xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06022497</url>
    </required_header>
    <id_info>
      <org_study_id>IRB Number: 21-11T/23</org_study_id>
      <nct_id>NCT06022497</nct_id>
    </id_info>
    <brief_title>Tidal Model's Effects on Emotion Regulation and Recovery</brief_title>
    <official_title>The Effect of Tidal Model-Based Emotion Regulation Nursing Interventions on Recovery in Individuals Diagnosed With Nursing Diagnosis of Impaired Mood Regulation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Izmir Katip Celebi University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ege University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Izmir Katip Celebi University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to investigate the effectiveness of Tidal Model-based emotion&#xD;
        regulation interventions on recovery in individuals diagnosed with depression and nursing&#xD;
        diagnosis of impaired mood regulation. The research was designed as a randomized controlled&#xD;
        trial.&#xD;
  &#xD;
        The main hypothesis; After nursing interventions for emotion regulation based on the Tidal&#xD;
        Model, there is a significant difference between the recovery, difficulty in emotion&#xD;
        regulation, depression levels and nursing outcome criteria of individuals in the intervention&#xD;
        and control groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research carried out with patients followed in psychiatry outpatient clinics. As a result&#xD;
        of the G-power analysis, the sample consisted of 23 interventions and 23 control groups. In&#xD;
        the study, while the control group received only routine treatment, in the intervention&#xD;
        group, Tidal Model-based nursing interventions were applied in addition to the routine&#xD;
        treatment. Pre-tests administered before individuals were randomly assigned to the&#xD;
        intervention and control groups. Randomization was created using the website randomizer.org.&#xD;
        After this randomization was created, it was hidden from the physician who made the diagnosis&#xD;
        of depression and from the researcher who conducted the interviews (allocation concealment).&#xD;
        After the pre-tests were completed, the researcher (consulting faculty member) who knew the&#xD;
        random assignment order was reached and the individuals were randomly assigned to the control&#xD;
        or intervention group. Tidal Model-based nursing interventions were structured as 8 sessions&#xD;
        in total. Each individual in the intervention group participated in a session for a total of&#xD;
        8 weeks, one session per week. In the eighth session, post-tests were applied to the&#xD;
        individuals in the intervention group. Individuals in the control group were asked to come&#xD;
        back 8 weeks after the first interviews and post-tests were applied. All interviews were&#xD;
        conducted face to face. Recovery Assessment Scale (RAS), Difficulties in Emotion Regulation&#xD;
        Scale (DERS), and Nursing Outcomes Criteria (NOC) were used.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Actual">June 23, 2023</completion_date>
    <primary_completion_date type="Actual">May 5, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recovery Assesment Scale</measure>
      <time_frame>before and end of the interventions (eight weeks)</time_frame>
      <description>Recovery Assesment Scale was developed by Corrigan et al. (2004), and adapted to Turkish by Guler and Gurkan (2017) who also carried out the validity and reliability. It consist of 24 items, 5 point likert type. A high total score from the scale indicates a high level of improvement.Scale has five factors: personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and no domination by symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Difficulties in Emotion Regulation</measure>
      <time_frame>before and end of the interventions (eight weeks)</time_frame>
      <description>Difficulties in Emotion Regulation was developed by Gratz and Roemer (2004), and adapted to Turkish by Rugancı and Gencoz (2010) who also carried out the validity and reliability. It consist of 36 items, 5 point likert type. A high score on the scale indicates difficulty in emotion regulation. Scale has six factors: Awareness, Clarity, Impulse, Goals, Non-acceptance, Strategies.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Depression Rating Scale</measure>
      <time_frame>before and end of the interventions (eight weeks)</time_frame>
      <description>Hamilton Depression Rating Scale was developed Hamilton et al. (1960), and adapted to Turkish by Akdemir et al. (1997) who also carried out the validity and reliability. The highest 51 points can be obtained from the scale.A score of less than 7 indicates that there is no depression, 8 to 15 points of mild depression, 16-28 points of moderate level, and 29 points and above indicate severe depression.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Nursing Outcome Criteria</measure>
      <time_frame>before and end of the interventions (eight weeks)</time_frame>
      <description>Nursing Outcome Criteria is used to evaluate the patient's condition and is scored on a five-point Likert scale.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">46</enrollment>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the intervention group, Tidal Model-based emotion regulation nursing interventions were applied in addition to the routine treatment. Tidal Model-based emotion regulation nursing interventions were structured as eight sessions in total. Each individual in the intervention group participated in a session for a total of 8 weeks, one session per week. All interviews were conducted face to face.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group received only routine treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Tidal Model Based Emotion Regulation Interventions</intervention_name>
      <description>The Tidal Model is a nursing model and was developed by Phil Barker. It is an important model for psychiatric nursing care. In the research, nursing interventions for emotion regulation were structured by using the Tidal Model.At each session, emotion regulation interventions were applied within the Tidal Model care domains.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of moderate Depression according to Diagnostic and Statistical Manual of&#xD;
               Mental Disorders (DSM)-V criteria&#xD;
  &#xD;
            -  Having a nursing diagnosis of Impaired Mood Regulation&#xD;
  &#xD;
            -  Psychiatrist prescribing serotonin reuptake inhibitor (SSRI)&#xD;
  &#xD;
            -  Man or Women aged 25-55&#xD;
  &#xD;
            -  Being followed by the psychiatry outpatient clinic&#xD;
  &#xD;
            -  Able to provide written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of an additional mental illness&#xD;
  &#xD;
            -  Diagnosis of severe Depression according to DSM-V criteria&#xD;
  &#xD;
            -  Presence of suicidal attempts or thoughts&#xD;
  &#xD;
            -  Presence of another physical illness that affects cognition&#xD;
  &#xD;
            -  Have received any kind of therapy in the last six months&#xD;
  &#xD;
            -  Voluntary involvement in another study at the same time&#xD;
  &#xD;
            -  Inability to read and write&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mahire Olcay Çam, Prof. Dr.</last_name>
      <role>Study Director</role>
      <affiliation>Ege University, Faculty of Nursing, Department of Pschiatric Nursing</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Gulsenay TAS SOYLU</last_name>
      <role>Principal Investigator</role>
      <affiliation>Izmir KAtip Celebi University, Faculty of Health Sciences, Department of Pschiatric Nursing</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ege University</name>
        <address>
          <city>Izmir</city>
          <state>Bornova</state>
          <zip>35100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Izmir Katip Celebi University</name>
        <address>
          <city>Izmir</city>
          <state>Cigli</state>
          <zip>35620</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Izmir Katip Celebi University</investigator_affiliation>
      <investigator_full_name>Gulsenay TAS SOYLU</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Emotional Regulation</keyword>
    <keyword>Psychiatric Nursing</keyword>
    <keyword>Tidal Model</keyword>
    <keyword>Recovery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06022497
  org study id: IRB Number: 21-11T/23
  nct id: NCT06022497
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to investigate the effectiveness of Tidal Model-based emotion
        regulation interventions on recovery in individuals diagnosed with depression and nursing
        diagnosis of impaired mood regulation. The research was designed as a randomized controlled
        trial.
  
        The main hypothesis; After nursing interventions for emotion regulation based on the Tidal
        Model, there is a significant difference between the recovery, difficulty in emotion
        regulation, depression levels and nursing outcome criteria of individuals in the intervention
        and control groups.
  The research carried out with patients followed in psychiatry outpatient clinics. As a result
        of the G-power analysis, the sample consisted of 23 interventions and 23 control groups. In
        the study, while the control group received only routine treatment, in the intervention
        group, Tidal Model-based nursing interventions were applied in addition to the routine
        treatment. Pre-tests administered before individuals were randomly assigned to the
        intervention and control groups. Randomization was created using the website randomizer.org.
        After this randomization was created, it was hidden from the physician who made the diagnosis
        of depression and from the researcher who conducted the interviews (allocation concealment).
        After the pre-tests were completed, the researcher (consulting faculty member) who knew the
        random assignment order was reached and the individuals were randomly assigned to the control
        or intervention group. Tidal Model-based nursing interventions were structured as 8 sessions
        in total. Each individual in the intervention group participated in a session for a total of
        8 weeks, one session per week. In the eighth session, post-tests were applied to the
        individuals in the intervention group. Individuals in the control group were asked to come
        back 8 weeks after the first interviews and post-tests were applied. All interviews were
        conducted face to face. Recovery Assessment Scale (RAS), Difficulties in Emotion Regulation
        Scale (DERS), and Nursing Outcomes Criteria (NOC) were used.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Recovery Assesment Scale
  time frame: before and end of the interventions (eight weeks)
  description: Recovery Assesment Scale was developed by Corrigan et al. (2004), and adapted to Turkish by Guler and Gurkan (2017) who also carried out the validity and reliability. It consist of 24 items, 5 point likert type. A high total score from the scale indicates a high level of improvement.Scale has five factors: personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and no domination by symptoms
  measure: Difficulties in Emotion Regulation
  time frame: before and end of the interventions (eight weeks)
  description: Difficulties in Emotion Regulation was developed by Gratz and Roemer (2004), and adapted to Turkish by Rugancı and Gencoz (2010) who also carried out the validity and reliability. It consist of 36 items, 5 point likert type. A high score on the scale indicates difficulty in emotion regulation. Scale has six factors: Awareness, Clarity, Impulse, Goals, Non-acceptance, Strategies.
  measure: Hamilton Depression Rating Scale
  time frame: before and end of the interventions (eight weeks)
  description: Hamilton Depression Rating Scale was developed Hamilton et al. (1960), and adapted to Turkish by Akdemir et al. (1997) who also carried out the validity and reliability. The highest 51 points can be obtained from the scale.A score of less than 7 indicates that there is no depression, 8 to 15 points of mild depression, 16-28 points of moderate level, and 29 points and above indicate severe depression.
  measure: Nursing Outcome Criteria
  time frame: before and end of the interventions (eight weeks)
  description: Nursing Outcome Criteria is used to evaluate the patient's condition and is scored on a five-point Likert scale.
  arm group label: Intervention Group
  arm group type: Experimental
  description: In the intervention group, Tidal Model-based emotion regulation nursing interventions were applied in addition to the routine treatment. Tidal Model-based emotion regulation nursing interventions were structured as eight sessions in total. Each individual in the intervention group participated in a session for a total of 8 weeks, one session per week. All interviews were conducted face to face.
  arm group label: Control Group
  arm group type: No Intervention
  description: The control group received only routine treatment.
  intervention type: Other
  intervention name: Tidal Model Based Emotion Regulation Interventions
  description: The Tidal Model is a nursing model and was developed by Phil Barker. It is an important model for psychiatric nursing care. In the research, nursing interventions for emotion regulation were structured by using the Tidal Model.At each session, emotion regulation interventions were applied within the Tidal Model care domains.
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: Mahire Olcay Çam, Prof. Dr.
  role: Study Director
  affiliation: Ege University, Faculty of Nursing, Department of Pschiatric Nursing
  last name: Gulsenay TAS SOYLU
  role: Principal Investigator
  affiliation: Izmir KAtip Celebi University, Faculty of Health Sciences, Department of Pschiatric Nursing
  facility: 
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Izmir Katip Celebi University
  investigator full name: Gulsenay TAS SOYLU
  investigator title: Principal Investigator
  mesh term: Depression
  sharing ipd: No