will be given a very positive description of the movie they are about to see, on the basis that the movie will be very enjoyable, such as: "This movie you are about to see is one of the best movies I've ever seen." It is a popular comedy that is very enjoyable. The aim of this statement is to induce excitement and positive emotion towards watching the clip in order to increase the interest of the person in watching the clip. Intervention 2: Control group: The people of this group will be given an explanation about the movie, which only explains the events and happenings in the movie without using any special emotional load.</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:
All potential data can be shared in SPSS file format after de-identifying people.

When:
Access start 6 months after the results publication

To whom:
The data will be available to researchers working in academic and scientific institutions

Conditions:
The necessary conditions for sending a request to access data or documents are email to the corresponding author. Only statistical analyzes similar to those performed in the present study are allowed, including independent t-student tests and multivariate analysis of variance tests.

Where to obtain:
Email to the corresponding author

How to obtain:
Applicants can send their request via e-mail to the responsible author, then within a maximum period of one month, the corresponding author will send them the required documents or files.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Daneshvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafez Hospital, Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194634786</zip>
        <telephone>+98 71 3612 8351</telephone>
        <email>somayedaneshvar@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Daneshvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafez Hospital, Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194634786</zip>
        <telephone>+98 71 3612 8351</telephone>
        <email>somayedaneshvar@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Initial diagnosis of major depressive disorder with anhedonia
Age range from 18 to 65 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of comorbid disorders, including substance abuse, psychotic disorders, bipolar disorder, anxiety disorders, and psychotic symptoms.
Active suicidal ideation
History of head injury or neurological diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Severe depressive episode without psychotic symptoms</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: induction of positive expectations. Individuals in this group will be given a very positive description of the movie they are about to see, on the basis that the movie will be very enjoyable, such as: "This movie you are about to see is one of the best movies I've ever seen." It is a popular comedy that is very enjoyable. The aim of this statement is to induce excitement and positive emotion towards watching the clip in order to increase the interest of the person in watching the clip.</i_keyword>
      <i_keyword>Control group: The people of this group will be given an explanation about the movie, which only explains the events and happenings in the movie without using any special emotional load.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anhedonia. Timepoint: Before and after the intervention. Method of measurement: Positive Valence Systems Scale-21 questionnaire.</prim_outcome>
      <prim_outcome>Affective Experience. Timepoint: Before and after the intervention. Method of measurement: Affective Experience questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Probabilistic reward Learning. Timepoint: Before and after the intervention. Method of measurement: Probabilistic reward task.</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>2022-12-04</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>5th floor, Shiraz University Central Building, Islamic Republic Blvd, Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
