Back to resultsTreating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression
Primary Purpose
Subthreshold Depression
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Smartphone Application (SPSRS)
Smartphone Application (YouTube)
Sponsored by
About this trial
This is an interventional treatment trial for Subthreshold Depression
Eligibility Criteria
Inclusion Criteria:
- Male and female
- 20 to 39 years old
- Beck Depression Inventory-II (BDI-II) score of 10 points or more
- Persons with written informed consent prior to participation
Exclusion Criteria:
- History of mental illness
- Currently receiving treatment from a professional for mental health issues
- Vision or hearing problems that interfere with daily life.
- With a major depressive episode in the last two weeks according to the Mini-International Neuropsychiatric Interview
Sites / Locations
- Gunma University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Smartphone Application (SPSRS)
Smartphone Application (YouTube)
Arm Description
The experimental group receives video-viewing intervention using the SPSRS application, which is a smartphone application. SPSRS is programmed to present 150 ms of positive words after presenting 17 ms of self-confidence-boosting words in videos. These words are repeated every 5 s. The words to increase self-confidence are "can," "let us try," "good luck," "able," and "do not worry". These self-confidence-boosting words randomly appear in the four corners of the screen. The positive words are "nice," "great," "fantastic," "satisfactory," and "enjoyable". These words are displayed at the center of the screen. Interveners use the SPSRS application according to the operating manual. The participants will use an iPhone managed by interveners to watch a pre-determined 10-minute video.
The control group uses the same iPhone as the experimental group. The control group uses the YouTube application to receive video-viewing intervention. The control group videos do not show confidence-boosting and positive words. The control group watches the same video as the experimental group for 10 min.
Outcomes
Primary Outcome Measures
Profile of Mood States 2nd Edition-Adult Short (POMS 2-A Short)
The POMS 2-A Short is a 35-item self-administered questionnaire used to measure mood states. Items are rated using a 5-point Likert-type scale (0 = not at all, 1 = a little, 2 = moderately, 3 = quite a lot, and 4 = extremely). The POMS 2-A Short assesses seven domains, namely, anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, vigor-activity, and friendliness. High scores indicate better vigor-activity and friendliness are better but more severe symptoms of the five other domains. In addition, the Total Mood Disturbance (TMD) score is calculated from anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, and vigor-activity. TDM is calculated based on a standard value (mean of 50 and standard deviation of 10).
Secondary Outcome Measures
State-Trait Anxiety Inventory State (STAI-S)
The STAI is a self-administered questionnaire consisting of two scales that each assesses state anxiety and trait anxiety. Each scale consists of 20 items. Items for STAI-S are scored using a 4-point Likert-type scale (1 = not at all, 2 = somewhat, 3 = moderately so, and 4 = very much so) with the total score ranging from 20 to 80 points. The higher the score, the greater the state anxiety.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04707495
Brief Title
Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression
Official Title
Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
June 14, 2021 (Actual)
Study Completion Date
June 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gunma 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
Major depressive disorder (MDD) is an important public health problem. Thus, preventive interventions against subthreshold depression (StD), which is one of the key risk factors for the development of MDD, are important. The study developed a smartphone application (SPSRS) that improves depressive symptoms in people with StD by automatically presenting positive word stimuli during videos. The SPSRS application has the potential to improve depressive symptoms in people with StDs. However, whether it can immediately improve depressed moods in people with StD is unclear. The study aims to investigate the immediate effects of SPSRS applications on depressed mood in people with StD.
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
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smartphone Application (SPSRS)
Arm Type
Experimental
Arm Description
The experimental group receives video-viewing intervention using the SPSRS application, which is a smartphone application. SPSRS is programmed to present 150 ms of positive words after presenting 17 ms of self-confidence-boosting words in videos.
These words are repeated every 5 s. The words to increase self-confidence are "can," "let us try," "good luck," "able," and "do not worry". These self-confidence-boosting words randomly appear in the four corners of the screen. The positive words are "nice," "great," "fantastic," "satisfactory," and "enjoyable". These words are displayed at the center of the screen. Interveners use the SPSRS application according to the operating manual. The participants will use an iPhone managed by interveners to watch a pre-determined 10-minute video.
Arm Title
Smartphone Application (YouTube)
Arm Type
Active Comparator
Arm Description
The control group uses the same iPhone as the experimental group. The control group uses the YouTube application to receive video-viewing intervention. The control group videos do not show confidence-boosting and positive words. The control group watches the same video as the experimental group for 10 min.
Intervention Type
Device
Intervention Name(s)
Smartphone Application (SPSRS)
Intervention Description
The experimental group receives video-viewing intervention using the SPSRS application, which is a smartphone application. SPSRS is programmed to present 150 ms of positive words after presenting 17 ms of self-confidence-boosting words in videos.
These words are repeated every 5 s. The words to increase self-confidence are "can," "let us try," "good luck," "able," and "do not worry". These self-confidence-boosting words randomly appear in the four corners of the screen. The positive words are "nice," "great," "fantastic," "satisfactory," and "enjoyable". These words are displayed at the center of the screen. Interveners use the SPSRS application according to the operating manual. The participants will use an iPhone managed by interveners to watch a pre-determined 10-minute video.
Intervention Type
Device
Intervention Name(s)
Smartphone Application (YouTube)
Intervention Description
The control group uses the same iPhone as the experimental group. The control group uses the YouTube application to receive video-viewing intervention. The control group videos do not show confidence-boosting and positive words. The control group watches the same video as the experimental group for 10 min.
Primary Outcome Measure Information:
Title
Profile of Mood States 2nd Edition-Adult Short (POMS 2-A Short)
Description
The POMS 2-A Short is a 35-item self-administered questionnaire used to measure mood states. Items are rated using a 5-point Likert-type scale (0 = not at all, 1 = a little, 2 = moderately, 3 = quite a lot, and 4 = extremely). The POMS 2-A Short assesses seven domains, namely, anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, vigor-activity, and friendliness. High scores indicate better vigor-activity and friendliness are better but more severe symptoms of the five other domains. In addition, the Total Mood Disturbance (TMD) score is calculated from anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, and vigor-activity. TDM is calculated based on a standard value (mean of 50 and standard deviation of 10).
Time Frame
Change of POMS 2-A Short from baseline at the end of 10 minutes of intervention.
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory State (STAI-S)
Description
The STAI is a self-administered questionnaire consisting of two scales that each assesses state anxiety and trait anxiety. Each scale consists of 20 items. Items for STAI-S are scored using a 4-point Likert-type scale (1 = not at all, 2 = somewhat, 3 = moderately so, and 4 = very much so) with the total score ranging from 20 to 80 points. The higher the score, the greater the state anxiety.
Time Frame
Change of STAI-S from baseline at the end of 10 minutes of intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female
20 to 39 years old
Beck Depression Inventory-II (BDI-II) score of 10 points or more
Persons with written informed consent prior to participation
Exclusion Criteria:
History of mental illness
Currently receiving treatment from a professional for mental health issues
Vision or hearing problems that interfere with daily life.
With a major depressive episode in the last two weeks according to the Mini-International Neuropsychiatric Interview
Facility Information:
Facility Name
Gunma University
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8514
Country
Japan
12. IPD Sharing Statement
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Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression
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