<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/NCT03012035</url>
  </required_header>
  <id_info>
    <org_study_id>SPFE 2017</org_study_id>
    <nct_id>NCT03012035</nct_id>
  </id_info>
  <brief_title>The Role of Treatment Expectation in Exposure Training With Spider Fearful Participants</brief_title>
  <official_title>The Role of Treatment Expectation in Exposure Training With Spider Fearful Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      This study evaluates the role of treatment success expectation in spider fearful individuals&#xD;
      on the actual treatment success. Half of participants will have positive treatment success&#xD;
      expectations, while the other half will have neutral treatment outcome expectations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigator plan to conduct a randomized, single blind study with two parallel groups.&#xD;
      Both groups undergo the same standardized psychotherapeutic intervention, i.e. exposure&#xD;
      training. All participants will receive the same exposure training in groups of maximum three&#xD;
      participants of the same study group. The two study groups only differ regarding the induced&#xD;
      treatment expectations towards the effects of the exposure training. While the experimental&#xD;
      group will get an open administration of treatment and be informed in order to have a&#xD;
      positive treatment expectation, the comparator group will receive a hidden administration of&#xD;
      treatment and get neutral information, thus treatment expectations will be neutral. Study&#xD;
      members conducting the exposure training with the participants will not be aware of the&#xD;
      allocation of the study participants. Study participants will be informed about the aim of&#xD;
      the allocated condition, but they will be blind to the aim of the study in order to induce&#xD;
      the specific expectation. Differences in treatment outcomes are compared between both groups&#xD;
      to investigate the association with treatment expectation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 18, 2017</start_date>
  <completion_date type="Actual">March 12, 2018</completion_date>
  <primary_completion_date type="Actual">March 12, 2018</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in subjective anxiety assessed by questionnaire</measure>
    <time_frame>Baseline, Pre exposition, Post exposition, Recovery; time between baseline and recovery approximately lasts 21 days</time_frame>
    <description>assessment of change in subjective anxiety by questionnaire at selcted time points</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Phobic Disorders</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Before participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>comparator group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>positive treatment expectations</intervention_name>
    <description>Before participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment).</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>neutral treatment expectations</intervention_name>
    <description>The comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment).</description>
    <arm_group_label>comparator group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  good knowledge of German language&#xD;
&#xD;
          -  fulfilling criteria A-E and G for specific phobia according to Diagnostic and&#xD;
             Statistical Manual of Mental Disorders (DSM)-V (fulfilling criteria F is not an&#xD;
             inclusion criteria)&#xD;
&#xD;
               -  marked fear or anxiety about spiders&#xD;
&#xD;
               -  spiders almost always provoke immediate fear or anxiety&#xD;
&#xD;
               -  spiders are actively avoided or endured with intense fear or anxiety&#xD;
&#xD;
               -  the fear or anxiety is out of proportion to the actual danger posed by spiders&#xD;
&#xD;
               -  the fear, anxiety, or avoidance is persistent, typically lasting for 6 months or&#xD;
                  more&#xD;
&#xD;
               -  the disturbance is not better explained by the symptoms of mental disorders as&#xD;
                  agoraphobia, obsessive-compulsive disorder, posttraumatic stress disorder,&#xD;
                  separation anxiety or social anxiety disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute or chronic psychiatric disorder&#xD;
&#xD;
          -  currently in psychological or psychiatric treatment&#xD;
&#xD;
          -  knowledge of exposure training&#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>Jens Gaab, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Clinical Psychology and Psychotherapy University of Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Clinical Psychology and Psychotherapy University of Basel</name>
      <address>
        <city>Basel</city>
        <zip>4055</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>March 20, 2018</last_update_submitted>
  <last_update_submitted_qc>March 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psychotherapy</keyword>
  <keyword>exposition</keyword>
  <keyword>spider fear</keyword>
  <keyword>expectation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phobic 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>


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/NCT03012035
org study id: SPFE 2017
nct id: NCT03012035
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the role of treatment success expectation in spider fearful individuals
      on the actual treatment success. Half of participants will have positive treatment success
      expectations, while the other half will have neutral treatment outcome expectations.
The investigator plan to conduct a randomized, single blind study with two parallel groups.
      Both groups undergo the same standardized psychotherapeutic intervention, i.e. exposure
      training. All participants will receive the same exposure training in groups of maximum three
      participants of the same study group. The two study groups only differ regarding the induced
      treatment expectations towards the effects of the exposure training. While the experimental
      group will get an open administration of treatment and be informed in order to have a
      positive treatment expectation, the comparator group will receive a hidden administration of
      treatment and get neutral information, thus treatment expectations will be neutral. Study
      members conducting the exposure training with the participants will not be aware of the
      allocation of the study participants. Study participants will be informed about the aim of
      the allocated condition, but they will be blind to the aim of the study in order to induce
      the specific expectation. Differences in treatment outcomes are compared between both groups
      to investigate the association with treatment expectation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change in subjective anxiety assessed by questionnaire
time frame: Baseline, Pre exposition, Post exposition, Recovery; time between baseline and recovery approximately lasts 21 days
description: assessment of change in subjective anxiety by questionnaire at selcted time points
arm group label: experimental group
arm group type: Experimental
description: Before participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment).
arm group label: comparator group
arm group type: Other
description: The comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment).
intervention type: Other
intervention name: positive treatment expectations
description: Before participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment).
arm group label: experimental group
intervention type: Other
intervention name: neutral treatment expectations
description: The comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment).
arm group label: comparator group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jens Gaab, Prof. Dr.
role: Principal Investigator
affiliation: Department of Clinical Psychology and Psychotherapy University of Basel
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Phobic Disorders
sharing ipd: No