<?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>IRCT20210306050594N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-09</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Internet-based Cognitive Behavioral Therapy</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Internet-based Cognitive Behavioral Therapy in Weight Loss and Outcome of Virtual Group Therapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54837</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The present research in the category is applied basic research in terms of purpose and semi-experimental in terms of collection method. The pre-test and post-test design template was between three groups of iCBT intervention, routine treatment (TAU) and waiting list control group (WL). The population of this study is overweight women with a body mass index of more than 25, Neishabour city in 1300-00. Of these, 82 are selected based on G * Power analysis to determine the size of the medium to large effect (alpha .05; power .80) and due to the possibility of shedding according to the research, which is online, 90 people are considered. شد. How to replace people after structured diagnostic interview based on DSM-5 (SCID-5) by a PhD student in psychology and review the inclusion and exclusion criteria in the first stage using the available sample of 90 people selected and replacing subjects in each intervention and control group It is simple random using a table of random numbers and is an individual randomization unit.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group :receive cognitive-behavioral therapy for weight loss. Cognitive-behavioral therapy sessions are based on Judith Beck's treatment plan for weight loss in 42 two-hour sessions over six weeks. This protocol is a treatment package that has been proven to be effective. Setsu and Zerwas research was also modeled on the correct implementation of ICBT. The content of the sessions used in the present study includes familiarity with the logic of treatment, familiarity with destructive thoughts and challenges with them, familiarity with the ABC pattern, setting goals, starting a diet, examining destructive thoughts related to dieting and responding to them, overcoming challenges The remaining destructive thoughts are adjusting and creating new skills, how to stop weight loss and stabilize new weight, and evaluate and summarize. CBT treatment is performed by a PhD student in clinical psychology who completed a CBT training course at the Tehran Psychiatric Institute. In this way, the therapist first forms two groups called psychotherapy in weight loss in WhatsApp (one intervention group 30 people, one control group waiting list 30 people) every morning audio file explaining psychotherapy sessions with exercise related to each session according to The goals of the program are recorded by a psychotherapist and placed in the virtual space created by the WhatsApp application, as well as the techniques are explained online. And to understand and perform correctly, the exercises of each person are examined (people have the opportunity to listen to the treatment file and perform the exercise and share it in the group until the evening) and for the exercises, feedback and answering questions for one hour. Every day from 6 to 7 pm, a consultation session can be held using online chat and WhatsApp voice and video calls. During the course, people communicate with each other and the therapist through online chat and support and give feedback to each other. Intervention 2: Control group 2: The control group did not apply any psychological treatment. Intervention 3: Control group 2: The as usual group undergoes treatment regimen once a week under the supervision of a nutritionist.</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:
Descriptive statistics information of all participants in the study
Research results

When:
6 months after printing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Be a research person in the field of research with the code of ethics

Where to obtain:
Email address:
NAJME.ABBEDI@GMAIL.COM

How to obtain:
Submit your request via email. One week to one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh Abedi Shargh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qods City</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9319363333</zip>
        <telephone>+98 51 4262 1060</telephone>
        <email>NAJME.ABEDI@GMAIL.COM</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Najme Abedi Shargh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neishabour, Quds Town, No. 141</address>
        <city>نیشابور</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9319363333</zip>
        <telephone>+98 51 4263 6798</telephone>
        <email>abede.n@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 50 years
Have at least a ninth grade degree
Internet access and skills in using it
Fluency in Persian
BMI≥ 25</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Menopause or pregnancy, lactation
Psychosis and bipolar disorder diagnosed by a PhD student in psychology
Certain diseases such as diabetes, thyroid, cancer, cardiovascular disease
Taking psychotropic drugs or drugs that affect weight</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group :receive cognitive-behavioral therapy for weight loss. Cognitive-behavioral therapy sessions are based on Judith Beck's treatment plan for weight loss in 42 two-hour sessions over six weeks. This protocol is a treatment package that has been proven to be effective. Setsu and Zerwas research was also modeled on the correct implementation of ICBT. The content of the sessions used in the present study includes familiarity with the logic of treatment, familiarity with destructive thoughts and challenges with them, familiarity with the ABC pattern, setting goals, starting a diet, examining destructive thoughts related to dieting and responding to them, overcoming challenges The remaining destructive thoughts are adjusting and creating new skills, how to stop weight loss and stabilize new weight, and evaluate and summarize. CBT treatment is performed by a PhD student in clinical psychology who completed a CBT training course at the Tehran Psychiatric Institute. In this way, the therapist first forms two groups called psychotherapy in weight loss in WhatsApp (one intervention group 30 people, one control group waiting list 30 people) every morning audio file explaining psychotherapy sessions with exercise related to each session according to The goals of the program are recorded by a psychotherapist and placed in the virtual space created by the WhatsApp application, as well as the techniques are explained online. And to understand and perform correctly, the exercises of each person are examined (people have the opportunity to listen to the treatment file and perform the exercise and share it in the group until the evening) and for the exercises, feedback and answering questions for one hour. Every day from 6 to 7 pm, a consultation session can be held using online chat and WhatsApp voice and video calls. During the course, people communicate with each other and the therapist through online chat and support and give feedback to each other.</i_keyword>
      <i_keyword>Control group 2: The control group did not apply any psychological treatment.</i_keyword>
      <i_keyword>Control group 2: The as usual group undergoes treatment regimen once a week under the supervision of a nutritionist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight Loss. Timepoint: two months. Method of measurement: Body mass index is calculated.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-28</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>Sattarkhan St., Maziar Mansouri St., Iran Psychiatric Institute Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
