<?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>IRCT20160103025817N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-25</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>A Comparative Study of the Effectiveness of Trans-diagnosis With Relaxation Therapy on Psychological Symptoms, Parental Beliefs About Neonatal Intensive Care Unit, Adaptation to Mother Role and Social and Occupational Adjustment in Parents of Premature Neonates Admitted to Neonatal Intensive Care Unit</public_title>
      <acronym></acronym>
      <scientific_title>A Comparative Study of the Effectiveness of Trans-diagnosis With Relaxation Therapy on Psychological Symptoms, Parental Beliefs About Neonatal Intensive Care Unit, Adaptation to Mother Role and Social and Occupational Adjustment in Parents of Premature Neonates Admitted to Neonatal Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52508</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will first be selected by purposive sampling method and then will be assigned to the four groups using a random quadratic blocking method. The participants are divided into four blocks (9 people in each block). In this method, usually, the number of people assigned to each group is almost equal and blocks are formed based on the desired variables, and within each block, half of the people are involved and half are considered as controls. The main purpose of this method is to balance the number of participants in each group. The four blocks of the intervention groups (A) and control (B) will be defined (AABB, ABAB, ABBA, BBAA, BABA, BAAB) and will be written on the number cards 1 to 6. The cards are then placed in an envelope. Finally, the cards are randomly selected and a random string is created from the sequence of selected cards. The participants of the intervention and control group enter the research based on this sequence.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: depression. Condition 2: anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The structure of meta-diagnostic treatment sessions will be based on Barlow (2011) model, which includes 8 sessions of 90 minutes and will be performed weekly. The structure and techniques of each session will be as follows: Session 1: Psychological training and motivation to treat emotional problems, Session 2: Emotional awareness training, Sessions 3 and 4: Correction of cognitive assessments, Sessions 5 and 6: Emotionally influenced behaviors and Emotional Avoidance, Sessions 7 and 8: Situational and Endogenous Exposure. Intervention 2: Control group: Participants in this group will receive a training booklet and relaxation technique CDs on a scheduled basis. At first, practical training will be provided to them by a trained specialist. They will then be given a booklet and CD of relaxation training. This treatment is performed by the participants themselves at home. The time required to perform this training does not take more than 5-7 minutes at a time.</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 Participants are not yet known.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. AA. parvizifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology, School of Medicine, Razi Blvd., Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3835 8239</telephone>
        <email>Parvizia@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. A.A parvizifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology, School of Medicine, Zakaria Azi Blvd., Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3835 8239</telephone>
        <email>Parvizia@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Premature baby survival
The baby is single
Conscious desire and satisfaction of parents to participate in research
If the mother is a participant in the study, she should not be hospitalized at the same time
Non-abuse of drugs, alcohol and psychotropic drugs, and other drugs (based on participants' comments)
Non-development of chronic mental disorders and personality disorders structured according to the principles of the clinical interview
Have a minimum cycle education
Scoring higher than the cut-off point in the Beck Depression and Anxiety Inventory
Not receiving other psychological services at the same time</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to answer the questions of the questionnaires used in the research (at least 5% of the questions in each questionnaire)
Absence from two sessions of treatment
Unwillingness to continue the process of any of the treatments</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F33.1</hc_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, recurrent, moderate</hc_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The structure of meta-diagnostic treatment sessions will be based on Barlow (2011) model, which includes 8 sessions of 90 minutes and will be performed weekly. The structure and techniques of each session will be as follows: Session 1: Psychological training and motivation to treat emotional problems, Session 2: Emotional awareness training, Sessions 3 and 4: Correction of cognitive assessments, Sessions 5 and 6: Emotionally influenced behaviors and Emotional Avoidance, Sessions 7 and 8: Situational and Endogenous Exposure.</i_keyword>
      <i_keyword>Control group: Participants in this group will receive a training booklet and relaxation technique CDs on a scheduled basis. At first, practical training will be provided to them by a trained specialist. They will then be given a booklet and CD of relaxation training. This treatment is performed by the participants themselves at home. The time required to perform this training does not take more than 5-7 minutes at a time.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bepression score in Beck Inventory. Timepoint: Pre-test, post-test and follow-up. Method of measurement: Beck Depression Inventory.</prim_outcome>
      <prim_outcome>Anxiety score in Beck Inventory. Timepoint: Pre-test, post-test and follow-up. Method of measurement: Beck Anxiety Inventory.</prim_outcome>
      <prim_outcome>Score emotion regulation strategies. Timepoint: pre-test, post-test, follow-up. Method of measurement: emotion regulation Gross and John questionnaire.</prim_outcome>
      <prim_outcome>Self-compassion score. Timepoint: pre-test, post-test and follow-up. Method of measurement: self-compassion questionnaire.</prim_outcome>
      <prim_outcome>Score of parents' beliefs about the neonatal intensive care unit. Timepoint: pre-test, post-test and follow-up. Method of measurement: Questionnaire of parents' beliefs about neonatal intensive care unit.</prim_outcome>
      <prim_outcome>Score of adaptation to mother role (For mothers). Timepoint: pre-test, post-test and follow-up. Method of measurement: questionnaire of adaptation to the mother role.</prim_outcome>
      <prim_outcome>Score work and social adjustment. Timepoint: pre-test, post-test and follow-up. Method of measurement: work and social adjustment 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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-10</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Kermanshah, Shahid Beheshti Blvd., Building No. 2, University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
