<?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>IRCT20220726055556N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-03</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mindfulness-based cognitive therapy via whats app social media on sexual function and sexual distress in women with diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mindfulness-based cognitive therapy via whats app social media on sexual function and sexual distress in women with diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64996</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: : For random allocation, considering that we have two intervention and control groups, we will use a block of 4. In order to determine the allocation sequence using the 4 block method, random allocation sequence generation software will be used. In order to hide the sequence of allocation, the papers identifying the group of people are placed inside the envelopes in the opaque package and coded in the same order. In this case, a questionnaire with the same code will be completed for the person who receives the code 1 intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Diabetic women with sexual dysfunction receiving  mindfulness-based cognitive therapy . Mindfulness-based cognitive therapy (MBCT) is an approach to psychotherapy that uses cognitive behavioral therapy (CBT) methods along with mindfulness meditation practices and similar psychological strategies. In MBCT, mindfulness is based on 4 principles including Body awareness (body position and body movement/activity), body sensations (including those related to emotions), mental states (including emotional states) and mental content (thoughts, images) are taught. Internet-based cognitive behavioral therapy has recently been introduced as a new method for treating sexual problems. This treatment uses traditional cognitive and behavioral therapy methods to treat sexual problems based on increasing comfort, privacy and anonymity of people. In this study, the participants who meet the study entry criteria are randomly assigned to two control and intervention groups. In the control group, there is no intervention, and in the intervention group, the method of cognitive therapy based on mindfulness (MBCT) is used. Before starting the treatment program, the training certificate of the MBCT course will be received and attached to the study, then the cognitive therapy program based on mindfulness for sexual function in the form of an 8-session program during 8 weeks (the first week in person and the next 7 weeks on WhatsApp) by The researcher will be presented. Meetings will be held individually. Contents and assignments will be presented to the people of the intervention group on a weekly basis through social media (WhatsApp). After presenting any new content, the researcher will inform the participants by SMS. It will be considered that the participants, whenever they have a problem in doing the assignments, have more interaction with the researcher in person or virtually to ensure the correctness of the assignments. How to follow up the samples in 4 steps by filling out the questionnaire The first session (pre-test), the last session (post-test), one month after the last session and 3 months after the last training session. Intervention 2: Control group: Diabetic women without receiving cognitive therapy based on mindfulness.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is عدم اتمام مطالعه</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Fathi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin, Shahid Bahonar Boulevard, University Campus Building</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415613911</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>fathimina66@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Fathi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin, Shahid Bahonar Boulevard, University Campus Building</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415613911</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>fathimina66@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>being married
Definite diabetes with a doctor's diagnosis
- Being 15 to 49 years old
Having sexual dysfunction based on the FSFI questionnaire
Access to social media such as internet and smartphone
At least 3 months have passed since having sex with your spouse
Willingness to participate in the study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having any symptoms of diseases such as depression, panic attacks, delusions, hallucinations and any other type of mental illness based on the person's self-report.
Unwillingness to continue participating in the study
Taking drugs that affect sexual performance, such as psychotropic drugs
Known physical, mental, sexual disorders in the spouse
Gestational diabetes and breastfeeding diabetes</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Diabetic women with sexual dysfunction receiving  mindfulness-based cognitive therapy . Mindfulness-based cognitive therapy (MBCT) is an approach to psychotherapy that uses cognitive behavioral therapy (CBT) methods along with mindfulness meditation practices and similar psychological strategies. In MBCT, mindfulness is based on 4 principles including Body awareness (body position and body movement/activity), body sensations (including those related to emotions), mental states (including emotional states) and mental content (thoughts, images) are taught. Internet-based cognitive behavioral therapy has recently been introduced as a new method for treating sexual problems. This treatment uses traditional cognitive and behavioral therapy methods to treat sexual problems based on increasing comfort, privacy and anonymity of people. In this study, the participants who meet the study entry criteria are randomly assigned to two control and intervention groups. In the control group, there is no intervention, and in the intervention group, the method of cognitive therapy based on mindfulness (MBCT) is used. Before starting the treatment program, the training certificate of the MBCT course will be received and attached to the study, then the cognitive therapy program based on mindfulness for sexual function in the form of an 8-session program during 8 weeks (the first week in person and the next 7 weeks on WhatsApp) by The researcher will be presented. Meetings will be held individually. Contents and assignments will be presented to the people of the intervention group on a weekly basis through social media (WhatsApp). After presenting any new content, the researcher will inform the participants by SMS. It will be considered that the participants, whenever they have a problem in doing the assignments, have more interaction with the researcher in person or virtually to ensure the correctness of the assignments. How to follow up the samples in 4 steps by filling out the questionnaire The first session (pre-test), the last session (post-test), one month after the last session and 3 months after the last training session.</i_keyword>
      <i_keyword>Control group: Diabetic women without receiving cognitive therapy based on mindfulness</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual performance score in women's sexual performance questionnai. Timepoint: The beginning of the study (pre-test), the end of the study (post-test), 1 month and 3 months after the last session. Method of measurement: Women's sexual performance index - shortened form.</prim_outcome>
      <prim_outcome>Sexual distress score based on revised sexual distress questionnaire. Timepoint: The beginning of the study (pre-test), the end of the study (post-test), 1 month and 3 months after the last session. Method of measurement: Revised Sexual Distress Questionnaire.</prim_outcome>
      <prim_outcome>Mindfulness score based on mindfulness questionnaire. Timepoint: The beginning of the study (pre-test), the end of the study (post-test), 1 month and 3 months after the last session. Method of measurement: Mindfulness questionnaire (awareness of conscious attention).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-23</approval_date>
        <contact_name>Working group/committee of ethics in research of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin, North Nawab St., Shahid Salmani Alley, Administration Complex, Headquarters Building of Qazvin University of Medical Sciences Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
