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/NCT06022393</url>
    </required_header>
    <id_info>
      <org_study_id>35-315 ex 22/23</org_study_id>
      <nct_id>NCT06022393</nct_id>
    </id_info>
    <brief_title>CBT Training for Cognitive Reappraisal as an Intervention for Patients With Functional Tremor - an EEG Study</brief_title>
    <official_title>CBT-Training Zur Kognitiven Umbewertung Als Lntervention Bei Patienten*Innen Mit Funktionellem Tremor - Eine EEG-Studie</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Graz</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Graz</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Medical University of Graz</source>
    <oversight_info>
      <has_dmc>No</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>
        The aim of this psychological study is to evaluate the effect of a cognitive behavioral&#xD;
        therapy (CBT) intervention aimed at improving cognitive reappraisal on (1) Clinical and&#xD;
        Self-Rated Health according to Patient Global Impression-Change (PGI-C), Patient Global&#xD;
        Impression-Severity (PGI-S), Clinical Global Impression-Change (CGI-C) and Clinical Global&#xD;
        Impression-Severity (CGI-S) after 4 weeks, (2) the change in the severity of the functional&#xD;
        movement disorder/tremor as assessed by a blinded clinician using the Simplified Version of&#xD;
        the Psychogenic Movement Disorders Rating Scale (S-FMDRS) after 4 weeks and (3) the change in&#xD;
        the severity of functional tremor assessed via the Fahn Tolosa Marin Tremor Rating Scale&#xD;
        (FTM) after 4 weeks.&#xD;
  &#xD;
        The knowledge gained about the introspective and neurobiological effect of this cognitive&#xD;
        behavioral therapy intervention should enable improved therapy options for patients with&#xD;
        functional tremor / functional motor disorders in the future.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an intervention study including patients of the outpatient clinic for movement&#xD;
        disorders at the University Clinic of Neurology in Graz.&#xD;
  &#xD;
        The patients will randomly be assigned to the intervention (cognitive reappraisal) or control&#xD;
        (reflection) group.&#xD;
  &#xD;
        The study consists of a first preliminary examination at the University clinic, followed by&#xD;
        an electroencephalogram (EEG)-lab-session at the Institute of Psychology of the&#xD;
        Karl-Franzens-University of Graz. The patients will complete emotion-regulation tasks while&#xD;
        the EEG is conducted and then be introduced to an App, with which they will either complete&#xD;
        14 cognitive-reappraisal-tasks (intervention) or 14 reflection-tasks (control) within the&#xD;
        next 4 weeks. A task will need to be completed in the App once every two days.&#xD;
  &#xD;
        After this training period, there will be a second preliminary examination at the University&#xD;
        Clinic as well as a second subsequent EEG-lab-sessions at the Institute of Psychology at the&#xD;
        Karl-Franzens-University.&#xD;
  &#xD;
        In addition, after two weeks of training, the patients will receive a short phone call and&#xD;
        will be asked to complete the PGI-S and PGI-C.&#xD;
  &#xD;
        Questionnaires completed during the first preliminary examination:&#xD;
  &#xD;
          1. CGI-S - Clinical Global Impression - severity&#xD;
  &#xD;
          2. PGI-S - Patient Global Impression - severity&#xD;
  &#xD;
          3. FTM - Fahn Tolosa Marin Tremor Rating Scale&#xD;
  &#xD;
          4. S-FMDRS - Simplified Version of the Psychogenic Movement Disorders Rating Scale&#xD;
  &#xD;
        Questionnaires completed during the first EEG-lab-session:&#xD;
  &#xD;
          1. VKT - Verbal creativity test&#xD;
  &#xD;
          2. RIT - Reappraisal Inventiveness Test&#xD;
  &#xD;
          3. ERQ - Emotion Regulation Questionnaire&#xD;
  &#xD;
          4. LPFS-BF - Level of Personality Functioning Scale:&#xD;
  &#xD;
          5. SF-36 - Short Form (36)&#xD;
  &#xD;
          6. EQ-5D-5L - Health Questionnaire&#xD;
  &#xD;
          7. PAHD - Psychosomatic Assessment Health-DISC&#xD;
  &#xD;
        Questionnaires completed during the second preliminary examination:&#xD;
  &#xD;
        All the questionnaires also used in the first examination plus:&#xD;
  &#xD;
          1. CGI-C - Clinical Global Impression - Change&#xD;
  &#xD;
          2. PGI-C - Patient Global Impression - Change&#xD;
  &#xD;
        Questionnaires completed during the second EEG-lab-session:&#xD;
  &#xD;
        The same as in the first EEG-lab-session.&#xD;
  &#xD;
        4 weeks after the completion of the last EEG-lab-session, the patients will receive another&#xD;
        short phone-call in which they will again be asked to complete the PGI-S and PGI-C.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 16, 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</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>
      <intervention_model_description>The patients are randomly assigned to one of two groups. The intervention group completes CBT-training to improve their cognitive reappraisal and consequently their emotion-regulation-skills and the control group completes tasks that ask them to reflect about their daily lifes.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The patients are randomly assigned to a group and do not know whether that is the intervention or the control group.&#xD;
  The physicians conducting the preliminary assessments do not know which group the patient was placed in.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Clinical health - Clinical Global Impression Severity Scale</measure>
      <time_frame>4 weeks</time_frame>
      <description>Clinical health according to Clinical Global Impression of Severity Scale (CGI-S) rated by a medical professional.&#xD;
  Three questions regarding patients current mood, influence of the symptoms on everyday motor function and overall severity.&#xD;
  Answer options:&#xD;
  Not at all/very easy&#xD;
  Lightly&#xD;
  Moderate&#xD;
  Strong&#xD;
  Very strong Higher values = worse outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical health - Clinical Global Impression of Change</measure>
      <time_frame>4 weeks</time_frame>
      <description>Clinical health according to Clinical Global Impression of Change Scale (CGI-C) rated by a medical professional.&#xD;
  Three questions regarding patients mood, everyday motor function and overall change as well as a rating regarding the relevance of the change (Yes or No). Answer options:&#xD;
  Very Much worse Much worse Slightly worse No change Marginally better Much better Very Much better&#xD;
  Higher values = better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Self-assessed health - Patient Global Impression Severity Scale</measure>
      <time_frame>4 weeks</time_frame>
      <description>Self-assessed health according to Patient Global Impression of Severity Scale (PGI-S) rated by the patients themselves.&#xD;
  Three questions regarding patients current mood, influence of the symptoms on everyday bodily function and overall severity.&#xD;
  Answer options:&#xD;
  Not at all/very easy&#xD;
  Lightly&#xD;
  Moderate&#xD;
  Strong&#xD;
  Very strong Higher values = worse outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Self-assessed health - Patient Global Impression of Change</measure>
      <time_frame>4 weeks</time_frame>
      <description>Self-assessed health according to Patient Gloabal Impression of Change Scale (PGI-C) rated by the patients themselves.&#xD;
  Three questions regarding patients mood, everyday bodily function and overall change as well as a rating regarding the relevance of the change (Yes or No). Answer options:&#xD;
  Very Much worse Much worse Slightly worse No change Marginally better Much better Very Much better&#xD;
  Higher values = better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change in severity of the functional movement disorder</measure>
      <time_frame>4 weeks</time_frame>
      <description>The change in severity as assessed by a blinded clinician using the severity of the functional movement disorder by means of the Simplified Version of the Psychogenic Movement Disorders Rating Scale (S-FMDRS). Scoring: 0-3, higher values indicate worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change in tremor severity</measure>
      <time_frame>4 weeks</time_frame>
      <description>The change in tremor severity assessed using the Fahn Tolosa Marin Tremor-Rating-Scale.&#xD;
  Scoring: 0-4, higher values indicate worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in the ability of emotion regulation</measure>
      <time_frame>4 weeks</time_frame>
      <description>The change in the ability of emotion regulation assessed using the Emotion Regulation Questionnaire.&#xD;
  High scores on the reassessment scale suggest that the person is more likely to use cognitive strategies to change the emotional meaning of situations. This may be associated with better emotional adaptability and well-being.&#xD;
  High scores on the suppression scale indicate that the person is more inclined to suppress or avoid the expression of emotions. This may be associated with lower emotional adaptability and well-being.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in patients EEG-activity.</measure>
      <time_frame>4 weeks</time_frame>
      <description>Training-based changes in patients' EEG activity will be assessed for a) tasks-related changes in EEG alpha frequency power (TRPs) as well as b) frontal alpha asymmetry changes during the generation of cognitive reappraisals. Changes in these parameters should unterline behavioral changes in reappraisal success, divergent thinking, and executive functioning. Moreover, we will look at c) the EEG theta/beta frequency ratio to map changes in stress coping, emotion regulation, and behavioral flexibility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the patients Creativity</measure>
      <time_frame>4 weeks</time_frame>
      <description>The change in creativity assessed using the Verbal Creativity Test. No Minimum or Maximum values, higher score = better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the patients Welfare- Health Questionnaire EQ-5D-5L.</measure>
      <time_frame>4 weeks</time_frame>
      <description>The change in the patients welfare assessed using the Health Questionnaire EQ-5D-5L.&#xD;
  5 Level, Scores: 1-5, higher values indicate worse outcome.&#xD;
  1 overall Scale: 0-100, higher values indicate better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the patients Welfare- Short Form Health Questionnaire</measure>
      <time_frame>4 weeks</time_frame>
      <description>The change in the patients welfare assessed using the Short Form Health Questionnaire.&#xD;
  The possible score ranges from 0 to 100 points, with 0 points representing the greatest possible restriction of health, while 100 points indicate no health restriction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the patients Welfare - Psychosomatic Assessment Health-DISC. Minimum value in each section: 0 Maximum value in each section: 10 Higher scores = better outcome.</measure>
      <time_frame>4 weeks</time_frame>
      <description>The change in the patients welfare assessed using the Psychosomatic Assessment Health-DISC 6 Levels, Scores: 0-10, higher values indicate better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in patients personality and behavioral aspects</measure>
      <time_frame>4 weeks</time_frame>
      <description>The change in patients personality and behavioral aspects assessed using the Level of Personality Functioning Scale.&#xD;
  The items are on a 4-point Likert scale from 1 (&quot;doesn't apply at all&quot;) to 4 (&quot;applies exactly&quot;) to&quot;). The evaluation is carried out by means of summaries, so that values on the Overall scale: 12 - 48 Subscales Self and Interpersonal: 6 - 24</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Long-term change in Self-assessed health - Patient Global Impression of Change</measure>
      <time_frame>8 weeks</time_frame>
      <description>Self-assessed health according to Patient Global Impression of Change Scale (PGI-C) rated by the patients themselves.&#xD;
  Three questions regarding patients mood, everyday bodily function and overall change as well as a rating regarding the relevance of the change (Yes or No). Answer options:&#xD;
  Very Much worse Much worse Slightly worse No change Marginally better Much better Very Much better Higher values = better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Long-term change in Self-assessed health - Patient Global Impression Severity Scale</measure>
      <time_frame>8 weeks</time_frame>
      <description>Self-assessed health according to Patient Global Impression of Severity Scale (PGI-S) rated by the patients themselves.&#xD;
  Three questions regarding patients current mood, influence of the symptoms on everyday bodily function and overall severity.&#xD;
  Answer options:&#xD;
  Not at all/very easy&#xD;
  Lightly&#xD;
  Moderate&#xD;
  Strong&#xD;
  Very strong Higher values = worse outcome</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Functional Movement Disorder</condition>
    <arm_group>
      <arm_group_label>Cognitive Reappraisal</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group completes CBT-training to improve their cognitive reappraisal and emotion-regulation-skills.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Reflection</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The control group completes tasks based on reflection about their daily lifes, which should have no impact on their emotion-regulation-skills or functional motor disorder.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Reappraisal</intervention_name>
      <description>Patients complete 14 tasks on an app in a time span of 4 weeks in which they are asked to cognitively reappraise fear or anger inducing situations and are encouraged to implement this strategy into their daily lifes.</description>
      <arm_group_label>Cognitive Reappraisal</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Reflection</intervention_name>
      <description>Patients complete 14 tasks on an app in a time span of 4 weeks in which they are asked to reflect on certain topics of their day.</description>
      <arm_group_label>Reflection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Diagnosis of a functional movement disorder&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patient is not capable of giving consent.&#xD;
  &#xD;
            -  The patient does not have sufficient knowledge of German to answer the questionnaires&#xD;
               (questionnaires are only available in German).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Corinna Perchtold-Stefan, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Graz</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Petra Schwingenschuh, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Medical University of Graz</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Daniela Kern, MD</last_name>
      <phone>004331638516051</phone>
      <email>daniela.eibl@medunigraz.at</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Petra Schwingenschuh, MD</last_name>
      <phone>004331638583379</phone>
      <email>petra.schwingenschuh@medunigraz.at</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Medical University of graz</name>
        <address>
          <city>Graz</city>
          <state>Styria</state>
          <zip>8010</zip>
          <country>Austria</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Melanie Suette, BSc, BSc</last_name>
        <phone>00436609385069</phone>
        <email>melanie.suette@stud.medunigraz.at</email>
      </contact>
    </location>
    <location_countries>
      <country>Austria</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>EEG</keyword>
    <keyword>Psychology</keyword>
    <keyword>neuropsychology</keyword>
    <keyword>cognitive reappraisal</keyword>
    <keyword>cognitive behavioral therapy</keyword>
    <keyword>Emotional Regulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Movement Disorders</mesh_term>
      <mesh_term>Conversion Disorder</mesh_term>
      <mesh_term>Hysteria</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/NCT06022393
  org study id: 35-315 ex 22/23
  nct id: NCT06022393
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this psychological study is to evaluate the effect of a cognitive behavioral
        therapy (CBT) intervention aimed at improving cognitive reappraisal on (1) Clinical and
        Self-Rated Health according to Patient Global Impression-Change (PGI-C), Patient Global
        Impression-Severity (PGI-S), Clinical Global Impression-Change (CGI-C) and Clinical Global
        Impression-Severity (CGI-S) after 4 weeks, (2) the change in the severity of the functional
        movement disorder/tremor as assessed by a blinded clinician using the Simplified Version of
        the Psychogenic Movement Disorders Rating Scale (S-FMDRS) after 4 weeks and (3) the change in
        the severity of functional tremor assessed via the Fahn Tolosa Marin Tremor Rating Scale
        (FTM) after 4 weeks.
  
        The knowledge gained about the introspective and neurobiological effect of this cognitive
        behavioral therapy intervention should enable improved therapy options for patients with
        functional tremor / functional motor disorders in the future.
  This is an intervention study including patients of the outpatient clinic for movement
        disorders at the University Clinic of Neurology in Graz.
  
        The patients will randomly be assigned to the intervention (cognitive reappraisal) or control
        (reflection) group.
  
        The study consists of a first preliminary examination at the University clinic, followed by
        an electroencephalogram (EEG)-lab-session at the Institute of Psychology of the
        Karl-Franzens-University of Graz. The patients will complete emotion-regulation tasks while
        the EEG is conducted and then be introduced to an App, with which they will either complete
        14 cognitive-reappraisal-tasks (intervention) or 14 reflection-tasks (control) within the
        next 4 weeks. A task will need to be completed in the App once every two days.
  
        After this training period, there will be a second preliminary examination at the University
        Clinic as well as a second subsequent EEG-lab-sessions at the Institute of Psychology at the
        Karl-Franzens-University.
  
        In addition, after two weeks of training, the patients will receive a short phone call and
        will be asked to complete the PGI-S and PGI-C.
  
        Questionnaires completed during the first preliminary examination:
  
          1. CGI-S - Clinical Global Impression - severity
  
          2. PGI-S - Patient Global Impression - severity
  
          3. FTM - Fahn Tolosa Marin Tremor Rating Scale
  
          4. S-FMDRS - Simplified Version of the Psychogenic Movement Disorders Rating Scale
  
        Questionnaires completed during the first EEG-lab-session:
  
          1. VKT - Verbal creativity test
  
          2. RIT - Reappraisal Inventiveness Test
  
          3. ERQ - Emotion Regulation Questionnaire
  
          4. LPFS-BF - Level of Personality Functioning Scale:
  
          5. SF-36 - Short Form (36)
  
          6. EQ-5D-5L - Health Questionnaire
  
          7. PAHD - Psychosomatic Assessment Health-DISC
  
        Questionnaires completed during the second preliminary examination:
  
        All the questionnaires also used in the first examination plus:
  
          1. CGI-C - Clinical Global Impression - Change
  
          2. PGI-C - Patient Global Impression - Change
  
        Questionnaires completed during the second EEG-lab-session:
  
        The same as in the first EEG-lab-session.
  
        4 weeks after the completion of the last EEG-lab-session, the patients will receive another
        short phone-call in which they will again be asked to complete the PGI-S and PGI-C.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The patients are randomly assigned to one of two groups. The intervention group completes CBT-training to improve their cognitive reappraisal and consequently their emotion-regulation-skills and the control group completes tasks that ask them to reflect about their daily lifes.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: The patients are randomly assigned to a group and do not know whether that is the intervention or the control group.
  The physicians conducting the preliminary assessments do not know which group the patient was placed in.
  measure: Change in Clinical health - Clinical Global Impression Severity Scale
  time frame: 4 weeks
  description: Clinical health according to Clinical Global Impression of Severity Scale (CGI-S) rated by a medical professional.
  Three questions regarding patients current mood, influence of the symptoms on everyday motor function and overall severity.
  Answer options:
  Not at all/very easy
  Lightly
  Moderate
  Strong
  Very strong Higher values = worse outcome
  measure: Change in Clinical health - Clinical Global Impression of Change
  time frame: 4 weeks
  description: Clinical health according to Clinical Global Impression of Change Scale (CGI-C) rated by a medical professional.
  Three questions regarding patients mood, everyday motor function and overall change as well as a rating regarding the relevance of the change (Yes or No). Answer options:
  Very Much worse Much worse Slightly worse No change Marginally better Much better Very Much better
  Higher values = better outcome
  measure: Change in Self-assessed health - Patient Global Impression Severity Scale
  time frame: 4 weeks
  description: Self-assessed health according to Patient Global Impression of Severity Scale (PGI-S) rated by the patients themselves.
  Three questions regarding patients current mood, influence of the symptoms on everyday bodily function and overall severity.
  Answer options:
  Not at all/very easy
  Lightly
  Moderate
  Strong
  Very strong Higher values = worse outcome
  measure: Change in Self-assessed health - Patient Global Impression of Change
  time frame: 4 weeks
  description: Self-assessed health according to Patient Gloabal Impression of Change Scale (PGI-C) rated by the patients themselves.
  Three questions regarding patients mood, everyday bodily function and overall change as well as a rating regarding the relevance of the change (Yes or No). Answer options:
  Very Much worse Much worse Slightly worse No change Marginally better Much better Very Much better
  Higher values = better outcome
  measure: The change in severity of the functional movement disorder
  time frame: 4 weeks
  description: The change in severity as assessed by a blinded clinician using the severity of the functional movement disorder by means of the Simplified Version of the Psychogenic Movement Disorders Rating Scale (S-FMDRS). Scoring: 0-3, higher values indicate worse outcome.
  measure: The change in tremor severity
  time frame: 4 weeks
  description: The change in tremor severity assessed using the Fahn Tolosa Marin Tremor-Rating-Scale.
  Scoring: 0-4, higher values indicate worse outcome.
  measure: Change in the ability of emotion regulation
  time frame: 4 weeks
  description: The change in the ability of emotion regulation assessed using the Emotion Regulation Questionnaire.
  High scores on the reassessment scale suggest that the person is more likely to use cognitive strategies to change the emotional meaning of situations. This may be associated with better emotional adaptability and well-being.
  High scores on the suppression scale indicate that the person is more inclined to suppress or avoid the expression of emotions. This may be associated with lower emotional adaptability and well-being.
  measure: Changes in patients EEG-activity.
  time frame: 4 weeks
  description: Training-based changes in patients' EEG activity will be assessed for a) tasks-related changes in EEG alpha frequency power (TRPs) as well as b) frontal alpha asymmetry changes during the generation of cognitive reappraisals. Changes in these parameters should unterline behavioral changes in reappraisal success, divergent thinking, and executive functioning. Moreover, we will look at c) the EEG theta/beta frequency ratio to map changes in stress coping, emotion regulation, and behavioral flexibility.
  measure: Change in the patients Creativity
  time frame: 4 weeks
  description: The change in creativity assessed using the Verbal Creativity Test. No Minimum or Maximum values, higher score = better outcome.
  measure: Change in the patients Welfare- Health Questionnaire EQ-5D-5L.
  time frame: 4 weeks
  description: The change in the patients welfare assessed using the Health Questionnaire EQ-5D-5L.
  5 Level, Scores: 1-5, higher values indicate worse outcome.
  1 overall Scale: 0-100, higher values indicate better outcome.
  measure: Change in the patients Welfare- Short Form Health Questionnaire
  time frame: 4 weeks
  description: The change in the patients welfare assessed using the Short Form Health Questionnaire.
  The possible score ranges from 0 to 100 points, with 0 points representing the greatest possible restriction of health, while 100 points indicate no health restriction.
  measure: Change in the patients Welfare - Psychosomatic Assessment Health-DISC. Minimum value in each section: 0 Maximum value in each section: 10 Higher scores = better outcome.
  time frame: 4 weeks
  description: The change in the patients welfare assessed using the Psychosomatic Assessment Health-DISC 6 Levels, Scores: 0-10, higher values indicate better outcome.
  measure: Change in patients personality and behavioral aspects
  time frame: 4 weeks
  description: The change in patients personality and behavioral aspects assessed using the Level of Personality Functioning Scale.
  The items are on a 4-point Likert scale from 1 ("doesn't apply at all") to 4 ("applies exactly") to"). The evaluation is carried out by means of summaries, so that values on the Overall scale: 12 - 48 Subscales Self and Interpersonal: 6 - 24
  measure: Long-term change in Self-assessed health - Patient Global Impression of Change
  time frame: 8 weeks
  description: Self-assessed health according to Patient Global Impression of Change Scale (PGI-C) rated by the patients themselves.
  Three questions regarding patients mood, everyday bodily function and overall change as well as a rating regarding the relevance of the change (Yes or No). Answer options:
  Very Much worse Much worse Slightly worse No change Marginally better Much better Very Much better Higher values = better outcome
  measure: Long-term change in Self-assessed health - Patient Global Impression Severity Scale
  time frame: 8 weeks
  description: Self-assessed health according to Patient Global Impression of Severity Scale (PGI-S) rated by the patients themselves.
  Three questions regarding patients current mood, influence of the symptoms on everyday bodily function and overall severity.
  Answer options:
  Not at all/very easy
  Lightly
  Moderate
  Strong
  Very strong Higher values = worse outcome
  arm group label: Cognitive Reappraisal
  arm group type: Experimental
  description: The intervention group completes CBT-training to improve their cognitive reappraisal and emotion-regulation-skills.
  arm group label: Reflection
  arm group type: Sham Comparator
  description: The control group completes tasks based on reflection about their daily lifes, which should have no impact on their emotion-regulation-skills or functional motor disorder.
  intervention type: Behavioral
  intervention name: Cognitive Reappraisal
  description: Patients complete 14 tasks on an app in a time span of 4 weeks in which they are asked to cognitively reappraise fear or anger inducing situations and are encouraged to implement this strategy into their daily lifes.
  arm group label: Cognitive Reappraisal
  intervention type: Behavioral
  intervention name: Reflection
  description: Patients complete 14 tasks on an app in a time span of 4 weeks in which they are asked to reflect on certain topics of their day.
  arm group label: Reflection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Corinna Perchtold-Stefan, PhD
  role: Study Chair
  affiliation: University of Graz
  last name: Petra Schwingenschuh, MD
  role: Study Chair
  affiliation: Medical University of Graz
  last name: Daniela Kern, MD
  phone: 004331638516051
  email: daniela.eibl@medunigraz.at
  last name: Petra Schwingenschuh, MD
  phone: 004331638583379
  email: petra.schwingenschuh@medunigraz.at
  facility: 
  status: Recruiting
  contact: 
  country: Austria
  responsible party type: Sponsor
  mesh term: Movement Disorders
  mesh term: Conversion Disorder
  mesh term: Hysteria
  sharing ipd: No