Smartphone Intervention for Subthreshold Depression

Not Applicable

Completed

• Conditions: Subthreshold Depression

• Registration Number: NCT03110016
• Lead Sponsor: Kibi International University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Start: 2017-05-16
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility, as measured by adherence to the smartphone application intervention.	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 Outcome Measures

Name	Time	Method
Usability and user satisfaction	5 weeks after initiating the intervention	USE Questionnaire
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	Mini-International Neuropsychiatric Interview
Depressive symptoms	baseline and 5 weeks after initiating the intervention	Center for Epidemiologic Studies Depression Scale score
Inflammatory biomarker	baseline and 5 weeks after initiating the intervention	Level of salivary interleukin-6
General self-efficacy	baseline and 5 weeks after initiating the intervention	General Self-Efficacy Scale score
Social anxiety	baseline and 5 weeks after initiating the intervention	Liebowitz Social Anxiety Scale score
Mental health	baseline and 5 weeks after initiating the intervention	12-item General Health Questionnaire score

Trial Locations

Locations (1)

Kibi International University; 🇯🇵 Takahashi, Okayama, Japan