Clinical trial NCT02955784: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Depression
Anxiety
Lead sponsor: Madigan Army Medical Center
Sponsor class: FED
First posted: 2016-11-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction. These data will be collected via questionnaire at the end of the study only
timeFrame: 12 wks
Secondary outcomes:
measure: Measure of perceived stress (PSS)
timeFrame: Pre/post (0, 6 and 12 wks)
measure: Quality of life (LiSAT-9)
timeFrame: Pre/post (0, 6 and 12 wks)
measure: Symptom reports: measure of depression symptoms (PHQ-9 score)
timeFrame: Pre/post (0, 6, and 12 wks)
measure: Symptom reports: measure of anxiety symptoms (GAD-7 score)
timeFrame: Pre/post (0, 6, and 12 wks)
measure: Measure of coping self-efficacy (CSE) questionnaire
timeFrame: Pre/post (0, 6 and 12 wks)
measure: App daily usage (minutes/day)
timeFrame: 12 wks
measure: App frequency usage (days/week)
timeFrame: 12 wks
measure: App duration of usage (total weeks)
timeFrame: 12 wks
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References: