Subthreshold DepressionNCT04136041
Study Protocol for a Smartphone Application-based 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 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 29 Oct 2019to 5 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Protocol for a Pilot Randomized Controlled Trial on a Smartphone Application-based Intervention for Subthreshold Depression
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.
- 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 experimental group will watch movies using the Smartphone application for at least 10 min a day for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone Application | Experimental | Participants watch a video using the Smartphone Application displaying positive word stimuli. Receives: Device: Smartphone Application |
| No Intervention | No intervention | No Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline CES-D at 5 weeks
Secondary outcomes (2)
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.
Measured: Change from Baseline K6 at 5 weeks
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.
Measured: Change from Baseline GAD-7 at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start29 Oct 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136041
- Sponsor's protocol ID
- 19-33
- Status last verified
- Mar 2020
- First submitted
- 21 Oct 2019
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31977910
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol for a Pilot Randomized Controlled Trial on a Smartphone Application-based Intervention for Subthreshold Depression
- ClinicalTrials.gov ID
- NCT04136041
- Acronym / sponsor ID
- 19-33
- Conditions
- Subthreshold Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kibi International UniversityUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 23 Oct 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone Application | Experimental | Device: Smartphone ApplicationParticipants watch a video using the Smartphone Application displaying positive word stimuli. |
| No Intervention | No intervention | –No Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 experimental group will watch movies using the Smartphone application for at least 10 min a day for 5 weeks. | Device | Smartphone Application |
Primary outcome
Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
Time frame: Change from Baseline CES-D at 5 weeks
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.
2 secondary outcomes
Psychological distress as measured by the Kessler Screening Scale for Psychological Distress (K6) score.
Time frame: Change from Baseline K6 at 5 weeks
Anxiety as measured by the 7-item Generalized Anxiety Disorder Scale (GAD-7).
Time frame: Change from Baseline GAD-7 at 5 weeks
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 1 Apr 2020.
- Derived from this study: PubMed 31977910Kato 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.
- Individual participant dataSharing planned: No
Related trials for Subthreshold Depression
Not yet recruiting
Dietary Education Intervention for Subthreshold Depression (MIND-Trial)
Subthreshold Depression
Recruiting
The Effect of Transcranial Direct Current Stimulation (tDCS) in Improving Emotion Health
Subthreshold Depression, Positive Emotions
Recruiting
Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors
Post-stroke Depression, Subthreshold Depression
Recruiting
A Pilot Study to Examine the Efficacy of Internet-Delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) for Individuals With Adverse Childhood Experiences and Subsyndromal Depression
Subthreshold Depression
Recruiting
tDCS in People With Subthreshold Depression
Subthreshold Depression
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 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 5 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 1 Apr 2020. 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?
Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score. (time frame: Change from Baseline CES-D at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04136041, which also lists 1 linked publication.
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 1 Apr 2020.