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/NCT05975918</url>
    </required_header>
    <id_info>
      <org_study_id>123456</org_study_id>
      <nct_id>NCT05975918</nct_id>
    </id_info>
    <brief_title>The Effect of Motivational Interview Intervention for Caregivers of Individuals With Severe Mental Disorders</brief_title>
    <official_title>The Effect of Motivational Interview Intervention for Caregivers of Individuals With Severe Mental Disorders on Psychological Distress and Coping Attitudes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kocaeli University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kocaeli University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Serious mental illnesses are all chronic illnesses such as schizophrenia, schizoaffective&#xD;
        disorder, and other psychotic disorders, major depression, and bipolar disorder, which cause&#xD;
        impaired functioning in areas such as activities of daily living, self-care, social&#xD;
        relationships, professional and academic life, quality time, etc. These chronic illnesses are&#xD;
        a significant source of stress for the patient and family members. With the transition to&#xD;
        community-based practices in the care of chronic mental illnesses, t he duties of families&#xD;
        have increased and as a result, have had significant negative effects on caregiver and family&#xD;
        functioning.&#xD;
  &#xD;
        Caregivers face many challenges and these challenges cause caregivers to experience feelings&#xD;
        such as anxiety, stress, fear, guilt, helplessness, hopelessness, powerlessness, loss, and&#xD;
        anger. It is understood that families are in significant need of psychosocial support&#xD;
        interventions that will enable them to develop effective coping methods and reduce stress and&#xD;
        anxiety.&#xD;
  &#xD;
        Themotivationall Interviewing Technique is one of the methods that can be applied to the&#xD;
        caregivers of individuals diagnosed with chronic mental illness to adapt to the situation and&#xD;
        cope with the difficulties they experience. Motivational Interviewing does not deal with&#xD;
        issues such as teaching new information or ensuring acceptance of the past. It focuses on the&#xD;
        individual's current stress, anxiety and dilemmas, goals, and plans. Studies show that any&#xD;
        intervention that will contribute to the caregiver's coping attitude and psychological&#xD;
        distress level will also support the empowerment of the sick individual. For this purpose,&#xD;
        the study was planned to determine the effect of motivational interviewing intervention for&#xD;
        caregivers of individuals with serious mental disorders on psychological distress and coping&#xD;
        attitudes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Before starting the study, approval was obtained from the Kocaeli Health and Technology&#xD;
        University Non-Interventional Research Ethics Committee dated 2023-38 and numbered 2023-38,&#xD;
        and institutional permission was obtained from the community mental health center where the&#xD;
        study would be conducted.&#xD;
  &#xD;
        In the calculation of the sample of the study, the power analysis based on the statistics&#xD;
        obtained from the study titled &quot;Psychological distress, perceived stigma, and coping among&#xD;
        caregivers of patients with schizophrenia&quot; was taken as &quot;α=0.05, 1-β (Power)= 0.95 and effect&#xD;
        size=0.77&quot; and accordingly, it was determined that a total of 36 people should be taken, 18&#xD;
        people in each group. In order to meet the sampling, possible losses and parametric test&#xD;
        assumptions, it was decided to include a total of 60 people, 30 people each in the&#xD;
        experimental and control groups.&#xD;
  &#xD;
        The randomization method (a stratified sample list (including gender, age and number of rows)&#xD;
        will be created by a third person who is not part of the research team, and a simple random&#xD;
        number table will be used to assign the caregivers to the experimental and control groups)&#xD;
        will be used.&#xD;
  &#xD;
        The implementation of the research will be done in two phases. Phase 1: Piloting,&#xD;
        identification of the intervention and control groups and pretesting&#xD;
  &#xD;
          -  The 6-session motivational interviewing intervention, which will be finalized according&#xD;
             to expert opinions, will be piloted and the results will be evaluated. The intervention&#xD;
             steps that require revision will be organized and the sample selection phase will begin.&#xD;
  &#xD;
          -  Caregivers who meet the research criteria and agree to participate in the study will be&#xD;
             assigned to the experimental and control groups by randomization method.&#xD;
  &#xD;
          -  The experimental and control groups will be informed about the study through preliminary&#xD;
             interviews and data (Caregiver Descriptive Characteristics Form, Patient Descriptive&#xD;
             Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes&#xD;
             Assessment Scale) will be collected through pre-tests.&#xD;
  &#xD;
        Phase 2: Intervention In the study, the intervention group will receive individual interviews&#xD;
        based on motivational interviewing techniques, while the control group will receive a one-day&#xD;
        group psychoeducation on coping with stress and problem solving skills.&#xD;
  &#xD;
        Within the scope of this research, a total of 6 sessions of motivational interviewing&#xD;
        interventions will be provided to the caregivers in the experimental group in 45-minute&#xD;
        sessions. Pre-tests will be completed by adding an additional session to the first session&#xD;
        and post-tests will be completed at the end of the last session.&#xD;
  &#xD;
        Quantitative data will be analyzed with SPSS 25.0 package program using descriptive&#xD;
        statistics (frequency distribution table) and inferential statistical tests. Significance&#xD;
        will be evaluated at p&lt;0.05 level.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>reducing psychological distress</measure>
      <time_frame>6 weeks</time_frame>
      <description>AIl participants will be pretested and the test will be repeated after 6 weeks. Depression, Anxiety, and Stress Scale (DASS-21) will be applied as the pretest-posttest. The posttest mean scores are expected to be low after the motivational interview intervention was applied to the experimental group for 6 weeks after the pretest.&#xD;
  Depression, Anxiety, and Stress Scale (DASS-21) This scale is a 4-point Likert-type scale and consists of seven questions each measuring &quot;depression, stress, and anxiety dimensions&quot;. Getting 5 points or more from the depression sub-dimension, 4 points or more from the anxiety sub-dimension, and 8 points or more from the stress sub-dimension indicates that the individual has a related problem.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>increasing coping attitudes</measure>
      <time_frame>6 weeks</time_frame>
      <description>All participants will be pretested and the test will be repeated after 6 weeks. The coping Attitudes Assessment Scale will be applied as a pretest-posttest. The posttest mean scores are expected to be low after the motivational interview intervention was applied to the experimental group for 6 weeks after the pretest.&#xD;
  Coping Attitudes Assessment Scale The highest score that can be obtained from the scale is 160, and the lowest score is 40. A high score on the scale means a high level of coping attitude, and a low score means a low level of coping attitude.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Caregiver</condition>
    <condition>Motivational Interview</condition>
    <condition>Mental Disorder</condition>
    <arm_group>
      <arm_group_label>Motivational İnterview</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants in the experimental group will be informed about the study through pre-interviews and data (Caregiver Identifying Characteristics Form, Patient Identifying Characteristics Form, Depression, Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests. A motivational interview intervention consisting of a total of 6 interviews will be conducted.Then, data will be collected with posttest (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants in the control group will be informed about the study through pre-interviews and data (Caregiver Identifying Characteristics Form, Patient Identifying Characteristics Form, Depression, Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests. 2 hours of training on coping with stress and problem solving skills will be provided. Then, data will be collected with posttest (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Motivational İnterview</intervention_name>
      <description>Participants in the experimental group will be informed about the study through pre-interviews and data (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests. A motivational interview intervention consisting of a total of 6 interviews will be conducted.</description>
      <arm_group_label>Motivational İnterview</arm_group_label>
      <other_name>Psychoeducation</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Psychoeducation</intervention_name>
      <description>2 hours of training on coping with stress and problem solving skills will be provided.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being responsible for the care of individuals receiving services from the Community&#xD;
               Mental Health Center&#xD;
  &#xD;
            -  Being the patient's primary caregiver for more than 6 months&#xD;
  &#xD;
            -  Over 18 years of age&#xD;
  &#xD;
            -  No other person to whom he/she is obliged to provide care&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being a paid caregiver&#xD;
  &#xD;
            -  No communication barriers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mehtap Akkoç, MSc</last_name>
      <phone>+905052461846</phone>
      <email>mehtapsenerakkoc@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sevil Yılmaz, PhD</last_name>
      <phone>+905332069290</phone>
      <email>sevilyilmaz72@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kocaeli Health and Tecnology University</name>
        <address>
          <city>Kocaeli</city>
          <zip>41275</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kocaeli University</investigator_affiliation>
      <investigator_full_name>Mehtap Akkoç</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>motivational interview</keyword>
    <keyword>coping attitudes</keyword>
    <keyword>caregiver</keyword>
    <keyword>Psychological Distress</keyword>
    <keyword>severe mental disorder</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Psychotic Disorders</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/NCT05975918
  org study id: 123456
  nct id: NCT05975918
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Serious mental illnesses are all chronic illnesses such as schizophrenia, schizoaffective
        disorder, and other psychotic disorders, major depression, and bipolar disorder, which cause
        impaired functioning in areas such as activities of daily living, self-care, social
        relationships, professional and academic life, quality time, etc. These chronic illnesses are
        a significant source of stress for the patient and family members. With the transition to
        community-based practices in the care of chronic mental illnesses, t he duties of families
        have increased and as a result, have had significant negative effects on caregiver and family
        functioning.
  
        Caregivers face many challenges and these challenges cause caregivers to experience feelings
        such as anxiety, stress, fear, guilt, helplessness, hopelessness, powerlessness, loss, and
        anger. It is understood that families are in significant need of psychosocial support
        interventions that will enable them to develop effective coping methods and reduce stress and
        anxiety.
  
        Themotivationall Interviewing Technique is one of the methods that can be applied to the
        caregivers of individuals diagnosed with chronic mental illness to adapt to the situation and
        cope with the difficulties they experience. Motivational Interviewing does not deal with
        issues such as teaching new information or ensuring acceptance of the past. It focuses on the
        individual's current stress, anxiety and dilemmas, goals, and plans. Studies show that any
        intervention that will contribute to the caregiver's coping attitude and psychological
        distress level will also support the empowerment of the sick individual. For this purpose,
        the study was planned to determine the effect of motivational interviewing intervention for
        caregivers of individuals with serious mental disorders on psychological distress and coping
        attitudes.
  Before starting the study, approval was obtained from the Kocaeli Health and Technology
        University Non-Interventional Research Ethics Committee dated 2023-38 and numbered 2023-38,
        and institutional permission was obtained from the community mental health center where the
        study would be conducted.
  
        In the calculation of the sample of the study, the power analysis based on the statistics
        obtained from the study titled "Psychological distress, perceived stigma, and coping among
        caregivers of patients with schizophrenia" was taken as "α=0.05, 1-β (Power)= 0.95 and effect
        size=0.77" and accordingly, it was determined that a total of 36 people should be taken, 18
        people in each group. In order to meet the sampling, possible losses and parametric test
        assumptions, it was decided to include a total of 60 people, 30 people each in the
        experimental and control groups.
  
        The randomization method (a stratified sample list (including gender, age and number of rows)
        will be created by a third person who is not part of the research team, and a simple random
        number table will be used to assign the caregivers to the experimental and control groups)
        will be used.
  
        The implementation of the research will be done in two phases. Phase 1: Piloting,
        identification of the intervention and control groups and pretesting
  
          -  The 6-session motivational interviewing intervention, which will be finalized according
             to expert opinions, will be piloted and the results will be evaluated. The intervention
             steps that require revision will be organized and the sample selection phase will begin.
  
          -  Caregivers who meet the research criteria and agree to participate in the study will be
             assigned to the experimental and control groups by randomization method.
  
          -  The experimental and control groups will be informed about the study through preliminary
             interviews and data (Caregiver Descriptive Characteristics Form, Patient Descriptive
             Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes
             Assessment Scale) will be collected through pre-tests.
  
        Phase 2: Intervention In the study, the intervention group will receive individual interviews
        based on motivational interviewing techniques, while the control group will receive a one-day
        group psychoeducation on coping with stress and problem solving skills.
  
        Within the scope of this research, a total of 6 sessions of motivational interviewing
        interventions will be provided to the caregivers in the experimental group in 45-minute
        sessions. Pre-tests will be completed by adding an additional session to the first session
        and post-tests will be completed at the end of the last session.
  
        Quantitative data will be analyzed with SPSS 25.0 package program using descriptive
        statistics (frequency distribution table) and inferential statistical tests. Significance
        will be evaluated at p<0.05 level.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: reducing psychological distress
  time frame: 6 weeks
  description: AIl participants will be pretested and the test will be repeated after 6 weeks. Depression, Anxiety, and Stress Scale (DASS-21) will be applied as the pretest-posttest. The posttest mean scores are expected to be low after the motivational interview intervention was applied to the experimental group for 6 weeks after the pretest.
  Depression, Anxiety, and Stress Scale (DASS-21) This scale is a 4-point Likert-type scale and consists of seven questions each measuring "depression, stress, and anxiety dimensions". Getting 5 points or more from the depression sub-dimension, 4 points or more from the anxiety sub-dimension, and 8 points or more from the stress sub-dimension indicates that the individual has a related problem.
  measure: increasing coping attitudes
  time frame: 6 weeks
  description: All participants will be pretested and the test will be repeated after 6 weeks. The coping Attitudes Assessment Scale will be applied as a pretest-posttest. The posttest mean scores are expected to be low after the motivational interview intervention was applied to the experimental group for 6 weeks after the pretest.
  Coping Attitudes Assessment Scale The highest score that can be obtained from the scale is 160, and the lowest score is 40. A high score on the scale means a high level of coping attitude, and a low score means a low level of coping attitude.
  arm group label: Motivational İnterview
  arm group type: Experimental
  description: The participants in the experimental group will be informed about the study through pre-interviews and data (Caregiver Identifying Characteristics Form, Patient Identifying Characteristics Form, Depression, Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests. A motivational interview intervention consisting of a total of 6 interviews will be conducted.Then, data will be collected with posttest (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale).
  arm group label: Control
  arm group type: Other
  description: Participants in the control group will be informed about the study through pre-interviews and data (Caregiver Identifying Characteristics Form, Patient Identifying Characteristics Form, Depression, Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests. 2 hours of training on coping with stress and problem solving skills will be provided. Then, data will be collected with posttest (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale).
  intervention type: Behavioral
  intervention name: Motivational İnterview
  description: Participants in the experimental group will be informed about the study through pre-interviews and data (Caregiver Descriptive Characteristics Form, Patient Descriptive Characteristics Form, Depression Anxiety and Stress Scale (DASS-21), Coping Attitudes Assessment Scale) will be collected through pre-tests. A motivational interview intervention consisting of a total of 6 interviews will be conducted.
  arm group label: Motivational İnterview
  other name: Psychoeducation
  intervention type: Other
  intervention name: Psychoeducation
  description: 2 hours of training on coping with stress and problem solving skills will be provided.
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mehtap Akkoç, MSc
  phone: +905052461846
  email: mehtapsenerakkoc@gmail.com
  last name: Sevil Yılmaz, PhD
  phone: +905332069290
  email: sevilyilmaz72@yahoo.com
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Kocaeli University
  investigator full name: Mehtap Akkoç
  investigator title: Lecturer
  mesh term: Mental Disorders
  mesh term: Psychotic Disorders
  sharing ipd: No