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Study protocol for a pilot randomized controlled trial on a smartphone application-based intervention for
Yudai Kato1, Kaito Kageyama1, Takanori Mesaki1
1Department of Occupational Therapy, Kibi International University, Takahashi.
Medicine
|January 25, 2020
Summary
This pilot study investigates a video app intervention for subthreshold depression (StD). The randomized controlled trial (RCT) aims to assess feasibility and inform future large-scale trials on this novel digital therapy.
Area of Science:
- Psychiatry and Mental Health
- Digital Therapeutics
- Clinical Trial Methodology
Background:
- Subthreshold depression (StD) requires interventions to prevent major depressive disorder onset.
- A novel video playback application (SPSRS) presents positive words to reduce depressive symptoms.
- No randomized controlled trials (RCTs) have evaluated this video application for StD treatment.
Purpose of the Study:
- To determine the feasibility of a full-scale randomized controlled trial (RCT).
- To investigate the utility of a video playback application intervention for individuals with StD.
- To establish a protocol for future research on digital interventions for StD.
Main Methods:
- A 5-week, single-blind, parallel-group pilot RCT with 32 participants.
- Participants randomly assigned to an experimental group (daily video app use) or a control group (no intervention).
- Primary outcome: change in Center for Epidemiologic Studies Depression Scale (CES-D) score; secondary outcomes: Kessler Screening Scale and GAD-7 scores.
Main Results:
- This section will report findings after study completion.
- Data analysis will employ linear mixed models with restricted maximum likelihood estimation.
Conclusions:
- This pilot RCT is the first to explore the utility of the SPSRS video application for StD.
- Results will inform the design and implementation of a full-scale RCT.
- The study protocol provides a foundation for investigating digital interventions for subthreshold depression.
