Effects of video viewing smartphone application intervention involving positive word stimulation in people with subthreshold depression: A pilot randomized controlled trial.

BACKGROUND: A smartphone application (i.e., SPSRS) was developed to help people with subthreshold depression (StD) improve depressive symptoms by presenting positive word stimuli in videos. However, to date, no randomized controlled trials (RCTs) were conducted to investigate SPSRS application interventions for depressive symptoms in people with StD. Therefore, a pilot RCT was conducted to assess the preliminary efficacy of the SPSRS application intervention for people with StD. METHODS: In a pilot RCT, 32 participants (female = 34.4%, mean age = 20.06, SD = 1.24) with StD were randomized to SPSRS application intervention for approximately 10 min/a day for 5 weeks (experimental group; n = 16) or no intervention (wait list control group; n = 16). The primary outcome is the change from baseline in the Center for Epidemiologic Studies Depression Scale (CES-D) score after the 5-week intervention. The secondary outcomes are the change from baseline in the Kessler Screening Scale for Psychological Distress (K-6) score and the Generalized Anxiety Disorder 7-item scale (GAD-7) after the 5-week intervention. RESULTS: No participants dropped out of the study. The experimental group displayed medium, small, and small improvements in CES-D, K-6, and GAD-7 scores (adjusted Hedge's g = -0.64, -0.29, and -0.40), respectively, compared with control. LIMITATIONS: The observed effects must be considered preliminary due to the small sample size. CONCLUSIONS: The results suggest the potential of intervention using the SPSRS application to reduce depressive symptoms in people with StD. Future studies should replicate these findings in a full-scale RCT.

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

INTRODUCTION: Interventions 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. METHODS: This 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 REGISTRATION: ClinicalTrials.gov Identifier: NCT04136041.