scholarly journals Effects of web‐based stress and depression literacy intervention on improving work engagement among workers with low work engagement: An analysis of secondary outcome of a randomized controlled trial

2017 ◽  
Vol 59 (1) ◽  
pp. 46-54 ◽  
Author(s):  
Kotaro Imamura ◽  
Norito Kawakami ◽  
Kanami Tsuno ◽  
Masao Tsuchiya ◽  
Kyoko Shimada ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Work Engagement ◽  
Controlled Trial ◽  
Literacy Intervention ◽  
Secondary Outcome ◽  
Web Based ◽  
Randomized Controlled ◽  
Depression Literacy

scholarly journals Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the �Fitter na kanker� Randomized Controlled Trial (Preprint)

2016 ◽  
Author(s):  
Fieke Z. Bruggeman-Everts ◽  
Marije D. J. Wolvers ◽  
Rens van de Schoot ◽  
Miriam M. R. Vollenbroek-Hutten ◽  
Marije L. Van der Lee
Keyword(s):  
Randomized Controlled Trial ◽  
Active Control ◽  
Controlled Trial ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Web Based ◽  
Technical Problems ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Fatigue Severity

BACKGROUND Approximately one third of all patients who have been successfully treated for cancer suffer from chronic cancer-related fatigue (CCRF). Effective and easily accessible interventions are needed for these patients. OBJECTIVE The current paper reports on the results of a 3-armed randomized controlled trial investigating the clinical effectiveness of two different guided Web-based interventions for reducing CCRF compared to an active control condition. METHODS Severely fatigued cancer survivors were recruited via online and offline channels, and self-registered on an open-access website. After eligibility checks, 167 participants were randomized via an embedded automated randomization function into: (1) physiotherapist-guided Ambulant Activity Feedback (AAF) therapy encompassing the use of an accelerometer (n=62); (2) psychologist-guided Web-based mindfulness-based cognitive therapy (eMBCT; n=55); or (3) an unguided active control condition receiving psycho-educational emails (n=50). All interventions lasted nine weeks. Fatigue severity was self-assessed using the Checklist Individual Strength - Fatigue Severity subscale (primary outcome) six times from baseline (T0b) to six months (T2). Mental health was self-assessed three times using the Hospital Anxiety and Depression Scale and Positive and Negative Affect Schedule (secondary outcome). Treatment dropout was investigated. RESULTS Multiple group latent growth curve analysis, corrected for individual time between assessments, showed that fatigue severity decreased significantly more in the AAF and eMBCT groups compared to the psycho-educational group. The analyses were checked by a researcher who was blind to allocation. Clinically relevant changes in fatigue severity were observed in 66% (41/62) of patients in AAF, 49% (27/55) of patients in eMBCT, and 12% (6/50) of patients in psycho-education. Dropout was 18% (11/62) in AAF, mainly due to technical problems and poor usability of the accelerometer, and 38% (21/55) in eMBCT, mainly due to the perceived high intensity of the program. CONCLUSIONS Both the AAF and eMBCT interventions are effective for managing fatigue severity compared to receiving psycho-educational emails. CLINICALTRIAL Trialregister.nl NTR3483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3483 (Archived by WebCite at http://www.webcitation.org/6NWZqon3o)

scholarly journals Effects of an Eight Week Online intervention for Depression, Anxiety and Stress in a university sample; randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Paul Ritvo ◽  
Farah Ahmad ◽  
Christo El Morr ◽  
Meysam Pirbaglou ◽  
Rahim Moineddin
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Psychological Characteristics ◽  
Secondary Outcome ◽  
Group Differences ◽  
Web Based ◽  
Randomized Controlled ◽  
The Impact ◽  
Labor Strike

BACKGROUND University students are experiencing higher levels of distress and mental health disorder. In addressing mental health needs, web-based interventions have shown increasing promise to overcome geographic distances and high student-to-counselor ratios, with a potential for widespread implementation. The Mindfulness Virtual Community (MVC) program, a web based program, guided by mindfulness and cognitive behavioural therapy principles, is among such efforts to effectively and efficiently reduce symptoms of depression, anxiety, and stress in students. OBJECTIVE To evaluate the efficacy of an 8-week MVC program in a 2 arm randomized controlled trial (RCT) in reducing depression, anxiety, and stress (primary outcomes), and improving mindfulness (secondary outcome) in undergraduate students at a Canadian university. Guided by two prior RCTs that each demonstrated efficacy when administered during regular university operations, the current study coincided with a university-wide labor strike. Given widespread closures as a result of COVID-19, student response to online mental health programming on a disrupted campus can provide useful information for anticipating the impact of COVID-19 related disruptions METHODS In this parallel arm RCT, 154 students were randomly allocated to the 8-week MVC intervention (n= 76) or a waitlist control (WLC) condition (n= 78). The intervention included (1) educational and mindfulness video modules, (2) anonymous peer-peer discussions, and (3) anonymous, group-based, professionally guided, videoconferences. Study outcomes were evaluated at baseline and at 8-week follow-up using: Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Generalized estimation equations with an AR(1) covariance structure were used to evaluate the impact of intervention, with outcome evaluations performed on both an intention to treat (ITT) and per protocol (PP) basis. RESULTS Participants (n= 154) were 35 males and 117 females with a mean age of 23.1 years. There were no statistically significant differences at baseline between MVC and WLC on demographics and psychological characteristics, indicating similar demographic-psychological characteristics across the MVC-WLC groups. Results under both ITT and PP approaches indicated significant between group differences for PSS (ITT: β= -2.31, P= .03; PP: β= -2.38, P= .03), but no significant between group differences in PHQ-9 (ITT: β= -0.44, P= 0.64; PP: β= -0.62, P= .053), BAI (ITT: β= -2.06, P= .31; PP: β= -2.32, P= .27), and FFMQ-SF (ITT: β= 1.33, P= .43; PP: β= 1.44, P= .41) (compared to WLC). CONCLUSIONS Under university labor strike conditions, the MVC program led to statistically significant reductions in PSS compared to WLC, but no other significant between group differences. Comparisons are made with previous study waves, undertaken during non-disrupted university conditions, where efficacy was demonstrated across depression, anxiety and mindfulness outcomes, are discussed. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275

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 Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

scholarly journals OP0010 EFFECTIVENESS OF THE MAKING IT WORK™ PROGRAM AT IMPROVING PRESENTEEISM AND WORK CESSATION IN WORKERS WITH INFLAMMATORY ARTHRITIS – RESULTS OF A RANDOMIZED CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 7.1-8
Author(s):  
A. Luquini ◽  
Y. Zheng ◽  
H. Xie ◽  
C. Backman ◽  
P. Rogers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Work Disability ◽  
Inflammatory Arthritis ◽  
Missing Values ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Mixed Effect ◽  
Randomized Controlled ◽  
Baseline Characteristics

Background:Arthritis often leads to presenteeism (decreased at-work productivity), missed days from work and permanent work disability, leading to reduced quality of life and high costs to individuals and society. Yet, health services addressing the employment needs of people with arthritis are lacking.Objectives:We evaluated the effectiveness of the Making-it-WorkTM(MiW) program, an online self-management program developed to help people with inflammatory arthritis (IA) deal with employment issues.Methods:A multi-center RCT evaluated the effectiveness of MiW at improving presenteeism and preventing work cessation (WC) over two years. Participants were recruited from rheumatologist practices, consumer organizations and arthritis programs, in three Canadian provinces. Eligibility criteria: diagnosis of IA, employed, age 18-59, and concerned about ability to work. Participants were randomized 1:1 to MiW or usual care plus printed material on workplace tips. MiW consists of five online self-learning modules and group meetings, and individual vocational counselling and ergonomic consultations. Questionnaires were administered every 6 months. Outcomes were presenteeism [Rheumatoid Arthritis Work Instability Scale (RA-WIS)], time to WC ≥ 6 months, and time to WC ≥ 2 months (secondary outcome). Baseline characteristics (age, gender, ethnicity, occupation, education, disease duration and self-employment) were collected. Intention-to-treat (ITT) longitudinal analysis of RA-WIS using linear mixed effect regression models with 2-year comparison as primary endpoint and survival analysis for time to WC using Kaplan-Meier and Cox Proportional Hazard models were performed. Robustness analyses were conducted by using various missing values imputation methods like last observation carried forward, imputation using worse possible outcomes and model-based multiple imputations; using square root transformation of RA-WIS outcome; and adjusting for baseline covariates. SAS version 9.4 was used.Results:A total of 564 participants were recruited, with 478 (84.75%) completing 2-year follow-up. Baseline characteristics were similar between groups. Mean RA-WIS scores were significantly lower in the intervention group from 6 months onwards, with the greatest difference observed at 2 years (-1.78, 95%CI: -2.7, -0.9, p < .0001), yielding a standardized effect size of 32%. Satisfactory robustness was observed. Work cessation occurred less often in intervention than control groups, but only reached statistical significance for WC ≥ 2 months (WC ≥ 6 months: 31 versus 44 events, aHR 0.70, 95%CI: 0.44, 1.11, p = 0.13; WC ≥ 2 months: 39 versus 61 events, aHR: 0.65, 95%CI: 0.43, 0.98, p = 0.04).Conclusion:Results of the RCT reveal the program was effective at improving presenteeism and preventing short-term WC. Effectiveness at preventing long-term work disability will be assessed at 5 years. This program fills one of the most important and costly unmet needs for people with inflammatory arthritis.References:[1]Carruthers EC, Rogers P, Backman CL, et al. “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol).BMC Med Inform Decis Mak. 2014;14:59. Published 2014 Jul 21. doi:10.1186/1472-6947-14-59Disclosure of Interests:Andre Luquini: None declared, Yufei Zheng: None declared, Hui Xie: None declared, Catherine Backman: None declared, Pamela Rogers: None declared, Alex Kwok: None declared, Astrid Knight: None declared, Monique Gignac: None declared, Dianne Mosher: None declared, Linda Li: None declared, John Esdaile: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Lacaille: None declared

scholarly journals COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study – study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Secondary Outcome ◽  
Study Success ◽  
Randomized Controlled ◽  
Supported Education

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.

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