The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention.
Ontology highlight
ABSTRACT:
SUBMITTER: Klein JP
PROVIDER: S-EPMC3850933 | biostudies-literature | 2013 Sep
REPOSITORIES: biostudies-literature
Publications
The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention.
Klein Jan Philipp JP Berger Thomas T Schröder Johanna J Späth Christina C Meyer Björn B Caspar Franz F Lutz Wolfgang W Greiner Wolfgang W Hautzinger Martin M Rose Matthias M Gräfe Viola V Hohagen Fritz F Andersson Gerhard G Vettorazzi Eik E Moritz Steffen S
BMC psychiatry 20130928
<h4>Background</h4>Depressive disorders are among the leading causes of worldwide disability with mild to moderate forms of depression being particularly common. Low-intensity treatments such as online psychological treatments may be an effective way to treat mild to moderate depressive symptoms and prevent the emergence or relapse of major depression.<h4>Methods/design</h4>This study is a currently recruiting multicentre parallel-groups pragmatic randomized-controlled single-blind trial. A tota ...[more]
Similar Datasets
Project description:Rehabilitation of patients with chronic obstructive pulmonary disease (COPD) is a key treatment in COPD. However, despite the existing evidence and a strong recommendation from lung associations worldwide, 50% of patients with COPD decline to participate in COPD rehabilitation program and 30-50% drop-out before completion. The main reasons are severe symptoms, inflexible accessibility and necessity for transportation. Currently there are no well-established and evident rehabilitation alternatives. Supervised online screen rehabilitation could be a useful approach to increase accessibility and compliance. The aim of this multicenter RCT study is to compare the potential benefits of a 10-week online COPD rehabilitation program (CORe) with conventional outpatient COPD rehabilitation (CCRe).This study is a randomized assessor- and statistician blinded superiority multicenter trial with two parallel groups, employing 1:1 allocation to the intervention and the comparison group.On the basis of a sample size calculation, 134 patients with severe or very severe COPD and eligible to conventional hospital based outpatient COPD rehabilitation will be included and randomized from eight different hospitals. The CORe intervention group receives group supervised resistance- and endurance training and patient education, 60 min, three times/week for 10 weeks at home via online-screen. The CCRe comparison group receives group based supervised resistance- and endurance training and patient education, 90 min, two times/week for 10 weeks (two hospitals) or 12 weeks (six hospitals) in groups at the local hospital. The primary outcome is change in the 6-min walking distance after 10/12 weeks; the secondary outcomes are changes in 30 s sit-to-stand chair test, physical activity level, symptoms, anxiety and depression symptoms, disease specific and generic quality of life. Primary endpoint is 10/12 weeks from baseline, while secondary endpoints are 22, 36, 62 weeks from baseline assessments.The study will likely contribute to knowledge regarding COPD tele-rehabilitation and to which extent it is more feasible and thereby more efficient than conventional COPD rehabilitation in patients with severe and very severe COPD.Clinicaltrials.gov Identifier: NCT02667171 . Registration data: January 28th 2016.
| S-EPMC5689178 | biostudies-literature
Project description:BackgroundPrevious studies show that university students experience higher psychological stress than the general population, resulting in increased vulnerability for mental disorders for the student population. Online mindfulness interventions will be delivered to students as a potentially promising and more flexible approach compared to face-to-face interventions with the aim of improving their mental health. This study purposes to investigate the effectiveness of a guided online mindfulness-focused intervention for university students by using both self-reported and psychobiological measures.Methods and analysesIn this multicentre, two-armed randomised controlled trial with a parallel design, a guided version of the online mindfulness-focused intervention 'StudiCare Mindfulness' will be compared with a waitlist control group. In total, 120 participants will be recruited at different universities (of Applied Sciences) in (Neu-) Ulm. Data will be assessed prior to randomisation, after eight weeks (post-intervention) and six months after randomisation (follow-up). The primary outcome measure is mindfulness. The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia. Psychobiological parameters comprise interoceptive accuracy, hair cortisol and FKBP5 genotype. Sociodemographic variables, treatment expectations, side and adverse side effects, as well as intervention satisfaction and adherence will be assessed. All data analyses will be conducted according to the intention-to-treat principle.Ethics and disseminationAll study procedures have been approved by the Ethics Committee of Ulm University (application No. 48/18). The findings will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration numberDRKS00014701.
| S-EPMC7202707 | biostudies-literature
Project description:New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging.A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness.Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health.Clinical Trials.gov Identifier: NCT02016014.
| S-EPMC4003852 | biostudies-literature
Project description:BackgroundYoung men who have sex with men (YMSM), particularly those who are partnered, are at unique risk for HIV. YMSM are among those at highest risk for HIV. Meanwhile, despite the fact that primary partners account for many-possibly most-new HIV infections, partnered men who have sex with men perceive themselves to be at much lower risk for HIV infection and therefore test less often than single men. In response to the risk of primary partner HIV transmission, couples HIV testing and counseling (CHTC) procedures have been developed for use in adult populations. Although promising, YMSM couples may require additional support to complete CHTC given their developmental context in which sexual and romantic relationships are relatively new, and communication skills are emergent.ObjectiveThe aim of this study was to test the additive benefit of adjunct treatment components tailored for YMSM, which enhance communication skills before the completion of CHTC. The intervention tests a continuum of prevention packages including assertive communication training videos and motivational interviewing focused on assisting with identification and development (MI-AID) before entering into the dyadic intervention components. This protocol is part of the Adolescent Medicine Trials Network (ATN) Scale It Up program described in this issue.MethodsThis is a comparative effectiveness trial that will be executed in 3 phases. Phase 1 will gather qualitative data related to intervention development and implementation from partnered YMSM at 4 subject recruitment venues (SRVs). Phase 2 will compare a continuum of these interventions in a pilot randomized controlled trial (RCT) at 2 SRVs. Phase 3 will compare the most successful adapted intervention package from phase 2 to CHTC as usual in a larger RCT at 4 SRVs. This phase is focused on implementation and sustainment phases of the Exploration, Preparation, Implementation, and Sustainment framework.ResultsPhase 1 data will be drawn from qualitative interviews with partnered YMSM (n=24) and staff from ATN sites (n=20). Baseline enrollment for phase 2 is expected to begin across 2 SRVs in June 2018 (ncouples=36). In phase 2, survey data collection along with HIV and sexually transmitted infection (STI) testing will occur at baseline, and 1- and 3-month (postintervention) follow-ups. Phase 3 will begin enrollment across 4 SRVs in September 2019 (ncouples=144) and follow-ups will occur at 1, 3, 6, and 9 months postintervention.ConclusionsAlthough MI-AID, video-based assertive communication training, and CHTC have established efficacy when administered on their own, this study will be the first to evaluate the strongest adjunctive version of these interventions to address the specific developmental needs of partnered YMSM.Trial registrationClinicalTrials.gov NCT03386110; http://clinicaltrials.gov/ct2/show/NCT03386110 (Archived by WebCite at http://www.webcitation.org/75mlO7GCx).International registered report identifier (irrid)DERR1-10.2196/11186.
| S-EPMC6592501 | biostudies-literature
Project description:BackgroundIn Turkey, there are serious deficiencies in mental health care. Although depression is highly prevalent, only a small number of people seek professional help. Innovative solutions are needed to overcome this treatment gap. Web-based problem-solving therapy (PST) is an intervention proven to be effective in the treatment of depression, although little is known about its clinical effects in Turkey.ObjectiveThis study aims to test the clinical effects of a Web and mobile app of an adapted PST for depressive symptoms among the general population in Turkey.MethodsParticipants will be recruited through announcements in social media and the Middle East Technical University. Adults (18-55 years) with mild to moderate depressive symptoms (Beck Depression Inventory-II [BDI-II] score between 10-29) will be included in the study. Participants with a medium-to-high suicidal risk (according to the Mini-International Neuropsychiatric Interview) will be excluded. A 3-armed randomized controlled trial with a waiting control group will be utilized. A sample size of 444 participants will be randomized across 3 groups. The first experimental group will receive direct access to the Web version of the intervention; the second experimental group will receive direct access to the mobile app of the intervention as well as automated supportive short message service text messages based on PST. The control group consists of a wait-list and will gain access to the intervention 4 months after the baseline. The intervention is based on an existing PST for the Turkish population, Her Şey Kontrol Altında (HŞKA), consisting of 5 modules each with a duration of 1 week and is guided by a clinical psychologist. The primary outcome is change in depressive symptoms measured by the BDI-II. Secondary outcomes include symptoms of anxiety, stress, worry, self-efficacy, and quality of life. Furthermore, satisfaction with, usability and acceptability of the intervention are important features that will be evaluated. All outcomes will take place online through self-assessment at posttest (6-8 weeks after baseline) and at follow-up (4 months after baseline).ResultsWe will recruit a total of 444 participants with mild to moderate depressive symptoms from March 2018 to February 2019 or until the recruitment is complete. We expect the final trial results to be available by the end of May 2019. This trial is funded by the Scientific and Technological Research Council of Turkey (National Postdoctoral Research Fellowship Programme 2016/1).ConclusionsResults from this study will reveal more information about the clinical effects of HŞKA as well as its applicability in a Turkish setting through the Web and mobile platforms. On the basis of the results, a guided Web- and mobile-based PST intervention might become an appropriate alternative for treating mild to moderate depressive symptoms.Trial registrationClinicalTrials.gov NCT03754829; https://clinicaltrials.gov/ct2/show/NCT03754829 (Archived by WebCite at http://www.webcitation.org/74HugwLo7).International registered report identifier (irrid)DERR1-10.2196/13239.
| S-EPMC6473215 | biostudies-literature
Project description:BackgroundBehavior change interventions have been the focus of recent studies, and the COVID-19 pandemic highlighted the importance of online interventions. However, no previous studies have investigated behavior change techniques to improve physical activity in adults with asthma through online intervention.MethodsThis double-blind clinical trial will investigate the effectiveness of an online behavior change intervention in increasing physical activity and reducing sedentary behavior in adults with asthma, as well as in improving other clinical outcomes in short and medium terms. Patients with clinically stable moderate to severe asthma, who are physically inactive and do not have cardiovascular and/or osteoneuromuscular impairments will be randomized into control or intervention groups (23 in each). Both groups will carry out an online educational program (1 h). Additionally, the intervention group will receive weekly individual online sessions for 12 weeks of motivation-based behavior change intervention to promote an increase in physical activity and reduce sedentary behavior based on both self-determination theory and transtheoretical model. The intervention group will also receive an activity monitor with specific strategies related to it. Both groups will be reassessed immediately after the intervention and 6 months after that. The primary outcomes are physical activity and sedentary behavior, which will be objectively assessed by a triaxial accelerometer (Actigraph wGT3X-BT). Secondary outcomes are Asthma Control Questionnaire, Incremental Step Test, Sit-To-Stand, Timed Up-and-Go, 4-Metre Gait Speed, Asthma Quality of Life Questionnaire, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Actiwatch 2, and the Hospital Anxiety and Depression Scale.DiscussionThe intervention is unprecedented and was carefully developed to joint most characteristics and techniques of both behavioral strategies (transtheoretical model and self-determination theory). Therefore, this intervention has the potential to improve physical activity levels and asthma management and reduce sedentary behavior. As a consequence, this novel intervention will improve global health in this population and support its use in clinical practice. The intervention will be carried out online with direct weekly contact with the therapist. Consequently, it has low implementation costs, might improve patient's attendance, and has the potential to be largely offered elsewhere.Trial registrationClinicalTrials.gov NCT05241223 . Registered on January 22, 2022.
| S-EPMC9727857 | biostudies-literature
Project description:BackgroundMotivational interviewing (MI) has been shown to effectively improve self-management for youth living with HIV (YLH) and has demonstrated success across the youth HIV care cascade-currently, the only behavioral intervention to do so. Substantial barriers prevent the effective implementation of MI in real-world settings. Thus, there is a critical need to understand how to implement evidence-based practices (EBPs), such as MI, and promote behavior change in youth HIV treatment settings as risk-taking behaviors peak during adolescence and young adulthood.ObjectiveThis study aims to describe the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) protocol of a tailored MI (TMI) implementation-effectiveness trial (ATN 146 TMI) to scale up an EBP in multidisciplinary adolescent HIV settings while balancing flexibility and fidelity. This protocol is part of the Scale It Up program described in this issue.MethodsThis study is a type 3, hybrid implementation-effectiveness trial that tests the effect of TMI on fidelity (MI competency and adherence to program requirements) while integrating findings from two other ATN protocols described in this issue-ATN 153 Exploration, Preparations, Implementation, Sustainment and ATN 154 Cascade Monitoring. ATN 153 guides the mixed methods investigation of barriers and facilitators of implementation, while ATN 154 provides effectiveness outcomes. The TMI study population consists of providers at 10 adolescent HIV care sites around the United States. These 10 clinics are randomly assigned to 5 blocks to receive the TMI implementation intervention (workshop and trigger-based coaching guided by local implementation teams) utilizing the dynamic wait-listed controlled design. After 12 months of implementation, a second randomization compares a combination of internal facilitator coaching with the encouragement of communities of practice (CoPs) to CoPs alone. Participants receive MI competency assessments on a quarterly basis during preimplementation, during the 12 months of implementation and during the sustainment period for a total of 36 months. We hypothesize that MI competency ratings will be higher among providers during the TMI implementation phase compared with the standard care phase, and successful implementation will be associated with improved cascade-related outcomes, namely undetectable viral load and a greater number of clinic visits among YLH.ResultsParticipant recruitment began in August 2017 and is ongoing. As of mid-May 2018, TMI has 150 active participants.ConclusionsThis protocol describes the underlying theoretical framework, study design, measures, and lessons learned for TMI, a type 3, hybrid implementation-effectiveness trial, which has the potential to scale up MI and improve patient outcomes in adolescent HIV settings.Trial registrationClinicalTrials.gov NCT03681912; https://clinicaltrials.gov/ct2/show/NCT03681912 (Archived by WebCite at http://www.webcitation.org/754oT7Khx).International registered report identifier (irrid)DERR1-10.2196/11200.
| S-EPMC6682301 | biostudies-literature
Project description:BackgroundDepression affects millions of people all over the world and implies a great socioeconomic burden. Despite there are different effective evidence-based interventions for treating depression, only a small proportion of these patients receives an appropriate treatment. In this regard, information and communication technologies (ICTs) can be used with therapeutic aims and this can contribute to make interventions more accessible. One example is "Smiling is fun", an internet-based treatment which has proved to be effective and cost-effective for treating depression in Spanish Primary Care (PC). However, the "know-do gap" between research and clinical settings implies that the actual implementation of such interventions could last up to 20 years. To overcome this obstacle, the implementation research establishes the methodology to implement the advances developed in the laboratories to the health care services maintaining the validity of the intervention and offering specific strategies for the implementation process.ObjectiveThis is the protocol of an implementation study for the Internet-based program "Smiling is fun", which will be conducted on patients with mild-to-moderate depression of Spanish PC settings. In the implementation study, the feasibility, efficacy, cost-efficacy, acceptability, adoption, appropriateness, fidelity, penetration, normalization, and sustainability will be assessed.MethodsThe current investigation is a Hybrid Effectiveness-Implementation Type II design. A Stepped Wedge randomized controlled trial design will be used, with a cohort of 420 adults diagnosed with depression (mild-to-moderate) who will undergo a first control phase (no treatment) followed by the intervention, which will last 16 weeks, and finishing with an optional use of the intervention. All patients will be assessed at baseline, during the treatment, and at post-treatment. The study will be conducted in three Spanish regions: Andalusia, Aragon, and the Balearic Islands. Two primary care centers of each region will participate, one located in the urban setting and the other in the rural setting. The primary outcome will be implementation success of the intervention assessing the reach, clinical effect, acceptability, appropriateness, adoption, feasibility, fidelity, penetration, implementation costs and sustainability services.Discussion"Smiling is Fun", which has already been established as effective and cost-effective, will be adapted according to users' experiences and opinions, and the efficacy and cost-efficacy of the program will again be assessed. The study will point out barriers and facilitators to consider in the implementation process of internet-based psychological interventions in health services. The ultimate goal is to break the research-to-practice split, which would undoubtedly contribute to reduce the high burden of depression in our society.Trial registrationClinicalTrials.gov, Identifier: NCT05294614.
| S-EPMC9789354 | biostudies-literature
Project description:BackgroundCurrent guidelines recommend behavioral intervention to achieve a modest weight loss (e.g., 3-5%) as a first-line obesity treatment. Online behavioral obesity treatment, delivered via the Rx Weight Loss (RxWL) program, produces clinically significant initial weight losses. However, the program's pragmatic utility in routine medical care has yet to be tested. Further, additional research is needed to determine how best to extend the RxWL program to facilitate weight loss maintenance. This paper summarizes methods for a pragmatic trial aimed at identifying optimal methods for implementation of RxWL in primary care and evaluating relative effectiveness of two approaches to weight loss maintenance.Study designRxWL will be implemented in a network of approximately 60 primary care clinics. Implementation outcomes (program uptake and completion metrics) will be compared between a Basic Implementation Intervention consisting primarily of access to RxWL, and an Enhanced Implementation Intervention with additional training in strategies for motivating and supporting patients in their use of RxWL and online clinician support tools for tracking patient progress. Second, two intervention approaches (Monthly Lessons versus Refresher Courses) within the RxWL patient platform will be tested against an educational control condition, and effects on 1-year weight loss maintenance will be compared.ConclusionThis study will provide essential information about the feasibility and utility of online obesity treatment in primary care. It will provide novel information on two approaches to weight loss maintenance for patients in this setting. This project fills key gaps in evidence regarding best practices for obesity treatment in primary care.
| S-EPMC6606329 | biostudies-literature
Project description:Age-related perceptual and cognitive declines are associated with difficulties performing everyday tasks required to remain independent. Encouraging improvements in cognitive abilities have been shown for various short-term interventions but there is little evidence for direct impact on independence. This project compares the effect of broad and directed (narrow) technology-based training on basic perceptual and cognitive abilities in older adults and on the performance of simulated tasks of daily living including driving and fraud avoidance. Participants (N = 230, Mean age = 72) were randomly assigned to one of four training conditions: broad training using either (1) a web-based brain game suite, Brain HQ, or (2) a strategy video game, Rise of Nations, or to directed training for (3) Instrumental Activities of Daily Living (IADL) training using web-based programs for both driving and fraud avoidance training, or (4) to an active control condition of puzzle solving. Training took approximately 15-20 h for each intervention condition across four weeks. Before training began, participants received baseline ability tests of perception, attention, memory, cognition, and IADL, including a driving simulator test for hazard perception, and a financial fraud recognition test. They were tested again on these measures following training completion (post-test). A one-year follow-up from training completion is also scheduled. The baseline results support that randomization was successful across the intervention conditions. We discuss challenges and potential solutions for using technology-based interventions with older adults. We also discuss how the current trial addressed methodological limitations of previous intervention studies. TRIAL REGISTRATION NUMBER: NCT03141281.
| S-EPMC6485952 | biostudies-literature