<?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>IRCT20210412050937N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-22</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Effectiveness of Acceptance and Commitment-Based Therapy (ACT) on Positive and Negative Psychotic Symptoms and Emotion regulation in Patients with schizophrenia spectrum disorders</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of Acceptance and Commitment-Based Therapy (ACT) on Positive and Negative Psychotic Symptoms and Emotion regulation of Patients with schizophrenia spectrum disorders: A Single-Subject study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>5</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55742</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia spectrum disorders.</hc_freetext>
      <i_freetext>Five patients with schizophrenia spectrum disorders participated in treatment sessions on a single-subject basis. The Acceptance and Commitment Therapy Manual consists of 16 sessions, each lasting 50 minutes. Two treatment sessions are performed for each patient every week. The duration of all treatment sessions is 60 days. In an ACT model, patients are taught to accept their feelings, as feelings; notice their own thoughts; contact the present moment; focus on their values; and act in accordance with their values.                                                                                                                                In each session, a complete assessment of positive and negative psychotic symptoms and problems related to the patient's emotional regulation is performed. During this session, the therapist also notes the participant’s degree of struggle with symptoms and motivation for change as basic indicators of the most useful starting point for subsequent interventions..</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:
After deleting the confidential information, I will share the data file of the patients of this research with other researchers; including age, sex, occupation, education and marital status.

When:
Start of access period 3 months after the end of treatment and follow-up

To whom:
The data is only available to research colleagues and other researchers and practitioners

Conditions:
The data can be used for publication in scientific research journals. Researchers are not allowed to do any analysis and they can only view and receive the data and analyze it. Researchers are also required to make a written commitment not to publish the data file.

Where to obtain:
Send me an email
ham.khakbaz@uswr.ac.ir
And the following email:
khakbaz.hamid@gmail.com
Also refer to the following address:
Hamid Khakbaz, Department of Counseling, University of Social Welfare and Rehabilitation Sciences, Daneshjoo Blvd., Evin, Tehran
phone number: 09129484583

How to obtain:
After sending me an email and confirming the identity of the applicant, and the final confirmation of the research colleagues, the data will be sent to them. The approximate time will be 2 to 3 months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Khakbaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd floor, No. 12, Shahsavari Alley, Asadollahi Street,</address>
        <city>Shahr-e-Rey</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1847888159</zip>
        <telephone>+98 21 5591 5322</telephone>
        <email>ham.khakbaz@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Khakbaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd floor, No. 12, Shahsavari Alley, Asadollahi St.</address>
        <city>Shahr-e-Rey</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1847888159</zip>
        <telephone>+98 21 5591 5322</telephone>
        <email>ham.khakbaz@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with the diagnosis of a psychiatrist based on DSM5 criteria, have positive and negative psychotic symptoms and their acute symptoms are in relative control
Being at the age of 18 and 45 years
Patients enter the study voluntarily and with informed consent or the opinion of the guardian

Patient's score in the positive and negative symptoms questionnaire and in the emotional regulation questionnaire should be higher than other patients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have criminal and judicial problems in terms of the judiciary (due to possible problems in accessing to patients)
Patients who have mental disorders other than schizophrenia according to a psychiatrist
Patients who have a drug addiction problem for any reason or have been admitted to a psychiatric hospital due to substance abuse
Patients with neurological disorders such as epilepsy, stroke, or severe concussion (based on patient records)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Five patients with schizophrenia spectrum disorders participated in treatment sessions on a single-subject basis. The Acceptance and Commitment Therapy Manual consists of 16 sessions, each lasting 50 minutes. Two treatment sessions are performed for each patient every week. The duration of all treatment sessions is 60 days. In an ACT model, patients are taught to accept their feelings, as feelings; notice their own thoughts; contact the present moment; focus on their values; and act in accordance with their values.                                                                                                                                In each session, a complete assessment of positive and negative psychotic symptoms and problems related to the patient's emotional regulation is performed. During this session, the therapist also notes the participant’s degree of struggle with symptoms and motivation for change as basic indicators of the most useful starting point for subsequent interventions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Positive and negative symptom score in Schizophrenia positive and negative symptom questionnaire. Timepoint: Measures of The Positive and Negative Symptoms two weeks before the start of the intervention (three baseline), all intervention sessions (16 Sessions), and 3 months after the end of the intervention (three follow-up lines). Method of measurement: The Positive and Negative Symptoms Questionnaire.</prim_outcome>
      <prim_outcome>Emotional regulation score in the Gratz and Roemer Emotional Regulation Difficulties Questionnaire. Timepoint: Measures of emotional regulation two weeks before the start of the intervention (three baseline), all intervention sessions (16 sessions), and 3 months after the end of the intervention (three follow-up lines). Method of measurement: Gratz and Roemer Emotional Regulation Difficulties Questionnaire.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-25</approval_date>
        <contact_name>Ethics Committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>3rd floor, No. 12, Shahsavari Alley, Asadollahi St., Shahr-e Rey, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
