Sinasprite: A Pilot Feasibility Study for Patients With Anxiety or Stress

NCT02955784 | Completed

• 1 other identifier: 215019
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are proposing a prospective one-arm cohort study testing the feasibility of a game designed to improve symptoms in adults with mild levels of stress, depression, and anxiety. The study will take place at Madigan Army Medical Center. Primary outcomes include usage data including time, frequency and duration of app use, participant satisfaction with the game, and comments and suggestions regarding participants' experiences using the Sinasprite game over a 12-week period. Participants will download Litesprite's game, Sinasprite, onto their personal smartphone. Elements of cognitive-behavioral therapies like cognitive strategies, diaphragmatic breathing, and visualization are embedded in the game enabling participants to learn to achieve the desired healthy habits. The game's goal is to help Socks the Fox become a Zen Master. Over six weeks, players help Socks to progress by describing and categorizing their concerns, entrusting Socks to "hold" these concerns, and engaging in bonding activities with Socks, such as fishing and meditation. The investigators currently have a prototype and have been told by insurance firms, providers, and self-funded employers that they need to see validated results from a pilot study that shows feasibility with subjects in the target audience before they can consider a commercial roll out. Participants will complete questions related to mood, stress, and well-being at baseline, 6 weeks, and 12 weeks. Data will be evaluated in real-time and reports of participant progress will be provided to the participant's provider, with the participant's consent. Data and feedback from this pilot study will be used to update the design and inform the technical development team to further refine the game experience in preparation for a larger randomized controlled trial evaluating the effectiveness of Sinasprite.

Conditions

Stress; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction. These data will be collected via questionnaire at the end of the study only

  Data is via a standardized satisfaction questionnaire developed by the authors that is a mixture of open ended and likert scale questions on satisfaction with the app.

  12 wks

Secondary Outcomes (8)

• Measure of perceived stress (PSS)

  Pre/post (0, 6 and 12 wks)

• Quality of life (LiSAT-9)

  Pre/post (0, 6 and 12 wks)

• Symptom reports: measure of depression symptoms (PHQ-9 score)

  Pre/post (0, 6, and 12 wks)

• Symptom reports: measure of anxiety symptoms (GAD-7 score)

  Pre/post (0, 6, and 12 wks)

• Measure of coping self-efficacy (CSE) questionnaire

  Pre/post (0, 6 and 12 wks)

Study Arms (1)

Sinasprite Mobile App

EXPERIMENTAL

Mobile App

Device: Sinasprite Mobile App

Interventions

Sinasprite Mobile App DEVICE

Mobile App

Sinasprite Mobile App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Eligible to receive care at a MHS clinic
• English-speaking
• In possession of a personal smartphone capable of downloading the Sinasprite application for use during the study
• Self-reported PHQ-9 score ≤ 10 and no self-reported suicidal or homicidal ideation
• Self-reported GAD-7 score ≤ 10 and no self-reported suicidal or homicidal ideation
• No change in antidepressant or antianxiety medication and/or dosage in past 3 months

You may not qualify if:

• Under 18 years of age
• English insufficient to interact with the game or complete assessments
• Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, people living in a rehabilitation facility)
• Self-reported PHQ-9 score \> 10 or self-reported suicidal or homicidal ideation
• Self-reported GAD-7 score \> 10 or self-reported suicidal or homicidal ideation
• Change in antidepressant or antianxiety medication and/or dosage in past 3 months

Sponsors & Collaborators

• Madigan Army Medical Center: lead

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98401, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: November 4, 2016
• Study Start: January 22, 2015
• Primary Completion: February 14, 2018
• Study Completion: February 14, 2018
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

US (1)