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

Kibi International University1 site in 1 country22 target enrollmentMay 16, 2017

ConditionsSubthreshold Depression

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Subthreshold Depression
Sponsor: Kibi International University
Enrollment: 22
Locations: 1
Primary Endpoint: Feasibility, as measured by adherence to the smartphone application intervention.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

May 16, 2017

End Date

June 30, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kibi International University

Responsible Party

Principal Investigator

Kazuki Hirao, PhD, OT

Assistant Professor

Kibi International University

Eligibility Criteria

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

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)