<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/NCT03780881</url>
  </required_header>
  <id_info>
    <org_study_id>2018-37k</org_study_id>
    <nct_id>NCT03780881</nct_id>
  </id_info>
  <brief_title>EXperimental Paradigm to Investigate Expectation Change in Depression 4</brief_title>
  <acronym>EXPECD4</acronym>
  <official_title>Worse Than Expected - Differences Between Healthy and Depressed People in Processing Unexpectedly Negative Information</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philipps University Marburg Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philipps University Marburg Medical Center</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>
      Research has shown that people with depressive symptoms maintain negative expectations even&#xD;
      if they have positive experiences that contradict their expectations. Healthy people,&#xD;
      however, change their expectations after unexpected positive experiences. In this&#xD;
      experimental study, it will now be examined whether there are also differences between&#xD;
      healthy people and people with depressive symptoms in dealing with unexpected negative&#xD;
      experiences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research has already shown that people with depressive symptoms continue to hold on to&#xD;
      negative expectations even if they have positive experiences that contradict their&#xD;
      expectations. By contrast, healthy people change their expectations after unexpectedly&#xD;
      positive experiences. In this experimental study, the authors will now examine whether there&#xD;
      are also differences between healthy people and people with depressive symptoms in processing&#xD;
      unexpectedly negative experiences. It is hypothesized that people with depressive symptoms&#xD;
      change their expectations in a negative direction after unexpectedly negative experiences,&#xD;
      while healthy people continue to hold on to an optimistic view.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 11, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</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>Participants are assigned to one of two experimental groups in parallel for the duration of the study</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The investigator randomly assigns participants to one of the experimental conditions. Participants are not aware which experimental condition they are allocated to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>2-Item Performance Expectations Scale - generalized</measure>
    <time_frame>Immediately before the performance test and immediately after completion of the performance test</time_frame>
    <description>Changes from baseline to postassessment in generalized performance expectations. Each item is scored from 1 to 7 (1 = very negative expectations, 7 = very positive expectations), yielding a total score between 2 and 14. Higher total scores reflect more positive expectations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2-Item Performance Expectations Scale - task-specific</measure>
    <time_frame>Immediately before the performance test and immediately after completion of the performance test</time_frame>
    <description>Changes from baseline to postassessment in task-specific performance expectations. Each item is scored from 1 to 7 (1 = very negative expectations, 7 = very positive expectations), yielding a total score between 2 and 14. Higher total scores reflect more positive expectations.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>5-Item Cognitive Immunization after Performance Feedback (CIPF) scale</measure>
    <time_frame>Immediately after completion of the performance test</time_frame>
    <description>Engagement in cognitive immunization strategies after receiving performance feedback. Each item is scored from 1 to 7 (1 = no cognitive immunization, 7 = great engagement in cognitive immunization), yielding a total score between 5 and 35. Higher total scores reflect a greater engagement in cognitive immunization strategies.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">171</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Expectation confirmation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in this group receive manipulated feedback indicating that their performance was very good in the test they had previously worked on. This feedback is intended to confirm the previously induced positive expectations of their own performance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expectation disconfirmation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in this group receive manipulated feedback indicating that their performance was below average in the test they had previously worked on. This feedback is intended to negatively disconfirm the previously induced positive expectations of their own performance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Expectation confirmation</intervention_name>
    <description>Participants receive manipulated feedback indicating that their performance was above average in the test they had previously worked on. This feedback is intended to confirm the previously induced positive expectations of their own performance.</description>
    <arm_group_label>Expectation confirmation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Expectation disconfirmation</intervention_name>
    <description>Participants receive manipulated feedback indicating that their performance was below average in the test they had previously worked on. This feedback is intended to negatively disconfirm the previously induced positive expectations of their own performance.</description>
    <arm_group_label>Expectation disconfirmation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (clinical sample):&#xD;
&#xD;
          -  diagnosis of major depression&#xD;
&#xD;
          -  at least 18 years old&#xD;
&#xD;
          -  sufficient German language skills&#xD;
&#xD;
        Exclusion Criteria (clinical sample):&#xD;
&#xD;
          -  participation in previous studies on changes in expectations&#xD;
&#xD;
        Inclusion Criteria (healthy sample):&#xD;
&#xD;
          -  at least 18 years old&#xD;
&#xD;
          -  sufficient German language skills&#xD;
&#xD;
        Exclusion Criteria (clinical sample):&#xD;
&#xD;
          -  participation in previous studies on changes in expectations&#xD;
&#xD;
          -  current diagnosis of any mental disorder&#xD;
&#xD;
          -  diagnosis of major depression in the past&#xD;
&#xD;
          -  currently receiving psychotherapeutic treatment&#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_official>
    <last_name>Tobias Kube, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Philipps University Marburg Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schoen Klinik Bad Arolsen</name>
      <address>
        <city>Bad Arolsen</city>
        <state>Hessen</state>
        <zip>34454</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 13, 2019</last_update_submitted>
  <last_update_submitted_qc>May 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD will be shared</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03780881
org study id: 2018-37k
nct id: NCT03780881
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Research has shown that people with depressive symptoms maintain negative expectations even
      if they have positive experiences that contradict their expectations. Healthy people,
      however, change their expectations after unexpected positive experiences. In this
      experimental study, it will now be examined whether there are also differences between
      healthy people and people with depressive symptoms in dealing with unexpected negative
      experiences.
Research has already shown that people with depressive symptoms continue to hold on to
      negative expectations even if they have positive experiences that contradict their
      expectations. By contrast, healthy people change their expectations after unexpectedly
      positive experiences. In this experimental study, the authors will now examine whether there
      are also differences between healthy people and people with depressive symptoms in processing
      unexpectedly negative experiences. It is hypothesized that people with depressive symptoms
      change their expectations in a negative direction after unexpectedly negative experiences,
      while healthy people continue to hold on to an optimistic view.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to one of two experimental groups in parallel for the duration of the study
primary purpose: Basic Science
masking: Single (Investigator)
masking description: The investigator randomly assigns participants to one of the experimental conditions. Participants are not aware which experimental condition they are allocated to.
measure: 2-Item Performance Expectations Scale - generalized
time frame: Immediately before the performance test and immediately after completion of the performance test
description: Changes from baseline to postassessment in generalized performance expectations. Each item is scored from 1 to 7 (1 = very negative expectations, 7 = very positive expectations), yielding a total score between 2 and 14. Higher total scores reflect more positive expectations.
measure: 2-Item Performance Expectations Scale - task-specific
time frame: Immediately before the performance test and immediately after completion of the performance test
description: Changes from baseline to postassessment in task-specific performance expectations. Each item is scored from 1 to 7 (1 = very negative expectations, 7 = very positive expectations), yielding a total score between 2 and 14. Higher total scores reflect more positive expectations.
measure: 5-Item Cognitive Immunization after Performance Feedback (CIPF) scale
time frame: Immediately after completion of the performance test
description: Engagement in cognitive immunization strategies after receiving performance feedback. Each item is scored from 1 to 7 (1 = no cognitive immunization, 7 = great engagement in cognitive immunization), yielding a total score between 5 and 35. Higher total scores reflect a greater engagement in cognitive immunization strategies.
arm group label: Expectation confirmation
arm group type: Experimental
description: The participants in this group receive manipulated feedback indicating that their performance was very good in the test they had previously worked on. This feedback is intended to confirm the previously induced positive expectations of their own performance.
arm group label: Expectation disconfirmation
arm group type: Experimental
description: The participants in this group receive manipulated feedback indicating that their performance was below average in the test they had previously worked on. This feedback is intended to negatively disconfirm the previously induced positive expectations of their own performance.
intervention type: Behavioral
intervention name: Expectation confirmation
description: Participants receive manipulated feedback indicating that their performance was above average in the test they had previously worked on. This feedback is intended to confirm the previously induced positive expectations of their own performance.
arm group label: Expectation confirmation
intervention type: Behavioral
intervention name: Expectation disconfirmation
description: Participants receive manipulated feedback indicating that their performance was below average in the test they had previously worked on. This feedback is intended to negatively disconfirm the previously induced positive expectations of their own performance.
arm group label: Expectation disconfirmation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tobias Kube, PhD
role: Principal Investigator
affiliation: Philipps University Marburg Medical Center
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
sharing ipd: No
ipd description: No IPD will be shared