Smartphone Intervention for Subthreshold Depression

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

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 Overview

• Status: Completed
• Conditions: Subthreshold Depression
• Intervention / Treatment: Device: Smartphone Application

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Okayama
    • Takahashi, Okayama, Japan
      • Kibi International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Smartphone Application; The participants use SPSRS to watch the motion picture for at least 10 min a day for 5 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kibi International University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 16, 2017
• Primary Completion (ACTUAL): June 30, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 16-55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No