Effect of psychoeducation website named “Imacoco-care” on improving psychological distress among workers under COVID-19 pandemic: a randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Kotaro Imamura ◽  
Natsu Sasaki ◽  
Yuki Sekiya ◽  
Kazuhiro Watanabe ◽  
Asuka Sakuraya ◽  
...  
Keyword(s):  
Mental Health ◽  
Adverse Effect ◽  
Psychological Distress ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychoeducational Intervention ◽  
Favorable Effect ◽  
Randomized Controlled ◽  
Small Effect Size

BACKGROUND The prolonged coronavirus disease 2019 (COVID-19) pandemic affected mental health among workers. Psychoeducational intervention via an Internet website could be effective for primary prevention of mental health among workers in the current COVID-19 pandemic. OBJECTIVE The aim of this randomized controlled trial (RCT) was to examine the effect of a newly developed online psychoeducational website named "Imacoco-care" on reducing psychological distress and fear about COVID-19 infection among workers. METHODS Participants in the present study were recruited from registered members of a web survey company in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to intervention or control groups. Participants in the intervention group were invited to access the Imacoco-care within a month after the baseline survey. Kessler’s Psychological Distress Scale (K6) and The Fear of COVID-19 Scale (FCV-19S) were obtained at baseline, 1-, and 3-month follow-ups. RESULTS A total of 1200 workers were randomly allocated to an intervention or control group (n = 600 for each). In the intention-to-treat (ITT) analyses, the Imacoco-care showed significant favorable effect on K6 (p = 0.03) with small effect size (d = -0.14), and adverse effect on FCV-19S (p = 0.01) with small effect size (d = 0.16) in the intervention group at 3-month follow-up. In the per-protocol analyses (only included participants who have read the Imacoco-care at least one time), the Imacoco-care also showed significant favorable effect on reducing K6 (p = 0.03), while adverse effect on FCV-19S was not significant (p = 0.06) in the intervention group at 3-month follow-up. CONCLUSIONS A web-based psychoeducation approach may be effective on improving psychological distress in a general working population, while it may be important not only distributing information but also encouraging to access and see the contents to prevent the adverse effect of psychoeducational intervention. CLINICALTRIAL The University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The registration number is UMIN000042556 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048548).

scholarly journals Efficacy and moderation of mobile application-based mindfulness-based training, self-compassion training, and cognitive-behavioral psychoeducation on mental health: A randomized controlled trial (Preprint)

2017 ◽  
Author(s):  
Winnie Wing Sze Mak ◽  
Alan Chun Yat Tong ◽  
Sindy Ying Chi Yip ◽  
Wacy Wai Sze Lui ◽  
Floria Hin Ngan Chio ◽  
...  
Keyword(s):  
Mental Health ◽  
Psychological Distress ◽  
Mobile Applications ◽  
Mobile Application ◽  
Controlled Trial ◽  
Well Being ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Self Compassion

BACKGROUND Mindfulness-based interventions, self-compassion training, and cognitive behavioral therapy have garnered much evidence in its salutary effects on mental health. With increasing application of smartphone and mobile technology on health promotion, the present study investigated the efficacy and possible moderators of mindfulness, self-compassion, and cognitive behavioral psychoeducation training mobile applications in the improvement of mental health. OBJECTIVE Our aim was to examine the efficacy of three mobile application-based programs: mindfulness-based program (MBP), self-compassion program (SCP), and cognitive behavioral psychoeducation control (CBP) in improving well-being and reducing psychological distress. To further delineate the suitability of each program for which type of individuals, individual difference variables (i.e., nonattachment, self-criticism, discomfort with emotion, and tolerance for ambiguity) were explored for potential moderation. METHODS The present study was a three-arm randomized controlled trial examining the efficacy of MBP, SCP with CBP. The course contents of the three programs were composed by a clinical psychologist and the mobile application was fully automated. Participants were recruited online and offline via mass mail, advertisements in newspapers and magazines, and social networking site. They were randomized into either one of the three conditions and completed pre-program survey assessment. Throughout the 4-week, 28-session program, participants spent 10 minutes daily in reviewing the course content and practicing various related exercises. Post-assessment and 3-month follow-up surveys were administered to measure changes over time. Indicators of mental health and psychological distress, as well as proposed moderators were self-assessed online at pre-program, post-program, and 3-month follow-up. RESULTS Among the 2,161 study participants, 508 and 349 completed the post- and 3-month follow-up assessment respectively. All three conditions (MBP, N = 703; CBP, N = 753; SCP, N = 705) were found to be efficacious in improving mental well-being and reducing psychological distress. No significant differences regarding usage and users’ satisfaction were found among the three conditions. None of the proposed moderators were found to be significant. CONCLUSIONS Mindfulness-based, self-compassion, and cognitive behavioral psychoeducation mobile applications were efficacious in improving mental health and reducing psychological distress among young adults at post-program, and such improvements were maintained at 3-month follow-up. Future app-based psychological training programs should consider gamification and personalization of content or feedback to enhance engagement and mitigate the high attrition rate that are common in app-based health promotion programs. CLINICALTRIAL Chinese Clinical Trial Registry (ChiCTR) ChiCTR-TRC-13003468; https://www2.ccrb.cuhk.edu.hk/registry/public/217 (Archived by WebCite at http://www.webcitation.org/6oaPwga7z).

scholarly journals Effectiveness of an Internet- and App-Based Intervention for College Students With Elevated Stress: Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Mathias Harrer ◽  
Sophia Helen Adam ◽  
Rebecca Jessica Fleischmann ◽  
Harald Baumeister ◽  
Randy Auerbach ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Waitlist Control ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
Waitlist Control Group

BACKGROUND Mental health problems are highly prevalent among college students. Most students with poor mental health, however, do not receive professional help. Internet-based self-help formats may increase the utilization of treatment. OBJECTIVE The aim of this randomized controlled trial was to evaluate the efficacy of an internet-based, app-supported stress management intervention for college students. METHODS College students (n=150) with elevated levels of stress (Perceived Stress Scale 4-item version, PSS-4 ≥8) were randomly assigned to either an internet- and mobile-based stress intervention group with feedback on demand or a waitlist control group. Self-report data were assessed at baseline, posttreatment (7 weeks), and 3-month follow-up. The primary outcome was perceived stress posttreatment (PSS-4). Secondary outcomes included mental health outcomes, modifiable risk and protective factors, and college-related outcomes. Subgroup analyses were conducted in students with clinically relevant symptoms of depression (Center for Epidemiological Studies’ Depression Scale >17). RESULTS A total of 106 participants (76.8%) indicated that they were first-time help-seekers, and 77.3% (intervention group: 58/75; waitlist control group: 58/75) showed clinically relevant depressive symptoms at baseline. Findings indicated significant effects of the intervention compared with the waitlist control group for stress (d=0.69; 95% CI 0.36-1.02), anxiety (d=0.76; 95% CI 0.43-1.09), depression (d=0.63; 95% CI 0.30-0.96), college-related productivity (d=0.33; 95% CI 0.01-0.65), academic work impairment (d=0.34; 95% CI 0.01-0.66), and other outcomes after 7 weeks (posttreatment). Response rates for stress symptoms were significantly higher for the intervention group (69%, 52/75) compared with the waitlist control group (35%, 26/75, P<.001; number needed to treat=2.89, 95% CI 2.01-5.08) at posttest (7 weeks). Effects were sustained at 3-month follow-up, and similar findings emerged in students with symptoms of depression. CONCLUSIONS Internet- and mobile-based interventions could be an effective and cost-effective approach to reduce consequences of college-related stress and might potentially attract students with clinically relevant depression who would not otherwise seek help. CLINICALTRIAL German Clinical Trial Register DRKS00010212; http://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010212 (Archived by WebCite at http://www.webcitation.org/6w55Ewhjd)

scholarly journals A Mobile Health Intervention for Mental Health Promotion Among University Students: Randomized Controlled Trial

10.2196/17208 ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. e17208 ◽  
Author(s):  
Marcus Bendtsen ◽  
Ulrika Müssener ◽  
Catharina Linderoth ◽  
Kristin Thomas
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
Positive Mental Health ◽  
Control Group ◽  
Depression And Anxiety ◽  
Randomized Controlled

Background High positive mental health, including the ability to cope with the normal stresses of life, work productively, and be able to contribute to one’s community, has been associated with various health outcomes. The role of positive mental health is therefore increasingly recognized in national mental health promotion programs and policies. Mobile health (mHealth) interventions could be a cost-effective way to disseminate positive psychological interventions to the general population. Objective The aim of this study was to estimate the effect of a fully automated mHealth intervention on positive mental health, and anxiety and depression symptomology among Swedish university students using a randomized controlled trial design. Methods A 2-arm, single-blind (researchers), parallel-groups randomized controlled trial with an mHealth positive psychology program intervention group and a relevant online mental health information control group was employed to estimate the effect of the novel intervention. Participants were recruited using digital advertising through student health care centers in Sweden. Inclusion criteria were (1) university students, (2) able to read and understand Swedish, (3) and have access to a mobile phone. Exclusion criteria were high positive mental health, as assessed by the Mental Health Continuum Short Form (MHC-SF), or high depression and anxiety symptomology, as assessed by the Hospital Anxiety Depression Scale (HADS). The primary outcome was positive mental health (MHC-SF), and the secondary outcomes were depression and anxiety symptomatology (HADS). The subscales of MHC-SF were also analyzed as exploratory outcomes. Outcomes were measured 3 months after randomization through questionnaires completed on the participants’ mobile phones. Results A total of 654 participants (median age 25 years), including 510 (78.0%) identifying as female, were randomized to either the intervention (n=348) or control group (n=306). At follow-up, positive mental health was significantly higher in the intervention group compared with the control group (incidence rate ratio [IRR]=1.067, 95% CI 1.024-1.112, P=.002). For both depression and anxiety symptomatology, the intervention group showed significantly lower scores at follow-up compared with the control group (depression: IRR=0.820, 95% CI 0.714-0.942, P=.005; anxiety: IRR=0.899, 95% CI 0.840-0.962, P=.002). Follow-up rates were lower than expected (58.3% for primary outcomes and 52.3% for secondary outcomes); however, attrition analyses did not identify any systematic attrition with respect to baseline variables. Conclusions The mHealth intervention was estimated to be superior to usual care in increasing positive mental health among university students. A protective effect of the intervention was also found on depressive and anxiety symptoms. These findings demonstrate the feasibility of using an automated mobile phone format to enhance positive mental health, which offers promise for the use of mHealth solutions in public mental health promotion. Trial Registration International Standard Randomized Controlled Trial Registry ISRCTN54748632; http://www.isrctn.com/ISRCTN54748632

Preventing depression using a smartphone app: a randomized controlled trial

2020 ◽  
pp. 1-10 ◽  
Author(s):  
Mark Deady ◽  
Nicholas Glozier ◽  
Rafael Calvo ◽  
David Johnston ◽  
Andrew Mackinnon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Intervention Group ◽  
Smartphone App ◽  
Control Group ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Small Effect Size

Abstract Background There is evidence that depression can be prevented; however, traditional approaches face significant scalability issues. Digital technologies provide a potential solution, although this has not been adequately tested. The aim of this study was to evaluate the effectiveness of a new smartphone app designed to reduce depression symptoms and subsequent incident depression amongst a large group of Australian workers. Methods A randomized controlled trial was conducted with follow-up assessments at 5 weeks and 3 and 12 months post-baseline. Participants were employed Australians reporting no clinically significant depression. The intervention group (N = 1128) was allocated to use HeadGear, a smartphone app which included a 30-day behavioural activation and mindfulness intervention. The attention-control group (N = 1143) used an app which included a 30-day mood monitoring component. The primary outcome was the level of depressive symptomatology (PHQ-9) at 3-month follow-up. Analyses were conducted within an intention-to-treat framework using mixed modelling. Results Those assigned to the HeadGear arm had fewer depressive symptoms over the course of the trial compared to those assigned to the control (F3,734.7 = 2.98, p = 0.031). Prevalence of depression over the 12-month period was 8.0% and 3.5% for controls and HeadGear recipients, respectively, with odds of depression caseness amongst the intervention group of 0.43 (p = 0.001, 95% CI 0.26–0.70). Conclusions This trial demonstrates that a smartphone app can reduce depression symptoms and potentially prevent incident depression caseness and such interventions may have a role in improving working population mental health. Some caution in interpretation is needed regarding the clinical significance due to small effect size and trial attrition. Trial Registration Australian and New Zealand Clinical Trials Registry (www.anzctr.org.au/) ACTRN12617000548336

scholarly journals Detection of Domestic Violence and Abuse by Community Mental Health Teams Using the BRAVE Intervention: A Multicenter, Cluster Randomized Controlled Trial

2021 ◽  
pp. 088626052110041
Author(s):  
Roos Ruijne ◽  
Cornelis Mulder ◽  
Milan Zarchev ◽  
Kylee Trevillion ◽  
Roel van Est ◽  
...  
Keyword(s):  
Mental Health ◽  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Referral Rates ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
And Control ◽  
Domestic Violence And Abuse

Despite increased prevalence of domestic violence and abuse (DVA), victimization through DVA often remains undetected in mental health care. To estimate the effectiveness of a system provider level training intervention by comparing the detection and referral rates of DVA of intervention community mental health (CMH) teams with rates in control CMH teams. We also aimed to determine whether improvements in knowledge, skills and attitudes to DVA were greater in clinicians working in intervention CMH teams than those working in control teams. We conducted a cluster randomized controlled trial in two urban areas of the Netherlands. Detection and referral rates were assessed at baseline and at 6 and 12 months after the start of the intervention. DVA knowledge, skills and attitudes were assessed using a survey at baseline and at 6 and 12 months after start of the intervention. Electronic patient files were used to identify detected and referred cases of DVA. Outcomes were compared between the intervention and control teams using a generalized linear mixed model. During the 12-month follow-up, detection and referral rates did not differ between the intervention and control teams. However, improvements in knowledge, skills and attitude during that follow-up period were greater in intervention teams than in control teams: β 3.21 (95% CI 1.18-4.60). Our trial showed that a training program on DVA knowledge and skills in CMH teams can increase knowledge and attitude towards DVA. However, our intervention does not appear to increase the detection or referral rates of DVA in patients with a severe mental illness. A low detection rate of DVA remains a major problem. Interventions with more obligatory elements and a focus on improving communication between CMH teams and DVA services are recommended.

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

scholarly journals Evaluation of a Brief Intervention for Promoting Mental Health among Employees in Social Enterprises: A Cluster Randomized Controlled Trial

2018 ◽  
Vol 15 (10) ◽  
pp. 2107 ◽  
Author(s):  
Benedicte Deforche ◽  
Jasmine Mommen ◽  
Anne Hublet ◽  
Winnie De Roover ◽  
Nele Huys ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Promotion ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Social Enterprises ◽  
Randomized Controlled ◽  
Cluster Randomized

Evidence on the effectiveness of workplace mental health promotion for people with disabilities is limited. This study aimed to evaluate the effectiveness of a brief mental health promotion intervention in social enterprises. It had a non-blinded cluster randomized controlled trial design with follow-up one and four months after the intervention. In total 196 employees agreed to participate (86 intervention and 110 control). Empowerment was the main outcome; secondary outcomes were resilience, palliative behavior, determinants of four coping strategies of mental health, quality of life, and life satisfaction. A brief participant satisfaction survey was conducted after the intervention. No significant intervention effect on empowerment was found. However, at one month follow-up, significant favorable effects were found on perceived social support for coping strategies for mental health and on palliative behavior. At four months follow-up, favorable intervention effects were found on quality of life, but unfavorable effects were found on unjustified worrying. In addition, the intervention was well received by the employees. This brief intervention might be a promising first step to improve mental health in people with disabilities working in social enterprises. Nevertheless, additional monitoring by professionals and managers working in the organizations might be needed to maintain these effects.

Effect of ICT-Based Self-Management System DialBeticsLite on Treating Abdominal Obesity: Randomized Controlled Trial. (Preprint)

2021 ◽  
Author(s):  
Masahiro Kondo ◽  
Teru Okitsu ◽  
Kayo Waki ◽  
Toshimasa Yamauchi ◽  
Masaomi Nangaku ◽  
...  
Keyword(s):  
Abdominal Obesity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Metabolic Parameters ◽  
Control Group ◽  
Physical Parameters ◽  
Lifestyle Behavior ◽  
Randomized Controlled

BACKGROUND Mobile health interventions, a more cost-effective approach compared to traditional methods of delivering lifestyle coaching in person, have been shown to improve physical parameters and lifestyle behavior among overweight populations. It is useful to know the efficacy of mobile apps in treating abdominal obesity, as it is a known risk factor for metabolic disorders and type 2 diabetes. OBJECTIVE This study aimed to determine whether a mobile self-management app (DialBeticsLite) could be used by patients with abdominal obesity to achieve a reduction in visceral fat area (VFA) and other physical parameters. METHODS This study was an open-label, 2-arm parallel-design randomized controlled trial. We recruited 122 people in September 2017, and randomly assigned them into either the intervention group or the control group. All participants attended an educational group session, which delivered information regarding diet and exercise. Additionally, participants in the intervention group were asked to use DialBeticsLite for 3 months. DialBeticsLite facilitated the daily recording of several physical parameters and lifestyle behavior, and provided feedback to encourage an improvement in behavior. The primary outcome was the change in VFA from baseline to the 3-month follow-up. Secondary outcomes included changes in both physical and metabolic parameters, from baseline to the 3-month follow-up. Welch t test was conducted to analyze the effects of DialBeticsLite on both the primary outcome and the secondary outcomes. RESULTS Out of the 122 participants recruited, 75 participants were analyzed due to 47 participants being excluded: 37 due to ineligibility and 10 due to withdrawal of consent. The mean age was 49.3 (standard deviation: SD 6.1) in the intervention group (n=41) and 48.5 (SD 5.3) in the control group (n=34), and all participants were male, though unintentionally. Baseline characteristics did not differ significantly between the intervention and control group, except for VFA. The averaged change of VFA was -23.5cm2 (SD 20.6) in the intervention group and +1.9cm2 (SD 16.2) in the control group (P<.001). Statistically significant differences were also found for the change of body weight, BMI and waist circumference. These findings did not change after adjusting for VFA at baseline. The intervention had no significant effect on any of the metabolic parameters. An exploratory analysis showed significant associations between the change in VFA and steps per day, and between the change in VFA and calorie intake per day within the intervention group. CONCLUSIONS Our findings indicate that although unsuccessful in improving metabolic parameters, a mobile health intervention facilitating the daily monitoring of several physical parameters and lifestyle behavior, can be highly effective in inducing visceral fat loss and weight loss among adults with abdominal obesity. CLINICALTRIAL Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042045 Retrospectively Registered; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000046495&type=summary&llanguag=J

Use of the Creating Opportunities for Parent Empowerment Program to Decrease Mental Health Problems in Ugandan Children Surviving Severe Malaria: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Paul Bangirana ◽  
Annet Birabwa ◽  
Mary Nyakato ◽  
Ann J. Nakitende ◽  
Maria Kroupina ◽  
...  
Keyword(s):  
Mental Health ◽  
Severe Malaria ◽  
Behavioral Problems ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Control Groups ◽  
Caregiver Depression ◽  
Randomized Controlled

Abstract Background: Severe malaria is associated with long-term mental health problems in Ugandan children. This study investigated the effect of a behavioral intervention for caregivers of children admitted with severe malaria, on the children’s mental health outcomes six months after discharge.Methods: This randomized controlled trial was conducted at Naguru Hospital in Kampala, Uganda from January 2018 to July 2019. Caregiver and child dyads were randomly assigned to either a psychoeducation arm providing information about hospital procedures during admission (control group) or a behavioral arm providing information about the child’s possible emotions and behavior during and after admission and providing age appropriate games for the caregiver and child (intervention group). Pre- and post-intervention assessments for caregiver anxiety and depression (Hopkins Symptom Checklist) and child mental health problems (Strength and Difficulties Questionnaire and the Child Behavioral Checklist) were done during admission and six months after discharge respectively. T-tests, analysis of covariance and Chi-Square were used to compare outcomes between the two treatment arms.Results: There were 120 caregiver-child dyads recruited at baseline with children aged 1.45 years to 4.89 years (mean age 2.85 years, SD = 1.01). The intervention and control groups had similar sociodemographic, clinical and behavioral characteristics at baseline. Caregiver depression at baseline, mother’s education and female sex of the child were associated with behavioral problems in the child at baseline (p<0.05). At six months follow-up, there was no difference in the frequency of behavioral problems between the groups (6.8% vs 10% in intervention vs. control groups, respectively, p = 0.72). Caregiver depression and anxiety scores between the treatment arms did not differ at six months follow-up. Conclusion: This behavioral intervention for caregivers and their children admitted with severe malaria had no effect on the child’s mental health outcomes at six months. Further studies need to develop interventions for mental health problems after severe malaria in children with longer follow-up time.ClinicalTrials.gov Identifier: NCT03432039

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