Open Pilot Research Articles

Comparative study on fixation of central venous catheter by suture versus adhesive device

ObjectivesTo assess the efficacy of a central venous catheter adhesive fixation device (CVC) to prevent associated complications. To establish the need for dressing changes, number of days’ catheterization and reasons for catheter removal in both study groups. To assess the degree of satisfaction of personnel with the adhesive system. MethodA, randomised, prospective and open pilot study, of parallel groups, with comparative evaluation between CVC fixation with suture and with an adhesive safety system. The study was performed in the Coronary Unit of the Universitari de Bellvitge Hospital, between April and November 2016. The population studied were patients with a CVC. The results were analysed using SPSS Statistics software. The study was approved by the Clinical Research Ethics Committee. Results100 patients (47 adhesive system and 53 suture) were analysed. Both groups were homogeneous in terms of demographic variables, anticoagulation and days of catheterization. The frequency of complications in the adhesive system group was 21.3%, while in the suture group it was 47.2% (p=.01). The suture group had a higher frequency of local signs of infection (p=.006), catheter displacement (p=.005), and catheter-associated bacteraemia (p=.05). The use of adhesive fixation was associated with a lower requirement for dressing changes due to bleeding (p=.006). Ninety-six point seven percent of the staff recommended using the adhesive safety system. ConclusionsThe catheters fixed with adhesive systems had fewer infectious complications and less displacement.

Internet-Delivered Exposure-Based Cognitive-Behavioral Therapy for Adolescents With Functional Abdominal Pain or Functional Dyspepsia: A Feasibility Study

Functional abdominal pain (FAP) and functional dyspepsia (FD) are common in adolescents and associated with low quality of life. Exposure-based cognitive-behavioral therapy (CBT) is efficient for adult and adolescent irritable bowel syndrome (IBS), but has never been evaluated for adolescent FAP/FD. The aim of this study was to evaluate the feasibility and potential efficacy of a novel disorder-specific Internet-delivered CBT (Internet-CBT) for adolescents with FAP or FD, using an uncontrolled open pilot including 31 adolescents. The Internet-CBT consisted of 10 weekly online modules, which focused mainly on exposure to abdominal symptoms. Parents received modules to help them reduce unhelpful parental behaviors. Participants reported the treatment to be credible, and an overall satisfaction with the treatment. Data attrition rate was low (7%) and adherence to treatment was acceptable. We saw a significant and large effect on the primary outcome, pain intensity, at posttreatment (d = 1.20, p < .001) that was further improved after 6 months (d = 1.69, p < .001). Participants also made significant and large improvements on gastrointestinal symptoms (d = 0.84, p < .001) and quality of life (d = 0.84, p < .001) that were sustained or further improved at follow-up 6 months after treatment. This study demonstrated that exposure-based Internet-CBT, tailored for adolescents with FAP or FD, is a feasible treatment that potentially improves pain intensity, gastrointestinal symptoms, and quality of life.

DuPont, ADM open FDME pilot plant

DuPont and Archer Daniels Midland have opened a 60-metric-ton-per-year furandicarboxylic methyl ester (FDME) pilot plant in Decatur, Ill. FDME, which is made via fructose dehydration, can be polymerized into polytrimethylene furandicarboxylate. PTF is a fully biobased plastic that can be used for beverage bottles and other applications now served by polyethylene terephthalate (PET). PTF has better gas-barrier properties than PET and can create lighter-weight packages, the companies claim.

ПРЯНЫЕ И АРОМАТИЧЕСКИЕ РАСТЕНИЯ В ПСИХИАТРИИ И НЕВРОЛОГИИ: НАУЧНЫЙ ОБЗОР. ЧАСТЬ I.

Цель исследования: Представить читателю подробный исторический обзор о применении пряных и ароматических растений в психиатрии и неврологии, а также данные современных исследований об их эффективности в терапии различных психических и психосоматических патологий, нейродегенеративных заболеваний.Методология проведения работы: В качестве начальной отправной точки для нашей работы мы взяли список всех применяемых в кулинарии различных народов специй и приправ из английской Википедии, как один из наиболее полных подобных списков в Интернете (en.wikipedia.org/wiki/List_of_spices). Затем мы изучили современную доказательную базу и исторические данные о применении каждого из упомянутых в данном списке растений, используя поисковые системы PubMed, Google Scholar, Science Direct, Web of Science, и представили найденные данные в настоящем обзоре.Результаты: Полученные нами в результате составления настоящего обзора данные свидетельствуют о значительном терапевтическом потенциале многих пряных и ароматических растений в психиатрии и неврологии, в особенности в лечении лёгких форм тревожных и депрессивных расстройств, лёгких когнитивных нарушений, а также в лечении таких психосоматических заболеваний, как синдром раздражённого кишечника, мигрень, синдром предменструального напряжения, климактерические расстройства. Доказательная база для применения в психиатрии и неврологии разных пряных и ароматических растений различна по качеству. Для одних пряных и ароматических растений и извлечённых из них биологически активных веществ пока существуют лишь данные экспериментов на животных в сочетании с эмпирическим опытом народной медицины, для других – имеются предварительные обнадёживающие результаты открытых пилотных исследований на человеке, для третьих, таких, как куркумин, сафранал – положительные результаты небольших рандомизированных клинических испытаний. Важно, однако, то, что исследование психотропного и нейротропного потенциала пряных и ароматических растений, судя по количеству публикаций именно в последние годы (2013–2017), рассматривается как одно из перспективных направлений для поиска новых антидепрессантов, анксиолитиков и антидементных препаратов.Область применения результатов: Полученные нами результаты дают теоретические и практические основания для применения экстрактов из некоторых пряных и ароматических растений, таких, как куркумин, сафранал, пиперин, эфирное масло лаванды, в лечении лёгких форм тревожных и депрессивных состояний, лёгких когнитивных нарушений, особенно у пациентов, отказывающихся от фармакотерапии или плохо её переносящих.

Estudio comparativo sobre fijación de catéter venoso central mediante sutura versus dispositivo adhesivo

ObjectivesTo assess the efficacy of a central venous catheter adhesive fixation device (CVC) to prevent associated complications. To establish the need for dressing changes, number of days’ catheterization and reasons for catheter removal in both study groups. To assess the degree of satisfaction of personnel with the adhesive system. MethodA, randomized, prospective and open pilot study, of parallel groups, with comparative evaluation between CVC fixation with suture and with an adhesive safety system. The study was performed in the Coronary Unit of the Universitari de Bellvitge Hospital, between April and November 2016. The population studied were patients with a CVC. The results were analyzed using SPSS Statistics software. The study was approved by the Clinical Research Ethics Committee. Results100 patients (47 adhesive system and 53 suture) were analyzed. Both groups were homogeneous in terms of demographic variables, anticoagulation and days of catheterization. The frequency of complications in the adhesive system group was 21.3%, while in the suture group it was 47.2% (P=.01). The suture group had a higher frequency of local signs of infection (p=.006), catheter displacement (p=.005), and catheter-associated bacteraemia (P=.05). The use of adhesive fixation was associated with a lower requirement for dressing changes due to bleeding (P=.006). Ninety-six point seven percent of the staff recommended using the adhesive safety system. ConclusionsThe catheters fixed with adhesive systems had fewer infectious complications and less displacement.

Integrating a Co-occurring Disorders Intervention in Drug Courts: An Open Pilot Trial.

Little research has focused on systematically integrating clinical treatment within existing drug court procedures. This could be particularly useful for clients with substance use disorders, who comprise those on court dockets and often have co-existing mental health issues. This article reports on the preliminary outcomes of integrating MISSION-Criminal Justice (MISSION-CJ), a co-occurring mental health and substance use wraparound intervention, within two Massachusetts drug courts. In this open pilot, clients completed intake and 6-month follow-up assessments. The participants were primarily Caucasian (86%), male (82%), had at least 2 prior arrests, and received outpatient treatment for mental health (54%), alcohol use (51%), or drug use (88%) prior to enrolling in MISSION-CJ. Six-month follow-up data suggested that participants showed statistically significant reductions in average number of nights spent in jail, alcohol use, and drug use, as well as an increase in full time employment.

Effect of Combined Gluten-Free, Dairy-Free Diet in Children With Steroid-Resistant Nephrotic Syndrome: An Open Pilot Trial

IntroductionSteroid-resistant nephrotic syndrome (SRNS) affects both children and adults and has a high rate of progression to end-stage renal disease. Although a subset of patients have well-characterized genetic mutation(s), in the majority of cases, the etiology is unknown. Over the past 50 years, a number of case reports have suggested the potential impact of dietary changes in controlling primary nephrotic syndrome, especially gluten and dairy restrictions.MethodsWe have designed a prospective, open-label, nonrandomized, pilot clinical trial, to study the effect of a gluten-free and dairy-free (GF/DF) diet in children with SRNS. The study will be organized as a 4-week summer camp to implement a GF/DF diet in a tightly controlled and monitored setting. Blood, urine, and stool samples will be collected at different time points during the study.ResultsThe primary end point is a reduction of more than 50% in the urine protein:creatinine ratio. The secondary end points include changes in urine protein, kidney function, and serum albumin, as well as effects in immune activation, kidney injury biomarkers, and gut microbiome composition and function (metagenomic/metatranscriptomic).ConclusionThis study will advance the field by testing the effect of dietary changes in patients with SRNS in a highly controlled camp environment. In addition, we hope the results will help to identify a responder profile that may guide the design of a larger trial for further investigation.

Psychosocial Treatment of Irritability in Youth.

Chronic, severe irritability is a common presenting problem in children and adolescents. Disruptive mood dysregulation disorder (DMDD) was added to the DSM-5 in recognition of this public health need. Currently there are no well-established, evidence-based pharmacological or psychosocial treatments specifically for DMDD. Here, we focus on psychosocial interventions. In addition to reviewing published research, we present preliminary, open trial data on a novel exposure-based cognitive-behavioral therapy (CBT) targeting severe irritability, as is present in DMDD. In the published literature, parent management training (PMT) comprises parent-based interventions designed to treat youth disruptive behavior. Child-based interventions for disruptive behavior include CBT focused on social cognition and problem-solving. Based on identified treatment gaps for severe irritability in children and adolescents, novel psychosocial interventions are being developed. We have developed a CBT for severe irritability that integrates exposure techniques, drawn from anxiety treatment, with selected PMT techniques. Data from an open pilot trial (N=10) suggest feasibility. Promising psychosocial treatments are being developed for DMDD. Future directions include testing these new therapies against extant interventions. Increased research on the biological and psychological mechanisms mediating irritability will further bridge the treatment gap for youth and families.

A brief peer gatekeeper suicide prevention training: Results of an open pilot trial.

The purpose of the present study was to test a 1-hour peer suicide gatekeeper training for students from the broad college community in the context of an open pilot trial. Two-hundred and thirty-one college students were recruited university-wide, Mage =20.7, 65.4% female, and completed a peer suicide prevention gatekeeping training program. Assessments were completed at pre-training and post-training as well as 3-month follow-up. This brief peer suicide gatekeeper training program was associated with increases in suicide prevention knowledge. It was also associated with an increase in the number of students who identified suicidal youth and made mental health referrals, as well as total number of referrals made, over the course of three months. Females reported greater improvement in suicide prevention skills and knowledge post-training than males. Offering peer suicide gatekeeper training to students from the general college population may hold promise in suicide prevention efforts.

Efficacy of bio-optimized extracts of turmeric and essential fennel oil on the quality of life in patients with irritable bowel syndrome.

BackgroundThe use of herbal products to treat irritable bowel syndrome (IBS), a disease that frequently affects the quality of life (QoL), is still under evaluation. This open pilot study assessed the efficacy of bio-optimized extracts of turmeric and essential fennel oil (Enterofytol®) in IBS patients.MethodsA total of 211 patients (14% diarrhea-predominant, IBS-D; 24% constipation-predominant, IBS-C; 62% mixed, IBS-M) were enrolled by general practitioners and completed questionnaires measuring symptom severity and QoL before and after Enterofytol®, two capsules b.i.d. for one month, followed by two capsules q.d. for another month.ResultsIBS severity index and QoL were inversely related. A significant reduction in the severity index and an improvement in QoL were evident following treatment in all IBS subgroups. IBS-D patients showed the worst clinical picture at entry, with the highest IBS severity index and the lowest QoL score, compared with IBS-C and IBS-M subtypes. IBS-D patients, however, also showed the most pronounced response to therapy, considering both scores. The improvement in the IBS severity index was independent of age and sex.ConclusionsResults from this “real-life” study show that the combination of turmeric and essential fennel oil over two months improves both symptoms and QoL in IBS patients, irrespectively of age, sex, initial severity of symptoms and IBS-subtypes, suggesting a potential role for the natural treatment of IBS.

Cardiovascular Risk Reduction in Persons Living With HIV: Treatment Development, Feasibility, and Preliminary Results

Persons living with HIV (PLWH) have elevated risks for cardiovascular disease (CVD). Our goal was to develop and pilot test a tailored intervention to improve CVD risk perception and the adoption of heart-healthy behaviors. In-depth qualitative interviews were conducted with 30 PLWH participants to examine learning needs and preferences. An intervention manual was developed and tested in an open pilot with eight participants. Participants were stable on antiretroviral therapy and were recruited from two urban HIV clinics in the northeastern United States. Thematic analysis identified five major themes: (a) tailored structure and design for PLWH, (b) learning needs (specific to HIV), (c) desire for prompts/reminders (to exercise), (d) importance of participant resources, and (e) need for personal evaluation and goal setting. Feasibility and acceptability of the intervention were demonstrated with high session attendance and treatment satisfaction. Further testing is warranted.

Aalto open access fund pilot

At the start of 2017, an Open Access Fund Pilot was launched to support Aalto University’s researchers with the OA article payments (APC-charges). The Open Access Fund Pilot is the first and one of a kind in Finland. This poster discusses current results and best practices learned from managing an Open Access fund in Finland’s context. The poster also presents the fund’s workflows including, e.g., departments’ personnel, publishers’ APC discount programs and the Learning Centre (previously the Library).Aalto University has reserved 120 000 euros for the pilot. Every department has its own quota for OA article payments. The quota depends on the publishing activity of the department during the past few years. The head of department makes final decisions for the use of the department quota. In order to get the funding, publications must meet certain criteria. The pilot funds only the open access publishing of journal and conference articles. Both Gold and Hybrid OA journals’ APC costs are accepted. Furthermore, Publication Forum, a classification of publication channels created by the Finnish scientific community, is used as a part of funding criteria. The Publication Forum’s levels are 1 = basic, 2 = leading, and 3 = top, and fully OA journals must be rated 1, 2 or 3 and Hybrid-model journals 2 or 3 in order to get the funding.The Learning Centre verifies that the publication meets the requirements of the OAF-pilot and checks if there are any discounts on APC-charges. If the publication meets all the requirements of the OAF-pilot, Learning Centre guides the researcher to apply for funding for APC-charges. The Learning Centre is also responsible for communications and informing of the OAF-pilot and for monitoring departments’ quotas. Currently, we have 34 applications from which most have met the requirements of AOF-pilot. So far, the total amount of funding granted is 29 796 €.

Does the low FODMAP diet improve symptoms of radiation-induced enteropathy? A pilot study

Rationale: Patients with radiation-induced enteropathy (RE) after cancer treatment show similar symptoms as patients with irritable bowel syndrome (IBS). The low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet (LFD) is a widespread management strategy for IBS. We aimed to investigate if there may be a positive effect of LFD on symptoms and health-related quality of life (HRQOL) in patients with RE.Methods: In an open non-controlled pilot study, 11 patients (all female) with RE-related IBS symptoms were recruited largely based on own initiative. All followed LFD for four weeks. IBS Severity Scoring System (IBS-SSS) and IBS Symptom Questionnaire (IBS-SQ) were used to assess symptoms. Short Form Nepean Dyspepsia Index (SF-NDI) and 12-item Short Form Health Survey (SF-12) evaluated HRQOL. A three day food record was used to estimate baseline intake of FODMAPs and to reveal dietary changes.Results: FODMAP intake was successfully reduced, although LFD was found a burdensome intervention. IBS symptoms improved significantly based on mean total score of IBS-SSS and IBS-SQ, which changed from 310.2 ± 60.7 to 171.4 ± 107.2 (p = .001) and 27.4 ± 4.1 to 15.7 ± 10.1 (p = .002). HRQOL improved based on SF-NDI total score (30.5 ± 9.4 to 18.3 ± 8.2, p = .001) and based on mental (p = .047) and physical (p = .134) score of SF-12. Main additional dietary changes were reduced intake of energy, carbohydrates, and fiber.Conclusion: Our findings from this small-scaled pilot study indicate that the LFD may alleviate symptoms and improve HRQOL in patients with RE. Further controlled studies with larger sample size should be conducted to verify our results and hopefully enable implementation of LFD as a future part of the management strategy for RE.

First Use of a Brief 60-second Mindfulness Exercise in an Orthopedic Surgical Practice; Results from a Pilot Study.

Mindfulness based interventions may be useful for patients with musculoskeletal conditions in orthopedic surgical practices as adjuncts to medical procedures or alternatives to pain medications. However, typical mindfulness programs are lengthy and impractical in busy surgical practices. We tested the feasibility, acceptability and preliminary effect of a brief, 60-second mindfulness video in reducing pain and negative emotions in patients presenting to an orthopedics surgical practice. This was an open pilot study. Twenty participants completed the Numerical Rating Scale to assess pain intensity, the State Anxiety subscale of the State Trait Anxiety Scale to assess state anxiety, and emotional thermometers to assess distress, anxiety, anger and depression immediately prior to and following the mindfulness video exercise. At the end of the exercise patients also answered three questions assessing satisfaction with the mindfulness video. Feasibility of the mindfulness video was high (100%). Usefulness, satisfaction and usability were also high. Participants showed improvements in state anxiety, pain intensity, distress, anxiety, depression and anger after watching the video. These changes were both statistically significant and clinically meaningful, when such information was available. People with musculoskeletal pain seeking orthopedic care seem receptive and interested in brief mindfulness exercises that enhance comfort and calm.

고등학생 학습몰입척도 개발 및 타당화1)

This study aims to, first, to develop the students’ learning flow scale base on the high school students’ learning flow experiences and, to validate it. I analyzed the concepts of learning flow through examining various literature reviews and then explored the constructs of learning flow through the open pilot survey and the group interview and with the help of expert’s advice. I prepared the sample questions through the open pilot survey and group interviews based on the previous learning flow scales and constructs. I carried out a preliminary survey of 540 high school students for the question analysis, the primary validation, exploratory factor analysis, and developed 30 learning flow scale questions. According to above process, I developed learning flow scales consisting of 3 “clear goals”, 3 “immediate feedback”, 3 “challenge-skill balance”, 3 “concentration on the task at hand”, 3 “merging of action and awareness”, 3 “loss of self-consciousness”, 4 “altered sense of time”, 3 “sense of control”, and 5 “autotelic experience” questions. I carried out main survey of 240 high school students. According to above process, concept reliability in each sub-factor ranged from .747. to. 832, indicating the scale possessed good internal consistency.After analyzing the structural equation model for the higher-order confirmative factor analysis, I had the result: χ² = 1617.708(df​​=394, p=.000, Q = 4.106, CFI = .907, TLI = .898, RMSEA=.036), which showed the goodness of fit of the structural model insufficient and confirmed the influence between relevant variables.

Effects of 35% carbon dioxide (CO2) inhalation in patients with post-traumatic stress disorder (PTSD): A double-blind, randomized, placebo-controlled, cross-over trial

BackgroundIn patients with post-traumatic stress disorder (PTSD) two open pilot studies about the effects of 35% carbon dioxide (CO2) exist. One shows an augmented panicogenic and anxiogenic response (Muhtz et al., 2011), the other does not (Talesnik et al. 2007). We further characterized the CO2 reactivity in PTSD using for the first time placebo-controlled and double-blind conditions. MethodsIn 20 patients with PTSD we assessed panic, anxiety, dissociative and PTSD symptoms after a single vital capacity inhalation of 35% CO2 compared to a placebo gas condition in a within-participant cross-over, placebo-controlled, double-blind and randomized design. ResultsInhalation of 35% CO2 versus placebo provoked significantly increased panic, anxiety, dissociative and PTSD symptoms. The reaction to placebo gas was minimal. Order of inhalation, patients' sex or age did not influence the results. The panic and anxiety response under CO2 was considerably higher in the PTSD patients than in healthy controls from our previous open study. ConclusionsThe results corroborate that our preceding findings of an increased CO2 reactivity in patients with PTSD are not false positive due to the open design or the lack of placebo control. Replication in a larger number of PTSD patients and matched control subjects is needed. The potential role of childhood traumatisation, psychiatric comorbidity, psychotropic medication and trait dissociation in prior contradictory reports should be clarified.

Changes in coping, autonomous motivation, and beliefs about exercise among women in early recovery from alcohol participating in a lifestyle physical activity intervention

Women are particularly likely to drink alcohol for the purpose of coping with or alleviating negative affect. Engaging in physical activity has been posited as a potentially effective alternate coping strategy during early recovery for managing mood and cravings. Utilizing exercise to cope may be associated with more adaptive coping strategies in general. Additionally, an intrinsic (autonomous) motivational style and positive beliefs about exercise are associated with long-term adherence to physical activity. The current study evaluates changes in coping strategies, autonomous motivation, and beliefs about exercise among women engaged in a physical activity intervention during early recovery (N = 20; mean age = 39.53). General coping strategies, motivational style, and beliefs about exercise were examined before and after engaging in the 12-week intervention which aimed to help women utilize physical activity as a means to cope with negative affect and alcohol craving. We found that, by the end of the intervention, participants significantly increased utilization of adaptive coping strategies such as the use of emotional support from others. Additionally, participants increased autonomous motivation over time. There were no significant changes in beliefs about exercise. Changes in beliefs about benefits of exercise, autonomous motivation, and adaptive coping were related to use of exercise to cope. However, even though these changes were associated with how women in the intervention used exercise, they were not associated with exercising more. Results from this open pilot suggest that women in early recovery from alcohol who increase physical activity – specifically as a means to cope with negative affect and craving – also demonstrate other wider coping strategies, more positive beliefs, and autonomous motivation.

Protocol for Co-Design, Development, and Open Trial of a Prototype Game-Based eHealth Intervention to Treat Anxiety in Young People With Long-Term Physical Conditions.

BackgroundApproximately 10% to 12% of New Zealand young people (and 21% of Maori young people) have long-term physical conditions and are more likely to develop psychological problems, particularly anxiety and depression. Delayed treatment leads to worse management of physical conditions, school absence, and poorer long-term outcomes. Recently, electronic health (eHealth) interventions have been shown to be as good as face-to-face therapy and biofeedback techniques have been shown to enhance relaxation during the treatment of anxiety. In addition, young people with long-term physical conditions have expressed a preference for more technologically based support, including game-based interventions, to deal with psychological issues, particularly anxiety.ObjectiveThe aim of this study is to develop a prototype game-based eHealth intervention to address anxiety in young people with long-term physical conditions. The game will be based on the principles of cognitive behavior therapy (CBT) and will integrate a module of biofeedback-based relaxation.MethodsDuring the first phase of the study, up to 48 young people with long-term physical conditions aged 13 to 18 years, attending a tertiary pediatric hospital will be invited to participate in a 3-stage series of co-design workshops. Following the design, development, and refinement of a working prototype, during the second phase of the study, a further 20 young people with long-term physical conditions and anxiety will be recruited from the same location to participate in an open pilot trial to evaluate its acceptability, usability, and preliminary efficacy.ResultsChanges in anxiety will be measured using the Generalized Anxiety Disorder 7-item scale (GAD-7) and the Spence Child Anxiety Scales (SCAS) at the end of every module (recommended to be completed weekly), post intervention, and 3 months later. Usability of the intervention will be measured using the System Usability Scale (SUS) and by measuring frequency and quantity of use of the intervention. Acceptability of the intervention will be assessed using brief, open-ended questionnaires and semi-structured interviews, the data from which will be analyzed using a general inductive approach. Recruitment to the study commenced in January 2017 and data collection will be completed by the end of December 2017.ConclusionsIf acceptable and useful, this game-based eHealth intervention may offer a cost-effective and clinically useful intervention for addressing the psychological needs of over 16,000 young people with long term health conditions in New Zealand.Trial RegistrationAustralian New Zealand Clinical Trials Network Registry (ANZCTR): ACTRN12616001253493p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371443 (Archived by WebCite at http://www.webcitation.org/6sYB716lf)

Feasibility and Accessibility of a Tailored Intervention for Informal Caregivers of People with Severe Psychiatric Disorders: a Pilot Study

This study aimed to assess the acceptability and feasibility of a new tailored intervention for informal caregivers: the Ensemble (Together) program. An open pre-post within-subject comparison pilot study was conducted. Twenty-one informal caregivers completed the five-session Ensemble program. Two measurement tools were used: The Brief Symptom Inventory (BSI) and the Life Orientation Scale (LOT-R). The results showed that informal caregivers were in need of individual support and were ready to participate in the Ensemble program independent of the patient's diagnosis or stage of illness. The participants were very satisfied, and 95.4% completed the program. The preliminary results also showed that in five sessions, informal caregivers' Global Severity Index measured by the BSI and their optimism about their future (measured by the LOT-R) were significantly improved. This pilot study provided preliminary results concerning the feasibility and acceptability of the tailored Ensemble program and indicates the need for a randomized trial. The Ensemble program is appropriate for both the acute and chronic phases of disease. Individualized brief and useful interventions for informal caregivers may provide more positive outcomes in care.

Tinnitus Treatment with Oxytocin: A Pilot Study.

Tinnitus is the perception of sound in the absence of an external stimulus. It is a frequent condition for which there is as yet no pharmacological treatment approved. Auditory and non-auditory pathways are involved in tinnitus' pathophysiology. Oxytocin is a neurohormone and eventual neurotransmitter that plays a complex role in social cognition and behavior. To evaluate the potential of oxytocin as a tinnitus treatment. Two studies were performed. Study 1 was a long-term open pilot study, while study 2 investigated short-term effects with a double-blinded placebo-controlled cross-over study. Ambulatory ENT care. In study 1, 15 patients were investigated over a 10-week period in an open pilot study. In study 2, 16 patients were included in a placebo-controlled crossover trial to investigate short-term effects following a single dose. For the long-term study (study 1), analysis of variance revealed a significant decrease in tinnitus sensation, both for the Tinnitus Handicap Inventory and Clinical Global Impression (CGI). Also, the short-term effects in study 2 revealed a significant reduction of tinnitus because of the oxytocin nasal spray as measured with the Visual Analog Scale and the CGI Scale. These preliminary studies demonstrated that oxytocin may represent a helpful tool for treating tinnitus and further larger controlled studies are warranted.