<?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>IRCT20260503069247N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-25</date_registration>
      <primary_sponsor>Islamic Azad University, Tonekabon Branch</primary_sponsor>
      <public_title>The effectiveness of acceptance and commitment therapy (ACT) on emotional overeating, emotion regulation and psychological</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of acceptance and commitment therapy (ACT) on emotional overeating, emotion regulation and psychological well-being in women with diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90993</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will receive 8 sessions of group-based Acceptance and Commitment Therapy. Each session will last 60 minutes and will be conducted by a trained psychologist. The content of the sessions includes training and practice on concepts such as acceptance, cognitive defusion, mindfulness, value clarification, and committed action, with the aim of improving emotional eating and emotion regulation. Intervention 2: Control group: Participants in this group will not receive any psychological intervention during the study period and will continue to receive routine medical care related to type 2 diabetes according to standard clinical practice. After the completion of data collection, and if they are willing, the educational content of Acceptance and Commitment Therapy (ACT) will be provided to this group in a condensed format.</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 results, tables, and the treatment protocol.

When:
The access period will begin 6 months after the publication of the results

To whom:
Access to the anonymized study data is restricted to researchers affiliated with academic universities, scientific institutions, and research centers holding valid ethical approval, subject to the review of their request and approval by the Ethics Committee.

Conditions:
Access to the documentation of this clinical trial is restricted to academic and scientific researchers and is permitted only upon obtaining authorization from the principal investigator.

Where to obtain:
Correspondence via email: Aveshen Aghaeipour. avishan_376@yahoo.com

How to obtain:
Any request for access to the data or documentation of this study must be submitted through a formal written request to the principal investigator or the academic supervisor. The request should include the applicant’s identification information, the purpose of using the data, the type of data requested, and the method for ensuring confidentiality of the information. After receiving the request, the following aspects will be reviewed: the applicant’s academic identity and institutional affiliation, evaluation of the research purpose and its alignment with the ethical principles of the study, and final approval by the principal investigator and, if necessary, the university ethics committee. If approved, the data will be provided in an anonymized form and limited to the requested items, in a format suitable for scientific use. Use of the data is permitted only with proper citation of the source and strict adherence to the confidentiality of participants’ information

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khadijeh Hatamipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Tonekabon Complex, Valiabad, Km 3, Chalous Road, Tonekabon, Mazandaran, Iran</address>
        <city>Tonekabon</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4415977591</zip>
        <telephone>+98 911 240 2337</telephone>
        <email>avishan_376@yahoo.com</email>
        <affiliation>Islamic Azad University, Tonekabon Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Avishan Aghaeipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th Dead-end, Sheikh Zahed St., Lahijan, Gilan, Iran</address>
        <city>Lahijan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4415977591</zip>
        <telephone>+98 911 240 2337</telephone>
        <email>avishan_376@yahoo.com</email>
        <affiliation>Islamic Azad University, Tonekabon Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>a) Diagnosis of diabetes confirmed by a specialist physician.b) Ability to attend 8 group sessions.c) Written informed consent for participation in the study.d) Age range between 20 and 50 years.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>a) Severe active mental disorders (clinical depression or anxiety requiring immediate treatment).b) Absence from at least two ACT sessions.c) Lack of willingness to continue attending the sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with hyperosmolarity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will receive 8 sessions of group-based Acceptance and Commitment Therapy. Each session will last 60 minutes and will be conducted by a trained psychologist. The content of the sessions includes training and practice on concepts such as acceptance, cognitive defusion, mindfulness, value clarification, and committed action, with the aim of improving emotional eating and emotion regulation.</i_keyword>
      <i_keyword>Control group: Participants in this group will not receive any psychological intervention during the study period and will continue to receive routine medical care related to type 2 diabetes according to standard clinical practice. After the completion of data collection, and if they are willing, the educational content of Acceptance and Commitment Therapy (ACT) will be provided to this group in a condensed format.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of emotional eating based on the Eating Behavior Questionnaire. Timepoint: Assessment of variables at baseline (pretest) and one week after the intervention sessions (posttest). Method of measurement: The study variables will be measured using the following instruments: Van Strien’s Eating Behavior Questionnaire for emotional eating.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Emotion regulation score based on the 16‑item short form of the Emotion Regulation Questionnaire (ERQ). Timepoint: At the beginning of the study (pretest) and one week after the completion of the intervention sessions (posttest). Method of measurement: Sixteen‑item short form of the Emotion Regulation Questionnaire for measuring emotion regulation.</sec_outcome>
      <sec_outcome>Psychological well‑being score based on Ryff’s Psychological Well‑Being Questionnaire. Timepoint: At the beginning of the study (pretest) and one week after the completion of the intervention sessions (posttest). Method of measurement: Ryff Psychological Well‑Being Questionnaire for measuring psychological well‑being.</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>Islamic Azad University, Tonekabon Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-04-15</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Tonekabon Branch</contact_name>
        <contact_address>Km 3, Chalous Road, Valiabad, Islamic Azad University Tonekabon Complex Tonekabon Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
