Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04423783
Other study ID # GaSpPh
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date August 2025

Study information

Verified date November 2023
Source Philipps University Marburg Medical Center
Contact Anke Haberkamp, PhD
Phone +49 6421 2823656
Email Anke.Haberkamp@staff.uni-marburg.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date August 2025
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
7-day exposure therapy via self-developed app according to (Haberkamp et al., submitted)
Confrontation with spiders via gamified app
Therapist-guided one-session online exposure therapy according to (Öst, 1989)
Massed exposure therapy over the course of one single session, applied in a remote-online context

Locations

Country Name City State
Germany Philipps University Marburg Marburg
Germany Philipps-University Marburg Clinical Psychology and Psychotherapy Marburg

Sponsors (1)

Lead Sponsor Collaborator
Anke Haberkamp

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Beck Depression Inventory II (BDI-II) 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)
Other Brief Symptom Inventory (BSI) Measures clinically relevant psychological symptoms. Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
Other German version of the Client Satisfaction Questionnaire (CSQ-8) Standardised satisfaction measurement (after one-session exposure if applied), Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
Other Mobile Application Rating Scale (MARS) Questionnaire assessing the quality of new user-oriented health applications Post-treatment (1-week after baseline)
Primary Change in avoidance behavior (Behavioral Approach Task; BAT) Scores range from 0 ("participant refuses to enter the room with spider") to 12 ("participant holds the spider at least for 20 sec"). Baseline; (after one-session exposure if applied); Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
Primary Change in spider fear (Spider Phobia Questionnaire; SPQ) The scale ranges from 0-31. 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)
Primary Change in spider fear: Spider-Anxiety Questionnaire (FAS) 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 Change in disgust before and after playing the app 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 Before starting and immediately after completing the game
Secondary Change in arousal before and after playing the app 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
Secondary Change in anxiety before and after playing the app 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
See also
  Status Clinical Trial Phase
Completed NCT02973919 - EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome N/A
Completed NCT03410264 - One-session Treatment for Spider Fears N/A
Completed NCT04470882 - Use of Safety Behaviors in Exposure Therapy for Arachnophobia N/A