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/NCT06022432</url>
    </required_header>
    <id_info>
      <org_study_id>2022-76k</org_study_id>
      <nct_id>NCT06022432</nct_id>
    </id_info>
    <brief_title>Overcoming Treatment Barriers</brief_title>
    <acronym>OBSTACLE-S</acronym>
    <official_title>Overcoming Treatment Barriers: The Role of Expectations in the Behavioral Intention of Treatment Seeking for Social Anxiety</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>
        This study aims to assess whether negative or rather the lack of positive treatment&#xD;
        expectations could be positively influenced by online short interventions and increase&#xD;
        intention so seek treatment and actual help-seeking behavior when compared to a no-treatment&#xD;
        control group. Further, the study investigators like to explore if specifically focusing on&#xD;
        intensifying positive treatment expectations vs. a reduction of expectations about negative&#xD;
        treatment effects will influence the pattern of results differently.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators expect that participants receiving an intervention e.g., amplifying&#xD;
        positive (performance) expectancies vs. reducing negative (performance) expectancies of&#xD;
        psychotherapeutic treatment, will show an increase in intentions to seek treatment and are&#xD;
        more likely to report actual treatment-seeking behavior after the intervention when compared&#xD;
        with participants who will describe their treatment expectations via a writing task.&#xD;
  &#xD;
        Further, the investigators want to explore if the expectancy-modulating interventions will&#xD;
        differently affect the intention to seek treatment within socially anxious individuals.&#xD;
  &#xD;
        If participants agree, the investigators plan to assess changes in expectations, attitudes as&#xD;
        well as actual treatment seeking behavior at a Follow-Up assessment one week later (data from&#xD;
        Follow-Up will be analyzed exploratively and is not part of the main hypotheses).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 17, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">September 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>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Treatment Expectations (Treatment Expectation Questionnaire, &quot;TEX-Q&quot;)</measure>
      <time_frame>At baseline (pre-measurement), immediately after intervention (post-measurement, approximately 20 minutes after beginning of study procedure) and at Follow-Up investigation (one week after post measurement)</time_frame>
      <description>Explicit treatment expectations measured by 15 items on a 11point Likert-scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in intention to seek treatment</measure>
      <time_frame>At baseline (pre-measurement), immediately after intervention (post-measurement, approximately 20 minutes after beginning of study procedure) and at Follow-Up investigation (one week after post measurement)</time_frame>
      <description>Estimated Probability to seek treatment on a self-generated rating scale from 0 (not likely at all) to 100 (very much likely)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intention to seek treatment (Behavioral Outcome 1)</measure>
      <time_frame>After intervention (post measurement, approximately 30 minutes after beginning of study procedure)</time_frame>
      <description>Participants respond with &quot;yes&quot; or &quot;no&quot; to indicate their interest to receive more concrete information about social anxiety and its treatment possibilities. If the answer was answered with &quot;yes&quot;, participants are asked to give their e-mail address to receive information which is used to assess intention to seek treatment in form of a behavioral outcome.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Treatment-seeking behavior (Behavioral Outcome 2)</measure>
      <time_frame>At Follow-Up investigation (one week after post measurement)</time_frame>
      <description>If participants agree to participate at our Follow Up, a second behavioral outcome will be assessed. Participants will be asked if they meanwhile have researched more concrete information about social anxiety online, connected with internet platforms or self-support groups, applied for online therapy programs/sessions, contacted or sought professional help for outpatient or psychiatric clinics. All categories have to be answered by a dichotomous scale (&quot;yes&quot; or &quot;no&quot;).</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Health Care Utilization</condition>
    <condition>Health Care Seeking Behavior</condition>
    <arm_group>
      <arm_group_label>Reducing Negative Expectations</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will watch a video of a patient-therapist interaction. The testimonial of the patient is framed to reduce negative expectations about therapeutic treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Maximizing Positive Expectations</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will watch a video of a patient-therapist interaction. The testimonial of the patient is framed to maximize positive expectations about therapeutic treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>This group will explicate their current treatment expectations in a writing task.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Video of a patients testimonial</intervention_name>
      <description>The intervention is a prerecorded video of a re-enacted patient-therapist interaction whereby the patient gives a testimonial about the treatment process while either reducing negative expectations or maximizing positive expectations about therapy, respectively.</description>
      <arm_group_label>Maximizing Positive Expectations</arm_group_label>
      <arm_group_label>Reducing Negative Expectations</arm_group_label>
      <other_name>Free-Writing Task</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Writing Task</intervention_name>
      <description>Participants write freely about their current treatment expectations / apprehensions to seek treatment</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  at least 18 years old&#xD;
  &#xD;
            -  fluent in German (C Level)&#xD;
  &#xD;
            -  access to a computer device with internet access&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  non correctable hearing or visual impairment&#xD;
  &#xD;
            -  current in psychotherapeutic treatment or on a waiting list&#xD;
  &#xD;
            -  no neurological impairment or psychotic disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Philipps-Universität Marburg</name>
        <address>
          <city>Marburg</city>
          <zip>35032</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Leonora Schäfer, M.Sc.</last_name>
        <phone>+49 6421 28-24050</phone>
        <email>leonora.schaefer@uni-marburg.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 22, 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>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT06022432
  org study id: 2022-76k
  nct id: NCT06022432
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to assess whether negative or rather the lack of positive treatment
        expectations could be positively influenced by online short interventions and increase
        intention so seek treatment and actual help-seeking behavior when compared to a no-treatment
        control group. Further, the study investigators like to explore if specifically focusing on
        intensifying positive treatment expectations vs. a reduction of expectations about negative
        treatment effects will influence the pattern of results differently.
  The investigators expect that participants receiving an intervention e.g., amplifying
        positive (performance) expectancies vs. reducing negative (performance) expectancies of
        psychotherapeutic treatment, will show an increase in intentions to seek treatment and are
        more likely to report actual treatment-seeking behavior after the intervention when compared
        with participants who will describe their treatment expectations via a writing task.
  
        Further, the investigators want to explore if the expectancy-modulating interventions will
        differently affect the intention to seek treatment within socially anxious individuals.
  
        If participants agree, the investigators plan to assess changes in expectations, attitudes as
        well as actual treatment seeking behavior at a Follow-Up assessment one week later (data from
        Follow-Up will be analyzed exploratively and is not part of the main hypotheses).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Change in Treatment Expectations (Treatment Expectation Questionnaire, "TEX-Q")
  time frame: At baseline (pre-measurement), immediately after intervention (post-measurement, approximately 20 minutes after beginning of study procedure) and at Follow-Up investigation (one week after post measurement)
  description: Explicit treatment expectations measured by 15 items on a 11point Likert-scale
  measure: Changes in intention to seek treatment
  time frame: At baseline (pre-measurement), immediately after intervention (post-measurement, approximately 20 minutes after beginning of study procedure) and at Follow-Up investigation (one week after post measurement)
  description: Estimated Probability to seek treatment on a self-generated rating scale from 0 (not likely at all) to 100 (very much likely)
  measure: Intention to seek treatment (Behavioral Outcome 1)
  time frame: After intervention (post measurement, approximately 30 minutes after beginning of study procedure)
  description: Participants respond with "yes" or "no" to indicate their interest to receive more concrete information about social anxiety and its treatment possibilities. If the answer was answered with "yes", participants are asked to give their e-mail address to receive information which is used to assess intention to seek treatment in form of a behavioral outcome.
  measure: Treatment-seeking behavior (Behavioral Outcome 2)
  time frame: At Follow-Up investigation (one week after post measurement)
  description: If participants agree to participate at our Follow Up, a second behavioral outcome will be assessed. Participants will be asked if they meanwhile have researched more concrete information about social anxiety online, connected with internet platforms or self-support groups, applied for online therapy programs/sessions, contacted or sought professional help for outpatient or psychiatric clinics. All categories have to be answered by a dichotomous scale ("yes" or "no").
  arm group label: Reducing Negative Expectations
  arm group type: Experimental
  description: This group will watch a video of a patient-therapist interaction. The testimonial of the patient is framed to reduce negative expectations about therapeutic treatment.
  arm group label: Maximizing Positive Expectations
  arm group type: Experimental
  description: This group will watch a video of a patient-therapist interaction. The testimonial of the patient is framed to maximize positive expectations about therapeutic treatment.
  arm group label: Control Group
  arm group type: Other
  description: This group will explicate their current treatment expectations in a writing task.
  intervention type: Other
  intervention name: Video of a patients testimonial
  description: The intervention is a prerecorded video of a re-enacted patient-therapist interaction whereby the patient gives a testimonial about the treatment process while either reducing negative expectations or maximizing positive expectations about therapy, respectively.
  arm group label: Maximizing Positive Expectations
  arm group label: Reducing Negative Expectations
  other name: Free-Writing Task
  intervention type: Other
  intervention name: Writing Task
  description: Participants write freely about their current treatment expectations / apprehensions to seek treatment
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: Germany
  responsible party type: Sponsor
  sharing ipd: No