Clinical trial NCT05850312: Gamified Digital Intervention to Enhance the Efficacy of Exposure Therapy for OCD
Official title: Gamified Digital Intervention to Enhance the Efficacy of Exposure Therapy for OCD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Experimental Video Games
Behavioral Assessment
Lead sponsor: Idaho State University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Aim 1 - Clinically analyze the game Militant of the Maze (MoM) as a vehicle for Exposure Theory, including, play, observation, and feedback from five clinicians. MoM, developed in our lab, emphasizes the significance of controlled alternation, while achieving a goal of an individual suffering from OCD who considers that there is only one optimal way of solving a problem. Since this game is already developed in the PI's research lab, this can accommodate OCD treatment strategies, a significant amount of time can be conserved. While the game runs on hand-held devices, all proposed subject testing will be conducted in the laboratory.

Aim 2: Based on the feedback, modifications will be made in MoM to inject narrative, mechanics, and gameplay to address the features of Exposure Therapy that aims to deal with the ob- session/compulsion of cleanliness. One of the key mechanisms of this game will be exposing the patients to simulated human sneezing by using animated splashes of droplets on the screen that the patent will need to wipe without becoming agitated.

Aim 3: Once the game is developed, another round of laboratory case study will be conducted. In the first phase of this round of study, 5 clinicians will play the game to evaluate the revised game MoMG. In the next phase, 5 carefully-selected non-clinician participants will play the game. under real-time observation of clinicians, to ensure that subjects experience no harm, and that the gameplay is interesting and enjoyable. Observational data, including stress measures such as real- time heart rate will be collected, along with verbal protocol and video recording for further analysis, game enhancement, and testing as an exposure therapy mechanism.

Detailed description: A laboratory experiment will be conducted to analyze the playability and feasibility of the proposed game as an effective tool of Exposure Therapy to treat people with cleanliness OCD. The experimental procedure will include the following 3 steps-

1. Initially the aim is to recruit 5 clinicians to play the existing MoM game in a controlled environment. The goal is to congregate their collective feedback about the existing game as well as additional features that needs to be implemented to comprise Exposure Therapy to treat OCD with cleanliness. In addition, a feasibility analysis will be conducted to the proposed gameplay. With these assessments, implementation process will be initiated.
2. A newer and updated version of the game MoM will be implemented based on the outcome of the analysis conducted in the first phase of this experiment. Upon the completion of the development procedure several test runs will be operated to ensure the playability and quality of the game.
3. A second round of data collection will be conducted with a sample size of 10 subjects. In this second round in is intended to recruit both clinicians and non-clinicians as participants of the study. While recruiting, it will be ensured none of the the participants have OCD or other germaphobia. This experiment as well will be conducted in a controlled environment with a goal to ensure that this game does not harm any individual and the gameplay is enjoyable. Data will be collected through various media. Players' certain actions and interactions (e.g. cognitive pause) will be logged in the back end during the gameplay. After certain gameplay, the players' will be provided survey questionnaires, which will long their positive and negative experience and the intrinsic motivation of the gameplay. In addition, to avoid any bias, observational data will be logged through video recording.

Eligibility criteria: Inclusion Criteria:

* Must be a clinician (for Group 1)
* Must be an adult with no symptom of OCD/phobia (for Group 2)

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: Measuring the heart rate control of the player
timeFrame: 2-3 months
measure: Measuring Game Experience Questionnaire (GEQ)
timeFrame: 2-3 months
measure: Measuring Intrinsic Motivational Inventory (IMI)
timeFrame: 2-3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor
name: Farjana Z Eishita, PhD
role: PRINCIPAL_INVESTIGATOR
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