Gamified App on Increasing Physical Activity and Reducing Anxiety in Autism

Anxiety Clinical Trial

Official title:

Effects of a Gamified, Behavior Change Technique-Based Mobile App on Increasing Physical Activity and Reducing Anxiety in Adults With Autism Spectrum Disorder: Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05466617
• Other study ID #: 1807483245
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: July 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Physical activity (PA) has an impact on physical and mental health in neurotypical populations, and addressing these variables may improve the prevalent burden of anxiety in adults with autism spectrum disorder (ASD). Gamified mobile apps using behavior change techniques present a promising way of increasing PA and reducing sedentary time, thus reducing anxiety in adults with ASD.

Objective: This study aimed to compare the effectiveness of a gamified and behavior change technique-based mobile app, PuzzleWalk, versus a commercially available app, Google Fit, on increasing PA and reducing sedentary time as an adjunct anxiety treatment for this population.

Methods: A total of 24 adults with ASD were assigned to either the PuzzleWalk or Google Fit group for 5 weeks using a covariate-adaptive randomization design. PA and anxiety were assessed over 7 days at 3 different data collection periods (ie, baseline, intervention start, and intervention end) using triaxial accelerometers and the Beck Anxiety Inventory. Group differences in outcome variables were assessed using repeated-measures analysis of covariance, adjusting for age, sex, and BMI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 30, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self-reported medical diagnosis of anxiety or self-identification of experiencing anxiety symptoms for the past 3 or more months

• Access to a supported device (smartphones with Android 4.4 and higher or iOS 9.0 and higher operating system)

• Cognitive ability to understand the purpose of the study

• No prior experience using the PA mobile apps used in the study

Exclusion Criteria:

• Individuals with low cognitive function, co-occurring intellectual disabilities, or mobility impairments

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Autism Spectrum Disorder
• Autistic Disorder
• Mobile Health
• Physical Activity

Intervention

Behavioral:
• Mobile Health for Physical Activity Behavior Change
All participants received visualized step-by-step instructions (eg, search and download on Google Play or App Store, user registration, goal setting, and PA behavior tracking) on the assigned PA app (PuzzleWalk or Google Fit) and used it from the beginning of the intervention start (fourth week) until the end of the intervention (eighth week). Both the PuzzleWalk and Google Fit groups received reminders regarding the use of the PA app during the first week of the intervention period and autonomously continued to use the app until the intervention ended.

Locations

Country	Name	City	State
United States	Indiana University School of Public Health	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	American College of Sports Medicine Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Physical Activity and Changes from Baseline Physical Activity at 4th and 8th weeks	Accelerometer-Measured Objective Physical Activity Levels	7 days over three different data collection periods (total 21 days)
Secondary	Baseline Anxiety and Changes from Baseline Anxiety at 4th and 8th weeks	Beck Anxiety Inventory (BAI; Beck, Epstein, Brown, & Steer, 1988) was used to assess participants' prolonged state of anxiety. The Beck Anxiety Inventory is a self-report scale comprising 21 items that measure the severity of anxiety symptoms during the past week. The score range is 0-63, with higher scores indicating greater degrees of anxiety.	7 days over three different data collection periods (total 21 days)