<?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>IRCT20190227042865N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-22</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of transdiagnostic treatment on procrastination</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness and mediating factors in unified transdiagnostic treatment on students’ procrastination</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39384</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We are going to use block randomization method . Randomization  unit is the person. Making a randomization sequence will be done through the website http://www.randomization.com/.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Procrastination.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Unified transdiagnostic protocol for emotional disorders (UP) introduced by Barlow et al (2010) in Unified Protocol Institute in Boston University, will be used. This protocol is available as a therapist's manual and a workbook for clients. The outline of the material to be presented at each session is presented in the table below: First session: Unified model of psychopathology; motivation enhancementstrategies; treatment goal setting (UP Module 1); Second Session: Psychoeducation on adaptive function of emotions; threecomponentmodel of emotional experiences (UP Module 2); Third Session: Natural course of emotions and role of avoidance; present-focused,nonjudgmental emotion awareness (UP Module 3). Forth Session: Cognitive appraisal; thinking traps and countering questions;downward arrow (UP Module 4). Fifth Session: Identification of emotional avoidance strategies; rationale forreplacing emotion-driven behaviors (EDBs) with incompatiblebehaviors (UP Module 5). Sixth Session: Psychoeducation on interoceptive conditioning; symptom inductiontest; interoceptive exercises (UP Module 6). Seventh to Eleventh Sessions: Exposure rationale; create and review individual hierarchies;situational emotion-focused exposures (UP Module 7). Twelfth  Session: Skill review; emphasis on continued implementation of exposures;review of progress and future goals; relapse prevention strategies(UP Module 8). Intervention 2: Intervention group: Cognitive-behavioral therapy is a kind of psychotherapy that helps patients to understand the thoughts and feelings that affect their behavior. This treatment is generally short-term and can be performed either individually or in groups. It also focuses on helping patients address a specific problem. During the course of treatment, one learns how to identify and modify the patterns of maladaptive or distorted thinking that have a negative effect on his or her behavior. In this study, we are going to use the CBT protocol for procrastination introduced by Rosenthal et al clinical trial in 2015.The therapeutic modules in the CBT treatment group are as follows: 1. An introduction to the current study and basic psychoeducation of CBT and procrastination.2. Information on the etiology and maintenance of procrastination.3. Psychoeducation on goal-setting techniques, avoidance behavior,and behavioral activation.4. Theories of motivation and use of reward systems to facilitate learned industriousness.5. Presentation of ego-depletion, mental fatigue, and their relationship to procrastination.6. The influence of distractions and using stimulus control to increase focused work.7. Different ways of practicing self-assertiveness and becoming better at prioritizing.8. The influence of dysfunctional beliefs and an introduction to performing behavioral experiments.9. Exploration of personal values using value clarification and information on acceptance.10. Information on the abstinence violation effect and the importance of relapse prevention. Intervention 3: Control group: since the participants are students, there would be no need for theraputic or heath care measures. thus the control group won't recive any kind of intervention or usual care.</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:
The treatment outcomes are assessed through questionnaires and analyzed in a group, so the people will be unidentified. SPSS file will be shared.

When:
the access starts 6 months after publishing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Since the questionnaires contain the demographic characteristics, consent forms and the participants' signature, and also in some steps, for example, the follow-up the questionnaires will be sent to the participants online, access to each questionnaire will not be possible. But for the SPSS file, researchers will be allowed to have any analyzes that are tailored to their purpose.

Where to obtain:
Requests by email will be answered by Mrs. Somayeh Zamirinejad.
Somayeh.zamiri@gmail.com

How to obtain:
Applicants must provide their reason for their request and explain how these data are relevant to their study, and the data will be sent to them in 1 month after we receive the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Zamirinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Apartment 1, number 36, 9th Daryanno, Sattarkhan Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1455973463</zip>
        <telephone>+98 21 6650 5019</telephone>
        <email>somayeh.zamiri@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Zamirinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Apartment 1, number 36, 9th Daryanno, Sattarkhan Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1455973463</zip>
        <telephone>+98 21 6650 5019</telephone>
        <email>somayeh.zamiri@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Bachelor and General Medical students who have completed the first year (first semester students are not  familiar with their performance style for university assignments yet) and students of other degrees
severe procrastination (75% of total score in pure procrastination scale)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>score &gt;1 in GSI index of SCL-90-R</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The Unified transdiagnostic protocol for emotional disorders (UP) introduced by Barlow et al (2010) in Unified Protocol Institute in Boston University, will be used. This protocol is available as a therapist's manual and a workbook for clients. The outline of the material to be presented at each session is presented in the table below: First session: Unified model of psychopathology; motivation enhancementstrategies; treatment goal setting (UP Module 1); Second Session: Psychoeducation on adaptive function of emotions; threecomponentmodel of emotional experiences (UP Module 2); Third Session: Natural course of emotions and role of avoidance; present-focused,nonjudgmental emotion awareness (UP Module 3). Forth Session: Cognitive appraisal; thinking traps and countering questions;downward arrow (UP Module 4). Fifth Session: Identification of emotional avoidance strategies; rationale forreplacing emotion-driven behaviors (EDBs) with incompatiblebehaviors (UP Module 5). Sixth Session: Psychoeducation on interoceptive conditioning; symptom inductiontest; interoceptive exercises (UP Module 6). Seventh to Eleventh Sessions: Exposure rationale; create and review individual hierarchies;situational emotion-focused exposures (UP Module 7). Twelfth  Session: Skill review; emphasis on continued implementation of exposures;review of progress and future goals; relapse prevention strategies(UP Module 8).</i_keyword>
      <i_keyword>Intervention group: Cognitive-behavioral therapy is a kind of psychotherapy that helps patients to understand the thoughts and feelings that affect their behavior. This treatment is generally short-term and can be performed either individually or in groups. It also focuses on helping patients address a specific problem. During the course of treatment, one learns how to identify and modify the patterns of maladaptive or distorted thinking that have a negative effect on his or her behavior. In this study, we are going to use the CBT protocol for procrastination introduced by Rosenthal et al clinical trial in 2015.The therapeutic modules in the CBT treatment group are as follows: 1. An introduction to the current study and basic psychoeducation of CBT and procrastination.2. Information on the etiology and maintenance of procrastination.3. Psychoeducation on goal-setting techniques, avoidance behavior,and behavioral activation.4. Theories of motivation and use of reward systems to facilitate learned industriousness.5. Presentation of ego-depletion, mental fatigue, and their relationship to procrastination.6. The influence of distractions and using stimulus control to increase focused work.7. Different ways of practicing self-assertiveness and becoming better at prioritizing.8. The influence of dysfunctional beliefs and an introduction to performing behavioral experiments.9. Exploration of personal values using value clarification and information on acceptance.10. Information on the abstinence violation effect and the importance of relapse prevention.</i_keyword>
      <i_keyword>Control group: since the participants are students, there would be no need for theraputic or heath care measures. thus the control group won't recive any kind of intervention or usual care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The participants' score in the Intolerance of Uncertainty Scale (IUS). Timepoint: before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention. Method of measurement: Intolerance of Uncertainty Scale (IUS).</prim_outcome>
      <prim_outcome>The participants' score in the Difficulties in Emotion Regulation Scale (DERS). Timepoint: before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention. Method of measurement: Difficulties in Emotion Regulation Scale (DERS).</prim_outcome>
      <prim_outcome>The participants' score in the Acceptance and Action Questionnaire–II (AAQ-II). Timepoint: before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention. Method of measurement: Acceptance and Action Questionnaire–II (AAQ-II).</prim_outcome>
      <prim_outcome>The participants' score in the Anxiety sub-scale of Depression, Anxiety, Stress Scale (DASS-21). Timepoint: before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention. Method of measurement: Anxiety sub-scale of Depression, Anxiety, Stress Scale (DASS-21).</prim_outcome>
      <prim_outcome>The participants' score in the Depression sub-scale of Depression, Anxiety, Stress Scale (DASS-21). Timepoint: before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention. Method of measurement: Depression sub-scale of Depression, Anxiety, Stress Scale (DASS-21).</prim_outcome>
      <prim_outcome>The participants' score in the Stress sub-scale of Depression, Anxiety, Stress Scale (DASS-21). Timepoint: before the intervention, 6th session of the intervention, after completing the intervention, 2 month after the intervention. Method of measurement: the Stress sub-scale of Depression, Anxiety, Stress Scale (DASS-21).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The participants' score in the Pure Procrastination Scale (PPS). Timepoint: Before the intervention. 6th session of the intervention, after completing the intervention, 2 months after the intervention. Method of measurement: Pure Procrastination Scale (PPS).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-28</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
