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

NCT ID: NCT04136041

Last Updated: 2020-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-29

Study Completion Date

2020-03-05

Brief Summary

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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

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Conditions

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Subthreshold Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Smartphone Application

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

Group Type EXPERIMENTAL

Smartphone Application

Intervention Type DEVICE

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

No Intervention

No Intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smartphone Application

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kibi International University

OTHER

Sponsor Role lead

Responsible Party

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Kazuki Hirao, PhD, OT

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kibi International University

Takahashi, Okayama-ken, Japan

Site Status

Countries

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Japan

References

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Kato Y, Kageyama K, Mesaki T, Uchida H, Sejima Y, Marume R, Takahashi K, Hirao K. Study protocol for a pilot randomized controlled trial on a smartphone application-based intervention for subthreshold depression: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Jan;99(4):e18934. doi: 10.1097/MD.0000000000018934.

Reference Type DERIVED
PMID: 31977910 (View on PubMed)

Other Identifiers

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19-33

Identifier Type: -

Identifier Source: org_study_id

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