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

NCT04707495 | Completed

• 1 other identifier: HS2020-157
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subthreshold Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• State-Trait Anxiety Inventory State (STAI-S)

  Change of STAI-S from baseline at the end of 10 minutes of intervention.

Study Arms (2)

Smartphone Application (SPSRS)

EXPERIMENTAL

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)

Smartphone Application (YouTube)

ACTIVE COMPARATOR

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)

Interventions

Smartphone Application (SPSRS) DEVICE

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.

Smartphone Application (SPSRS)

Smartphone Application (YouTube) DEVICE

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.

Smartphone Application (YouTube)

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gunma University: lead

Study Sites (1)

Gunma University

Maebashi, Gunma, 371-8514, Japan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: March 4, 2021
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

JP (1)