Subthreshold DepressionNCT04707495
Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression
A study testing Smartphone Application (SPSRS) and Smartphone Application (YouTube) in people with Subthreshold Depression, run by Gunma University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 39 years
- Conditions the study is for
- Subthreshold Depression
- What is being tested?
- Smartphone Application (SPSRS) and Smartphone Application (YouTube)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 4 Mar 2021to 14 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial
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.
- Conditions
- Subthreshold Depression
- Being tested
- Smartphone Application (SPSRS), Smartphone Application (YouTube)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone Application (SPSRS)Device
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.
Smartphone Application (YouTube)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone Application (SPSRS) | Experimental | 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. Receives: Device: Smartphone Application (SPSRS) |
| Smartphone Application (YouTube) | Active comparator | 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. Receives: Device: Smartphone Application (YouTube) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change of POMS 2-A Short from baseline at the end of 10 minutes of intervention.
Secondary outcomes (1)
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.
Measured: Change of STAI-S from baseline at the end of 10 minutes of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start4 Mar 2021
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subthreshold DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gunma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazuki Hirao, Gunma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707495
- Sponsor's protocol ID
- HS2020-157
- Status last verified
- Oct 2021
- First submitted
- 11 Jan 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04707495
- Acronym / sponsor ID
- HS2020-157
- Conditions
- Subthreshold Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gunma UniversityUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone Application (SPSRS) | Experimental | Device: Smartphone Application (SPSRS)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. |
| Smartphone Application (YouTube) | Active comparator | Device: Smartphone Application (YouTube)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. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone Application (SPSRS)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. | Device | Smartphone Application (SPSRS) |
| Smartphone Application (YouTube)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. | Device | Smartphone Application (YouTube) |
Primary outcome
Profile of Mood States 2nd Edition-Adult Short (POMS 2-A Short)
Time frame: Change of POMS 2-A Short from baseline at the end of 10 minutes of intervention.
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).
1 secondary outcome
State-Trait Anxiety Inventory State (STAI-S)
Time frame: Change of STAI-S from baseline at the end of 10 minutes of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Application (SPSRS) and Smartphone Application (YouTube) in people with Subthreshold Depression, run by Gunma University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of Mood States 2nd Edition-Adult Short (POMS 2-A Short) (time frame: Change of POMS 2-A Short from baseline at the end of 10 minutes of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.