Efficacy of ‘Foundations’, a Digital Mental Health App to Improve Mental Well-Being, during COVID-19: A Proof-of-Principle Randomised Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Silvina Catuara-Solarz ◽  
Bartlomiej Skorulski ◽  
Inaki Estella ◽  
Claudia Avella-Garcia ◽  
Sarah Shepherd ◽  
...  

BACKGROUND Against a long-term trend of increasing demand, the COVID-19 pandemic has led to a global rise in common mental disorders. Now more than ever, there is an urgent need for scalable, evidence-based interventions to support mental well-being. OBJECTIVE The aim of this proof-of-principle study was to evaluate the efficacy of a mobile-based app in adults with self-reported symptoms of anxiety and stress in a randomised control trial that took place during the first wave of the COVID-19 pandemic in the UK. METHODS Adults with mild to severe anxiety and moderate to high levels of perceived stress were randomised to either the intervention or control arm. Participants in the intervention arm were given access to the app, Foundations, for the duration of the 4-week study. All participants were required to self-report a range of validated measures of mental well-being (10-item Connor-Davidson Resilience scale [CD-RISC-10]; 7-item Generalised Anxiety Disorder scale [GAD-7]; Office of National Statistics Four Subjective Well-being Questions [ONS-4]; World Health Organisation-5 Well-Being Index [WHO-5]) and sleep (Minimal Insomnia Scale [MISS]) at baseline and weeks 2 and 4; and, in addition, on perceived stress weekly (10-item Perceived Stress Score [PSS]). RESULTS 136 participants completed the study and were included in the final analysis. The intervention group (n=62) showed significant improvements compared to the control group (n=74) on measures of anxiety (GAD-7 score, delta from baseline to week 2 in the intervention group: -1.35 [SD 4.43]; control group: -0.23 [SD 3.24]; t134= 1.71 , P=.04), resilience (CD-RISC score, delta from baseline to week 2 in the intervention group: 1.79 [± SD 4.08]; control group: -0.31 [± SD 3.16]; t134 -3.37, P<.001), sleep (MISS score, delta from baseline to week 2 in the intervention group: -1.16 [± SD 2.67]; control group: -0.26 [± SD 2.29]; t134= 2.13, P=.01), and mental well-being (WHO-5 score, delta from baseline to week 2 in the intervention group: 1.53 [5.30]; control group: -0.23 [± SD 4.20]; t134= -2.16, P=.02) within 2 weeks of using Foundations, with further improvements emerging at week 4. Perceived stress was also reduced within the intervention group, although the results did not reach statistical significance relative to the control group (PSS score, delta from baseline to week 2 in the intervention group: -2.94 [± SD 6.84]; control group: -2.05 [± SD 5.34]; t134= 0.84, P=.20). CONCLUSIONS This study provides proof-of-principle that the digital mental health app, Foundations, can improve measures of mental well-being, anxiety, resilience, and sleep within 2 weeks of use, with greater effects after 4 weeks. It therefore offers potential as a scalable, cost-effective, and accessible solution to enhance mental well-being, even during times of crisis such as the COVID-19 pandemic.

2021 ◽  
Vol 12 ◽  
Author(s):  
Lise Juul ◽  
Eva Brorsen ◽  
Katinka Gøtzsche ◽  
Birgitte Lund Nielsen ◽  
Lone Overby Fjorback

Background: In this study, we aimed to investigate the effects of a mindfulness program including Mindfulness-Based Stress Reduction (MBSR) on the mental health of student teachers when offered at their educational institution in a real-life context.Methods: A parallel randomized controlled trial (RCT) was conducted among self-selected student teachers at a Danish undergraduate program for teacher education in the autumns of 2019 and 2020. Participation was not recommended in case of (1) clinical depression or a diagnosis of psychosis or schizophrenia, (2) abuse of alcohol, drugs, and/or medicine. Randomization was performed by a Statistician who was blinded to the identity of the students. Data was collected using self-reported questionnaires. The primary outcome was a change in perceived stress 3 months from baseline. Secondary outcome measures were symptoms of anxiety and depression, well-being, resilience, mindfulness, and thoughts and feelings during rest. The effects were analyzed according to the intention-to-treat principle using mixed-effect linear regression models. Mediating effects of mindfulness skills on the mental health outcomes were explored using structural equation modeling.Results: The study group included 67 student teachers with 34 allocated to the intervention group (median age: 25 years; women: n = 24, 71%); and 33 students (median age: 25 years; women: n = 25, 76%) allocated to a waiting list control group. At baseline, mean Perceived Stress Scale (PSS) scores were 18.88 (SD: 5.75) in the intervention group and 17.91 (SD: 6.36) in the waiting list control group. A total of 56 students completed the questionnaire at a 3-month follow-up (28 in both the intervention- and the control group). Statistically significant effects of the intervention were found on perceived stress, symptoms of anxiety and depression, well-being, and on three of seven resting-state dimensions. No effects were found on resilience or mindfulness. Statistically significant mediated effects via resting-state dimensions were found.Conclusion The findings suggested that offering a mindfulness program at an undergraduate program for teacher education could significantly improve the mental health among self-selected students within 3 months. Results of mediation analysis supported the hypothesis that some of the effects might be explained by reduced distracting thoughts.Clinical Trial Registration: [www.ClinicalTrials.gov], identifier [NCT04558099].


10.2196/14269 ◽  
2019 ◽  
Vol 21 (11) ◽  
pp. e14269 ◽  
Author(s):  
Cássia Canha Coelhoso ◽  
Patricia Renovato Tobo ◽  
Shirley Silva Lacerda ◽  
Alex Heitor Lima ◽  
Carla Regina Camara Barrichello ◽  
...  

Background Although the availability and use of mobile mental health apps has grown exponentially in recent years, little data are available regarding their efficacy. Objective This study aimed to evaluate the effectiveness of an app developed to promote stress management and well-being among working women compared with a control app. Methods Female employees at a private hospital were invited to participate in the study via mailing lists and intranet ads. A total of 653 individuals self-enrolled through the website. Eligible participants were randomized between control (n=240) and intervention (n=250) groups. The well-being mobile app provides an 8-week program with 4 classes per week (including a brief theoretical portion and a 15-min guided practice). The active control app also provided 4 assessments per week that encouraged participants to self-observe how they were feeling for 20 min. We also used the app to conduct Web-based questionnaires (10-item Perceived Stress Scale and 5-item World Health Organization Well-Being Index) and ask specific questions to assess subjective levels of stress and well-being at baseline (t1), midintervention (t4=4 weeks after t1) and postintervention (t8=8 weeks after t1). Both apps were fully automated without any human involvement. Outcomes from the control and intervention conditions at the 3 time points were analyzed using a repeated measures analysis of variance. Results Among the randomized participants (n=490), 185 participants were excluded at the 4-week follow-up and another 79 at the 8-week follow-up because of noncompliance with the experimental protocol. Participants who did not complete t4 and t8 assessments were equally distributed between groups (t4: control group=34.6% [83/240] and intervention group=40.8% [102/250]; P=.16; t8: control group=29.9% [47/157] and intervention group=21.6% [32/148]; P=.10). Both groups showed a significant increase in general well-being as a function of time (F2,426=5.27; P=.006), but only the intervention group presented a significant increase in work-related well-being (F2,426=8.92; P<.001), as well as a significant reduction in work-related and overall stress (F2,426=5.50; P=.004 and F2,426=8.59; P<.001, respectively). Conclusions The well-being mobile app was effective in reducing employee stress and improving well-being. Trial Registration Clinicaltrials.gov NCT02637414; https://clinicaltrials.gov/ct2/show/NCT02637414.


2019 ◽  
Author(s):  
Cássia Canha Coelhoso ◽  
Patricia Renovato Tobo ◽  
Shirley Silva Lacerda ◽  
Alex Heitor Lima ◽  
Carla Regina Camara Barrichello ◽  
...  

BACKGROUND Although the availability and use of mobile mental health apps has grown exponentially in recent years, little data are available regarding their efficacy. OBJECTIVE This study aimed to evaluate the effectiveness of an app developed to promote stress management and well-being among working women compared with a control app. METHODS Female employees at a private hospital were invited to participate in the study via mailing lists and intranet ads. A total of 653 individuals self-enrolled through the website. Eligible participants were randomized between control (n=240) and intervention (n=250) groups. The well-being mobile app provides an 8-week program with 4 classes per week (including a brief theoretical portion and a 15-min guided practice). The active control app also provided 4 assessments per week that encouraged participants to self-observe how they were feeling for 20 min. We also used the app to conduct Web-based questionnaires (10-item Perceived Stress Scale and 5-item World Health Organization Well-Being Index) and ask specific questions to assess subjective levels of stress and well-being at baseline (<italic>t</italic><sub>1</sub>), midintervention (<italic>t</italic><sub>4</sub>=4 weeks after <italic>t</italic><sub>1</sub>) and postintervention (<italic>t</italic><sub>8</sub>=8 weeks after <italic>t</italic><sub>1</sub>). Both apps were fully automated without any human involvement. Outcomes from the control and intervention conditions at the 3 time points were analyzed using a repeated measures analysis of variance. RESULTS Among the randomized participants (n=490), 185 participants were excluded at the 4-week follow-up and another 79 at the 8-week follow-up because of noncompliance with the experimental protocol. Participants who did not complete <italic>t</italic><sub>4</sub> and <italic>t</italic><sub>8</sub> assessments were equally distributed between groups (<italic>t</italic><sub>4</sub>: control group=34.6% [83/240] and intervention group=40.8% [102/250]; <italic>P</italic>=.16; <italic>t</italic><sub>8</sub>: control group=29.9% [47/157] and intervention group=21.6% [32/148]; <italic>P</italic>=.10). Both groups showed a significant increase in general well-being as a function of time (<italic>F</italic><sub>2,426</sub>=5.27; <italic>P</italic>=.006), but only the intervention group presented a significant increase in work-related well-being (<italic>F</italic><sub>2,426</sub>=8.92; <italic>P</italic>&lt;.001), as well as a significant reduction in work-related and overall stress (<italic>F</italic><sub>2,426</sub>=5.50; <italic>P</italic>=.004 and <italic>F</italic><sub>2,426</sub>=8.59; <italic>P</italic>&lt;.001, respectively). CONCLUSIONS The well-being mobile app was effective in reducing employee stress and improving well-being. CLINICALTRIAL Clinicaltrials.gov NCT02637414; https://clinicaltrials.gov/ct2/show/NCT02637414.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rong Rong ◽  
Wei Chen ◽  
Zihao Dai ◽  
Jingli Gu ◽  
Weiying Chen ◽  
...  

Abstract Background Among Chinese medical students, there is a high prevalence of mental health-related issues and low empathy. Effective strategies to improve this situation are lacking. This study aims to investigate the efficacy of the intervention courses designed to enhance the mental health and empathy of senior Chinese medical students. Methods A total of 146 3rd - and 4th -year medical students were randomized to an intervention group (n = 74) and a control group (n = 72). A pilot study including 5 pre-clinical students and 5 interns was first carried out to determine the themes and content of the intervention courses. The designed courses were delivered in the intervention group once a month three times, while the control group had no specific intervention. Five self-assessment questionnaires, including the General Self-Efficacy (GSE) scale, Medical Outcomes Study Short Form 8 (SF-8), Patient Health Questionnaire-9 (PHQ-9), Maslach Burnout Inventory (MBI), and Jefferson Scale of Empathy-Health Care Provider Student version (JSE-HPS), were completed by the students before and one month after the courses to evaluate their levels of self-efficacy (SE), quality of life (QoL), depression, burnout, and empathy, respectively. Qualitative data were collected via e-mail two years after the intervention. Results Compared to the control group, the intervention group showed significantly higher scores for empathy (111.0 [IQR 102.0, 118.0] vs. 106.0 [IQR 93.0, 111.5]; P = .01) and QoL (32.0 [IQR 28.0, 35.0] vs. 29.5 [IQR 26.0, 34.0]; P = .04). The rate of depression was significantly lower in the intervention group than in the control group (13.5 % vs. 29.2 %; chi-square test, P = .02). However, no significant differences in self-efficacy (25.6 ± 4.8 vs. 24.3 ± 6.3; P = .16) or burnout (27.0 % vs. 34.7 %; Chi-square test, P = .31) were observed between the two groups. Conclusions The intervention courses had a positive impact on mental well-being and empathy in senior Chinese medical students, which might help provide novel information for their incorporation into the medical school curriculum. Trial registration ClinicalTrials.gov Identifier: NCT02645643; Date of registration: 05/01/2016.


2021 ◽  
pp. 014303432110250
Author(s):  
Celeste Simões ◽  
Anabela C. Santos ◽  
Paula Lebre ◽  
João R. Daniel ◽  
Cátia Branquinho ◽  
...  

Resilience is an individual’s ability to adapt successfully to and persevere during and after significant challenges. Resilience programmes based on a socioemotional learning approach have been associated with an increase in protextive factors (e.g., prosocial competencies), improvements in physical and mental health, and a decrease in internalised and externalised symptoms. The present study aimed to evaluate the impact of the RESCUR curriculum implemented in Portuguese schools on students’ academic, behavioural, and socioemotional outcomes, based on child and teacher reports. Participants included 1,084 children (53.2% male) aged 3-15 ( M = 7.24, SD = 2.31). A quasi-experimental study compared outcomes for an experimental intervention group (AIG) with a waiting list control group (WG). The results showed the RESCUR programme decreased mental health difficulties while increasing both prosocial behaviours and well-being. In addition, academic performance increased for those in preschool after implementation. Both teachers and children consistently reported positive behavioural changes in resilience-related competencies after implementing RESCUR. Our findings contribute to the recent research on the potential of RESCUR to address key socioemotional competencies and improve relevant protextive factors. Study limitations and future recommendations are addressed.


Author(s):  
Rida Muhammad Akbar ◽  
Muhammad Naveed Riaz

Objective The study also examined the moderating impact of proactive coping strategies in the relationship of psychological place attachment and mental health related outcomes in sojourners. Methods The study was based upon self-report measures including Psychological Place Attachment Scale, Proactive Coping Inventory, Warwick Edinburg Mental Well-being Scale and Kasler Psychological Distress Scale. Total 300 sojourners participated in the study.  Participants Academic sojourners are students who stay in a place for a limited period of time. Data of sojourners (N = 300) was collected from Sargodha using four self-report measures. Results Data analysis through PROCSS 3.2 revealed that Proactive coping, preventive coping and reflective coping were significantly moderated the relationship between affective and psychological distress. Proactive coping and reflective coping were significantly moderated the relationship between affective bonding and mental wells-being. Proactive coping preventive coping and avoidance coping significantly moderated the relationship home meaning and psychological distress. Proactive coping was moderated the relationship between home meaning and psychological distress. Proactive coping and reflective coping were moderated the relationship between place identity and psychological distress. Proactive coping was moderated the relationship between place identity and mental well-being. Instrumental support seeking was moderating the relationship between place dependence and psychological distress. Preventive coping and reflective coping were moderated the relationship between psychological place attachment and psychological distress. Reflective coping, strategic planning and preventive coping were significantly moderated the relationship between psychological place attachment and mental well-being. Continuous...


2021 ◽  
Author(s):  
Rong Rong ◽  
Wei Chen ◽  
Zihao Dai ◽  
Jingli Gu ◽  
Weiying Chen ◽  
...  

Abstract Background: The Chinese medical students suffer from high prevalent mental health-related issues and low empathy. Effective strategies to improve the situations are lacking. This study aims to investigate the efficacy of the well-designed interventional courses to enhance the mental health and empathy of the senior Chinese medical students. Methods: A total of 146 3rd and 4th year medical students were randomized to intervention group (n=74) and control group (n=72). A pilot study including 5 pre-clinical students and 5 interns was first carried out to determine the themes and contents of the interventional courses. The designed courses were delivered in the intervention group once a month for three times, while the control group had no specific intervention. Five self-assessment questionnaires including the General Self-Efficacy (GSE), Medical Outcomes Study Short Form 8 (SF-8), Patient Health Questionnaire-9 (PHQ-9), Maslach Burnout Inventory (MBI), and Jefferson Scale of Empathy-Health Care Provider Student version (JSE-HPS) that separately evaluated the level of self-efficacy (SE), quality of life (QoL), depression, burnout, and empathy were completed by the students before and one month after the courses. Qualitative data were collected via e-mails two year after the intervention.Results: Compared to the control group, the interventional group showed significantly higher scores of the empathy (111.0 [IQR 102.0, 118.0] vs 106.0 [IQR 93.0, 111.5]; P = .01) and QoL (32.0 [IQR 28.0, 35.0] vs 29.5 [IQR 26.0, 34.0]; P = .04). The rate of depression was significantly decreased in the interventional group compared to that in the control group (13.5% vs 29.2%; Chi-square test, P = .02). However, no significant differences of self-efficacy (25.6 ± 4.8 vs 24.3 ± 6.3; P = .16) and burnout (27.0% vs 34.7%; Chi-square test, P = .31) were observed between the two groups.Conclusions: The well-designed interventional courses had a positive impact on the mental well-being and empathy in senior Chinese medical students, which may help provide novel information for incorporation into the medical school curriculum.


2020 ◽  
Vol 11 (SPL4) ◽  
pp. 1805-1812
Author(s):  
Sharath Hullumani V ◽  
Purusotham Chippala

Flat foot is also called Plano-valgus foot, and it is a term, that is commonly used in describing flat foot. Some studies have suggested, that certain foot-specific exercises and barefoot weight bear walking can change foot function like flat foot, and also confirm that shoed walking children are more likely to get a flat foot. An Assessor blinded, Randomized controlled trial with thirty-eight children with flat foot aged 6 – 14 years, both male and female were randomised to the control group (n= 19) and intervention group (n=19). The control group had performed barefoot walking for 45 minutes a day for eight weeks, and the intervention group had received foot-specific exercises with barefoot walking for eight weeks. Foot posture was evaluated by the arch index, while the Oxford foot and ankle questionnaire was used to measure the subjective well-being of children. Measurements were taken before and after the eight weeks of intervention. The outcome of the randomised control trial showed that the barefoot walking group faired far better than that which didn't (p-value <0.05). The intervention group outcomes measure Arch Index, and Oxford Foot and Ankle Questionnaire were p-values is <0.05 from seventh and eight weeks. This study results suggest that barefoot walking and specific foot exercises are effective in improving the flat foot in school-going children.


2021 ◽  
Vol 12 ◽  
Author(s):  
Qianyun Zhao ◽  
Sen Zhang ◽  
Ran Yu

Background: Patients who are on hemodialysis (HD) and are waiting for kidney transplantation encounter various psychological issues.Objective: The current research aimed to compare the effectiveness of regular nursing care with that of nursing care coupled with dedicated psychological counseling in patients who were on HD before they underwent kidney transplantation.Methods: Baseline data were collected 1 month before kidney transplantation in patients of both the control (patients who received general nursing care between August 2011 and June 2015) and intervention (patients who received nursing care and psychological counseling between June 2015 and July 2018) groups. The Mental Status Scale in Non-Psychiatric Settings (MSSNS) was administered to assess and record the psychological status. Clinicodemographic and end-stage renal disease (ESRD)-related details, including duration of dialysis, causes for ESRD, the number of dialysis sessions performed before transplantation, and MSSNS scores, were recorded and compared between the groups.Results: A total of 37 patients were enrolled, including 19 in the control group and 18 in the intervention group. The number of dialysis sessions performed before transplantation was 143 (26, 564) and 227.5 (39, 767), and dialysis duration was 20.4 ± 14.5 and 14.4 ± 12.1 months in the intervention and control groups, respectively. There was no significant difference in baseline negative emotions between the two groups (P &gt; 0.05). The psychological intervention group reported significantly lower anxiety, depression, anger, and loneliness scores than the control group (P &lt; 0.05).Conclusion: Psychological counseling before kidney transplantation in patients on HD could reduce their negative emotions and enhance mental well-being.


2019 ◽  
Vol 7 (1) ◽  
Author(s):  
Hiromi Tobe ◽  
Mariko Sakka ◽  
Kiyoko Kamibeppu

Abstract Background The demands of daily life often cause mothers high levels of distress and other negative emotions. Anger, including harsh verbal discipline, has been linked to child maltreatment, with long-term adverse effects on a child’s well-being. It is critically important to teach mothers stress management and emotion regulation in addition to parenting skills, but this is yet to be conducted in a formalized manner. Strengthening the multiple protective factors that constitute resilience helps reduce distress. The aim of this study is to evaluate the efficacy of a resilience-enhancement program for mothers. Methods We designed a two-arm, parallel, randomized trial with an active control. Mothers and their partners with children between three and six years old will be recruited. Following an online baseline survey, 140 mothers will be randomly allocated to either an intervention or control group. Self-report assessment will be conducted online post-intervention and at a two-month follow-up. The control group will participate in a serious of group discussions. The intervention group will participate in four bi-weekly 120-min sessions of a Cognitive Behavior Therapy-based program designed to enhance resilience, focusing on emotion regulation through cognitive reappraisal. Participants will be encouraged to apply and share the skills they acquire with their partner and children at home. Partners will also be assessed to explore their indirect influence from the mothers. Intention-to-treat analysis will be conducted and the two groups will be compared, applying covariate analysis. The primary outcome of the intervention is improved resilience. Secondary outcomes include improved anger control, self-esteem, cognition of children’s misbehavior, and reduced parental stress. Discussion To the best of our knowledge, this study will evaluate the first resilience-enhancement program focused on emotion regulation for mothers in Japan. It will contribute to the existing body of knowledge on building emotional resilience. If the program is found to be effective, it will provide an alternative means to enhance mothers’ resilience against stress and improve their ability to regulate emotion. In so doing, it will offer a way to prevent child maltreatment and protect the mental health of children and families. Trial registration UMIN000027232, May 3, 2017.


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