Subthreshold DepressionNCT03110016
Smartphone Intervention for Subthreshold Depression
A study testing Smartphone Application in people with Subthreshold Depression, run by Kibi International University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Subthreshold Depression
- What is being tested?
- Smartphone Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteJapan
- Study dates
- 16 May 2017to 30 Jun 2017
- 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 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-24 years
- Has a Center for Epidemiologic Studies Depression Scale score of ≥16
- Owns a smartphone with the iOS® operating system
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Usability, User Satisfaction, and Preliminary Efficacy of a Smartphone Intervention for Subthreshold Depression
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.
- Conditions
- Subthreshold Depression
- Being tested
- Smartphone Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone ApplicationDevice
The participants use SPSRS to watch the motion picture for at least 10 min a day for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone Application | Experimental | 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. Receives: Device: Smartphone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 weeks after initiating the intervention
Secondary outcomes (7)
Usability and user satisfaction
USE Questionnaire
Measured: 5 weeks after initiating the intervention
Number of participants with treatment-related adverse events as assessed by Mini-International Neuropsychiatric Interview.
Mini-International Neuropsychiatric Interview
Measured: baseline and 1, 2, 3, 4, and 5 weeks after initiating the intervention
Depressive symptoms
Center for Epidemiologic Studies Depression Scale score
Measured: baseline and 5 weeks after initiating the intervention
Inflammatory biomarker
Level of salivary interleukin-6
Measured: baseline and 5 weeks after initiating the intervention
General self-efficacy
General Self-Efficacy Scale score
Measured: baseline and 5 weeks after initiating the intervention
Social anxiety
Liebowitz Social Anxiety Scale score
Measured: baseline and 5 weeks after initiating the intervention
Mental health
12-item General Health Questionnaire score
Measured: baseline and 5 weeks after initiating the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start16 May 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kibi International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazuki Hirao, PhD, OT, Kibi International University
- Investigators
- Kazuki Hirao, PhD, Principal investigator, Kibi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110016
- Sponsor's protocol ID
- 16-55
- Status last verified
- Jul 2017
- First submitted
- 3 Apr 2017
- Last updated
- 28 Jul 2017
- 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 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Usability, User Satisfaction, and Preliminary Efficacy of a Smartphone Intervention for Subthreshold Depression
- ClinicalTrials.gov ID
- NCT03110016
- Acronym / sponsor ID
- 16-55
- Conditions
- Subthreshold Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kibi International UniversityUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 12 Apr 2017 (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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smartphone Application | Experimental | Device: Smartphone ApplicationSPSRS 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-24 years
- Has a Center for Epidemiologic Studies Depression Scale score of ≥16
- Owns a smartphone with the iOS® operating system
Key exclusion criteria (4 listed)
- 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
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 ApplicationThe participants use SPSRS to watch the motion picture for at least 10 min a day for 5 weeks. | Device | Smartphone Application |
Primary outcome
Feasibility, as measured by adherence to the smartphone application intervention.
Time frame: 5 weeks after initiating the 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).
7 secondary outcomes
Usability and user satisfaction
Time frame: 5 weeks after initiating the intervention
Number of participants with treatment-related adverse events as assessed by Mini-International Neuropsychiatric Interview.
Time frame: baseline and 1, 2, 3, 4, and 5 weeks after initiating the intervention
Depressive symptoms
Time frame: baseline and 5 weeks after initiating the intervention
Inflammatory biomarker
Time frame: baseline and 5 weeks after initiating the intervention
General self-efficacy
Time frame: baseline and 5 weeks after initiating the intervention
Social anxiety
Time frame: baseline and 5 weeks after initiating the intervention
Mental health
Time frame: baseline and 5 weeks after initiating the 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 28 Jul 2017.
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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.
Kazuki Hirao, PhD principal investigator
Kibi International University
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 in people with Subthreshold Depression, run by Kibi International 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 3 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 28 Jul 2017. 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?
Feasibility, as measured by adherence to the smartphone application intervention. (time frame: 5 weeks after initiating the 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 28 Jul 2017.