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Background: Postoperative recovery after live donor nephrectomy is largely determined by the consequences of postoperative pain and analgesia consumptions. The use of deep neuromuscular blockade has been shown to reduce postoperative pain scores after laparoscopic surgery. In this study, we will investigate whether deep neuromuscular blockade also improves the early quality of recovery after live donor nephrectomy.Methods: The RELAX-study is a phase IV, multicenter, double-blinded, randomized controlled trial, in which 96 patients, scheduled for living donor nephrectomy, will be randomized into two groups: one with deep and one with moderate neuromuscular blockade. Deep neuromuscular blockade is defined as a post-tetanic count of 1-2. Our primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 24 h after extubation.Discussion: This study is, to our knowledge, the first randomized study to assess the effectiveness of deep neuromuscular blockade during laparoscopic donor nephrectomy in enhancing postoperative recovery. The study findings may also be applicable for other laparoscopic procedures.Trial Registration: clinicaltrials.gov, NCT02838134 . Registered on 29 June 2016. [ABSTRACT FROM AUTHOR]

Background: The introduction of anti-tumor necrosis factor medications has revolutionized the treatment of psoriasis with achievement of treatment goals (Psoriasis Area and Severity Index score 75, remission) that are not usually met with conventional systemics. Nevertheless, some patients continue to experience persistent disease activity or treatment failure over time. Strategies to optimize treatment outcomes include the use of concomitant methotrexate, which has demonstrated beneficial effects on pharmacokinetics and treatment efficacy in psoriasis and other inflammatory diseases.Methods: This is an investigator-initiated, multicenter randomized controlled trial (RCT) designed to compare the combination treatment of adalimumab and methotrexate with adalimumab monotherapy in patients with psoriasis. The primary outcome is adalimumab drug survival at week 49. Other outcomes include improvement in disease severity and quality of life, tolerability, and safety. Moreover, anti-adalimumab antibodies and adalimumab serum concentrations will be measured and correlations between genotypes and clinical outcomes will be assessed. Patient recruitment started in March 2014. Up to now, 36 patients have been randomized. Many more patients have been (pre)screened. A total of 93 patients is desired to meet an adequate sample size. In our experience, the main limitation for recruitment is prior adalimumab therapy and intolerability or toxicity for methotrexate in the past.Discussion: OPTIMAP is the first RCT to examine combination therapy with adalimumab and methotrexate in a psoriasis population. With data derived from this study we expect to provide valuable clinical data on long-term treatment outcomes. These data will be supported by assessment of the impact of concomitant methotrexate on adalimumab pharmacokinetics. Furthermore, the influence of several single nucleotide polymorphisms on adalimumab response will be analyzed in order to support the development of a more personalized approach for this targeted therapy.Trial Registration: NTR4499 . Registered on 7 April 2014. [ABSTRACT FROM AUTHOR]

Background: The worksite cafeteria is a suitable setting for interventions focusing on changing eating behavior, because a lot of employees visit the worksite cafeteria regularly and a variety of interventions could be implemented there. The aim of this paper is to describe the intervention development and design of the evaluation of an intervention to make the purchase behavior of employees in the worksite cafeteria healthier. The developed intervention called "the worksite cafeteria 2.0" consists of a set of 19 strategies based on theory of nudging and social marketing (marketing mix). The intervention will be evaluated in a real-life setting, that is Dutch worksite cafeterias of different companies and with a number of contract catering organizations.Methods/design: The study is a randomized controlled trial (RCT), with 34 Dutch worksite cafeterias randomly allocated to the 12-week intervention or to the control group. Primary outcomes are sales data of selected products groups like sandwiches, salads, snacks and bread topping. Secondary outcomes are satisfaction of employees with the cafeteria and vitality.Discussion: When executed, the described RCT will provide better knowledge in the effect of the intervention "the worksite cafeteria 2.0" on the purchasing behavior of Dutch employees in worksite cafeterias.Trial Registration: Dutch Trial register: NTR5372 . [ABSTRACT FROM AUTHOR]

Background: Overweight youngsters are better in absolute strength exercises than their normal-weight counterparts; a physiological phenomenon with promising psychological impact. In this paper we describe the study protocol of the Dutch, school-based program 'Focus on Strength' that aims to improve body composition of 11-13 year old students, and with that to ultimately improve their quality of life.Methods: The development of this intervention is based on the Intervention Mapping (IM) protocol, which starts from a needs assessment, uses theory and empirical research to develop a detailed intervention plan, and anticipates program implementation and evaluation. This novel intervention targets first year students in preparatory secondary vocational education (11-13 years of age). Teachers are the program implementers. One part of the intervention involves a 30 % increase of strength exercises in the physical education lessons. The other part is based on Motivational Interviewing, promoting autonomous motivation of students to become more physically active outside school. Performance and change objectives are described for both teachers and students. The effectiveness of the intervention will be tested in a Randomized Controlled Trial in 9 Dutch high schools.Discussion: Intervention Mapping is a useful framework for program planning a school-based program to improve body composition and motivation to exercise in 11-13 year old adolescents by a "Focus on Strength".Trial Registration: NTR5676 , registered 8 February 2016 (retrospectively registered). [ABSTRACT FROM AUTHOR]

Background: Nonprofessional caregivers are highly important in the everyday life of patients with depression. Yet, they may experience increased levels of burden, stress, depression, and anxiety. Therefore, there is a need for interventions that relieve symptoms and are accessible and time-efficient. This paper describes the protocol of a pilot study to evaluate (1) the feasibility of an online self-management intervention, E-care 4 caregivers, for the nonprofessional caregiver of patients with depression, and (2) the initial effects of E-care 4 caregivers on psychological distress, subjective burden, symptoms of anxiety and depression, and quality of life.Methods/design: The study is a randomized controlled trial in which we are comparing the E-care 4 caregivers online intervention with a wait list control group. Eighty-four nonprofessional caregivers of patients with depression aged 18 years or older are being recruited from among the general population. Feasibility is determined by semistructured telephone interviews evaluating the subjects' satisfaction with the intervention and by using a questionnaire on the user-friendliness of the system. The primary outcome measure used to examine the initial effects of the intervention is psychological distress. Secondary outcome measures are subjective burden, symptoms of anxiety and depression, level of mastery, and quality of life. Assessments will be done at baseline and 6 weeks later. Statistical analysis of the effects of the intervention will be carried out on the basis of the intention-to-treat principle.Discussion: E-care 4 caregivers could potentially benefit nonprofessional caregivers, as well as patients and professionals indirectly.Trial Registration: Netherlands Trial Register identifier: NTR5268 . Registered on 30 June 2015. [ABSTRACT FROM AUTHOR]

Background: Many people living with HIV suffer from depressive symptoms. In a previous pilot study, self-help cognitive behavioral therapy (in booklet format) was found to be effective in treating depressive symptoms in people with HIV. We developed an online self-help program in Dutch and English (based on the booklet) for people with HIV and depressive symptoms. Besides the main question regarding the effectiveness of the program aimed at lowering depressive symptoms, sub-questions will focus on the moderators of treatment success (for which patients is the program especially beneficial?) and the mechanisms of change underlying the treatment outcome (which mediators affect the outcome of treatment?). In this paper, the protocol of the study will be described.Methods/design: The effectiveness of the program will be investigated by comparing the intervention group with a waiting list-control group in a randomized controlled design, by including a pretest and three post-tests. The self-help program contains four main components: activation, relaxation, changing maladaptive cognitions, and goal attainment. Participants with mild to moderate depressive symptoms will work on the program for 6 to 10 weeks, during which a coach will provide motivational support by telephone once a week. Participants in the control condition will receive weekly minimal support from a coach for 8 weeks, and after the second post-test, they can gain access to the self-help program. Depressive symptoms and possible mediators (e.g., activation, cognitive coping, self-efficacy, and goal adjustment) will be assessed by self-report three times during the intervention/waiting period and at the pretest and first post-test.Discussion: The proposed study aims to evaluate the effectiveness of an online self-help intervention for people with HIV and depressive symptoms. If the intervention is shown to be effective, the program will be implemented. Consequently, many patients with HIV could be reached, and their psychological care may be improved.Trial Registration: Netherlands Trial Register: NTR5407. [ABSTRACT FROM AUTHOR]

Background: Undergoing an extraction has been shown to pose a significantly increased risk for the development of chronic apprehension for dental surgical procedures, disproportionate forms of dental anxiety (that is, dental phobia), and symptoms of post-traumatic stress. Evidence suggests that intrusive emotional memories of these events both induce and maintain these forms of anxiety. Addressing these problems effectively requires an intervention that durably reduces both the intrusiveness of key fear-related memories and state anxiety during surgery. Moreover, evidence suggests that propranolol is capable of inhibiting "memory reconsolidation" (that is, it blocks the process of storing a recently retrieved fear memory). Hence, the purpose of this trial is to determine the anxiolytic and fear memory reconsolidation inhibiting effects of the ß-adrenoreceptor antagonist propranolol on patients with high levels of fear in anticipation of a dental extraction.Methods/design: This trial is designed as a multicenter, randomized, placebo-controlled, two-group, parallel, double-blind trial of 34 participants. Consecutive patients who have been referred by their dentist to the departments of oral and maxillofacial surgery of a University hospital or a secondary referral hospital in the Netherlands for at least two tooth and/or molar removals and with self-reported high to extreme fear in anticipation of a dental extraction will be recruited. The intervention is the administration of two 40 mg propranolol capsules 1 hour prior to a dental extraction, followed by one 40 mg capsule directly postoperatively. Placebo capsules will be used as a comparator. The primary outcome will be dental trait anxiety score reduction from baseline to 4-weeks follow-up. The secondary outcomes will be self-reported anxiety during surgery, physiological parameters (heart rate and blood pressure) during recall of the crucial fear-related memory, self-reported vividness, and emotional charge of the crucial fear-related memory.Discussion: This randomized trial is the first to test the efficacy of 120 mg of perioperative propranolol versus placebo in reducing short-term ("state") anxiety during dental extraction, fear memory reconsolidation, and lasting dental ("trait") anxiety in a clinical population. If the results show a reduction in anxiety, this would offer support for routinely prescribing propranolol in patients who are fearful of undergoing dental extractions.Trial Registration: ClinicalTrials.gov identifier: NCT02268357 , registered on 7 October 2014. The Netherlands National Trial Register identifier: NTR5364 , registered on 16 August 2015. [ABSTRACT FROM AUTHOR]