Clinical Trials Directory

Trials / Completed

CompletedNCT06348511

XTics - A Gamified Enhancer of Non-Pharmacological Interventions in Tic Disorders

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Tel-Aviv Sourasky Medical Center · Other Government
Sex
All
Age
7 Years – 15 Years
Healthy volunteers
Not accepted

Summary

The investigators developed a neuroscientifically-informed gamified tic-therapy platform. The investigators previously identified tic-triggering elements in movies and video games. Next, the investigators employed these elements to generate and validate a gamified intervention protocol, which is based on a video game the investigators designed (called XTics). The study tests the efficacy of the gamified tool integrated in an exposure and response prevention (ERP) protocol to enhance both patient's compliance and clinical outcome.

Detailed description

Background: Behavioral treatments are recommended as first-line interventions for tic disorders (TDs) in children and adults, which affect 2.99% of children. However, the effectiveness of these interventions is often undermined by the limited compliance especially of young individuals with the demanding treatment protocols. Addressing this issue, gamification of the treatment can enhance engagement and adherence in children. In the context of TDs, gamification provides significant additional benefits, particularly robust immediate feedback. This feedback can counteract the negative reinforcement processes, wherein the tic, believed to relieve the unpleasant premonitory urge, becomes consolidated. The investigators developed a gamified Protocol XTics, which leverages the previously untapped potential of combining various tic triggers with immediate reinforcement of tic suppression. The investigators evaluated the clinical value of XTics, focusing particularly on the benefits of immediate reward contingency in enhancing tic suppression performance. Methods: The investigators developed a game incorporating tic triggers validated in a prior study. In one version of the game, its progression was influenced by real-time input from an experimenter who continuously monitored the participant's tics, rewarding tic suppression with favorable game outcomes. Employing a crossover design, the investigators trained 35 participants, aged 7-15, in both this version and another where the game's progression was independent of tic suppression. Following two online group Exposure and Response Prevention (ERP) training sessions, each participant engaged in three hourly sessions for each of the two conditions. Our evaluation focused on how the overall XTics protocol influenced tics and how this influence differed between the contingent and non-contingent versions of the game.

Conditions

Interventions

TypeNameDescription
DEVICEXTicsXTics is a gamified protocol of behavioral treatment for tic disorders. The participant's tics are monitored in real-time and they are reflected as achievements in a game that the participant plays at the same time. The rewards aim to counteract processes that consolidate the tic. XTics is compatible with ERP treatment, and it includes an introductory psychoeducation session and three behavioral training sessions.

Timeline

Start date
2022-07-01
Primary completion
2022-12-31
Completion
2022-12-31
First posted
2024-04-04
Last updated
2024-04-04

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT06348511. Inclusion in this directory is not an endorsement.