Subthreshold Depression
Conditions
Brief 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.
Interventions
DEVICESmartphone Application
The experimental group will watch movies using the Smartphone application for at least 10 min a day for 5 weeks.
Sponsors
Kibi International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological distress as measured by the Kessler Screening Scale for Psychological Distress (K6) score. | Change from Baseline K6 at 5 weeks | 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. |
| Anxiety as measured by the 7-item Generalized Anxiety Disorder Scale (GAD-7). | Change from Baseline GAD-7 at 5 weeks | 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. |
Countries
Japan
Outcome results
None listed