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

Primary Purpose

Stress, Depression, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sinasprite Mobile App
Sponsored by
Madigan Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Under 18 years of age
  2. English insufficient to interact with the game or complete assessments
  3. 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)
  4. Self-reported PHQ-9 score > 10 or self-reported suicidal or homicidal ideation
  5. Self-reported GAD-7 score > 10 or self-reported suicidal or homicidal ideation
  6. Change in antidepressant or antianxiety medication and/or dosage in past 3 months

Sites / Locations

  • Madigan Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sinasprite Mobile App

Arm Description

Mobile App

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Measure of perceived stress (PSS)
Participants will complete the 10 item perceived stress scale (PSS validated questionnaire) at 0, 6 and 12 wks.
Quality of life (LiSAT-9)
Participants will complete the LiSAT-9 validated questionnaire at 0, 6, and 12 weeks to assess their quality of life during the study.
Symptom reports: measure of depression symptoms (PHQ-9 score)
Participants will complete the 9 item PHQ-9 validated questionnaire at 0, 6, and 12 wks to assess participant symptoms of self-reported depression during the study.
Symptom reports: measure of anxiety symptoms (GAD-7 score)
Participants will complete the 7 item GAD-7 validated questionnaire at 0, 6, and 12 wks to assess participant symptoms of self-reported anxiety during the study.
Measure of coping self-efficacy (CSE) questionnaire
Participants will complete the 26 item coping self-efficacy (CSE) validated questionnaire at 0, 6 and 12 wks to assess their coping self-efficacy during the study.
App daily usage (minutes/day)
Time (minutes per day) app was used
App frequency usage (days/week)
Frequency (days/week) app was used
App duration of usage (total weeks)
Weeks app was used

Full Information

First Posted
January 6, 2015
Last Updated
May 4, 2017
Sponsor
Madigan Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02955784
Brief Title
Sinasprite: A Pilot Feasibility Study for Patients With Anxiety or Stress
Official Title
Sinasprite: A Pilot Feasibility Study of a Casual Game for Primary Care Patients With Mild Stress, Anxiety or Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2015 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Madigan Army Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In the U.S. anxiety disorders cost over $55 billion, and major depression is second only to back and neck pain for having the greatest impact on disability days at 386.6 million days/year. Primary care providers (PCPs) are overwhelmingly responsible for screening and treating their patients for behavioral health conditions such as depression and anxiety, and approximately 70-80% of antidepressants are prescribed in primary care. Nearly 17% of the population will experience depression at some point in their lifetime, but of those treated for depression in the primary care setting, only 20-40% show substantial improvement over 12 months. Insurance companies spend $1 trillion annually on behavioral health conditions. $250 billion is spent on our target segment - those with high stress or mild to moderate depression/anxiety, but no serious mental illness requiring intensive or inpatient treatment. These populations have significantly adopted and use mobile technologies for health purposes. Current solutions, like AppsRx, ORCAS, or SuperBetter, are clinically-focused or, at best, use game elements as opposed to a full gaming experience and do not target payers or hospitals. LinkedWellness has a true gaming experience for anxiety/depression, but their target audience is solely focused on teens. None of these incorporate the player's social networks, biosensors, collect information from the phone, or provide predictive insights. Therefore, tools to enhance management of these patients in a primary care setting, such as the casual health-related game Sinasprite, may improve treatment of difficult-to-manage behavioral health conditions. 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 players 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sinasprite Mobile App
Arm Type
Experimental
Arm Description
Mobile App
Intervention Type
Device
Intervention Name(s)
Sinasprite Mobile App
Intervention Description
Mobile App
Primary Outcome Measure Information:
Title
Patient satisfaction. These data will be collected via questionnaire at the end of the study only
Description
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.
Time Frame
12 wks
Secondary Outcome Measure Information:
Title
Measure of perceived stress (PSS)
Description
Participants will complete the 10 item perceived stress scale (PSS validated questionnaire) at 0, 6 and 12 wks.
Time Frame
Pre/post (0, 6 and 12 wks)
Title
Quality of life (LiSAT-9)
Description
Participants will complete the LiSAT-9 validated questionnaire at 0, 6, and 12 weeks to assess their quality of life during the study.
Time Frame
Pre/post (0, 6 and 12 wks)
Title
Symptom reports: measure of depression symptoms (PHQ-9 score)
Description
Participants will complete the 9 item PHQ-9 validated questionnaire at 0, 6, and 12 wks to assess participant symptoms of self-reported depression during the study.
Time Frame
Pre/post (0, 6, and 12 wks)
Title
Symptom reports: measure of anxiety symptoms (GAD-7 score)
Description
Participants will complete the 7 item GAD-7 validated questionnaire at 0, 6, and 12 wks to assess participant symptoms of self-reported anxiety during the study.
Time Frame
Pre/post (0, 6, and 12 wks)
Title
Measure of coping self-efficacy (CSE) questionnaire
Description
Participants will complete the 26 item coping self-efficacy (CSE) validated questionnaire at 0, 6 and 12 wks to assess their coping self-efficacy during the study.
Time Frame
Pre/post (0, 6 and 12 wks)
Title
App daily usage (minutes/day)
Description
Time (minutes per day) app was used
Time Frame
12 wks
Title
App frequency usage (days/week)
Description
Frequency (days/week) app was used
Time Frame
12 wks
Title
App duration of usage (total weeks)
Description
Weeks app was used
Time Frame
12 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas M Maurer, DO, MPH
Phone
253-968-2911
Email
douglas.m.maurer.mil@mail.mil
Facility Information:
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas M Maurer, DO, MPH
Phone
253-968-2911
Email
douglas.m.maurer.mil@mail.mil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study still in data collection process

Learn more about this trial

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

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