Feasibility, Usability, User Satisfaction, and Preliminary Efficacy of a Smartphone Intervention for Subthreshold Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Feasibility, as measured by adherence to the smartphone application intervention.
Study Overview
Brief Summary
The study aimed to examine the feasibility, usability, user satisfaction, safety, and preliminary efficacy of a smartphone application intervention for young adults with subthreshold depression.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 24 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18-24 years
- •Has a Center for Epidemiologic Studies Depression Scale score of ≥16
- •Owns a smartphone with the iOS® operating system
Exclusion Criteria
- •Lifetime history of major depressive disorder
- •Lifetime history of bipolar disorder
- •Currently receiving treatment for a mental health problem from a mental health professional
- •Experience of a major depressive episode in the 2 weeks prior to the study, as ascertained using the Mini-International Neuropsychiatric Interview
Arms & Interventions
Smartphone Application
SPSRS is a smartphone application system designed to improve self-confidence in individuals with subthreshold depression. The application presents a motion picture that displays words every 5 s for improving self-confidence of the user.
Intervention: Smartphone Application (Device)
Outcomes
Primary Outcomes
Feasibility, as measured by adherence to the smartphone application intervention.
Time Frame: 5 weeks after initiating the intervention
Adherence is calculated as the number of minutes in a week for which the participant uses the SPSRS application divided by the recommended weekly duration (70 min).
Secondary Outcomes
- Usability and user satisfaction(5 weeks after initiating the intervention)
- Number of participants with treatment-related adverse events as assessed by Mini-International Neuropsychiatric Interview.(baseline and 1, 2, 3, 4, and 5 weeks after initiating the intervention)
- Depressive symptoms(baseline and 5 weeks after initiating the intervention)
- Inflammatory biomarker(baseline and 5 weeks after initiating the intervention)
- General self-efficacy(baseline and 5 weeks after initiating the intervention)
- Social anxiety(baseline and 5 weeks after initiating the intervention)
- Mental health(baseline and 5 weeks after initiating the intervention)
Investigators
Kazuki Hirao, PhD, OT
Assistant Professor
Kibi International University