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Gamification in the Treatment of Spider Phobia

Primary Purpose

Spider Phobia

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
7-day exposure therapy via self-developed app according to (Haberkamp et al., submitted)
Therapist-guided one-session online exposure therapy according to (Öst, 1989)
Sponsored by
Anke Haberkamp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spider Phobia focused on measuring Gamification, Anxiety Disorder, Avoidance, App

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Philipps University MarburgRecruiting
  • Philipps-University Marburg Clinical Psychology and PsychotherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Spider gamification app

Online exposure + spider gamification app

Online exposure + non-spider gamification app

Arm Description

Participants play the spider gamification app twice a day for 7 days

Participants receive a therapist-guided one-session online exposure therapy and play the spider gamification app twice a day for 7 days

Participants receive a therapist-guided one-session online exposure therapy and play a non-spider gamification app twice a day for 7 days

Outcomes

Primary Outcome Measures

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").
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.
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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
May 14, 2020
Last Updated
April 27, 2022
Sponsor
Anke Haberkamp
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1. Study Identification

Unique Protocol Identification Number
NCT04423783
Brief Title
Gamification in the Treatment of Spider Phobia
Official Title
Testing a Gamified App to Reduce Avoidance and Fear of Spiders in Spider Phobia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anke Haberkamp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spider Phobia
Keywords
Gamification, Anxiety Disorder, Avoidance, App

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spider gamification app
Arm Type
Experimental
Arm Description
Participants play the spider gamification app twice a day for 7 days
Arm Title
Online exposure + spider gamification app
Arm Type
Experimental
Arm Description
Participants receive a therapist-guided one-session online exposure therapy and play the spider gamification app twice a day for 7 days
Arm Title
Online exposure + non-spider gamification app
Arm Type
Active Comparator
Arm 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(s)
7-day exposure therapy via self-developed app according to (Haberkamp et al., submitted)
Other Intervention Name(s)
Spider Gamification App
Intervention Description
Confrontation with spiders via gamified app
Intervention Type
Behavioral
Intervention Name(s)
Therapist-guided one-session online exposure therapy according to (Öst, 1989)
Other Intervention Name(s)
Online exposure
Intervention Description
Massed exposure therapy over the course of one single session, applied in a remote-online context
Primary Outcome Measure Information:
Title
Change in avoidance behavior (Behavioral Approach Task; BAT)
Description
Scores range from 0 ("participant refuses to enter the room with spider") to 12 ("participant holds the spider at least for 20 sec").
Time Frame
Baseline; (after one-session exposure if applied); Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
Title
Change in spider fear (Spider Phobia Questionnaire; SPQ)
Description
The scale ranges from 0-31. High scores reflect high subjective levels and low scores low subjective levels of spider fear.
Time Frame
Baseline; Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
Title
Change in spider fear: Spider-Anxiety Questionnaire (FAS)
Description
The scale ranges from 0-108. High scores reflect high subjective levels and low scores low subjective levels of spider fear.
Time Frame
Baseline; Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
Secondary Outcome Measure Information:
Title
Change in disgust before and after playing the app
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
Time Frame
Before starting and immediately after completing the game
Title
Change in arousal before and after playing the app
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
Time Frame
Before starting and immediately after completing the game
Title
Change in anxiety before and after playing the app
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
Time Frame
Before starting and immediately after completing the game
Other Pre-specified Outcome Measures:
Title
Beck Depression Inventory II (BDI-II)
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.
Time Frame
Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
Title
Brief Symptom Inventory (BSI)
Description
Measures clinically relevant psychological symptoms.
Time Frame
Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
Title
German version of the Client Satisfaction Questionnaire (CSQ-8)
Description
Standardised satisfaction measurement
Time Frame
(after one-session exposure if applied), Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)
Title
Mobile Application Rating Scale (MARS)
Description
Questionnaire assessing the quality of new user-oriented health applications
Time Frame
Post-treatment (1-week after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anke Haberkamp, PhD
Phone
+49 6421 2823656
Email
Anke.Haberkamp@staff.uni-marburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anke Haberkamp, PhD
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philipps University Marburg
City
Marburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anke Haberkamp, PhD
Email
Anke.Haberkamp@staff.uni-marburg.de
First Name & Middle Initial & Last Name & Degree
Anke Haberkamp, PhD
First Name & Middle Initial & Last Name & Degree
Filipp Schmidt, PhD
Facility Name
Philipps-University Marburg Clinical Psychology and Psychotherapy
City
Marburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anke Haberkamp, PhD
Phone
+49 6421 28-23656
Email
Anke.Haberkamp@staff.uni-marburg.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Gamification in the Treatment of Spider Phobia

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