Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression

Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial

Major depressive disorder (MDD) is an important public health problem. Thus, preventive interventions against subthreshold depression (StD), which is one of the key risk factors for the development of MDD, are important. The study developed a smartphone application (SPSRS) that improves depressive symptoms in people with StD by automatically presenting positive word stimuli during videos. The SPSRS application has the potential to improve depressive symptoms in people with StDs. However, whether it can immediately improve depressed moods in people with StD is unclear. The study aims to investigate the immediate effects of SPSRS applications on depressed mood in people with StD.

Study Overview

• Status: Completed
• Conditions: Subthreshold Depression
• Intervention / Treatment: Device: Smartphone Application (SPSRS); Device: Smartphone Application (YouTube)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Gunma
    • Maebashi, Gunma, Japan, 371-8514
      • Gunma University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female
2. 20 to 39 years old
3. Beck Depression Inventory-II (BDI-II) score of 10 points or more
4. Persons with written informed consent prior to participation

Exclusion Criteria:

1. History of mental illness
2. Currently receiving treatment from a professional for mental health issues
3. Vision or hearing problems that interfere with daily life.
4. With a major depressive episode in the last two weeks according to the Mini-International Neuropsychiatric Interview

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Smartphone Application (SPSRS); The experimental group receives video-viewing intervention using the SPSRS application, which is a smartphone application. SPSRS is programmed to present 150 ms of positive words after presenting 17 ms of self-confidence-boosting words in videos. These words are repeated every 5 s. The words to increase self-confidence are "can," "let us try," "good luck," "able," and "do not worry". These self-confidence-boosting words randomly appear in the four corners of the screen. The positive words are "nice," "great," "fantastic," "satisfactory," and "enjoyable". These words are displayed at the center of the screen. Interveners use the SPSRS application according to the operating manual. The participants will use an iPhone managed by interveners to watch a pre-determined 10-minute video.	Device: Smartphone Application (SPSRS); The experimental group receives video-viewing intervention using the SPSRS application, which is a smartphone application. SPSRS is programmed to present 150 ms of positive words after presenting 17 ms of self-confidence-boosting words in videos. These words are repeated every 5 s. The words to increase self-confidence are "can," "let us try," "good luck," "able," and "do not worry". These self-confidence-boosting words randomly appear in the four corners of the screen. The positive words are "nice," "great," "fantastic," "satisfactory," and "enjoyable". These words are displayed at the center of the screen. Interveners use the SPSRS application according to the operating manual. The participants will use an iPhone managed by interveners to watch a pre-determined 10-minute video.
ACTIVE_COMPARATOR: Smartphone Application (YouTube); The control group uses the same iPhone as the experimental group. The control group uses the YouTube application to receive video-viewing intervention. The control group videos do not show confidence-boosting and positive words. The control group watches the same video as the experimental group for 10 min.	Device: Smartphone Application (YouTube); The control group uses the same iPhone as the experimental group. The control group uses the YouTube application to receive video-viewing intervention. The control group videos do not show confidence-boosting and positive words. The control group watches the same video as the experimental group for 10 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profile of Mood States 2nd Edition-Adult Short (POMS 2-A Short)	The POMS 2-A Short is a 35-item self-administered questionnaire used to measure mood states. Items are rated using a 5-point Likert-type scale (0 = not at all, 1 = a little, 2 = moderately, 3 = quite a lot, and 4 = extremely). The POMS 2-A Short assesses seven domains, namely, anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, vigor-activity, and friendliness. High scores indicate better vigor-activity and friendliness are better but more severe symptoms of the five other domains. In addition, the Total Mood Disturbance (TMD) score is calculated from anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, and vigor-activity. TDM is calculated based on a standard value (mean of 50 and standard deviation of 10).	Change of POMS 2-A Short from baseline at the end of 10 minutes of intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory State (STAI-S)	The STAI is a self-administered questionnaire consisting of two scales that each assesses state anxiety and trait anxiety. Each scale consists of 20 items. Items for STAI-S are scored using a 4-point Likert-type scale (1 = not at all, 2 = somewhat, 3 = moderately so, and 4 = very much so) with the total score ranging from 20 to 80 points. The higher the score, the greater the state anxiety.	Change of STAI-S from baseline at the end of 10 minutes of intervention.

Collaborators and Investigators

• Sponsor: Gunma University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2021
• Primary Completion (ACTUAL): June 14, 2021
• Study Completion (ACTUAL): June 14, 2021

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (ACTUAL): January 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 30, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: HS2020-157

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No