Smartphone Intervention for Subthreshold Depression

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility, Usability, User Satisfaction, and Preliminary Efficacy of a Smartphone Intervention for Subthreshold Depression

Conditions
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Subthreshold Depression

Intervention / Treatment
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* Device: Smartphone Application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone Application<br>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. | Device: Smartphone Application<br>* The participants use SPSRS to watch the motion picture for at least 10 min a day for 5 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility, as measured by adherence to the smartphone application 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). | 5 weeks after initiating the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability and user satisfaction | USE Questionnaire | 5 weeks after initiating the intervention | 
| Number of participants with treatment-related adverse events as assessed by Mini-International Neuropsychiatric Interview. | Mini-International Neuropsychiatric Interview | baseline and 1, 2, 3, 4, and 5 weeks after initiating the intervention | 
| Depressive symptoms | Center for Epidemiologic Studies Depression Scale score | baseline and 5 weeks after initiating the intervention | 
| Inflammatory biomarker | Level of salivary interleukin-6 | baseline and 5 weeks after initiating the intervention | 
| General self-efficacy | General Self-Efficacy Scale score | baseline and 5 weeks after initiating the intervention | 
| Social anxiety | Liebowitz Social Anxiety Scale score | baseline and 5 weeks after initiating the intervention | 
| Mental health | 12-item General Health Questionnaire score | baseline and 5 weeks after initiating the intervention |