NCT04423783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

4.2 years

First QC Date

May 14, 2020

Last Update Submit

November 6, 2024

Conditions

Keywords

GamificationAnxiety DisorderAvoidanceApp

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (3)

  • Change in disgust before and after playing the app

    Before starting and immediately after completing the game

  • Change in arousal before and after playing the app

    Before starting and immediately after completing the game

  • Change in anxiety before and after playing the app

    Before starting and immediately after completing the game

Other Outcomes (4)

  • Beck Depression Inventory II (BDI-II)

    Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)

  • Brief Symptom Inventory (BSI)

    Baseline, Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)

  • German version of the Client Satisfaction Questionnaire (CSQ-8)

    (after one-session exposure if applied), Post-treatment (1-week after baseline); 3-week follow-up (4-weeks after baseline)

  • +1 more other outcomes

Study Arms (3)

Spider gamification app

EXPERIMENTAL

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)

Online exposure + spider gamification app

EXPERIMENTAL

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)Behavioral: Therapist-guided one-session online exposure therapy according to (Öst, 1989)

Online exposure + non-spider gamification app

ACTIVE COMPARATOR

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

Behavioral: Therapist-guided one-session online exposure therapy according to (Öst, 1989)

Interventions

Confrontation with spiders via gamified app

Also known as: Spider Gamification App
Online exposure + spider gamification appSpider gamification app

Massed exposure therapy over the course of one single session, applied in a remote-online context

Also known as: Online exposure
Online exposure + non-spider gamification appOnline exposure + spider gamification app

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must
  • be 18 years or older,
  • SPQ score ≥ 14
  • BDI-II score ≤ 18

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Philipps University Marburg

Marburg, Germany

Location

Philipps-University Marburg Clinical Psychology and Psychotherapy

Marburg, Germany

Location

MeSH Terms

Conditions

ArachnophobiaAnxiety DisordersAlzheimer Disease

Condition Hierarchy (Ancestors)

Mental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive Disorders

Study Officials

  • Anke Haberkamp, PhD

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2020

First Posted

June 9, 2020

Study Start

July 1, 2020

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Share anonymized IPD via a general-purpose open-access repository

Time Frame
end of the study; unlimited
Access Criteria
open-access

Locations