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

March 30, 2020 updated by: Kazuki Hirao, PhD, OT, Kibi International University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Okayama
      • Takahashi, Okayama, Japan, 716-8508
        • Kibi International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smartphone Application
Participants watch a video using the Smartphone Application displaying positive word stimuli.
Device: Smartphone Application
The experimental group will watch movies using the Smartphone application for at least 10 min a day for 5 weeks.
No Intervention: No Intervention
No Intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline CES-D at 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological distress as measured by the Kessler Screening Scale for Psychological Distress (K6) score.
Time Frame: 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.
Change from Baseline K6 at 5 weeks
Anxiety as measured by the 7-item Generalized Anxiety Disorder Scale (GAD-7).
Time Frame: 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.
Change from Baseline GAD-7 at 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kibi International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2019

Primary Completion (Actual)

March 5, 2020

Study Completion (Actual)

March 5, 2020

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 22, 2019

First Posted (Actual)

October 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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