Evidence map›Paper›PMID 31977910›Full record

ArticleMedicine2020

Study protocol for a pilot randomized controlled trial on a smartphone application-based intervention for subthreshold depression: Study protocol clinical trial (SPIRIT Compliant).

Yudai Kato, Kaito Kageyama, Takanori Mesaki, Hiroyuki Uchida, Yoshiyuki Sejima, Risako Marume, Kana Takahashi, Kazuki Hirao

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04136041 (Study Protocol for a Pilot Randomized Controlled Trial on a Smartphone Application-based Intervention for Subthreshold Depression), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04136041 nacompletednot on this map

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

TypeinterventionalSponsorKibi International UniversityRan2019 to 2020Enrolled32ConditionsSubthreshold DepressionArmsSmartphone Application
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Yudai KatoDepartment of Occupational Therapy, Kibi International University, Takahashi.
Kaito KageyamaDepartment of Occupational Therapy, Kibi International University, Takahashi.
Takanori MesakiDepartment of Occupational Therapy, Kibi International University, Takahashi.
Hiroyuki UchidaDepartment of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki.
Yoshiyuki SejimaDepartment of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki.
Risako MarumeDepartment of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki.
Kana TakahashiDepartment of Rehabilitation, Okayama Kounan Hospital, Okayama, Japan.
Kazuki HiraoDepartment of Occupational Therapy, Kibi International University, Takahashi.
Kibi International University · JPKurashiki Central Hospital · JPOkayama Psychiatric Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInterventions aimed at addressing subthreshold depression (StD) are important to prevent the onset of major depressive disorder. Our video playback application (SPSRS) is designed to reduce depressive symptoms by presenting positive words in videos, shedding new light on the treatment of StD. However, no randomized controlled trial (RCT) has utilized this video playback application for the treatment of individuals with StD. Therefore, a pilot RCT was designed to determine the feasibility of a full-scale trial. We herein present a study protocol for investigating the utility of a video playback application intervention for individuals with StD.

methodsThis 5-week, single-blind, 2-arm, parallel-group, pilot RCT will determine the effectiveness of the video playback application by comparing individuals who had and had not been exposed to the same. A total of 32 individuals with StD will be randomly assigned to the experimental or control group at a 1:1 ratio. The experimental group will receive a 10-minute intervention containing the video playback application per day, whereas the control group will receive no intervention. The primary outcome will include changes in the Center for Epidemiologic Studies Depression Scale score after the 5-week intervention, while secondary outcomes will include changes in the Kessler Screening Scale for psychological distress and the generalized anxiety disorder 7-item scale score after the 5-week intervention. Statistical analysis using linear mixed models with the restricted maximum likelihood estimation method will then be performed. DISCUSSION: This pilot RCT will have been the first to explore the utility of SPSRS application interventions that display positive words in videos for individuals with StD. The results of this pilot trial are expected to help in the design and implementation of a full-scale RCT that investigates the effects of SPSRS applications among individuals with StD.

trial registrationClinicalTrials.gov Identifier: NCT04136041.

Indexed as

DepressionMobile ApplicationsSmartphoneFeasibility StudiesHumansPilot ProjectsRandomized Controlled Trials as Topic

Identifiers

PMID31977910
PMCPMC7004731
OpenAlexW3001732779

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.