<?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>IRCT20180104038214N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-08</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of two transdiagnostic therapy on symptoms of anxiety disorders</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of the transdiagnostic therapy based on emotion regulation with religious/spiritual design versus Barlow transdiagnostic therapy on symptoms and general function in women with anxiety disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28703</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Randomization method: simple randomization through lottery
Random unit: Individual.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Phobic disorders. Condition 2: generalized anxiety disorder. Condition 3: panic disorder.</hc_freetext>
      <i_freetext>Intervention 1: first Intervention group: transdiagnostic therapy based on emotion regulation with religious / spiritual design. The treatment protocol includes 12 one-hour session which run weekly and for three months. The titles of the sessions are, respectively, 1.the preparation for the treatment and enhance motivation of client, 2. understanding emotions in the balanced system of human, 3. introducing the role of cognition in regulating and modifying emotions to client, 4. identifying and modifying the god-images of client, 5. adapting the cognitive evaluations of client with god concept, 6. identifying the world- images of client and modifying them, 7.  identifying the hereafter- images of client and modifying them, 8. behavioral self-caring, 9. awareness of physical feelings and reinforcement tolerance of them, 10.directing awareness to god, 11. Intrinsic and situation-based emotional exposure 12. relapse prevention. Intervention 2: second Intervention group: Barlow transdiagnostic therapy. This intervention includes 8 modules, each module taking between one or two sessions. Modules include: 1. Increasing the motivation for participate in treatment, 2. Psychological training and seeking emotional experience, 3. Mindfulness-based emotional awareness, 4. Cognitive flexibility, 5. emotional avoidance and emotional behaviors, 6. awareness and tolerance of physical feelings, 7. Intrinsic and situation-based emotional exposure, 8. Prevention of relapse. sessions lengthen from 8 to 12 sessions and between approximately 50 to 60 minutes. sessions are held on a weekly basis.</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 is publishable after unrecognizing people. 
Designed protocol of transdiagnostic therapy based on emotion regulation with religious / spiritual design is Shareable.
The data analysis plan includes visual charts in single case studies, and statistical indicators of Improvement percentages and effect sizes.

When:
6 months after the publication of results

To whom:
academic reasherchers

Conditions:
treatment protocol can be used to evaluate its efficacy in other clinical groups and to compare its efficacy with other therapeutic protocols.

Where to obtain:
roghaye sadat mirjalili
mirjalili.r14@gmail.com

How to obtain:
The applicant must send  an email in order to receive files and the documents and a request files will be sent  for a maximum of two weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roghaye Sadat Mirjalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO. 67 , Kargar ave, Yadavaran Blvd, Shahedie town</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8943114386</zip>
        <telephone>+98 35 3521 1663</telephone>
        <email>ra.mirjalili@modares.ac.ir</email>
        <affiliation>Tarbiat Modares university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roghaye Sadat Mirjalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO. 67 , Kargar ave, Yadavaran Blvd, Shahedie town</address>
        <city>YAZD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8943114386</zip>
        <telephone>+98 35 3521 1663</telephone>
        <email>ra.mirjalili@modares.ac.ir</email>
        <affiliation>Tarbiat Modares university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female sex
Age 18-30 years
Have at least high school diploma
Having one of the anxiety disorders based on DSM-5
Having full satisfaction to participate in sessions</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having schizophrenia and other psychotic disorders
Having Obsessive-compulsive disorder and related disorders
Having Post traumatic stress disorder and related disorders
Having Bipolar mood disorder and related disorders
Having substance and alcohol abuse
Having substance/medication-induced anxiety disorder
Having a history of suicidal thoughts and actions
taking medication or receiving psychotherapy during the past 6 months for the treatment of anxiety disorders
lack of religious adherence</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40</hc_code>
      <hc_code>F41</hc_code>
      <hc_code>F41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Phobic anxiety disorders</hc_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>first Intervention group: transdiagnostic therapy based on emotion regulation with religious / spiritual design. The treatment protocol includes 12 one-hour session which run weekly and for three months. The titles of the sessions are, respectively, 1.the preparation for the treatment and enhance motivation of client, 2. understanding emotions in the balanced system of human, 3. introducing the role of cognition in regulating and modifying emotions to client, 4. identifying and modifying the god-images of client, 5. adapting the cognitive evaluations of client with god concept, 6. identifying the world- images of client and modifying them, 7.  identifying the hereafter- images of client and modifying them, 8. behavioral self-caring, 9. awareness of physical feelings and reinforcement tolerance of them, 10.directing awareness to god, 11. Intrinsic and situation-based emotional exposure 12. relapse prevention</i_keyword>
      <i_keyword>second Intervention group: Barlow transdiagnostic therapy. This intervention includes 8 modules, each module taking between one or two sessions. Modules include: 1. Increasing the motivation for participate in treatment, 2. Psychological training and seeking emotional experience, 3. Mindfulness-based emotional awareness, 4. Cognitive flexibility, 5. emotional avoidance and emotional behaviors, 6. awareness and tolerance of physical feelings, 7. Intrinsic and situation-based emotional exposure, 8. Prevention of relapse. sessions lengthen from 8 to 12 sessions and between approximately 50 to 60 minutes. sessions are held on a weekly basis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety symptoms. Timepoint: before intervention, Sessions 3, 6, 9,12 of therapy and one-month and three-month follow-up. Method of measurement: Beck anxiety disorder, adult version of Screen for Child Anxiety Related Emotional Disorders (SCARED-A), generalized anxiety disorder scale- 7(GAD-7).</prim_outcome>
      <prim_outcome>General function. Timepoint: before intervention, Sessions  6, 12 of therapy and one-month and three-month follow-up. Method of measurement: Work and Social Adjustment Scale (WSAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression status. Timepoint: 2 stages in baseline, sessions 3, 6, 9, 12 and one-months and three-months follow-up. Method of measurement: beck depression inventory (BDI).</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>2018-02-28</approval_date>
        <contact_name>ethics comittee of Iran University of Medical Sciences</contact_name>
        <contact_address>NO. 1., Mansoori ave., Niayesh street, Sattarkhan Blvd. tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
