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

Subthreshold Depression Clinical Trial

Official title:

Study Protocol for a Pilot Randomized Controlled Trial on a Smartphone Application-based Intervention for Subthreshold Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04136041
• Other study ID #: 19-33
• Status: Completed
• Phase: N/A
• Start date: October 29, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: March 2020
• Source: Kibi International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Subthreshold Depression

Intervention

Device:
• Smartphone Application
The experimental group will watch movies using the Smartphone application for at least 10 min a day for 5 weeks.

Locations

Country	Name	City	State
Japan	Kibi International University	Takahashi	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
Kibi International University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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