<?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>IRCT20211223053494N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-11</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Transdiagnostic Cognitive-Behavioral Therapy Protocol on Subclinical Symptoms of Anxiety and Depression, Emotion Regulation, Resilience and Spiritual Health</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Transdiagnostic Cognitive-Behavioral Therapy Protocol on Reducing Subclinical Symptoms of Anxiety and Depression, Improving Emotion Regulation, Resilience and Spiritual Health in Students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69938</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be simple randomization. The randomization unit is people. 56 student subjects will be divided into intervention and control groups by Microsoft Excel software using Rand function. Based on this, a table of random numbers is prepared and the Randbetween function is created, and the subjects are placed in two groups of 28 people according to the rows of this table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety, Depression, Emotion Regulation, Resilience and Spiritual Health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: includes all students of Farhangian University of Tehran province who receive integrated transdiagnostic treatment as a group according to the protocol in 14 sessions of 60 minutes on a weekly basis. This treatment was designed by Barlow et al (2011). The content of the first session: (module one): improving motivation to engage in treatment, introducing motivation and discussing its importance for the outcome of treatment, helping the patient to evaluate the pros and cons of changing, helping the patient to evaluate the pros and cons of not changing, helping the patient to establish specific treatment goals, helping the patient to determine manageable steps to achieve the treatment goals. The second session (second module): psychological education and the logic of therapy, reviewing the assignment of the previous session, creating an overview of the functional and adaptive nature of emotions, presenting the three components of emotional experiences (thoughts, physical feelings and behaviors), introducing the concept of behaviors arising from emotions, Introducing the antecedents, responses and consequences of emotional experiences, discussing the learned responses of the third and fourth session (third module): emotional awareness training, reviewing the assignment of the previous session, introducing non-judgmental emotional awareness, introducing present-focused awareness, implementing emotional awareness exercises within the session, help To the patient to practice techniques using mood induction using music in the fifth and sixth session (fourth module): Cognitive Appraisal and Reappraisal, review of the assignment of the previous session, explanation of the mutual relationship between thoughts and emotions, introduction of automatic evaluations, introduction of mental traps common and helping the patient to identify them, introducing cognitive re-evaluation and helping the patient to practice it in order to increase flexibility in thinking, the seventh session (fifth module): emotional avoidance and behaviors arising from emotion, review of the assignment of the previous session, introducing the concept of emotional avoidance, Introducing the types of emotional avoidance strategies and discussing the contribution of these strategies in the negative cycle of emotional response, helping the patient to identify his emotional avoidance strategies, proving the contradictory effects of emotional avoidance, re-introducing the concept of behaviors arising from emotion and discussing them more deeply, introducing the logic of confrontation with behaviors arising from emotions, identifying behaviors arising from maladaptive emotions, the eighth session (sixth module): Awareness and Tolerance of Physical Sensations, reviewing the previous session's assignment, helping the patient to identify internal physical feelings related to emotions, helping the patient to gain more understanding From the role of internal physical feelings in creating an emotional response, performing symptomatic exercises designed to evoke uncomfortable physical feelings, sessions 9 to 13 (seventh module): Interoceptive and Situational Emotion Exposures, reviewing the assignment of the previous session, helping the patient to understand the purpose of emotional exposures. , helping the patient to create a hierarchy of emotional and situational avoidance, designing effective emotion coping exercises, helping patients to face strong emotions through emotional coping exercises, the fourteenth session (eighth module): Accomplishments, Maintenance, and Relapse Prevention, Reviewing the assignment of the previous session, reviewing coping skills, reviewing treatment progress, identifying and fixing potential or common triggers, promoting the generalization of skills, and establishing goals for continuous improvement. Intervention 2: Control group: includes students who do not receive 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Elnaz Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1452687818</zip>
        <telephone>+98 24 3353 4500</telephone>
        <email>Dr.Emousavi@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh Elnaz Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1452368712</zip>
        <telephone>+98 24 3353 4500</telephone>
        <email>Dr.Emousavi@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having preclinical anxiety and depression symptoms based on the cut-off point of a score of 18 and above in the DASS-42 subscale and a score of 16 and above in the anxiety subscale of the DASS-42 scale,
Not suffering from specific or underlying physical diseases,
Not suffering from severe psychiatric disorders such as bipolar spectrum disorders, psychotic spectrum disorders, and cognitive disorders.
Not using drugs and alcohol in the last three months.
Absence of speech or hearing problems
Willingness to participate in research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>absence of more than two sessions,
receiving another similar psychological intervention at the same time as the current research,
receiving cognitive-behavioral interventions for at least 8 sessions in the last 1 year,
receiving psychiatric drugs at the same time as the intervention or within a month before the intervention,
Lack of consent to continue the treatment during the intervention process,
Aggravation of the person's problems during the intervention and the need to provide another intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F54</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Psychological and behavioral factors associated with disorders or diseases classified elsewhere</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: includes all students of Farhangian University of Tehran province who receive integrated transdiagnostic treatment as a group according to the protocol in 14 sessions of 60 minutes on a weekly basis. This treatment was designed by Barlow et al (2011). The content of the first session: (module one): improving motivation to engage in treatment, introducing motivation and discussing its importance for the outcome of treatment, helping the patient to evaluate the pros and cons of changing, helping the patient to evaluate the pros and cons of not changing, helping the patient to establish specific treatment goals, helping the patient to determine manageable steps to achieve the treatment goals. The second session (second module): psychological education and the logic of therapy, reviewing the assignment of the previous session, creating an overview of the functional and adaptive nature of emotions, presenting the three components of emotional experiences (thoughts, physical feelings and behaviors), introducing the concept of behaviors arising from emotions, Introducing the antecedents, responses and consequences of emotional experiences, discussing the learned responses of the third and fourth session (third module): emotional awareness training, reviewing the assignment of the previous session, introducing non-judgmental emotional awareness, introducing present-focused awareness, implementing emotional awareness exercises within the session, help To the patient to practice techniques using mood induction using music in the fifth and sixth session (fourth module): Cognitive Appraisal and Reappraisal, review of the assignment of the previous session, explanation of the mutual relationship between thoughts and emotions, introduction of automatic evaluations, introduction of mental traps common and helping the patient to identify them, introducing cognitive re-evaluation and helping the patient to practice it in order to increase flexibility in thinking, the seventh session (fifth module): emotional avoidance and behaviors arising from emotion, review of the assignment of the previous session, introducing the concept of emotional avoidance, Introducing the types of emotional avoidance strategies and discussing the contribution of these strategies in the negative cycle of emotional response, helping the patient to identify his emotional avoidance strategies, proving the contradictory effects of emotional avoidance, re-introducing the concept of behaviors arising from emotion and discussing them more deeply, introducing the logic of confrontation with behaviors arising from emotions, identifying behaviors arising from maladaptive emotions, the eighth session (sixth module): Awareness and Tolerance of Physical Sensations, reviewing the previous session's assignment, helping the patient to identify internal physical feelings related to emotions, helping the patient to gain more understanding From the role of internal physical feelings in creating an emotional response, performing symptomatic exercises designed to evoke uncomfortable physical feelings, sessions 9 to 13 (seventh module): Interoceptive and Situational Emotion Exposures, reviewing the assignment of the previous session, helping the patient to understand the purpose of emotional exposures. , helping the patient to create a hierarchy of emotional and situational avoidance, designing effective emotion coping exercises, helping patients to face strong emotions through emotional coping exercises, the fourteenth session (eighth module): Accomplishments, Maintenance, and Relapse Prevention, Reviewing the assignment of the previous session, reviewing coping skills, reviewing treatment progress, identifying and fixing potential or common triggers, promoting the generalization of skills, and establishing goals for continuous improvement.</i_keyword>
      <i_keyword>Control group: includes students who do not receive intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive Emotion Regulation Score (CERQ) in the Garnevsky Questionnaire, Craig Vaspinhaven. Timepoint: At the beginning of the study (before the intervention), after the intervention and 2 months after the intervention. Method of measurement: Cognitive Emotion Regulation Questionnaire (CERQ).</prim_outcome>
      <prim_outcome>Depression, anxiety and stress score in Lovibond and Lovibond scale. Timepoint: At the beginning of the study (before the intervention), after the intervention and 2 months after the intervention. Method of measurement: Depression- Anxiety- Stress Scale (DASS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Spiritual well-being score in Paloutzian and Ellison questionnaire. Timepoint: At the beginning of the study (before the intervention), after the intervention and 2 months after the intervention. Method of measurement: Spiritual well-being (SWB).</sec_outcome>
      <sec_outcome>Cognitive flexibility score in Dennis scale. Timepoint: At the beginning of the study (before the intervention), after the intervention and 2 months after the intervention. Method of measurement: Cognitive flexibility scale (CFI).</sec_outcome>
      <sec_outcome>Connor and Davidson Resilience Scale (CD-RISC). Timepoint: At the beginning of the study (before the intervention), after the intervention and 2 months after the intervention. Method of measurement: Connor and Davidson Resilience Scale (CD-RISC).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-11</approval_date>
        <contact_name>Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences, Shahid Chamran Evin Highwa Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
