Reliability of the Two-dimensional Mood Scale for self-reported mood assessment by older adults with dementia.

The purpose of this study was to evaluate the reliability of the Two-dimensional Mood Scale (TDMS) for mood assessment among older adults with dementia. The study included 100 elderly patients with dementia admitted to two hospitals. For each mood state measured by the TDMS, the intraclass correlation coefficient of agreement (ICCagreement) was calculated to evaluate test-retest reliability. Scores corresponding to the minimal detectable change (MDC) in each mood state at the individual level (MDCind) was also calculated to evaluate measurement error, while McDonald's omega was calculated to evaluate internal consistency. The TDMS ICC was 0.54 for vitality, 0.74 for stability, 0.70 for pleasure, and 0.55 for arousal. The MDCind was 6.89 for vitality, 5.88 for stability, 9.96 for pleasure, and 4.11 for arousal. McDonald's omega ranged from 0.60 to 0.84. The TDMS has generally acceptable reliability for the self-assessment of mood states by older adults with dementia.

Effectiveness of Comprehensive Environmental Support for Community-Dwelling Older Adults: A Single-Blind Randomized Controlled Trial.

IMPORTANCE: The importance of developing age-friendly environments is globally recognized. However, few clinical trials have comprehensively evaluated physical and social components of environments and examined the effects of offering support. OBJECTIVE: To clarify the effectiveness of occupational therapy-based comprehensive environmental support for community-dwelling older adults. DESIGN: A single-blind parallel-groups randomized controlled trial with blinded participants. SETTING: Eight community-based settings under the long-term-care insurance system in regional towns and cities throughout Japan. PARTICIPANTS: Sixty older adults age ≥65 yr who were new users of adult day care or adult day health care and allocated by stratified block randomization on the basis of age. INTERVENTION: Comprehensive environmental support was provided to participants for 3 mo according to results on the Comprehensive Environmental Questionnaire for older adults (CEQ) to make improvements in environmental factors participants wanted to change to create a more satisfying life. OUTCOMES AND MEASURES: The primary outcome measure was the Japanese Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) score at 3 mo postrandomization. Additionally, scores on the Short-Form Six-Dimension utility index were calculated. RESULTS: The experimental group showed significant improvements in the SF-36's Role/Social Component Summary (p = .005) and Role-Physical (p = .02), Role-Emotional (p = .01), and Mental Health (p = .05) domains, with moderate effect sizes. The number needed to treat was 3.46, showing statistical significance. CONCLUSIONS AND RELEVANCE: Occupational therapy-based comprehensive environmental support based on CEQ scores was effective, resulting in moderate improvements in health-related quality of life among community-dwelling older adults. Plain-Language Summary: Older adults experience a decline in physical and mental functions along with changes in social relationships. These problems make it challenging for older adults to perform valuable occupations, thus reducing their quality of life. This study demonstrated that occupational therapy based on the Comprehensive Environmental Questionnaire for older adults can improve health-related quality of life among community-dwelling older adults. Our findings pave the way for the development of an effective compensatory intervention model in occupational therapy practice.

Prefrontal cortex hypoactivity distinguishes severe from mild-to-moderate social anxiety as revealed by a palm-sized near-infrared spectroscopy system.

The purpose of this study was to compare prefrontal cortex (PFC) activity among subjects with differing social anxiety (SA) severity levels to identify a possible biomarker for severe SA. Further, SA is generally under-diagnosed, so we examined if such measurements could be acquired conveniently, non-invasively, and at low cost using a portable near-infrared spectroscopy (NIRS) system. We classified 96 participants into three groups based on Liebowitz Social Anxiety Scale (LSAS) total score: Low SA (LSA, n = 40), Moderate SA (MSA, n = 39), and High SA (HSA, n = 17). We compared the prefrontal hemodynamic responses among LSAS severity groups during a verbal fluency task using a palm-sized NIRS system. The HSA group exhibited a significantly lower hemodynamic response in the left PFC compared to LSA and MSA groups, whereas there was no significant difference between LSA and MSA groups. There was also no significant difference in the right PFC hemodynamic response among groups. Differences in the severity of SA symptoms may be related to the left PFC function. Low PFC activity during specific cognitive tasks may provide a biomarker for distinguishing severe from mild/moderate SA symptoms to guide subsequent therapeutic decisions.

The effect on subjective quality of life of occupational therapy based on adjusting the challenge-skill balance: a randomized controlled trial.

OBJECTIVE: To verify the effect of adjusting the challenge-skill balance with respect to rehabilitation process. DESIGN: A single-blind, two-arm, parallel-group, randomized controlled trial. SETTING: Recovery rehabilitation unit of Harue Hospital, Japan. SUBJECTS: The trial included 72 clients (mean (SD): age, 74.64 (9.51) years; Functional Independence Measure score, 98.26 (15.27)) with cerebral or spinal disease or musculoskeletal disease. INTERVENTIONS: Clients were randomly divided into two groups: the experimental group, who received occupational therapy with adjustment of the challenge-skill balance, and the control group who received conventional occupational therapy. Time from admission to discharge was considered the implementation period; the final evaluation was conducted at three months after discharge. MAIN MEASURES: The primary outcome was subjective quality of life (Ikigai-9). Secondary outcomes were the health-related quality of life (EuroQol-5 Dimensions, Five Levels (EQ-5D-5L)), the Flow State Scale for Occupational Tasks, and the Functional Independence Measure. A cost-effectiveness analysis was conducted using total cost and quality-adjusted life-year based on the EQ-5D-5L. RESULTS: Significant differences were observed between the experimental and control groups with respect to the Ikigai-9 score (P = 0.008) and EQ-5D-5L (P = 0.038), and the effect sizes were 0.76 (95% confidence interval [CI]: 0.27-1.24) and 0.62 (95% CI: 0.14-1.10), respectively. No significant between-group differences in other outcomes were observed, for example, the Functional Independence Measure score improved in both experimental and control groups (119.80 (5.50) and 118.84 (6.97), respectively. The incremental cost-effectiveness ratio was US$5518.38. CONCLUSIONS: Adjusting the challenge-skill balance may be a useful approach to improve the participant's subjective quality of life in the rehabilitation process.

Low sense of coherence is associated with anxiety among adults: Results based on data from all 47 prefectures of Japan.

BACKGROUND: Anxiety disorder is a major societal, economic, and healthcare burden, so it is essential to identify underlying risk factors. Sense of coherence (SOC), defined as an individual's perceived ability to control events and cope with challenges, is strongly associated with healthcare outcomes. METHODS: This study investigated the association between SOC and anxiety among adults in all 47 prefectures of Japan using a cross-sectional online panel survey. SOC was assessed using the University of Tokyo Health Sociology version of the SOC Scale and anxiety was assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. RESULTS: Among 2100 participants (1051 males and 1049 females), 475 (22.6%) were identified with anxiety (scoring 8 points or higher on the GAD-7 scale). Before adjustment for potential confounders, there was a significant negative association between SOC and presence of anxiety. Even after adjustment, the presence of anxiety was significantly higher among the lower SOC subgroup than the higher SOC subgroup. CONCLUSIONS: These results indicate that approximately one-fifth of adults in Japan suffer from anxiety and that low SOC is a significant risk factor.

Adjusting Challenge-Skill Balance to Improve Quality of Life in Older Adults: A Randomized Controlled Trial.

OBJECTIVE: We sought to investigate whether occupational therapy that includes adjusting the challenge-skill balance improves health-related quality of life (HRQOL) for older adults in comparison with standard occupational therapy. METHOD: In this single-blind, randomized controlled trial, 56 older adults were assigned to two groups that received 10 sessions of occupational therapy with and without adjustment of challenge-skill balance. The primary outcome was change in HRQOL after 10 sessions of occupational therapy. RESULTS: Significant differences were observed in HRQOL using the EuroQol-5 Dimension score (p = .022, d = 0.76) and the eight-item Short-Form Health Survey scores for general health (p = .001, d = 0.99) and in flow experience using the Flow State Scale for Occupational Tasks (p = .008, d = 0.82). CONCLUSION: Assessment and adjustment of the challenge-skill balance of activities may effectively improve older adults' HRQOL.

Measurement error in the Liebowitz Social Anxiety Scale: results from a general adult population in Japan.

Objective: Although the self-report version of Liebowitz Social Anxiety Scale (LSAS) is frequently used to measure social anxiety, data is lacking on the smallest detectable change (SDC), an important index of measurement error. We therefore aimed to determine the SDC of LSAS. Methods: Japanese adults aged 20-69 years were invited from a panel managed by a nationwide internet research agency. We then conducted a test-retest internet survey with a two-week interval to estimate the SDC at the individual (SDCind) and group (SDCgroup) levels. Results: The analysis included 1300 participants. The SDCind and SDCgroup for the total fear subscale (scoring range: 0-72) were 23.52 points (32.7%) and 0.65 points (0.9%), respectively. The SDCind and SDCgroup for the total avoidance subscale (scoring range: 0-72) were 32.43 points (45.0%) and 0.90 points (1.2%), respectively. The SDCind and SDCgroup for the overall total score (scoring range: 0-144) were 45.90 points (31.9%) and 1.27 points (0.9%), respectively. Conclusions: Measurement error is large and indicate the potential for major problems when attempting to use the LSAS to detect changes at the individual level. These results should be considered when using the LSAS as measures of treatment change.

Habituation of Brain Activity with Repetition in Color and Picture-Word Stroop Tests.

As a widely used mental task for functional near-infrared spectroscopy (fNIRS), the original color-word Stroop task has the advantage of being difficult to habituate, but also the disadvantage of being difficult to understand, especially for children. While the introduction of derived Stroop tasks offers highly promising countermeasures, changes in brain activity during these tests have not been well tested. We investigated the degree of habituation between the original and a derived Stroop task by measuring brain activity to obtain a better fNIRS task design. Fourteen healthy adults participated in the study, and a 10-channel fNIRS device was used. A picture-word Stroop task with lower linguistic conflict than the original was conducted. The original and derived Stroop tests were repeated four times in a 1-week interval. We found that the original Stroop test did not show any significant changes in brain activity with repeated measures; however, brain activity decreased during the derived test. The differences in habituation between the original and derived tests may be due to the differences in the strength of the linguistic conflict. Our findings also highlight the need to consider the effects of habituation when using derived Stroop tasks in repeated measures.

Escalation on Kihon Checklist Scores Preceding the Certification of Long-Term Care Need in the Older Population in Japan. A 9-Year Retrospective Study.

Objectives: The Kihon Checklist (KCL) is valuable for predicting long-term care (LTC) certification. However, the precise association between KCL scores and the temporal dynamics of LTC need certification remains unclear. This study clarified the characteristic trajectory of KCL scores in individuals certified for LTC need. Methods: The KCL scores spanning from 2011 to 2019 were obtained from 5630 older individuals, including those certified for LTC need in November 2020, in Iiyama City, Nagano, Japan. We analyzed the KCL score trajectories using a linear mixed model, both before and after propensity score matching. Results: Throughout the 9-year observation period, the KCL scores consistently remained higher in the certified group compared to the non-certified group. Notably, a significant score increase occurred within the 3 years preceding LTC certification. Discussion: Our findings highlight the effectiveness of continuous surveillance using the KCL in identifying individuals likely to require LTC within a few years.

Effects of a video-viewing intervention with positive word stimulation on the depressive symptoms of older patients with cardiac disease and subthreshold depression: a pilot randomized controlled trial protocol.

BACKGROUND: Intervention for older patients with cardiac disease and subthreshold depression (StD) may be an effective strategy to prevent the development of major depressive disorder. The subliminal priming with supraliminal reward stimulation (SPSRS) website developed by us is an advanced intervention that can improve depressive symptoms in individuals with StD by presenting positive word stimuli in videos. However, its efficacy for treating depressive symptoms in older patients with cardiac disease and StD has not been investigated. Here, we present a pilot randomized controlled trial protocol to investigate the preliminary efficacy of an intervention for older patients with cardiac disease with StD. METHODS: The study was designed as a single-center, open-label, pilot, randomized, parallel-group trial. The participants will include 30 older patients with cardiac disease and StD who are hospitalized in acute wards. The Experimental group received the SPSRS intervention (video viewing with positive word stimuli; n = 15) and the Control group will receive the YouTube intervention (video viewing without positive word stimuli; n = 15). In both groups, the intervention will be administered for 10 min per day, five times per week for 1 week. The primary outcome will be the change in the scores on the Japanese version of the Beck Depression Inventory-II at 1 week after the baseline assessment. The secondary outcomes will be the changes in the Specific Activity Scale, New York Heart Association functional classification, as well as grip strength at 1 week after the baseline assessment. DISCUSSION: This pilot randomized controlled trial will be the first to evaluate the SPSRS intervention for depressive symptoms in older patients with cardiac disease and StD who are admitted to acute wards. The results will provide tentative indications regarding the impact of the intervention on depressive symptoms among older patients with cardiac disease and StD who are admitted to acute wards, and will contribute to the planning of a full-scale study. TRIAL REGISTRATION: UMIN, UMIN000052155. Registered September 8, 2023, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000059526 . This study was registered with the University Hospital Medical Information Network (UMIN) (UMIN000052155) in Japan.

Effects of rhythmic auditory stimulation on gait speed in older adult inpatients in a convalescent rehabilitation ward: a pilot randomized controlled trial.

PURPOSE: To assess the impact of gait training with rhythmic auditory stimulation (RAS) on enhancing gait speed in older people admitted to a convalescent rehabilitation ward (CRW), compared to conventional gait training methods. METHODS: The study was designed as a single-center, open-label, pilot, randomized, parallel-group study. Thirty older people admitted to CRW were divided into two groups: the experimental group, which received gait training with RAS (n = 15, females = 53.3%, mean age = 83.9, SD = 6.5), and the control group, which underwent usual gait training (n = 15, females = 60.0%, mean age = 81.3, SD = 8.4). Regardless of their assigned group, all participants underwent 30 min training sessions, five times a week, for 3 weeks. The primary outcome was the 10 m walk test (10mWT), and the secondary outcomes included the Medical Outcome Study 8-Item Short-Form Health Survey and the Japanese version of the modified Gait Efficacy Scale. All measurements were taken at baseline and again at week 3. RESULTS: Results indicated that older people in CRWs in the experimental group showed significant improvements in their 10mWT (effect size - 1.02) compared to the control group. None of the secondary outcomes were significant. CONCLUSIONS: This study suggests the preliminary effectiveness and feasibility of a gait practice intervention using RAS in a CRW. TRIAL REGISTRATION: The University Hospital Medical Information Network (UMIN) Registered 1 October 2022 (UMIN000049089).

Immediate Effects of Mobile Phone App for Depressed Mood in Young Adults with Subthreshold Depression: A Pilot Randomized Controlled Trial.

Background: Preventive interventions for subthreshold depression (StD) are essential to reduce the incidence of major depressive disorder. Our smartphone application presenting positive word stimulation in video (ie, Subliminal Priming with Supraliminal Reward Stimulation, SPSRS) was suggested to improve depressive symptoms in people with StD, although it is unclear whether it can immediately improve depressed mood. This pilot randomized controlled trial (RCT) aimed to investigate the preliminary efficacy of SPSRS application intervention on depressive mood in people with StD. Methods: Thirty-two participants with StD were randomly assigned to the experimental (n = 16) or control group (n = 16). The experimental group received SPSRS application intervention (10-minute video with positive word stimulation) and the control group received YouTube application intervention (10-minute video without positive word stimulation). Both groups used identical iPhones managed by the research team. The primary outcome was the change from baseline in depression-dejection on the Profile of Mood States 2nd Edition-Adult Short (POMS 2-A Short) after the intervention. Results: No participants dropped out of the study. The experimental group showed a small improvement in depression-dejection on the POMS 2-A Short score (adjusted Hedges's g = -0.32) compared to the control group. Post-hoc power analyses estimated a sample size of 56 per group (112 total) to evaluate depression-dejection on the POMS 2-A Short in a future full-scale RCT. Conclusion: SPSRS application intervention may be effective in immediately improving depressive mood in people with StD. A future full-scale RCT based on a formally calculated sample size should be conducted to replicate these findings.

Differences in Center for Epidemiologic Studies Depression Scale, Generalized Anxiety Disorder-7 and Kessler Screening Scale for Psychological Distress Scores between Smartphone Version versus Paper Version Administration: Evidence of Equivalence.

The use of electronic patient-reported outcomes has increased recently, and smartphones offer distinct advantages over other devices. However, previous systematic reviews have not investigated the reliability of the Center for Epidemiologic Studies Depression Scale (CES-D), Generalized Anxiety Disorder-7 (GAD-7), and Kessler Screening Scale for Psychological Distress (K6) when used with smartphones, and this has not been fully explored. This study aimed to evaluate the equivalence of the paper and smartphone versions of the CES-D, GAD-7, and K6, which were compared following a randomized crossover design method in 100 adults in Gunma, Japan. Participants responded to the paper and smartphone versions at 1-week intervals. The equivalence of paper and smartphone versions was evaluated using the intraclass correlation coefficient (ICCagreement). The mean participant age was 19.86 years (SD = 1.08, 23% male). The ICCagreements for the paper and smartphone versions of the CES-D, GAD-7, and K6 were 0.76 (95% confidence interval [CI] 0.66-0.83), 0.68 (95% CI 0.59-0.77), and 0.83 (95% CI 0.75-0.88), respectively. Thus, the CES-D and K6 scales are appropriate for use in a smartphone version, which could be applied to clinical and research settings in which the paper or smartphone versions could be used as needed.

Assessing the Smallest Detectable Change of the Kessler Psychological Distress Scale Score in an Adult Population in Japan.

Background: Psychological distress is prevalent worldwide and can lead to the development of mental conditions such as major depression and anxiety disorders. It is essential to assess the severity of patient-reported outcomes to provide effective treatment for psychological distress. The Kessler Psychological Distress Scale (K6) is one of the most widely used psychological distress scales. However, the smallest detectable change (SDC) of the K6 score has not been elucidated. Therefore, the current study aimed to determine the SDC of the K6 score in a Japanese adult population. Methods: Participants aged 20-59 years who are native Japanese speakers were recruited from the panel list of a web research firm. The K6 score was assessed at baseline (T1) and at 2-week follow-up (T2). SDCs were calculated at the individual (SDCind) and group (SDCgroup) levels. Intraclass correlation coefficient agreement (ICCagreement) was calculated to assess test-retest reliability and Cronbach's alpha to evaluate internal consistency. Results: A total of 3254 (1627 [50%] female) responded at T1 and T2. The mean (standard deviation) K6 scores were 5.71 (5.84) at T1 and 5.65 (5.83) at T2. The SDCind and SDCgroup of the K6 score were 8.47 (35.31%) and 0.15 (0.63%), respectively. The ICCagreement was 0.73, and the Cronbach's alpha was 0.94. Conclusion: Our study provided evidence on the reliability and interpretation of the K6 score. Calculating the SDC of the K6 score can help identify the significance of changes in psychological distress over time and can determine the efficacy of interventions for psychological distress.

Effect of gait training using rhythmic auditory stimulation on gait speed in older adults admitted to convalescent rehabilitation wards: A study protocol for a pilot randomized controlled clinical trial.

Background: Decreased walking speed in older patients admitted to convalescent rehabilitation wards (CRWs) is one of the factors that inhibit home discharge. Therefore, interventions to improve gait speed in older patients admitted to CRWs are important, and rhythmic auditory stimulation (RAS) may be an effective intervention strategy. However, the effect of RAS on gait speed in older patients admitted to CRWs is not well known. Therefore, this study protocol aims to determine the feasibility of the RAS-based gait practice for older patients admitted to the CRW. Methods: The study is designed as a single-center, open-label, pilot, randomized, parallel-group study. Participants will be 30 patients aged ≥65 years admitted to the CRW and randomly assigned to the experimental group (RAS-based gait practice; n = 15) or the control group (normal gait practice; n = 15). In both groups, interventions will be conducted for 30 min per session, 5 times per week for 3 weeks. The primary outcome is the change in the 10-m walk test 3 weeks after the baseline assessment. Secondary outcome is the change in the score of the Medical Outcome Study 8-Item Short-Form Health Survey and the Japanese version of the modified Gait Efficacy Scale from baseline assessment to 3 weeks later. Discussion: This exploratory RCT was developed using strict scientific standards and is based on defined protocols. Thus, this study will be used to assess the viability of a larger investigation into RAS-based gait practice. If our theory is accurate, this study could serve as a foundation for establishing RAS-based gait practice in CRWs as a common rehabilitation strategy. Trial registration: This study was registered in the University Hospital Medical Information Network (UMIN) clinical trials registry in Japan (UMIN000049089).

Flow experience and health-related quality of life in community dwelling elderly Japanese.

This study was performed to investigate the relationship between mental state (especially flow experience [Flow Experience Checklist of Ishimura]) health-related quality of life (Medical Outcome Study 8-Item Short-Form Health Survey), and stress (salivary amylase concentrations). The subjects were 119 healthy elderly persons living in rural areas who participated in a "meeting for the elderly" at a nursing home in Kagawa Prefecture, Japan. The subjects were classified into apathetic, anxious, relaxed, and flow groups. It was found that physical health was significantly better when performing important daily activities in the group who experienced flow and the relaxed group than in the group that was in an apathetic state. However, no significant relationship was observed between the degree of flow experience and stress. The present findings suggested that interventions which make the activities of daily life either "high-challenge, high-skill" situations or "low-challenge, high-skill" situations could have a positive influence on the physical health of community-living elderly Japanese. A longitudinal study should be performed in the future.

Performing One-Session Cognitive Stimulation to Interact with Patients with Dementia in a Hospital for Mood Improvement: A Retrospective Single-Arm Cohort Study.

Developing support and an environment for patients with dementia in hospitals is important. This study aims to assess the immediate effect of one-session cognitive stimulation intervention on the mood of patients with dementia in a hospital as preliminary evidence. This study included 33 female patients. The cognitive stimulation intervention was conducted in the day room of the hospital ward by two occupational therapists. The patients participated in one or more sessions. The cognitive stimulation intervention was designed to discuss current affairs that implicitly stimulate memory, executive function, and language skills, according to the cognitive stimulation definition. Outcomes were evaluated using a two-dimensional mood scale. The primary outcome was pleasure. The before and after session scores for the first session and the average score before and after each session at multiple times were compared. The patients' pleasure showed significant improvements in both analyses. These results may indicate that one-session Cognitive stimulation intervention in a hospital effectively improves a mood of pleasure immediately. This study is the first report to provide preliminary evidence on the beneficial alterations of mood after one-session cognitive stimulation intervention for patients with dementia in hospitals. Cognitive stimulation intervention may be an effective non-pharmacotherapy for these patients.

Effects of Smartphone-Delivered Positive-Word Stimulation on Depressed Mood in People with Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: 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 presents a protocol for investigating the immediate effects of the SPSRS application intervention on depressed mood in people with StD. METHODS: The study is designed as an open-label, parallel-group, and pilot randomized controlled trial (RCT). Thirty-two people who meet the criteria for StD (Beck Depression Inventory-II score of 10 points or more and fails to meet the diagnostic criteria for MDD) will be recruited and studied. It compares the immediate effects of the SPSRS application intervention (with positive word stimulus in a 10-minute video; n = 16) and YouTube application intervention (without positive word stimulus in 10-minute video; n = 16). The primary outcome is the change in the score for the Profile of Mood States 2nd Edition-Adult Short after 10 minutes of intervention. The secondary outcome is the change in the State-Trait Anxiety Inventory State after 10 min of intervention. DISCUSSION: The pilot RCT is the first to evaluate the immediate effects of the SPSRS application intervention on depressed mood in people with StD. The results are expected to provide a preliminary outcome of the immediate effect of the SPSRS application on the depressed mood of people with StD and aid in planning a full-scale trial. TRIAL REGISTRATION: ClinicalTrials.gov; Identifier: NCT03864484.

Positive-word stimuli via a smartphone application have no immediate-term effects on multi-directional reach ability in standing position: a randomized controlled trial.

OBJECTIVES: The purpose of the study was to examine the immediate-term effect of positive-word stimuli via a smartphone application on the multi-directional reach ability in standing position in young adults. METHODS: This study was an immediate-term, assessor-blinded, two-arm, parallel-group, randomized controlled trial among young adults recruited from one university in Japan. Participants were randomly assigned to the experimental group or control group using a computer-based random number-generating programme. Participants of the experimental group used an application on iPhone and watched 3-min videos displaying positive-word stimuli. This application repeatedly displayed positive-word stimuli every 5 s. The participants of the control group used an application on iPhone and watched the same videos as in the experimental group. However, a positive-word stimulus did not appear in the videos. The primary outcome was the multi-directional reach test (MDRT) from baseline to immediately after the intervention protocol. RESULTS: Among the 62 randomized participants (experimental group, n = 31; control group, n = 31), 62 (100%) completed the MDRT immediately after the intervention protocol. There were no differences in mean group change values in MDRT between the experimental and control groups. CONCLUSIONS: Among young adults, positive-word stimuli via a smartphone application did not significantly improve multi-directional reach ability in standing position. These findings do not support the superiority of this intervention among young adults. Trial Registration: Clinicaltrials.gov, NCT03546218. Registered 6 June 2018, https://clinicaltrials.gov/ct2/show/NCT03546218KEY MESSAGESIn our study, among young adults, positive-word stimuli via an SPSRS application did not significantly improve the multi-directional reach ability in the standing position.These findings do not support the superiority of this intervention among young adults.

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.