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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartphone Application | Experimental | Participants watch a video using the Smartphone Application displaying positive word stimuli. |
|
| No Intervention | No Intervention | No Intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone Application | Device | The experimental group will watch movies using the Smartphone application for at least 10 min a day for 5 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline CES-D at 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline K6 at 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kibi International University | Takahashi | Okayama-ken | 716-8508 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31977910 | Derived | 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. |
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| 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. | Change from Baseline GAD-7 at 5 weeks |