Study Protocol for a Smartphone Application-based Intervention for Subthreshold Depression
Primary Purpose
Subthreshold Depression
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Smartphone Application
Sponsored by
About this trial
This is an interventional treatment trial for Subthreshold Depression
Eligibility Criteria
Inclusion Criteria:
- 18 Years and older
- Males and females
- Center for Epidemiologic Studies Depression Scale score ≥16
- Written informed consent prior to participation
- Owns a smartphone with the iOS® operating system
Exclusion Criteria:
- Lifetime history of psychiatric disorders
- 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
- Vision or hearing deficits that negatively impact everyday life
Sites / Locations
- Kibi International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Smartphone Application
No Intervention
Arm Description
Participants watch a video using the Smartphone Application displaying positive word stimuli.
No Intervention.
Outcomes
Primary Outcome Measures
Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
The CES-D is a 20-item self-report questionnaire used to measure depressive symptoms. The CES-D is a four-point Likert scale, with each item scored from 0 to 3. The total score ranges from 0 to 60 points. The higher the score, the stronger the depressive symptoms.
Secondary Outcome Measures
Psychological distress as measured by the Kessler Screening Scale for Psychological Distress (K6) score.
The K6 is a 6-item self-report questionnaire used to measure psychological distress. The K6 is a five-point Likert scale, with each item scored from 0 to 4. The total score ranges from 0 to 24 points. The higher the score, the stronger the psychological distress.
Anxiety as measured by the 7-item Generalized Anxiety Disorder Scale (GAD-7).
The GAD-7 is a 7-item self-report questionnaire used to measure anxiety. The GAD-7 is a four-point Likert scale, with each item scored from 0 to 3. The total score ranges from 0 to 21 points. The higher the score, the stronger the anxiety.
Full Information
NCT ID
NCT04136041
First Posted
October 21, 2019
Last Updated
March 30, 2020
Sponsor
Kibi International University
1. Study Identification
Unique Protocol Identification Number
NCT04136041
Brief Title
Study Protocol for a Smartphone Application-based Intervention for Subthreshold Depression
Official Title
Study Protocol for a Pilot Randomized Controlled Trial on a Smartphone Application-based Intervention for Subthreshold Depression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
March 5, 2020 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators plan to conduct a randomized controlled trial to examine whether a Smartphone-based Intervention improves subthreshold depression symptoms compared to no intervention.
The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smartphone Application
Arm Type
Experimental
Arm Description
Participants watch a video using the Smartphone Application displaying positive word stimuli.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No Intervention.
Intervention Type
Device
Intervention Name(s)
Smartphone Application
Intervention Description
The experimental group will watch movies using the Smartphone application for at least 10 min a day for 5 weeks.
Primary Outcome Measure Information:
Title
Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
Description
The CES-D is a 20-item self-report questionnaire used to measure depressive symptoms. The CES-D is a four-point Likert scale, with each item scored from 0 to 3. The total score ranges from 0 to 60 points. The higher the score, the stronger the depressive symptoms.
Time Frame
Change from Baseline CES-D at 5 weeks
Secondary Outcome Measure Information:
Title
Psychological distress as measured by the Kessler Screening Scale for Psychological Distress (K6) score.
Description
The K6 is a 6-item self-report questionnaire used to measure psychological distress. The K6 is a five-point Likert scale, with each item scored from 0 to 4. The total score ranges from 0 to 24 points. The higher the score, the stronger the psychological distress.
Time Frame
Change from Baseline K6 at 5 weeks
Title
Anxiety as measured by the 7-item Generalized Anxiety Disorder Scale (GAD-7).
Description
The GAD-7 is a 7-item self-report questionnaire used to measure anxiety. The GAD-7 is a four-point Likert scale, with each item scored from 0 to 3. The total score ranges from 0 to 21 points. The higher the score, the stronger the anxiety.
Time Frame
Change from Baseline GAD-7 at 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 Years and older
Males and females
Center for Epidemiologic Studies Depression Scale score ≥16
Written informed consent prior to participation
Owns a smartphone with the iOS® operating system
Exclusion Criteria:
Lifetime history of psychiatric disorders
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
Vision or hearing deficits that negatively impact everyday life
Facility Information:
Facility Name
Kibi International University
City
Takahashi
State/Province
Okayama
ZIP/Postal Code
716-8508
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31977910
Citation
Kato Y, Kageyama K, Mesaki T, Uchida H, Sejima Y, Marume R, Takahashi K, Hirao K. Study protocol for a pilot randomized controlled trial on a smartphone application-based intervention for subthreshold depression: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Jan;99(4):e18934. doi: 10.1097/MD.0000000000018934.
Results Reference
derived
Learn more about this trial
Study Protocol for a Smartphone Application-based Intervention for Subthreshold Depression
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