<?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>IRCT20230513058161N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-11</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Stimulation along with Affective Expectations Manipulation on  Anhedonia</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Transcranial Direct Current Stimulation along with Affective Expectations Manipulation on Affective Experience and Anhedonia among Anhedonic Patients Suffering from Major Depression Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70376</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of people to desired groups by simple random method and by lottery. For this purpose, we prepare three sheets on which we write the experimental groups. Then, with each patient's visit, one of the sheets is randomly removed and the patient is assigned to the selected group, Blinding description: All the participants will be explained how the device works, and all individuals who participate in the study think that they will receive the intervention, however, some do not. In this way, after placing the transcranial direct current stimulation device on the subjects' heads, some receive actual stimulation, while others receive fake or sham stimulation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Major Depression Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: transcranial direct current stimulation and then induction of positive emotions. In this group, the participants first receive electrical stimulation through one session, at the rate of 2 milliamps for 20 minutes, on the dorsomedial prefrontal cortex via the tDCS device, and then positive emotions will be induced. In this way, the short pleasurable video clip will be shown to the subject at the end of the stimulation. Before playing the movie, the positive emotional information about the movie will be presented to the subjects in order to manipulate the emotional expectations of the individuals. Intervention 2: Intervention group 2: Sham transcranial electrical stimulation then induction of positive emotions. In this group, during a session the participants first receive sham stimulation on the dorsomedial prefrontal cortex through the tDCS device, and then positive emotions are induced. In this way, at the end of the stimulation, the person will be shown the desired short pleasurable movie, and before playing the movie, in order to manipulate the emotional expectations of the person, positive emotional information about the movie will be presented to the person. Intervention 3: Intervention group 3: In this group, during a session the participants first receive electrical stimulation at the rate of 2 milliamps for 20 minutes on the dorsomedial prefrontal cortex through the tDCS device, and then neutral emotions are induced. In this way, at the end of the stimulation, the person will be shown the desired short pleasurable movie, and before playing the movie, neutral emotional information about the movie will be presented to the person.</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 data  can be shared in spss file format

When:
One month after results publication

To whom:
Researchers working in academic and scientific institutions

Conditions:
The data can be used for any statistical analysis, subject to permission from the researchers

Where to obtain:
E-mail address of the corresponding author

How to obtain:
After request, the responsible author will send the data within a maximum period of one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Daneshvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafez Hospital, Chamran Blv</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71946-34786</zip>
        <telephone>+98 71 3647 9080</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 Blv</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194634786</zip>
        <telephone>+98 71 3647 9080</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>Obtaining the initial diagnosis of major depressive disorder with anhedonia using a structured clinical interview and questionnaire.
The patient should be able to perform the behavioral test and answer the questionnaires.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of comorbid disorders such as substance abuse, psychotic disorders, bipolar disorder, anxiety disorders, and psychotic symptoms.
The presence of metal parts in the head</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: transcranial direct current stimulation and then induction of positive emotions. In this group, the participants first receive electrical stimulation through one session, at the rate of 2 milliamps for 20 minutes, on the dorsomedial prefrontal cortex via the tDCS device, and then positive emotions will be induced. In this way, the short pleasurable video clip will be shown to the subject at the end of the stimulation. Before playing the movie, the positive emotional information about the movie will be presented to the subjects in order to manipulate the emotional expectations of the individuals.</i_keyword>
      <i_keyword>Intervention group 2: Sham transcranial electrical stimulation then induction of positive emotions. In this group, during a session the participants first receive sham stimulation on the dorsomedial prefrontal cortex through the tDCS device, and then positive emotions are induced. In this way, at the end of the stimulation, the person will be shown the desired short pleasurable movie, and before playing the movie, in order to manipulate the emotional expectations of the person, positive emotional information about the movie will be presented to the person.</i_keyword>
      <i_keyword>Intervention group 3: In this group, during a session the participants first receive electrical stimulation at the rate of 2 milliamps for 20 minutes on the dorsomedial prefrontal cortex through the tDCS device, and then neutral emotions are induced. In this way, at the end of the stimulation, the person will be shown the desired short pleasurable movie, and before playing the movie, neutral emotional information about the movie will be presented to the person.</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>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Probabilistic reward. 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>2023-05-28</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>5th floor, Shiraz University Central Building, Islamic Republic Blv, Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
