Smartphone Intervention for Subthreshold Depression

Subthreshold Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110016
• Other study ID #: 16-55
• Status: Completed
• Phase: N/A
• First received: April 3, 2017
• Last updated: July 26, 2017
• Start date: May 16, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2017
• Source: Kibi International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Subthreshold Depression

Intervention

Device:
• Smartphone Application
The participants use SPSRS to watch the motion picture for at least 10 min a day for 5 weeks.

Locations

Country	Name	City	State
Japan	Kibi International University	Takahashi	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
Kibi International University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Usability and user satisfaction	USE Questionnaire	5 weeks after initiating the intervention
Secondary	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
Secondary	Depressive symptoms	Center for Epidemiologic Studies Depression Scale score	baseline and 5 weeks after initiating the intervention
Secondary	Inflammatory biomarker	Level of salivary interleukin-6	baseline and 5 weeks after initiating the intervention
Secondary	General self-efficacy	General Self-Efficacy Scale score	baseline and 5 weeks after initiating the intervention
Secondary	Social anxiety	Liebowitz Social Anxiety Scale score	baseline and 5 weeks after initiating the intervention
Secondary	Mental health	12-item General Health Questionnaire score	baseline and 5 weeks after initiating the intervention