Study Protocol for a Smartphone Application-based Intervention for Subthreshold Depression

Not Applicable

Completed

• Conditions: Subthreshold Depression
• Interventions: Device: Smartphone Application

• Registration Number: NCT04136041
• Lead Sponsor: Kibi International University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-23
• Study Start: 2019-10-29
• Status Verified: 2020-03
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-05
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone Application	Smartphone Application	Participants watch a video using the Smartphone Application displaying positive word stimuli.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Kibi International University; 🇯🇵 Takahashi, Okayama, Japan