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StressNCT02955784

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

A study testing Sinasprite Mobile App in people with Stress and Depression, run by Madigan Army Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stress, Depression, Anxiety
What is being tested?
Sinasprite Mobile App
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
22 Jan 2015to 14 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Madigan Army Medical Center

    Tacoma, Washington, 98401

Other trials in United States

About this study

Official title: Sinasprite: A Pilot Feasibility Study of a Casual Game for Primary Care Patients With Mild Stress, Anxiety or Depression

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.

Read the 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.

Being tested
Sinasprite Mobile App
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sinasprite Mobile AppDevice

    Mobile App

Study groups in NCT02955784
Study groupRoleWhat they receive
Sinasprite Mobile AppExperimentalMobile App
Receives: Device: Sinasprite Mobile App

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 wks

Secondary outcomes (8)
  1. Measure of perceived stress (PSS)

    Participants will complete the 10 item perceived stress scale (PSS validated questionnaire) at 0, 6 and 12 wks.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. App daily usage (minutes/day)

    Time (minutes per day) app was used

    Measured: 12 wks

  7. App frequency usage (days/week)

    Frequency (days/week) app was used

    Measured: 12 wks

  8. App duration of usage (total weeks)

    Weeks app was used

    Measured: 12 wks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2016 (estimated)
  2. Study start22 Jan 2015
  3. Primary completion14 Feb 2018
  4. Study completion14 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02955784
Sponsor's protocol ID
215019
Status last verified
Dec 2024
First submitted
6 Jan 2015
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: Study still in data collection process

Questions about this trial

What is this clinical trial studying?

A study testing Sinasprite Mobile App in people with Stress and Depression, run by Madigan Army Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient satisfaction. These data will be collected via questionnaire at the end of the study only (time frame: 12 wks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.

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