- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04423783
Gamification in the Treatment of Spider Phobia
November 16, 2023 updated by: Anke Haberkamp
Testing a Gamified App to Reduce Avoidance and Fear of Spiders in Spider Phobia
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anke Haberkamp, PhD
- Phone Number: +49 6421 2823656
- Email: Anke.Haberkamp@staff.uni-marburg.de
Study Locations
-
-
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Marburg, Germany
- Recruiting
- Philipps University Marburg
-
Contact:
- Anke Haberkamp, PhD
- Email: Anke.Haberkamp@staff.uni-marburg.de
-
Principal Investigator:
- Anke Haberkamp, PhD
-
Principal Investigator:
- Filipp Schmidt, PhD
-
Marburg, Germany
- Recruiting
- Philipps-University Marburg Clinical Psychology and Psychotherapy
-
Contact:
- Anke Haberkamp, PhD
- Phone Number: +49 6421 28-23656
- Email: Anke.Haberkamp@staff.uni-marburg.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Participants must
- be 18 years or older,
- SPQ score ≥ 14
- BDI-II score ≤ 18
Exclusion Criteria:
Participants will be deemed ineligible if they do not meet the above inclusion criteria or
- are allergic to spiders or bee stings,
- are currently undergoing psychotherapeutic and/or psychopharmacological treatments,
- are experiencing current psychosis, mania, or substance abuse, or
- successfully complete 8 or more of 12 possible BAT steps at baseline (to ensure that participants are indeed spider fearful)
- are at higher risk from Covid-19 or
- participated in a pilot study in 2019.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spider gamification app
Participants play the spider gamification app twice a day for 7 days
|
Behavioral: 7-day exposure therapy via self-developed app according to (Haberkamp et al., submitted)
Confrontation with spiders via gamified app
Other Names:
|
Experimental: Online exposure + spider gamification app
Participants receive a therapist-guided one-session online exposure therapy and play the spider gamification app twice a day for 7 days
|
Behavioral: 7-day exposure therapy via self-developed app according to (Haberkamp et al., submitted)
Confrontation with spiders via gamified app
Other Names:
Massed exposure therapy over the course of one single session, applied in a remote-online context
Other Names:
|
Active Comparator: Online exposure + non-spider gamification app
Participants receive a therapist-guided one-session online exposure therapy and play a non-spider gamification app twice a day for 7 days
|
Massed exposure therapy over the course of one single session, applied in a remote-online context
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Scores range from 0 ("participant refuses to enter the room with spider") to 12 ("participant holds the spider at least for 20 sec").
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Baseline; (after one-session exposure if applied); Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
|
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)
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The scale ranges from 0-31.
High scores reflect high subjective levels and low scores low subjective levels of spider fear.
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Baseline; Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
|
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)
|
The scale ranges from 0-108.
High scores reflect high subjective levels and low scores low subjective levels of spider fear.
|
Baseline; Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in disgust before and after playing the app
Time Frame: Before starting and immediately after completing the game
|
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
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Before starting and immediately after completing the game
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Change in arousal before and after playing the app
Time Frame: Before starting and immediately after completing the game
|
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
|
Before starting and immediately after completing the game
|
Change in anxiety before and after playing the app
Time Frame: Before starting and immediately after completing the game
|
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
|
Before starting and immediately after completing the game
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory II (BDI-II)
Time Frame: Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
|
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.
|
Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
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Brief Symptom Inventory (BSI)
Time Frame: Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
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Measures clinically relevant psychological symptoms.
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Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
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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)
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Standardised satisfaction measurement
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(after one-session exposure if applied), Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
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Mobile Application Rating Scale (MARS)
Time Frame: Post-treatment (1-week after baseline)
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Questionnaire assessing the quality of new user-oriented health applications
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Post-treatment (1-week after baseline)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anke Haberkamp, PhD, Philipps University Marburg Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
May 14, 2020
First Submitted That Met QC Criteria
June 8, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaSpPh
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Share anonymized IPD via a general-purpose open-access repository
IPD Sharing Time Frame
end of the study; unlimited
IPD Sharing Access Criteria
open-access
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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