scholarly journals Challenges and Innovations in a Community-Based Participatory Randomized Controlled Trial

2016 ◽  
Vol 44 (1) ◽  
pp. 123-130 ◽  
Author(s):  
Jessica R. Goodkind ◽  
Suha Amer ◽  
Charlisa Christian ◽  
Julia Meredith Hess ◽  
Deborah Bybee ◽  
...  
Keyword(s):  
Mental Health ◽  
Controlled Trial ◽  
Control Group ◽  
Ethical Challenges ◽  
Community Based ◽  
Support Intervention ◽  
Randomized Controlled ◽  
Research Interviews ◽  
Important Design

Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants’ intervention experiences, and their feasibility and acceptability. In the current mixed-methods study, academic and community partners developed and implemented an RCT to test the effectiveness of a collaboratively developed community-based advocacy, learning, and social support intervention. The goals of the intervention were to address social determinants of health and build trust and connections with other mental health services in order to reduce mental health disparities among Afghan, Great Lakes Region African, and Iraqi refugee adults and to engage and retain refugees in trauma-focused treatment, if needed. Two cohorts completed the intervention between 2013 and 2015. Ninety-three adult refugees were randomly assigned to intervention or control group and completed four research interviews (pre-, mid-, and postintervention, and follow-up). Several challenges to conducting a community-based RCT emerged, including issues related to interviewer intervention to assist participants in the control group, diffusion of intervention resources throughout the small refugee communities, and staff and community concerns about the RCT design and what evidence is meaningful to demonstrate intervention effectiveness. These findings highlight important epistemological, methodological, and ethical challenges that should be considered when conducting community-based RCTs and interpreting results from them. In addition, several innovations were developed to address these challenges, which may be useful for other community–academic partnerships engaged in RCTs.

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

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 MyCare study: protocol for a controlled trial evaluating the effect of a community-based intervention on psychosocial, clinical outcomes and hospital admission rates for adults with severe mental illness

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040610
Author(s):  
Renée O'Donnell ◽  
Melissa Savaglio ◽  
Debra Fast ◽  
Ash Vincent ◽  
Dave Vicary ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Hospital Admission ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Community Based ◽  
Admission Rates ◽  
Mental Health Support ◽  
Health Support

IntroductionPeople with serious mental illness (SMI) often fail to receive adequate treatment. To provide a higher level of support, mental health systems have been reformed substantially to integrate mental healthcare into the community. MyCare is one such community-based mental health model of care. This paper describes the study protocol of a controlled trial examining the effect of MyCare on psychosocial and clinical outcomes and hospital admission and duration rates for adults with SMI.Methods and analysisThis is a multisite non-randomised controlled trial with a 3, 6 and 12-month follow-up period. The study participants will be adults (18–64 years of age) with SMI recruited from Hobart, Launceston and the North-West of Tasmania. The treatment group will include adults who receive both the MyCare intervention and standard mental health support; the control group will include adults who receive only standard mental health support. The primary outcome includes psychosocial and clinical functioning and the secondary outcome will examine hospital admission rates and duration of stay. Mixed-effects models will be used to examine outcome improvements between intake and follow-up. This trial will generate the evidence needed to evaluate the effect of a community mental health support programme delivered in Tasmania, Australia. If MyCare results in sustained positive outcomes for adults with SMI, it could potentially be scaled up more broadly across Australia, addressing the inequity and lack of comprehensive treatment that many individuals with SMI experience.Ethics and disseminationThis study has been approved by the Tasmanian Health and Medical Human Research Ethics Committee. The findings will be disseminated to participants and staff who delivered the intervention, submitted for publication in a peer-reviewed journal and shared at academic conferences.Trial registration numberACTRN12620000673943.

Effects of Aerobic, Resistance, or Combined Exercise Training Among Older Adults with Subjective Memory Complaints: A Randomized Controlled Trial

2021 ◽  
pp. 1-17
Author(s):  
Taeko Makino ◽  
Hiroyuki Umegaki ◽  
Masahiko Ando ◽  
Xian Wu Cheng ◽  
Koji Ishida ◽  
...  
Keyword(s):  
Older Adults ◽  
Exercise Training ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Control Group ◽  
Subjective Memory ◽  
Logical Memory ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

Background: Physical exercise is suggested to be effective for preventing cognitive decline in older adults, but the relative efficacy of different types of exercise have yet to be clarified. Objective: This single-blinded randomized controlled trial was designed to investigate the differential effects of aerobic exercise training (AT), resistance exercise training (RT), and combined exercise training (CT) on cognition in older adults with subjective memory complaints (SMC). Methods: Community-dwelling older adults with SMC (n = 415; mean age = 72.3 years old) were randomly assigned to one of the four groups: AT, RT, CT, or control group. The study consisted of two phases: a 26-week intervention and a 26-week follow-up. The participants were evaluated at baseline, 26 weeks (postintervention), and 52 weeks (follow-up). The primary outcome of this study was memory function, which was assessed using the Logical Memory II subtest of the Wechsler Memory Scale-Revised (WMS-R) score. The secondary outcomes included global cognitive function, verbal fluency, working memory, processing speed, and executive functions. Results: Intention-to-treat analysis by a mixed-effect model repeated measure showed that the AT group had significantly improved performance on the WMS-R Logical Memory II test (2.74 [1.82–3.66] points) than the control group (1.36 [0.44–2.28] points) at the postintervention assessment (p = 0.037). The effect was more pronounced in those without amnesia than those with amnesia. No significant improvement was observed in the RT and CT groups. Conclusion: This study suggests that AT intervention can improve delayed memory in community-dwelling older adults, particularly in individuals without objective memory decline.

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 Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

Structured Counselling and Regular Telephonic Follow Up among Diabetic Retinopathy Patients to improve Timely Referral Flow and Compliance from peripheral eye care centre to tertiary centre in Nepal: A Randomised Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Binita Bhattarai ◽  
Saraswati Khadka, Thapa ◽  
Hari Bahadur Thapa ◽  
Sandip Bashyal ◽  
Bhesh Bikram Thapa, Chhetri ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Controlled Trial ◽  
Treatment Options ◽  
Control Group ◽  
Intervention Package ◽  
Referral Centre ◽  
Randomized Controlled ◽  
Referral Compliance ◽  
Timely Referral

BACKGROUND Diabetic Retinopathy (DR) is an emerging public health issue. DR may lead to severe visual impairment or blindness. Referral communication and tracking system is helpful to monitor patients flow, timeliness and compliance; ensures a close relationship across health facilities and improves patient’s satisfaction. The aim of the study is to improve timely referral flow and compliance of patients diagnosed with DR. OBJECTIVE Primary objective: To assess the effect of intervention on timely referral compliance Secondary objectives: To assess the determinants and cost effectiveness of the intervention for timely referral compliance. METHODS This is an operational research study using cluster randomized controlled health facility-based trial. A situational analysis was conducted and problem tree was developed to identify different barriers to referral compliance (long waiting time, lack of knowledge about diabetic retinopathy, its impact on vision and different treatment options).Appropriate solutions were identified through comprehensive literature review and addressing individual barriers to improve poor referral and compliance of patients diagnosed with DR from peripheral centres (referring centre). These solutions were systemically arranged in the form of an intervention package, which will be tested using a cluster-based randomized controlled trial. Ten eligible peripheral hospitals out of 19will be randomly selected and allocated (lottery method); five each in intervention and control groups. Structured counselling and referral communication linkage will be implemented to the intervention group. Structured counselling, health educational material, and telephonic follow-up will be provided by a trained counsellor at the referring centre; patients will be told in detail about DR, its impact on eyes and vision, treatment options available and the treatment cost for different procedures. They will be explained process at LEIRC (referral centre) and a contact person shall facilitate their treatment at the referral centre. Patients in Control group will receive ongoing routine counselling and health education material. We collected data on referral and compliance, and their determinants using referral-and DR-registers, and structured questionnaires for 1.demographic and socioeconomic profile of patients, 2.telephonicfollow-up with noncompliant patients,3.Feedback of those referred, and 4.Performa for clinical information. Compliance is considered when the referred participant reports at referral centre within one month of counselling. Referral compliance between the two groups will be compared using appropriate statistical tests. Adjusted analysis will be conducted. RESULTS Due to COVID-19 pandemic the inflow of patients is reduced, thus the duration of the data collection will be increased. In the first 6 months of pilot data collection73 in intervention and 34 in control group were screened for referral; 12(21.82%) and 15(27,2%) already had severe NPDR or PDR at the time of screening. CONCLUSIONS Early stage of DR is asymptomatic and can go unnoticed until it affects vision leading to visual impairment and blindness. This study will assess the feasibility and effectiveness of a referral intervention package for improving early diagnosis and treatment with preservation of vision among DR patients. CLINICALTRIAL Clinicaltrials.gov NCT 04834648

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