Evaluation of My Stress Control, a web-based stress management program for persons experiencing work-related stress: A randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Caroline Eklund ◽  
Anne Söderlund ◽  
Magnus L Elfström
Keyword(s):  
Randomized Controlled Trial ◽  
Stress Management ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Intervention Group ◽  
Wait List ◽  
Post Intervention ◽  
Web Based ◽  
Stress Control ◽  
Randomized Controlled

BACKGROUND Stress is one of the most common reasons for sick leave. Web-based interventions have the potential to reach an unlimited number of users at a low cost and have been shown effective at addressing several health-related problems. To handle stress on an individual level is about behavior change. To support behavior change in stress management My Stress Control (MSC) was developed. The development of MSC was based on several health psychology theories and models but central in the development was Social Cognitive Theory, Theory of Reasoned Action, Theory of Planned Behavior, Transactional Theory of Stress and Coping and the Transtheoretical Model and Stages of Change. MSC is a fully automated program. The program is tailored to the user's specific need for stress management and behavior change. OBJECTIVE The aim of this study was to conduct a randomized controlled trial to evaluate the extent to which MSC affected perceived stress in persons experiencing work-related stress. METHODS This study was conducted as a randomized controlled trial with two arms. Study participants were recruited by visiting worksites and workplace meetings. Participants were assigned to intervention or wait list group. Web-based questionnaires were used pre- and post-intervention to collect data. Perceived stress measured with the Perceived Stress Scale (PSS-14) was the primary outcome measurement. Analyses were conducted for both between- and within-group changes. RESULTS A total of 92 participants were included in this study, 48 in intervention group and 44 in waitlist group. Twelve participants in the intervention group and 19 participants in the waitlist group completed the post intervention assessment. There were no significant effects on perceived stress between the intervention and wait list groups or within the groups. A small effect size (dCohen=0.25) was found when comparing mean change over time on the primary outcome measure between the intervention and wait list groups. Additionally, a small effect size was found between pre- and post-intervention assessment within the intervention group (dCohen=0.38) as well as within the wait list group (dCohen=0.25). CONCLUSIONS It is still uncertain what effect My Stress Control (MSC) may have on perceived stress. Because adherence was low in the intervention group, elements or features that facilitate adherence must be further developed before firmer conclusions of the effect of MSC can be studied. CLINICALTRIAL This RCT was registered at clinicaltrials.gov, protocol record 2015/0646.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

2021 ◽  
Vol 18 (14) ◽  
pp. 7510
Author(s):  
Guillermo García Pérez de Sevilla ◽  
Olga Barceló Guido ◽  
María de la Paz De la Cruz ◽  
Ascensión Blanco Fernández ◽  
Lidia B. Alejo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Effect Size ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nutrition Intervention ◽  
Sitting Time ◽  
Post Intervention ◽  
University Employees ◽  
Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

scholarly journals Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

2021 ◽  
Author(s):  
Remi Yoshikata ◽  
Khin Zay Yar Myint ◽  
Hiroaki Ohta ◽  
Yoko Ishigaki
Keyword(s):  
Randomized Controlled Trial ◽  
Visceral Fat ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Climacteric Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Menopausal Women ◽  
Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

scholarly journals Web-based stress management for newly diagnosed cancer patients (STREAM): A randomized, wait-list controlled intervention study.

2017 ◽  
Vol 35 (18_suppl) ◽  
pp. LBA10002-LBA10002 ◽  
Author(s):  
Viviane Hess ◽  
Astrid Grossert ◽  
Judith Alder ◽  
Sandra Scherer ◽  
Barbara Handschin ◽  
...  
Keyword(s):  
Stress Management ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Intervention Group ◽  
Management Program ◽  
Control Group ◽  
Wait List ◽  
Newly Diagnosed ◽  
Web Based ◽  
Minimal Contact

LBA10002 Background: Being diagnosed with cancer causes major distress, yet the majority of newly diagnosed cancer patients (pts) lack psychological support. Internet interventions overcome many barriers for seeking support. We assess efficacy and feasibility of a web-based minimal-contact stress management intervention (STREAM) for newly diagnosed cancer pts. Methods: In a prospective, wait-list controlled trial, newly diagnosed cancer pts were randomized within 12 weeks of starting anti-cancer treatment to an immediate or delayed (control group) 8-week, web-based intervention. The intervention consisted of 8 modules with weekly written feedback by a psychologist (“minimal-contact”) based on well-established stress management manuals. The aim of this study was to evaluate efficacy in terms of improvement in QoL (FACIT-F), decrease in distress (DT), anxiety/depression (HADS), as compared to pts in the wait-list group. 120 pts were needed to show (80% power, 2-sided α of 0.05) a clinically meaningful difference of ≥ 9 in FACT score after the immediate intervention (week 8 = T2). Results: 225 pts applied online. 128 pts were randomized. Median age was 52 (22-77)y. 108 (84%) were female. The majority of pts were treated in the curative setting (117pts; 91%), with chemotherapy (74 pts; 58%), for breast cancer (91pts; 71%). Self-reported distress at baseline ( = stratification factor) was above 4 on a 10-point scale (DT) with 96 pts (75%). At T2, QoL (FACIT-F) was sign. increased (p = 0.044; ANCOVA adjusted for baseline-distress) and distress sign. lowered (p = 0.032) in the intervention group as compared to the wait-list control. Median score (lower/upper quartile) for FACIT-F at baseline/T2 was 101.0(80.8/120)/119.0(98.0/132) and 108.3(87.8/124.0) /109.5(97.2/121.0); of DT at baseline/T2 was 6(5/8)/4(3/6) and 6(5/8)/6(4/7) for the intervention and control group, respectively. Decrease in HADS was not sign. different between the groups (p = 0.273). Conclusions: With STREAM, we open the field of minimal-contact online interventions to newly diagnosed cancer pts and show that an 8-week web-based stress management program is feasible and effective in improving QoL and distress. Clinical trial information: NCT02289014.

scholarly journals Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0244717
Author(s):  
Jennifer L. Huberty ◽  
Jeni Green ◽  
Megan E. Puzia ◽  
Linda Larkey ◽  
Breanne Laird ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Disturbance ◽  
Daytime Sleepiness ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile App ◽  
Wait List ◽  
Wait List Control ◽  
Randomized Controlled ◽  
Sleep Arousal

The objective of this randomized controlled trial was to test whether a commercially available, mindfulness meditation mobile app, (i.e., Calm app), was effective in reducing fatigue (primary outcome), pre-sleep arousal, and daytime sleepiness (secondary outcomes) in adults with sleep disturbance (Insomnia Severity Index Score >10) as compared to a wait-list control group. Associations between the use of the Calm app (i.e., adherence to the intervention) and changes in sleep quality was also explored in the intervention group only. Adults with sleep disturbance were recruited (N = 640). Eligible and consenting participants (N = 263) were randomly assigned to the intervention (n = 124) or a wait-list control (n = 139) group. Intervention participants were asked to meditate using the Calm app ≥10 minutes/day for eight weeks. Fatigue, daytime sleepiness, and pre-sleep arousal were assessed at baseline, mid- (4-weeks) and post-intervention (8-weeks) in both groups, whereas sleep quality was evaluated only in the intervention group. Findings from intent-to-treat analyses suggest the use of the Calm app for eight weeks significantly decreased daytime fatigue (p = .018) as well as daytime sleepiness (p = .003) and cognitive (p = .005) and somatic (p < .001) pre-sleep arousal as compared to the wait-list control group. Within the intervention group, use of the Calm app was associated with improvements in sleep quality (p < .001). This randomized controlled trial demonstrates that the Calm app can be used to treat fatigue, daytime sleepiness, and pre-sleep arousal in adults with sleep disturbance. Given that the Calm app is affordable and widely accessible, these data have implications for community level dissemination of a mobile app to improve sleep-related symptoms associated with sleep disturbance. Trial registration: ClinicalTrials.gov NCT04045275.

scholarly journals Effectiveness of an 8-Week Web-Based Mindfulness Virtual Community Intervention for University Students on Symptoms of Stress, Anxiety, and Depression: Randomized Controlled Trial

10.2196/18595 ◽  
2020 ◽  
Vol 7 (7) ◽  
pp. e18595 ◽  
Author(s):  
Christo El Morr ◽  
Paul Ritvo ◽  
Farah Ahmad ◽  
Rahim Moineddin ◽  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Undergraduate Students ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Virtual Community ◽  
Depression And Anxiety ◽  
Discussion Forums ◽  
Web Based ◽  
Randomized Controlled

Background A student mental health crisis is increasingly acknowledged and will only intensify with the COVID-19 crisis. Given accessibility of methods with demonstrated efficacy in reducing depression and anxiety (eg, mindfulness meditation and cognitive behavioral therapy [CBT]) and limitations imposed by geographic obstructions and localized expertise, web-based alternatives have become vehicles for scaled-up delivery of benefits at modest cost. Mindfulness Virtual Community (MVC), a web-based program informed by CBT constructs and featuring online videos, discussion forums, and videoconferencing, was developed to target depression, anxiety, and experiences of excess stress among university students. Objective The aim of this study was to assess the effectiveness of an 8-week web-based mindfulness and CBT program in reducing symptoms of depression, anxiety, and stress (primary outcomes) and increasing mindfulness (secondary outcome) within a randomized controlled trial (RCT) with undergraduate students at a large Canadian university. Methods An RCT was designed to assess undergraduate students (n=160) who were randomly allocated to a web-based guided mindfulness–CBT condition (n=80) or to a waitlist control (WLC) condition (n=80). The 8-week intervention consisted of a web-based platform comprising (1) 12 video-based modules with psychoeducation on students’ preidentified life challenges and applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided 20-minute live videoconferences. The outcomes (depression, anxiety, stress, and mindfulness) were measured via an online survey at baseline and at 8 weeks postintervention using the Patient Health Questionnaire-9 (PHQ9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible covariates (gender, age, country of birth, ethnicity, English as first language, paid work, unpaid work, relationship status, physical exercise, self-rated health, and access to private mental health counseling). Results Of the 159 students who provided T1 data, 32 were males and 125 were females with a mean age of 22.55 years. Participants in the MVC (n=79) and WLC (n=80) groups were similar in sociodemographic characteristics at T1 with the exception of gender and weekly hours of unpaid volunteer work. At postintervention follow-up, according to the adjusted comparisons, there were statistically significant between-group reductions in depression scores (β=–2.21, P=.01) and anxiety scores (β=–4.82, P=.006), and a significant increase in mindfulness scores (β=4.84, P=.02) compared with the WLC group. There were no statistically significant differences in perceived stress for MVC (β=.64, P=.48) compared with WLC. Conclusions With the MVC intervention, there were significantly reduced depression and anxiety symptoms but no significant effect on perceived stress. Online mindfulness interventions can be effective in addressing common mental health conditions among postsecondary populations on a large scale, simultaneously reducing the current burden on traditional counseling services. Trial Registration ISRCTN Registry ISRCTN12249616; http://www.isrctn.com/ISRCTN12249616

scholarly journals A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a Mixed-Methods Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Jolie N Haun ◽  
Lisa M Ballistrea ◽  
Christine Melillo ◽  
Maisha Standifer ◽  
Kevin Kip ◽  
...  
Keyword(s):  
Posttraumatic Stress Disorder ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Wait List ◽  
Web Based ◽  
Wait List Control ◽  
Integrative Health ◽  
Randomized Controlled

BACKGROUND Complementary and integrative health (CIH) is a viable solution to PTSD and chronic pain. Many veterans believe CIH can be performed only by licensed professionals in a health care setting. Health information technology can bring effective CIH to veterans and their partners. OBJECTIVE This paper describes the rationale, design, and methods of the Mission Reconnect protocol to deliver mobile and Web-based complementary and integrative health programs to veterans and their partners (eg, spouse, significant other, caregiver, or family member). METHODS This three-site, 4-year mixed-methods randomized controlled trial uses a wait-list control to determine the effects of mobile and Web-based CIH programs for veterans and their partners, or dyads. The study will use two arms (ie, treatment intervention arm and wait-list control arm) in a clinical sample of veterans with comorbid pain and posttraumatic stress disorder, and their partners. The study will evaluate the effectiveness and perceived value of the Mission Reconnect program in relation to physical and psychological symptoms, global health, and social outcomes. RESULTS Funding for the study began in November 2018, and we are currently in the process of recruitment screening and data randomization for the study. Primary data collection will begin in May 2019 and continue through May 2021. Projected participants per site will be 76 partners/dyads, for a total of 456 study participants. Anticipated study results will be published in November 2022. CONCLUSIONS This work highlights innovative delivery of CIH to veterans and their partners for treatment of posttraumatic stress disorder and chronic pain. CLINICALTRIAL ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 (Archived by WebCite at http://www.webcitation.org/77Q2giwtw) INTERNATIONAL REGISTERED REPOR PRR1-10.2196/13666

scholarly journals Go Play Outside! A web-based and in-person risk reframing intervention to influence mothers’ tolerance for, and parenting practices associated with, children’s outdoor risky play: Results of a randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Mariana Brussoni ◽  
Christina S Han ◽  
Yingyi Lin ◽  
John Jacob ◽  
Ian Pike ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Social Cognitive Theory ◽  
Social Cognitive ◽  
Cognitive Theory ◽  
Controlled Trial ◽  
Post Intervention ◽  
Web Based ◽  
Randomized Controlled ◽  
Risky Play ◽  
The Web

BACKGROUND Outdoor risky play, such as climbing, racing and independent exploration, is an important part of childhood and is associated with various positive physical, mental and developmental outcomes for children. Parental attitudes and fears, particularly mothers’, are a major deterrent to children’s opportunities for outdoor risky play. OBJECTIVE To evaluate the efficacy of two versions of an intervention to reframe mothers’ perceptions of risk and change parenting behaviours: web-based intervention or an in-person workshop, compared to the control condition. METHODS The Go Play Outside! randomized controlled trial was conducted in Canada in 2017 to 2018. Participants were recruited through social media, snowball sampling, and community notices. Mothers of children aged 6-12 years were self-assessed through eligibility questions, and those eligible and consented to participate in the study were randomized into a fully automated web-based intervention, the in-person workshop or the control condition. The intervention was underpinned by social cognitive theory, incorporating behaviour change techniques. Participants progressed through a series of self-reflection exercises and developed a goal for change. Control participants received the Position Statement on Active Outdoor Play. The primary outcome was increase in tolerance of risky play and the secondary outcome was goal attainment. Data were collected online via REDCap at baseline, 1-week and 3-months post-intervention. Randomization was conducted using sealedenvelope.com. Allocations were concealed to researchers at assignment and data analysis. We conducted mediation analyses to examine whether the intervention influenced elements of social cognitive theory, as hypothesized. RESULTS A total of 451 mothers were randomized and completed baseline socio-demographic assessments: 150 in the web-based intervention, 153 in the in-person workshop, and 148 in the control condition; of which a total of 351 mothers completed the intervention. At 1-week post-intervention, 121, 85, and 135 mothers completed assessments for each condition, respectively, and at 3-months post-intervention, 105, 84 and 123 completed the assessments, respectively. Compared to mothers in the control condition, mothers in the web-based intervention had significantly higher tolerance of risky play at 1-week, and 3-months post-intervention; and mothers in the in-person workshop had significantly higher tolerance of risky play at 1-week post-intervention. No other significant outcomes were found. None of the potential mediators were found to significantly mediate the outcomes. CONCLUSIONS The trial demonstrates that the web-based intervention was effective in increasing mothers’ tolerance for risk in play. CLINICALTRIAL ClinicalTrials.gov, NCT03374683. Retrospectively registered on December 15, 2017. INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-018-2552-4

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