XTics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

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Tic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study tested the impact of contingent and immediate reward (ICR) given by the game in respect to the participant's tic frequency relative to a random and non-contingent delayed reward (DR) provided by the end of the training day. Each participant underwent three training days in each of the the modes during one week. The training days included 3 (first day) or 4 (second and third days) game sessions. The order of the training modes was random.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Personnel who interact directly with the study subjects were not aware of the assigned treatments. Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group.

Study Groups

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Immediate and contingent reward (ICR)

Tic suppression directly affects gameplay, with participants informed that suppressing tics weakens opponents and improves card acquisition. Daily sessions end with feedback on suppression performance relative to that day's baseline.

Group Type EXPERIMENTAL

Intervention Type DEVICE

XTics 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.

Delayed reward (DR)

The gameplay does not depend on performance, but participants still receive end-of-session feedback on tic suppression.

Group Type ACTIVE_COMPARATOR

XTics

Intervention Type DEVICE

XTics 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.

Interventions

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XTics

XTics 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children and youths aged 7-15 years,
* At least moderate tic severity as indicated by a Yale Global Tic Severity Scale (YGTSS) tic severity score ≥ 11 and
* Tic frequency of over one tic per minute on average in the screening interview.

Exclusion Criteria

* Behavioral treatment for tics in the past 12 months
* Pharmacological treatment for tics that has not been stable the for the past 6 weeks or with planned changes during study participation
* Evidence of tics that may produce physical harm to the child
* A history of psychiatric or neurological disorders requiring hospitalisation or a known cognitive decline.

Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No