<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/NCT04423783</url>
  </required_header>
  <id_info>
    <org_study_id>GaSpPh</org_study_id>
    <nct_id>NCT04423783</nct_id>
  </id_info>
  <brief_title>Gamification in the Treatment of Spider Phobia</brief_title>
  <official_title>Testing a Gamified App to Reduce Avoidance and Fear of Spiders in Spider Phobia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anke Haberkamp</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>
      Mobile applications are more and more considered when implementing programs for treating&#xD;
      mental disorders. The study aims to reduce avoidance and fear of spiders in spider-fearful&#xD;
      individuals by combining exposure principles with gamification elements (e.g. narrative&#xD;
      background, level progression, points, feedback). We investigate the efficacy of the gamified&#xD;
      app in a remote online-therapy context.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2022</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in avoidance behavior (Behavioral Approach Task; BAT)</measure>
    <time_frame>Baseline; (after one-session exposure if applied); Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)</time_frame>
    <description>Scores range from 0 (&quot;participant refuses to enter the room with spider&quot;) to 12 (&quot;participant holds the spider at least for 20 sec&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in spider fear (Spider Phobia Questionnaire; SPQ)</measure>
    <time_frame>Baseline; Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)</time_frame>
    <description>The scale ranges from 0-31. High scores reflect high subjective levels and low scores low subjective levels of spider fear.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in spider fear: Spider-Anxiety Questionnaire (FAS)</measure>
    <time_frame>Baseline; Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)</time_frame>
    <description>The scale ranges from 0-108. High scores reflect high subjective levels and low scores low subjective levels of spider fear.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in disgust before and after playing the app</measure>
    <time_frame>Before starting and immediately after completing the game</time_frame>
    <description>Seven-point rating scale scoring from 0 to 6: high scores reflect high levels and low scores low levels of experienced disgust; participants play twice a day (between 8 - 11 am and 4 - 7 pm); ratings are part of the app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in arousal before and after playing the app</measure>
    <time_frame>Before starting and immediately after completing the game</time_frame>
    <description>Seven-point rating scale scoring from 0 to 6: high scores reflect high levels and low scores low levels of experienced arousal; participants play twice a day (between 8 - 11 am and 4 - 7 pm); ratings are part of the app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety before and after playing the app</measure>
    <time_frame>Before starting and immediately after completing the game</time_frame>
    <description>Seven-point rating scale scoring from 0 to 6: high scores reflect high levels and low scores low levels of experienced anxiety; participants play twice a day (between 8 - 11 am and 4 - 7 pm); ratings are part of the app</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Beck Depression Inventory II (BDI-II)</measure>
    <time_frame>Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)</time_frame>
    <description>Measures severity of depression; The scale ranges from 0-63: 0-13 minimal depressive symptoms; 14-19 mild symptoms; 20-28 moderate symptoms; 29-63 severe symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Brief Symptom Inventory (BSI)</measure>
    <time_frame>Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)</time_frame>
    <description>Measures clinically relevant psychological symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>German version of the Client Satisfaction Questionnaire (CSQ-8)</measure>
    <time_frame>(after one-session exposure if applied), Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)</time_frame>
    <description>Standardised satisfaction measurement</description>
  </other_outcome>
  <other_outcome>
    <measure>Mobile Application Rating Scale (MARS)</measure>
    <time_frame>Post-treatment (1-week after baseline)</time_frame>
    <description>Questionnaire assessing the quality of new user-oriented health applications</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Spider Phobia</condition>
  <arm_group>
    <arm_group_label>Spider gamification app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants play the spider gamification app twice a day for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Online exposure + spider gamification app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive a therapist-guided one-session online exposure therapy and play the spider gamification app twice a day for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Online exposure + non-spider gamification app</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive a therapist-guided one-session online exposure therapy and play a non-spider gamification app twice a day for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>7-day exposure therapy via self-developed app according to (Haberkamp et al., submitted)</intervention_name>
    <description>Confrontation with spiders via gamified app</description>
    <arm_group_label>Online exposure + spider gamification app</arm_group_label>
    <arm_group_label>Spider gamification app</arm_group_label>
    <other_name>Spider Gamification App</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapist-guided one-session online exposure therapy according to (Öst, 1989)</intervention_name>
    <description>Massed exposure therapy over the course of one single session, applied in a remote-online context</description>
    <arm_group_label>Online exposure + non-spider gamification app</arm_group_label>
    <arm_group_label>Online exposure + spider gamification app</arm_group_label>
    <other_name>Online exposure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants must&#xD;
&#xD;
          -  be 18 years or older,&#xD;
&#xD;
          -  SPQ score ≥ 14&#xD;
&#xD;
          -  BDI-II score ≤ 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants will be deemed ineligible if they do not meet the above inclusion criteria or&#xD;
&#xD;
          -  are allergic to spiders or bee stings,&#xD;
&#xD;
          -  are currently undergoing psychotherapeutic and/or psychopharmacological treatments,&#xD;
&#xD;
          -  are experiencing current psychosis, mania, or substance abuse, or&#xD;
&#xD;
          -  successfully complete 8 or more of 12 possible BAT steps at baseline (to ensure that&#xD;
             participants are indeed spider fearful)&#xD;
&#xD;
          -  are at higher risk from Covid-19 or&#xD;
&#xD;
          -  participated in a pilot study in 2019.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anke Haberkamp, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Philipps University Marburg Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anke Haberkamp, PhD</last_name>
    <phone>+49 6421 2823656</phone>
    <email>Anke.Haberkamp@staff.uni-marburg.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Philipps University Marburg</name>
      <address>
        <city>Marburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anke Haberkamp, PhD</last_name>
      <email>Anke.Haberkamp@staff.uni-marburg.de</email>
    </contact>
    <investigator>
      <last_name>Anke Haberkamp, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Filipp Schmidt, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Philipps-University Marburg Clinical Psychology and Psychotherapy</name>
      <address>
        <city>Marburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anke Haberkamp, PhD</last_name>
      <phone>+49 6421 28-23656</phone>
      <email>Anke.Haberkamp@staff.uni-marburg.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Philipps University Marburg Medical Center</investigator_affiliation>
    <investigator_full_name>Anke Haberkamp</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Gamification</keyword>
  <keyword>Anxiety Disorder</keyword>
  <keyword>Avoidance</keyword>
  <keyword>App</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>Yes</sharing_ipd>
    <ipd_description>Share anonymized IPD via a general-purpose open-access repository</ipd_description>
    <ipd_time_frame>end of the study; unlimited</ipd_time_frame>
    <ipd_access_criteria>open-access</ipd_access_criteria>
  </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/NCT04423783
org study id: GaSpPh
nct id: NCT04423783
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mobile applications are more and more considered when implementing programs for treating
      mental disorders. The study aims to reduce avoidance and fear of spiders in spider-fearful
      individuals by combining exposure principles with gamification elements (e.g. narrative
      background, level progression, points, feedback). We investigate the efficacy of the gamified
      app in a remote online-therapy context.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in avoidance behavior (Behavioral Approach Task; BAT)
time frame: Baseline; (after one-session exposure if applied); Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
description: Scores range from 0 ("participant refuses to enter the room with spider") to 12 ("participant holds the spider at least for 20 sec").
measure: Change in spider fear (Spider Phobia Questionnaire; SPQ)
time frame: Baseline; Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
description: The scale ranges from 0-31. High scores reflect high subjective levels and low scores low subjective levels of spider fear.
measure: Change in spider fear: Spider-Anxiety Questionnaire (FAS)
time frame: Baseline; Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
description: The scale ranges from 0-108. High scores reflect high subjective levels and low scores low subjective levels of spider fear.
measure: Change in disgust before and after playing the app
time frame: Before starting and immediately after completing the game
description: Seven-point rating scale scoring from 0 to 6: high scores reflect high levels and low scores low levels of experienced disgust; participants play twice a day (between 8 - 11 am and 4 - 7 pm); ratings are part of the app
measure: Change in arousal before and after playing the app
time frame: Before starting and immediately after completing the game
description: Seven-point rating scale scoring from 0 to 6: high scores reflect high levels and low scores low levels of experienced arousal; participants play twice a day (between 8 - 11 am and 4 - 7 pm); ratings are part of the app
measure: Change in anxiety before and after playing the app
time frame: Before starting and immediately after completing the game
description: Seven-point rating scale scoring from 0 to 6: high scores reflect high levels and low scores low levels of experienced anxiety; participants play twice a day (between 8 - 11 am and 4 - 7 pm); ratings are part of the app
measure: Beck Depression Inventory II (BDI-II)
time frame: Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
description: Measures severity of depression; The scale ranges from 0-63: 0-13 minimal depressive symptoms; 14-19 mild symptoms; 20-28 moderate symptoms; 29-63 severe symptoms.
measure: Brief Symptom Inventory (BSI)
time frame: Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
description: Measures clinically relevant psychological symptoms.
measure: German version of the Client Satisfaction Questionnaire (CSQ-8)
time frame: (after one-session exposure if applied), Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
description: Standardised satisfaction measurement
measure: Mobile Application Rating Scale (MARS)
time frame: Post-treatment (1-week after baseline)
description: Questionnaire assessing the quality of new user-oriented health applications
arm group label: Spider gamification app
arm group type: Experimental
description: Participants play the spider gamification app twice a day for 7 days
arm group label: Online exposure + spider gamification app
arm group type: Experimental
description: Participants receive a therapist-guided one-session online exposure therapy and play the spider gamification app twice a day for 7 days
arm group label: Online exposure + non-spider gamification app
arm group type: Active Comparator
description: Participants receive a therapist-guided one-session online exposure therapy and play a non-spider gamification app twice a day for 7 days
intervention type: Behavioral
intervention name: 7-day exposure therapy via self-developed app according to (Haberkamp et al., submitted)
description: Confrontation with spiders via gamified app
arm group label: Online exposure + spider gamification app
arm group label: Spider gamification app
other name: Spider Gamification App
intervention type: Behavioral
intervention name: Therapist-guided one-session online exposure therapy according to (Öst, 1989)
description: Massed exposure therapy over the course of one single session, applied in a remote-online context
arm group label: Online exposure + non-spider gamification app
arm group label: Online exposure + spider gamification app
other name: Online exposure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Anke Haberkamp, PhD
role: Principal Investigator
affiliation: Philipps University Marburg Medical Center
last name: Anke Haberkamp, PhD
phone: +49 6421 2823656
email: Anke.Haberkamp@staff.uni-marburg.de
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Philipps University Marburg Medical Center
investigator full name: Anke Haberkamp
investigator title: Principal Investigator
mesh term: Phobic Disorders
sharing ipd: Yes
ipd description: Share anonymized IPD via a general-purpose open-access repository
ipd time frame: end of the study; unlimited
ipd access criteria: open-access