<?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>IRCT20170326033144N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-24</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of  Acceptance and Commitment Therapy on eating disorders in adolescents.</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Acceptance and Commitment Therapy in Adolescents with Eating Disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71987</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to either the intervention group (receiving acceptance and commitment therapy) or the control group (receiving psychoeducation for eating disorders) using the simple randomization method. 
Simple randomization is based on a single sequence of random assignments. At first, each participant will be given a number code. Then, using the randomization software of the website https://www.sealedenvelope.com/, the participants are randomly and consecutively assigned to two groups A and B (intervention and control groups), Blinding description: Blinding will be applied to the evaluator and statistical analyst, which means that the factors that can cause deviation of the test result will be hidden from the statistical analyst and the evaluator.
Due to the nature of the research, the participants are not blinded to the research process, and due to reasons such as the fact that the therapists perform the treatments, it is practically impossible to blind the therapist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Eating disorders.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group receives acceptance and commitment therapy for adolescents with eating disorders in eight weekly, one-hour sessions. the intervention procedures include the Session 1: Establishing a therapeutic contract, introducing treatment, and writing about the harms and consequences of eating disorders. Session 2: Introducing creative hopelessness using the metaphor of "tug of war with a monster." Sessions 3 and 4: Introducing control as a problem, as well as using the "milk, milk, milk exercise" for cognitive defusion and introducing acceptance using the metaphor of "bus passengers." Sessions 5 and 6: Continuing cognitive defusion exercises, mindfulness exercises, and self-as-context exercises. Sessions 7 and 8: Explaining the values of each participant and increasing behavioral commitment for a more sustainable life. Finally, the therapist assists the participant in applying the learned exercises such as acceptance, contacting the present moment, cognitive defusion, self-as-context, and engaging in meaningful activities to prevent the return of symptoms. Intervention 2: The control group also receives the psychoeducational protocol for eating disorders in 8 weekly one-hour sessions. Procedures of the protocol include introducing eating disorders, prevalence and consequences of etiology of eating disorders, risk factors, prevention of relapse, and introduction of standard treatments of eating disorders.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Javad Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1655</telephone>
        <email>shabani.mjavad@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Javad Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1655</telephone>
        <email>shabani.mjavad@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Presence of eating disorder diagnosis based on DSM-5 criteria
Age between 10 and 19 years
Not taking psychiatric drugs or taking anti-depressants and anti-anxiety drugs for at least two months before the intervention, the drug dose must be constant, and the patient must agree to the drug dose remaining constant during the study.</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>19 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of severe psychiatric disorders (psychotic disorders, bipolar disorder, and bipolar disorder with psychotic features)
Having serious suicidal thoughts
Organic brain disorder based on self-report
Substance use disorder
The presence of cognitive disabilities such as mental retardation
Having a history of incurable physical illness such as cancer
Receiving psychological treatment interventions in the last year and at the time of the research
The need to change, stop or increase the drug dose or start a new drug after pre-test evaluations</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Eating disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group receives acceptance and commitment therapy for adolescents with eating disorders in eight weekly, one-hour sessions. the intervention procedures include the Session 1: Establishing a therapeutic contract, introducing treatment, and writing about the harms and consequences of eating disorders. Session 2: Introducing creative hopelessness using the metaphor of "tug of war with a monster." Sessions 3 and 4: Introducing control as a problem, as well as using the "milk, milk, milk exercise" for cognitive defusion and introducing acceptance using the metaphor of "bus passengers." Sessions 5 and 6: Continuing cognitive defusion exercises, mindfulness exercises, and self-as-context exercises. Sessions 7 and 8: Explaining the values of each participant and increasing behavioral commitment for a more sustainable life. Finally, the therapist assists the participant in applying the learned exercises such as acceptance, contacting the present moment, cognitive defusion, self-as-context, and engaging in meaningful activities to prevent the return of symptoms.</i_keyword>
      <i_keyword>The control group also receives the psychoeducational protocol for eating disorders in 8 weekly one-hour sessions. Procedures of the protocol include introducing eating disorders, prevalence and consequences of etiology of eating disorders, risk factors, prevention of relapse, and introduction of standard treatments of eating disorders.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Eating disorder symptoms. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Eating Disorder Examination Questionnaire (EDE-Q).</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: Before and after interventions and three month follow-up. Method of measurement: weight with kilograms on a scale, height with meters with the use of a rubber meter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Inflexibility of body image. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Body-Image Acceptance and Action Questionnaire (BA-AAQ).</sec_outcome>
      <sec_outcome>Values living. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Valuing Questionnaire (VQ).</sec_outcome>
      <sec_outcome>Self-esteem. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Rosenberg self-esteem scale  (RSES).</sec_outcome>
      <sec_outcome>Experiential avoidance. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Avoidance and Fusion Questionnaire for Youth (AFQ-Y).</sec_outcome>
      <sec_outcome>Psychological symptoms ( Depression, Anxiety, Stress). Timepoint: Before and after interventions and three month follow-up. Method of measurement: Depression Anxiety Stress Scales – Youth Version (DASS-Y).</sec_outcome>
      <sec_outcome>Therapeutic alliance. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Therapeutic Alliance Scale for Children: Youth Version.</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>2023-08-09</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 Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
