Study Protocol for a Pilot Randomized Controlled Trial on a Smartphone Application-based Intervention for Subthreshold Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Psychological distress as measured by the Kessler Screening Scale for Psychological Distress (K6) score.(Change from Baseline K6 at 5 weeks)
- Anxiety as measured by the 7-item Generalized Anxiety Disorder Scale (GAD-7).(Change from Baseline GAD-7 at 5 weeks)
Investigators
Kazuki Hirao, PhD, OT
Assistant Professor
Kibi International University