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Smartphone Intervention for Subthreshold Depression

Primary Purpose

Subthreshold Depression

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Smartphone Application
Sponsored by
Kibi International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Subthreshold Depression

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kibi International University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Smartphone Application

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Usability and user satisfaction
USE Questionnaire
Number of participants with treatment-related adverse events as assessed by Mini-International Neuropsychiatric Interview.
Mini-International Neuropsychiatric Interview
Depressive symptoms
Center for Epidemiologic Studies Depression Scale score
Inflammatory biomarker
Level of salivary interleukin-6
General self-efficacy
General Self-Efficacy Scale score
Social anxiety
Liebowitz Social Anxiety Scale score
Mental health
12-item General Health Questionnaire score

Full Information

First Posted
April 3, 2017
Last Updated
July 26, 2017
Sponsor
Kibi International University
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1. Study Identification

Unique Protocol Identification Number
NCT03110016
Brief Title
Smartphone Intervention for Subthreshold Depression
Official Title
Feasibility, Usability, User Satisfaction, and Preliminary Efficacy of a Smartphone Intervention for Subthreshold Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kibi International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subthreshold Depression

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone Application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Smartphone Application
Intervention Description
The participants use SPSRS to watch the motion picture for at least 10 min a day for 5 weeks.
Primary Outcome Measure Information:
Title
Feasibility, as measured by adherence to the smartphone application intervention.
Description
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).
Time Frame
5 weeks after initiating the intervention
Secondary Outcome Measure Information:
Title
Usability and user satisfaction
Description
USE Questionnaire
Time Frame
5 weeks after initiating the intervention
Title
Number of participants with treatment-related adverse events as assessed by Mini-International Neuropsychiatric Interview.
Description
Mini-International Neuropsychiatric Interview
Time Frame
baseline and 1, 2, 3, 4, and 5 weeks after initiating the intervention
Title
Depressive symptoms
Description
Center for Epidemiologic Studies Depression Scale score
Time Frame
baseline and 5 weeks after initiating the intervention
Title
Inflammatory biomarker
Description
Level of salivary interleukin-6
Time Frame
baseline and 5 weeks after initiating the intervention
Title
General self-efficacy
Description
General Self-Efficacy Scale score
Time Frame
baseline and 5 weeks after initiating the intervention
Title
Social anxiety
Description
Liebowitz Social Anxiety Scale score
Time Frame
baseline and 5 weeks after initiating the intervention
Title
Mental health
Description
12-item General Health Questionnaire score
Time Frame
baseline and 5 weeks after initiating the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuki Hirao, PhD
Organizational Affiliation
Kibi International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kibi International University
City
Takahashi
State/Province
Okayama
Country
Japan

12. IPD Sharing Statement

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Smartphone Intervention for Subthreshold Depression

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