<?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>IRCT20191028045261N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-25</date_registration>
      <primary_sponsor>Pezhvak Rehabilitation Center</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Schema Therapy and Cognitive-Speech Integrative Approach on Emotional   Regulation and  Negative ¬ Emotions and distress tolerance of  People with Stuttering</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Schema Therapy and Cognitive-Speech Integrative Approach on Emotional   Regulation and  Negative ¬ Emotions and distress tolerance of  People with Stuttering</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43590</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The selected people are given a unique code, we write the specific codes of the whole sample size on separate sheets, put them in a box and then take them out of the box one by one and put them in order into experimental group of schema therapy, the experimental group of integrated cognitive-speech approach and the control group. We continue this method until a total of 30 people are randomly divided into three groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>People with Stuttering.</hc_freetext>
      <i_freetext>Intervention 1: Schema therapy: Schema therapy consists of a set of techniques that will be performed in a 12-session course of treatment, each session will last 90 minutes (Young et al., 2003). Intervention 2: Integrated cognitive-speech approach: This therapeutic approach was formulated by Farazi (2013) in a structured manner. Our intervention will be  included 12 specific treatment sessions (initial assessment, individual and group therapeutic interventions and final assessment) on stuttering in adults aged 18-30 years in an organized manner. , Purposeful and coherent in four sections, psychological reconstruction of speech and reading, psychological reconstruction of stuttering, cognitive reconstruction and group therapy sessions.</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:
Part of the participants' personal data in an unrecognizable way related to the main outcome
- Informing the study protocol (schema therapy and integrated cognitive-speech approach) in group therapy
- Publication of comparison results of analysis and statistical analysis of the study
- Informally scan the consent form and share it in the group.
- The clinical study report should be provided to the subject based on the conclusions and findings.

When:
After the end of the research

To whom:
public

Conditions:
With payment terms and in order to research and increase knowledge

Where to obtain:
Neishabour Azad University

How to obtain:
Login to Neishabour Azad University - Thesis Portal - Department of Psychology - Research Name

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kazem Farzinfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne Yamin Street - Corner of Ebne Yamin 40</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613887575</zip>
        <telephone>+98 51 4423 3094</telephone>
        <email>kfarzinfar@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Nejat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne Yamin Street - Corner of Ebne Yamin 40</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613887575</zip>
        <telephone>+98 51 4423 3094</telephone>
        <email>Hnejat54@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The Participants with stuttering
The Participants between 18- 30 years of age
The Participants should not have any psychological problems</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absent more than two sessions,
Use of psychotropic drugs,
Clinical and personality disorders,
Receiving simultaneous drug therapy courses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F80.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Childhood onset fluency disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Schema therapy: Schema therapy consists of a set of techniques that will be performed in a 12-session course of treatment, each session will last 90 minutes (Young et al., 2003).</i_keyword>
      <i_keyword>Integrated cognitive-speech approach: This therapeutic approach was formulated by Farazi (2013) in a structured manner. Our intervention will be  included 12 specific treatment sessions (initial assessment, individual and group therapeutic interventions and final assessment) on stuttering in adults aged 18-30 years in an organized manner. , Purposeful and coherent in four sections, psychological reconstruction of speech and reading, psychological reconstruction of stuttering, cognitive reconstruction and group therapy sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional regulation variables. Timepoint: - Pre-test: at the beginning of the study (before the intervention)                   - Post-test: three months after the beggining of intervention                                                - Follow-up test: 2 months after the intervention. Method of measurement: Questionnaire: consist of two subscales of 6-item reassessment and 4-item repression. Participants respond on a 7-point Likert scale from strongly disagree (with a score of 1) to strongly agree (with a score of 7).</prim_outcome>
      <prim_outcome>The negative emotions variable. Timepoint: Post-test, pre-test, follow-up test. Method of measurement: Questionnaire: consist of 10 items. In front of each item, there is a range of 5 options from very low (score 1) and very high (score 5), which is ranked by the subject and the range of scores for each subscale is 10 to 50.</prim_outcome>
      <prim_outcome>The distress tolerance variable. Timepoint: - Pre-test: at the beginning of the study (before the intervention)                   - Post-test: three months after the intervention                                                - Follow-up test: 2 months after the intervention. Method of measurement: Questionnaire: consist of 15 items and four sub-scales of tolerance (emotional distress tolerance), absorption (absorption of stress by negative emotions), evaluation (mental estimation of distress) and adjustment (adjustment of efforts to relieve distress). The scoring method is scored on a five-point scale (1: strongly agree; 2: slightly agree; 3: neither agree nor disagree; 4: slightly disagree and 5: strongly disagree).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life variable has 4 subscales and an overall score. These subscales include: physical health, mental health, social relationships, environmental health, and an overall score. Initially, a raw score is obtained for each subscale, which must be converted to a standard score between 0 and 100 through a formula. A higher score indicates a higher quality of life. Timepoint: Second  Quarter of 2019. Method of measurement: Questionnaire.</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>Pezhvak Rehabilitation Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-31</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University,NEYSHABUR.</contact_name>
        <contact_address>Ebne Yamine Street - Ebne Yamine 40 Corner- Pezhvak Rehibilation Center Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
