Smartphone Intervention for Subthreshold Depression
Feasibility, Usability, User Satisfaction, and Preliminary Efficacy of a Smartphone Intervention for Subthreshold Depression
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
May 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedJuly 28, 2017
July 1, 2017
2 months
April 3, 2017
July 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Smartphone Application
EXPERIMENTALSPSRS 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.
Interventions
The participants use SPSRS to watch the motion picture for at least 10 min a day for 5 weeks.
Eligibility Criteria
You may qualify if:
- Aged 18-24 years
- Has a Center for Epidemiologic Studies Depression Scale score of ≥16
- Owns a smartphone with the iOS® operating system
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kibi International University
Takahashi, Okayama-ken, Japan
Study Officials
- PRINCIPAL INVESTIGATOR
Kazuki Hirao, PhD
Kibi International University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 3, 2017
First Posted
April 12, 2017
Study Start
May 16, 2017
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
July 28, 2017
Record last verified: 2017-07