<?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>IRCT20220902055850N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-13</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Group Dialectical Behavior Therapy (DBT) on Covid-19 Caused Anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Group Dialectical Behavior Therapy (DBT) on Covid-19 Caused Anxiety and its Complications on Mental Health in Adults Living in Pishva City.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65652</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, a number of 60 subjects are selected according to similar research by convenience sampling method. Then, a random replacement is done by the random draw method so that each subject is assigned a number and we write down the numbers on the paper, then fold them and put them in a container. Later on, we mix the papers and take out the papers one by one and place one number in the first group and one number in the second group, respectively. Then random assignment will be done. In this way, one group will be assigned as the control group and the other group will be assigned as the intervention group by putting each group in an envelope and randomly taking out one envelope from the container and assigning it to the intervention group and the other envelope to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety disorder, unspecified.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the intervention group will undergo eight 2-hour sessions of group Dialectical behavior therapy (DBT) once a week. The treatment package used in this research will be derived from the group Dialectical behavior therapy (DBT) method derived from Linehan. The first session: First, the time of the sessions will be set, then the necessary explanations will be given to the subject regarding the rules and regulations of each session, followed by descriptions of the principles and methods of thinking and behavior in dialectical ways, and familiarity with mindfulness, rational mind, emotion mind, and wise mind. And then the subjects will be provided with explanations about the main goal of DBT, which is to learn how to live in the moment and develop healthy ways to cope with stress, control their emotions and improve their relationships. At the end of the session, assignments will be given to the subjects.The second session: First, the assignments of the previous session will be reviewed, and then the distress tolerance skill will be explained to subjects to equip them with the ability to cope with themselves and the current situation. Also, basic skills of coping with disturbance, including different methods of diverting attention from self-harming behaviors, diverting attention through pleasurable activities, diverting attention to work or another subject, leaving the situation, etc., will be taught. Then we will draw up a plan for returning the attention, and self-relaxation, drawing up a relaxation plan, and at the end of the session, assignments will be given to the subjects.The third session: At the beginning of the session, the exercises of the previous session will be reviewed, and then in this session, advanced skills of distress tolerance, will be trained including imaging from a safe place, discovering values, living in the present, radical acceptance, developing new coping strategies, and developing a coping plan for the necessary situation. At the end of the session, assignments will be given to the subjects for the next session.The fourth session: At the beginning of the session, the exercises given in the previous session will be reviewed, and then the importance of mindfulness will be explained to the subjects. Mindfulness can help people to focus on the present and live in the moment, and this helps them to pay attention to what is going on inside them, and they will be taught basic skills of mindfulness, such as practicing inattention.The fifth session: At the beginning of the session, the assignments of the previous session will be reviewed, and in this session, advanced mindfulness skills including radical acceptance, beginner's mind, judgments and labels, non-judgment of conscious communication with others, daily schedule for mindfulness, awareness of obstacles to the implementation of exercises will be taught. At the end of the session, assignments will be given to the subjects for the next session.The sixth session: At the beginning of the session, the assignments of the previous session will be reviewed, then emotional regulation will be explained to the subjects. people can cope more effectively with strong emotions by regulating their emotions. The acquired skills help people identify, name, and change their feelings. We will teach basic and advanced skills such as emotions and how they work, emotional regulation skills, overcoming obstacles to healthy emotions, reducing physical vulnerability to emotions, increasing positive emotions, dealing with emotions, and solving problems. At the end of the session, assignments will be given to the subjects for the next session.The seventh session: At the beginning of the session, the assignments of the previous session will be reviewed, then effective communication will be explained to subjects it is said that interpersonal effectiveness helps them to be more assertive in relationships by maintaining a positive and healthy relationship (for example, being able to express themselves and say no). They will learn to listen and communicate better. In this regard, the basic skills of effective communication such as passive-aggressive behavior, compatibility of my desires and theirs, the ratio of wants and needs, skills training, key interpersonal skills, and barriers to using interpersonal skills will be taught and at the end of the session, assignments will be given to the subjects for the next session. The eighth session: At the beginning of this session, the assignments of the previous session will be reviewed, and then advanced skills of effective communication such as identifying goals, adjusting the intensity of goals, boldness scripts, courageous listening, saying no, how to negotiate, how to analyze interpersonal problems will be taught. And at the end of the session, assignments will be given to the subjects for the next session. Intervention 2: Control group: no intervention is done for the control group. One week before the intervention, a pre-test was taken from the control group and they are placed on the waiting list. At the end of the intervention, they will be given a post-test and the results will be analyzed.</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 Ther is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Kouhivar Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.6, seylsepour al., 22Bahman ST., Shohada SQ., Rah ahan BLVD., Pishva Town., Tehran Province</address>
        <city>Pishva</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۳۸۱۹۷۵۳۶۸</zip>
        <telephone>+98 21 3672 4801</telephone>
        <email>hasti.ham@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Kouhivar Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.6, Seylsepour al., 22Bahman ST., Shohada SQ., Rah ahan BLVD., Pishva Town.,Tehran Province</address>
        <city>Pishva</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۳۸۱۹۷۵۳۶۸</zip>
        <telephone>+98 21 3672 4801</telephone>
        <email>hasti.ham@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Covid-19 infected based on CPR test
Adults in the age range of 19 to 45 years
Adults living in Pishva city</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissociative psychotic disorders, 
Drug and alcohol abuse
Having underlying diseases such as cancer
Mental retardation disorders
The presence of psychotic disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder, unspecified</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>Intervention group: the intervention group will undergo eight 2-hour sessions of group Dialectical behavior therapy (DBT) once a week. The treatment package used in this research will be derived from the group Dialectical behavior therapy (DBT) method derived from Linehan. The first session: First, the time of the sessions will be set, then the necessary explanations will be given to the subject regarding the rules and regulations of each session, followed by descriptions of the principles and methods of thinking and behavior in dialectical ways, and familiarity with mindfulness, rational mind, emotion mind, and wise mind. And then the subjects will be provided with explanations about the main goal of DBT, which is to learn how to live in the moment and develop healthy ways to cope with stress, control their emotions and improve their relationships. At the end of the session, assignments will be given to the subjects.The second session: First, the assignments of the previous session will be reviewed, and then the distress tolerance skill will be explained to subjects to equip them with the ability to cope with themselves and the current situation. Also, basic skills of coping with disturbance, including different methods of diverting attention from self-harming behaviors, diverting attention through pleasurable activities, diverting attention to work or another subject, leaving the situation, etc., will be taught. Then we will draw up a plan for returning the attention, and self-relaxation, drawing up a relaxation plan, and at the end of the session, assignments will be given to the subjects.The third session: At the beginning of the session, the exercises of the previous session will be reviewed, and then in this session, advanced skills of distress tolerance, will be trained including imaging from a safe place, discovering values, living in the present, radical acceptance, developing new coping strategies, and developing a coping plan for the necessary situation. At the end of the session, assignments will be given to the subjects for the next session.The fourth session: At the beginning of the session, the exercises given in the previous session will be reviewed, and then the importance of mindfulness will be explained to the subjects. Mindfulness can help people to focus on the present and live in the moment, and this helps them to pay attention to what is going on inside them, and they will be taught basic skills of mindfulness, such as practicing inattention.The fifth session: At the beginning of the session, the assignments of the previous session will be reviewed, and in this session, advanced mindfulness skills including radical acceptance, beginner's mind, judgments and labels, non-judgment of conscious communication with others, daily schedule for mindfulness, awareness of obstacles to the implementation of exercises will be taught. At the end of the session, assignments will be given to the subjects for the next session.The sixth session: At the beginning of the session, the assignments of the previous session will be reviewed, then emotional regulation will be explained to the subjects. people can cope more effectively with strong emotions by regulating their emotions. The acquired skills help people identify, name, and change their feelings. We will teach basic and advanced skills such as emotions and how they work, emotional regulation skills, overcoming obstacles to healthy emotions, reducing physical vulnerability to emotions, increasing positive emotions, dealing with emotions, and solving problems. At the end of the session, assignments will be given to the subjects for the next session.The seventh session: At the beginning of the session, the assignments of the previous session will be reviewed, then effective communication will be explained to subjects it is said that interpersonal effectiveness helps them to be more assertive in relationships by maintaining a positive and healthy relationship (for example, being able to express themselves and say no). They will learn to listen and communicate better. In this regard, the basic skills of effective communication such as passive-aggressive behavior, compatibility of my desires and theirs, the ratio of wants and needs, skills training, key interpersonal skills, and barriers to using interpersonal skills will be taught and at the end of the session, assignments will be given to the subjects for the next session. The eighth session: At the beginning of this session, the assignments of the previous session will be reviewed, and then advanced skills of effective communication such as identifying goals, adjusting the intensity of goals, boldness scripts, courageous listening, saying no, how to negotiate, how to analyze interpersonal problems will be taught. And at the end of the session, assignments will be given to the subjects for the next session.</i_keyword>
      <i_keyword>Control group: no intervention is done for the control group. One week before the intervention, a pre-test was taken from the control group and they are placed on the waiting list. At the end of the intervention, they will be given a post-test and the results will be analyzed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Covid-19 caused anxiety: the score obtained from the coronavirus anxiety scale questionnaire prepared by Alipour, Abdullahzadeh, and Gadami (2019). Timepoint: The measurement periods will be at the beginning of the study, one week before the beginning of the intervention, and one week after the end of the intervention (i.e. after 8 sessions of group Dialectical Behavior Therapy (DBT) intervention). Method of measurement: Corona anxiety scale questionnaire.</prim_outcome>
      <prim_outcome>Mental Health: The score obtained from the General Health Questionnaire (GHQ-28) was first adjusted by Goldberg (1972, citing Taqvi 2018). Timepoint: The measurement periods will be at the beginning of the study, one week before the beginning of the intervention, and one week after the end of the intervention (i.e. after 8 sessions of group Dialectical Behavior Therapy (DBT) intervention). Method of measurement: Goldberg mental health questionnaire.</prim_outcome>
      <prim_outcome>Depression: the score obtained from the Depression, Anxiety, Stress Scale (DASS) questionnaire prepared by Alvibond, (5991). Timepoint: The measurement periods will be at the beginning of the study, one week before the beginning of the intervention, and one week after the end of the intervention (i.e. after 8 sessions of group Dialectical Behavior Therapy (DBT) intervention). Method of measurement: Depression, Anxiety, Stress Scale Questionnaire (DASS).</prim_outcome>
      <prim_outcome>Aggression: the score obtained from the Aggression Questionnaire (Buss &amp; Perry, 1992). Timepoint: The measurement periods will be at the beginning of the study, one week before the beginning of the intervention, and one week after the end of the intervention (i.e. after 8 sessions of group Dialectical Behavior Therapy (DBT) intervention). Method of measurement: Bass and Perry Aggression Questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality: the score obtained from the Pittsburgh Sleep Quality Index (PSQI). This questionnaire was developed in 1989 by Dr. Boyce and his colleagues at the Pittsburgh Psychiatric Institute. Timepoint: The measurement periods will be at the beginning of the study, one week before the beginning of the intervention, and one week after the end of the intervention (i.e. after 8 sessions of group Dialectical Behavior Therapy (DBT) intervention). Method of measurement: Pittsburgh Sleep Quality Questionnaire (PSQI).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-23</approval_date>
        <contact_name>Ethics Committee of Semnan Islamic Azad University</contact_name>
        <contact_address>Islamic Azad University of semnan, shahrak daneshgahi Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
