<?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>IRCT20170719035180N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-29</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of mindfulness intervention on patients with bipolar disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of smartphone-based mindfulness intervention, face-to-face and combined, on sleep disorders, suicidal thoughts, psychological flexibility, fusion of thought and action, and intensity of manic and mixed phases in patients with bipolar disorder.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69087</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bipolar Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: face-to-face intervention of mindfulness: first introduction and familiarization and explanation of the concept of automatic guidance: introduction of the program and a brief description of 8 sessions, familiarization of the group members with each other and the consultant, determination of group goals and rules, familiarization with the concepts of mindfulness training and the need for training Mindfulness, explanation about automatic guidance and raisin eating meditation, and then for 30 minutes, body check meditation and conscious breathing, assignment. Second, facing obstacles: reviewing the tasks of the previous session (doing body check meditation and discussing this experience), practice obstacles and Mindfulness program solutions for it and breathing mindfulness meditation practice, discussing the difference between thoughts and feelings, doing sitting meditationAssignment. Third, awareness of breathing or conscious breathing: practicing seeing and hearing, sitting meditation and breathing with attention to bodily senses, discussing homework, three-minute breathing space practice, doing yoga exercises, assignment. Fourth, staying in the present. : Sitting meditation with attention to breathing, body sounds and thoughts (which is also called four-dimensional sitting meditation). Teaching how to stay in the present, assigning assignments. Fifth, permission/permission to attend (accepting thoughts and feelings): reviewing the assignment of the previous session, explaining the concept of acceptance, doing sitting meditation (awareness and presence of the mind from breathing, sounds, thoughts and feelings), presenting and performing yoga movements,Assignment. Sixth, thoughts are not facts: practice of three-minute breathing space, discussion of homework in pairs, presentation of an exercise entitled "creating thoughts, separate views" with this theme: the content of thoughts are mostly not real, use of poetry and metaphor and Its connection with the quality of mindfulness, assignment. Seventh, how can I take care of myself in the best way? Sitting meditation and awareness of everything that comes into awareness in the moment. Presenting an exercise for making a list of pleasant and unpleasant life events, experiencing awareness and non-judgmental (non-selective) acceptance, assignment. 8. Acceptance and change (using what you have learned so far): body check meditation, three-minute breathing space exercise, discussion of Methods of coping with obstaclesMeditation, getting feedback from the participants and taking the post-test, preparing for the end of the sessions and the end of the intervention. Intervention 2: Intervention group: Mindfulness based on a smart phone. 1st body scan in 5 minutes, restful sleep on the first day, self-love training. 2nd body scan in 10 minutes, restful sleep on the second day, letting go of comparison and perfectionism. 3rd body scan in 20 minutes, restful sleep on the day Third, getting rid of stress and fear. Fourth, body scan in 30 minutes, easy sleep on the fourth day, self-acceptance and challenging the main beliefs. Fifth, easy sleep on the fifth day, source of inner happiness, correct breathing training, breathing according to the time of exhalation. Exhalation and breath holding, (simple breathing exercise for relief) 6th day, restful sleep, sixth day, order and law in relationships, breathing according to the time of inhalation, exhalation and breath holding (attention breathing exercise), 7th day, restful sleep, balance, breathing according to time Inhale, exhale and hold your breath (square breathing exercise)8th day, comfortable sleep, empathy, breathing according to the time of inhalation, exhalation and breath holding (heart breathing exercise). Intervention 3: Intervention group: Combining the intervention of face-to-face mindfulness training and training through the first training application of the meditation technique with the sound of fire. Automatic guidance and meditation of eating raisins. 2. Teaching meditation technique with the sound of the forest. Practicing seeing and hearing. The third training of meditation technique with the sound of rain. Sitting meditation, teaching how to stay in the present moment. Fourth, teaching the technique of meditation with the sound of flight. The use of poetry and metaphor and its relationship with the quality of mindfulness.Fifth, correct breathing training, breathing based on the time of inhalation, exhalation and breath holding, (simple breathing exercise for relief). Preparation of a list of pleasant and unpleasant events in life. Sixth breathing based on the time of inhaling, exhaling and holding the breath (attention breathing exercise). Experience awareness and acceptance without judgment (non-selective). 7th breathing based on the time of inhaling, exhaling and holding the breath (square breathing exercise). Methods of dealing with the obstacles of doing meditation. Eighth breathing based on the time of inhaling, exhaling and holding the breath (heart breathing exercise). Summarizing the content and conducting the post-exam. Intervention 4: Control group: no intervention.</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:
after de-identification ,All data is shared.

When:
Access starts after the articles are published

To whom:
Psychology students and researchers

Conditions:
En The results of the research are done without sending the statistics, if the statistics are requested, they will cooperate according to the needs of the researcher.

Where to obtain:
mzamani.zahra@gmail.com

How to obtain:
En A request for documentation is made and the documentation is provided to the researcher within a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Mosa Tabatabaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan University, Psychology and Educational sciences Faculty</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519956549</zip>
        <telephone>+98 23 3342 2765</telephone>
        <email>s.mosatabatabaee@semnan.ac.ir</email>
        <affiliation>Semnan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mosa Tabatabaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan University, Psychology and Educational sciences Faculty</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519956549</zip>
        <telephone>+98 23 3342 2765</telephone>
        <email>s.mosatabatabaee@semnan.ac.ir</email>
        <affiliation>Semnan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of bipolar disorder according to the opinion of a psychiatrist.
At least a diploma education.
At least 6 months have passed since the diagnosis of the disease.
Not receiving electronic shock.
Not pregnant.
Not receiving other psychological interventions during the intervention.
Access to a smart mobile phone.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in research.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bipolar disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: face-to-face intervention of mindfulness: first introduction and familiarization and explanation of the concept of automatic guidance: introduction of the program and a brief description of 8 sessions, familiarization of the group members with each other and the consultant, determination of group goals and rules, familiarization with the concepts of mindfulness training and the need for training Mindfulness, explanation about automatic guidance and raisin eating meditation, and then for 30 minutes, body check meditation and conscious breathing, assignment. Second, facing obstacles: reviewing the tasks of the previous session (doing body check meditation and discussing this experience), practice obstacles and Mindfulness program solutions for it and breathing mindfulness meditation practice, discussing the difference between thoughts and feelings, doing sitting meditationAssignment. Third, awareness of breathing or conscious breathing: practicing seeing and hearing, sitting meditation and breathing with attention to bodily senses, discussing homework, three-minute breathing space practice, doing yoga exercises, assignment. Fourth, staying in the present. : Sitting meditation with attention to breathing, body sounds and thoughts (which is also called four-dimensional sitting meditation). Teaching how to stay in the present, assigning assignments. Fifth, permission/permission to attend (accepting thoughts and feelings): reviewing the assignment of the previous session, explaining the concept of acceptance, doing sitting meditation (awareness and presence of the mind from breathing, sounds, thoughts and feelings), presenting and performing yoga movements,Assignment. Sixth, thoughts are not facts: practice of three-minute breathing space, discussion of homework in pairs, presentation of an exercise entitled "creating thoughts, separate views" with this theme: the content of thoughts are mostly not real, use of poetry and metaphor and Its connection with the quality of mindfulness, assignment. Seventh, how can I take care of myself in the best way? Sitting meditation and awareness of everything that comes into awareness in the moment. Presenting an exercise for making a list of pleasant and unpleasant life events, experiencing awareness and non-judgmental (non-selective) acceptance, assignment. 8. Acceptance and change (using what you have learned so far): body check meditation, three-minute breathing space exercise, discussion of Methods of coping with obstaclesMeditation, getting feedback from the participants and taking the post-test, preparing for the end of the sessions and the end of the intervention</i_keyword>
      <i_keyword>Intervention group: Mindfulness based on a smart phone. 1st body scan in 5 minutes, restful sleep on the first day, self-love training. 2nd body scan in 10 minutes, restful sleep on the second day, letting go of comparison and perfectionism. 3rd body scan in 20 minutes, restful sleep on the day Third, getting rid of stress and fear. Fourth, body scan in 30 minutes, easy sleep on the fourth day, self-acceptance and challenging the main beliefs. Fifth, easy sleep on the fifth day, source of inner happiness, correct breathing training, breathing according to the time of exhalation. Exhalation and breath holding, (simple breathing exercise for relief) 6th day, restful sleep, sixth day, order and law in relationships, breathing according to the time of inhalation, exhalation and breath holding (attention breathing exercise), 7th day, restful sleep, balance, breathing according to time Inhale, exhale and hold your breath (square breathing exercise)8th day, comfortable sleep, empathy, breathing according to the time of inhalation, exhalation and breath holding (heart breathing exercise)</i_keyword>
      <i_keyword>Intervention group: Combining the intervention of face-to-face mindfulness training and training through the first training application of the meditation technique with the sound of fire. Automatic guidance and meditation of eating raisins. 2. Teaching meditation technique with the sound of the forest. Practicing seeing and hearing. The third training of meditation technique with the sound of rain. Sitting meditation, teaching how to stay in the present moment. Fourth, teaching the technique of meditation with the sound of flight. The use of poetry and metaphor and its relationship with the quality of mindfulness.Fifth, correct breathing training, breathing based on the time of inhalation, exhalation and breath holding, (simple breathing exercise for relief). Preparation of a list of pleasant and unpleasant events in life. Sixth breathing based on the time of inhaling, exhaling and holding the breath (attention breathing exercise). Experience awareness and acceptance without judgment (non-selective). 7th breathing based on the time of inhaling, exhaling and holding the breath (square breathing exercise). Methods of dealing with the obstacles of doing meditation. Eighth breathing based on the time of inhaling, exhaling and holding the breath (heart breathing exercise). Summarizing the content and conducting the post-exam.</i_keyword>
      <i_keyword>Control group: no intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep disorders. In this study, sleep disorders mean the score that the participants receive from answering questions 1 to 18. Timepoint: before the start of intervention (pre-test), immediately after the end of the intervention(post - test) and one month after that(follow up). Method of measurement: Sleep quality questionnaire of Petersburg et al.</prim_outcome>
      <prim_outcome>Suicidal thoughts: In the present study, suicidal thoughts mean the score that participants get from answering questions 1 to 19 of Beck et al.'s suicide thoughts questionnaire. Timepoint: Before the start of the intervention (pre-test), immediately after the end of the intervention (post-test) and one month after that (follow-up). Method of measurement: Beck et al.'s suicidal ideation questionnaire.</prim_outcome>
      <prim_outcome>Psychological flexibility: Psychological flexibility in the present study is the score that the participants get from answering questions 1 to 20 of the psychological flexibility questionnaire of Dennis et al. (2010). Timepoint: Before the start of the intervention (pre-test), immediately after the end of the intervention (post-test) and one month after that (follow-up). Method of measurement: Psychological flexibility questionnaire of Dennis et al.</prim_outcome>
      <prim_outcome>Fusion of thought-action: The meaning of fusion of thought-action in the present study is the score that the participants get from answering questions 1 to 19 of the questionnaire of fusion of thought-action by Rachman et al. (1988). Timepoint: before the start of intervention (pre-test), immediately after the end of the intervention(post - test) and one month after that(follow up). Method of measurement: Thought-action fusion questionnaire Rachman et al.</prim_outcome>
      <prim_outcome>Bipolar disorder: Bipolar disorder in the present study is the score that the participants get from answering questions 1 to 11 of the Maniai Yang et al. questionnaire (1978). Timepoint: Before the start of the intervention (pre-test), immediately after the end of the intervention (post-test) and one month after that (follow-up). Method of measurement: Yang et al.'s mania questionnaire.</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>2023-02-15</approval_date>
        <contact_name>Ethics committee of Shahrood Azad University</contact_name>
        <contact_address>University Blvd., Shahrood, SemnanTown Shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
