http://www.trialsjournal.com The latest research articles published by Trials 2013-05-17T00:00:00Z Background: Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments, most of the cases evolve with only partial remission, relapse and recurrence.Cognitive models have contributed significantly to the understanding of unipolar depression and its psychological treatment. However, success is only partial and many authors affirm the need to improve those models and also the treatment programs derived from them. One of the issues that requires further elaboration is the difficulty these patients experience in responding to treatment and in maintaining therapeutic gains across time without relapse or recurrence. Our research group has been working on the notion of cognitive conflict viewed as personal dilemmas according to personal construct theory. We use a novel method for identifying those conflicts using the repertory grid technique (RGT). Preliminary results with depressive patients show that about 90% of them have one or more of those conflicts. This fact might explain the blockage and the difficult progress of these patients, especially the more severe and/or chronic. These results justify the need for specific interventions focused on the resolution of these internal conflicts. This study aims to empirically test the hypothesis that an intervention focused on the dilemma(s) specifically detected for each patient will enhance the efficacy of cognitive behavioral therapy (CBT) for depression.DesignA therapy manual for a dilemma-focused intervention will be tested using a randomized clinical trial by comparing the outcome of two treatment conditions: combined group CBT (eight, 2-hour weekly sessions) plus individual dilemma-focused therapy (eight, 1-hour weekly sessions) and CBT alone (eight, 2-hour group weekly sessions plus eight, 1-hour individual weekly sessions).MethodParticipants are patients aged over 18 years meeting diagnostic criteria for major depressive disorder or dysthymic disorder, with a score of 19 or above on the Beck depression inventory, second edition (BDI-II) and presenting at least one cognitive conflict (implicative dilemma or dilemmatic construct) as assessed using the RGT. The BDI-II is the primary outcome measure, collected at baseline, at the end of therapy, and at 3- and 12-month follow-up; other secondary measures are also used.DiscussionWe expect that adding a dilemma-focused intervention to CBT will increase the efficacy of one of the more prestigious therapies for depression, thus resulting in a significant contribution to the psychological treatment of depression.Trial registrationISRCTN92443999; ClinicalTrials.gov Identifier: NCT01542957. http://www.trialsjournal.com/content/14/1/144 Guillem Feixas Arturo Bados Eugeni García-Grau Adrián Montesano Gloria Dada Victoria Compañ Mari Aguilera Marta Salla Joan Soldevilla Adriana Trujillo Clara Paz Lluís Botella Sergi Corbella Luis Saúl-Gutiérrez José Cañete Miquel Gasol Montserrat Ibarra Leticia Medeiros-Ferreira José Soriano Eugénia Ribeiro Franz Caspar David Winter Trials 2013, null:144 2013-05-17T00:00:00Z doi:10.1186/1745-6215-14-144 /content/figures/1745-6215-14-144-toc.gif Trials 1745-6215 ${item.volume} 144 2013-05-17T00:00:00Z PDF Background: A frequent complication in patients with subarachnoid hemorrhage (SAH) is recurrent bleeding from the aneurysm. The risk is highest within the first 6 hours after the initial hemorrhage. Securing the aneurysm within this timeframe is difficult owing to logistical delays. The rate of recurrent bleeding can also be reduced by ultra-early administration of antifibrinolytics, which probably improves functional outcome. The aim of this study is to investigate whether ultra-early and short-term administration of the antifibrinolytic agent tranexamic acid (TXA), as add-on to standard SAH management, leads to better functional outcome. Methods: This is a multicenter, prospective, randomized, open-label trial with blinded endpoint (PROBE) assessment. Adult patients with the diagnosis of non-traumatic SAH, as proven by computed tomography (CT) within 24 hours after the onset of headache, will be randomly assigned to the treatment group or the control group. Patients in the treatment group will receive standard treatment with the addition of a bolus of TXA (1 g intravenously) immediately after randomization, followed by continuous infusion of 1 g per 8 hours until the start of aneurysm treatment, or a maximum of 24 hours after the start of medication. Patients in the control group will receive standard treatment without TXA. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin Scale (mRS), at 6 months after SAH. Primary outcome will be determined by a trial nurse blinded for treatment allocation. We aim to include 950 patients in 3 years.DiscussionThe strengths of this study are: 1. the ultra-early and short-term administration of TXA, resulting in a lower dose as compared to previous studies, which should reduce the risk for delayed cerebral ischemia (DCI), an important risk factor in the long-term treatment with antifibrinolytics; 2. the power calculation is based on functional outcome and calculated with use of recent study results of our own population, supported by data from prominent studies; and 3. the participation of several specialized SAH centers, and their referring hospitals, in the Netherlands with comparative treatment protocols.Trial registration: Nederlands Trial Register (Dutch Trial Registry) number NTR3272. http://www.trialsjournal.com/content/14/1/143 Menno Germans René Post Bert Coert Gabriël Rinkel W Vandertop Dagmar Verbaan Trials 2013, null:143 2013-05-16T00:00:00Z doi:10.1186/1745-6215-14-143 /content/figures/1745-6215-14-143-toc.gif Trials 1745-6215 ${item.volume} 143 2013-05-16T00:00:00Z PDF Background: There are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical research has concentrated on community- or hospital-based research, with little documentation, if any, of community engagement in school-based health research. In this paper we discuss our experiences of consent, assent and community engagement in implementing a large school-based cluster randomized trial in rural Kenya. Methods: Data collected as part of a qualitative study investigating the acceptability of the main trial, focus group discussions with field staff, observations of practice and authors' experiences are used to: 1) highlight the challenges faced in obtaining assent/consent; and 2) strategies taken to try to both protect participant rights (including to refuse and to withdraw) and ensure the success of the trial. Results: Early meetings with national, district and local level stakeholders were important in establishing their co-operation and support for the project. Despite this support, both practical and ethical challenges were encountered during consenting and assenting procedures. Our strategy for addressing these challenges focused on improving communication and understanding of the trial, and maintaining dialogue with all the relevant stakeholders throughout the study period. Conclusions: A range of stakeholders within and beyond schools play a key role in school based health trials. Community entry and information dissemination strategies need careful planning from the outset, and with on-going consultation and feedback mechanisms established in order to identify and address concerns as they arise. We believe our experiences, and the ethical and practical issues and dilemmas encountered, will be of interest for others planning to conduct school-based research in Africa.Trial registration: National Institute of Health NCT00878007 http://www.trialsjournal.com/content/14/1/142 George Okello Caroline Jones Maureen Bonareri Sarah Ndegwa Carlos Mcharo Juddy Kengo Kevin Kinyua Margaret Dubeck Katherine Halliday Matthew Jukes Sassy Molyneux Simon Brooker Trials 2013, null:142 2013-05-16T00:00:00Z doi:10.1186/1745-6215-14-142 /content/figures/1745-6215-14-142-toc.gif Trials 1745-6215 ${item.volume} 142 2013-05-16T00:00:00Z PDF Background: Damage control laparotomy, or abbreviated initial laparotomy followed by temporary abdominal closure (TAC), intensive care unit resuscitation, and planned re-laparotomy, is frequently used to manage intra-abdominal bleeding and contamination among critically ill or injured adults. Animal data suggest that TAC techniques that employ negative pressure to the peritoneal cavity may reduce the systemic inflammatory response and associated organ injury. The primary objective of this study is to determine if use of a TAC dressing that affords active negative pressure peritoneal therapy, the ABThera Open Abdomen Negative Pressure Therapy system, reduces the extent of the systemic inflammatory response after damage control laparotomy for intra-abdominal sepsis or injury as compared to a commonly used TAC method that provides potentially less efficient peritoneal negative pressure, the Barker's vacuum pack. Methods: The Intra-peritoneal Vacuum trial will be a single-center, randomized controlled trial. Adults will be intraoperatively allocated to TAC with either the ABThera or Barker's vacuum pack after the decision has been made by the attending surgeon to perform a damage control laparotomy. The study will use variable block size randomization. On study days 1, 2, 3, 7, and 28, blood will be collected. Whenever possible, peritoneal fluid will also be collected at these time points from the patient's abdomen or TAC device. Luminex technology will be used to quantify the concentrations of 65 mediators relevant to the inflammatory response in peritoneal fluid and plasma. The primary endpoint is the difference in the plasma concentration of the pro-inflammatory cytokine IL-6 at 24 and 48 h after TAC dressing application. Secondary endpoints include the differential effects of these dressings on the systemic concentration of other pro-inflammatory cytokines, collective peritoneal and systemic inflammatory mediator profiles, postoperative fluid balance, intra-abdominal pressure, and several patient-important outcomes, including organ dysfunction measures and mortality.DiscussionResults from this study will improve understanding of the effect of active negative pressure peritoneal therapy after damage control laparotomy on the inflammatory response. It will also gather necessary pilot information needed to inform design of a multicenter trial comparing clinical outcomes among patients randomized to TAC with the ABThera versus Barker's vacuum pack.Trial registration: ClinicalTrials.gov identifier NCT01355094 http://www.trialsjournal.com/content/14/1/141 Derek Roberts Craig Jenne Chad Ball Corina Tiruta Caroline Léger Zhengwen Xiao Peter Faris Paul McBeth Christopher Doig Christine Skinner Stacy Ruddell Paul Kubes Andrew Kirkpatrick Trials 2013, null:141 2013-05-16T00:00:00Z doi:10.1186/1745-6215-14-141 /content/figures/1745-6215-14-141-toc.gif Trials 1745-6215 ${item.volume} 141 2013-05-16T00:00:00Z PDF Background: Anxiety disorders affect approximately 10% to 20% of young people, can be enduring if left untreated, and have been associated with psychopathology in later life. Despite this, there is a paucity of empirical research to assist clinicians in determining appropriate treatment options. We describe a protocol for a randomized controlled trial in which we will examine the effectiveness of a group-based Acceptance and Commitment Therapy program for children and adolescents with a primary diagnosis of anxiety disorder. For the adolescent participants we will also evaluate the elements of the intervention that act as mechanisms for change. Methods: We will recruit 150 young people (90 children and 60 adolescents) diagnosed with an anxiety disorder and their parent or caregiver. After completion of baseline assessment, participants will be randomized to one of three conditions (Acceptance and Commitment Therapy, Cognitive Behavior Therapy or waitlist control). Those in the Acceptance and Commitment Therapy and Cognitive Behavior Therapy groups will receive 10 x 1.5 hour weekly group-therapy sessions using a manualized treatment program, in accordance with the relevant therapy, to be delivered by psychologists. Controls will receive the Cognitive Behavior Therapy program after 10 weeks waitlisted. Repeated measures will be taken immediately post-therapy and at three months after therapy cessation.DiscussionTo the best of our knowledge, this study will be the largest trial of Acceptance and Commitment Therapy in the treatment of children and young people to date. It will provide comprehensive data on the use of Acceptance and Commitment Therapy for anxiety disorders and will offer evidence for mechanisms involved in the process of change. Furthermore, additional data will be obtained for the use of Cognitive Behavior Therapy in this population and this research will illustrate the comparative effectiveness of these two interventions, which are currently implemented widely in contemporary clinical practice. Anticipated difficulties for the trial are the recruitment and retention of participants, particularly adolescents. To avert these concerns and maximize recruitment, several strategies will be adopted to optimize referral rates as well as reduce participant drop-outs.Trial registration: This trial is registered with the Australian and New Zealand Clinical Trials Registry, registration number: ACTRN12611001280998. http://www.trialsjournal.com/content/14/1/140 Jessica Swain Karen Hancock Angela Dixon Siew Koo Jenny Bowman Trials 2013, null:140 2013-05-15T00:00:00Z doi:10.1186/1745-6215-14-140 /content/figures/1745-6215-14-140-toc.gif Trials 1745-6215 ${item.volume} 140 2013-05-15T00:00:00Z PDF Background: People with type 1 diabetes who use electronic self-help tools register a large amount of information about their disease on their participating devices; however, this information is rarely utilized beyond the immediate investigation. We have developed a diabetes diary for mobile phones and a statistics-based feedback module, which we have named Diastat, to give data-driven feedback to the patient based on their own data.MethodIn this study, up to 40 participants will be given a smartphone on which is loaded a diabetes self-help application (app), the Few Touch Application (FTA). Participants will be randomized into two groups to be given access to Diastat 4 or 12 weeks, respectively after receiving the smartphone, and will use the FTA with Diastat for 8 weeks after this point. The primary endpoint is the frequency of high and low blood-glucose measurements.DiscussionThe study will investigate the effect of data-driven feedback to patients. Our hypothesis is that this will improve glycemic control and reduce variability. The endpoints are robust indicators that can be assembled with minimal effort by the patient beyond normal routine.Trial registrationClinicaltrials.gov: NCT01774149 http://www.trialsjournal.com/content/14/1/139 Stein Olav Skrøvseth Eirik Årsand Fred Godtliebsen Ragnar Joakimsen Trials 2013, null:139 2013-05-14T00:00:00Z doi:10.1186/1745-6215-14-139 /content/figures/1745-6215-14-139-toc.gif Trials 1745-6215 ${item.volume} 139 2013-05-14T00:00:00Z XML Background: Heart failure (HF) is associated with decreased quality of life, high re-admission rate and poor prognosis. In particular, ischemic heart failure (IHF) has a worse prognosis than nonischemic HF. The use of traditional Chinese medicine (TCM) alongside Western medicine to treat HF has developed into an integrative treatment model in China. There have been small clinical trials and experimental studies to demonstrate the efficacy of TCM for treating HF; however, there is still a lack of high-quality trials. Qishen Yiqi dripping pills (QSYQ), a TCM drug, have been commonly used alongside standardized Western medicine to treat IHF. This paper describes the protocol for the clinical assessment of QSYQ in IHF patients.MethodA randomized, double-blind, multicenter, placebo-controlled trial will assess the efficacy and safety of QSYQ in the treatment of IHF. The trial is to enroll 640 IHF patients from 32 hospitals in China. Besides their standardized Western medicine, patients will be randomized to receive treatment of either QSYQ or placebo for 6 months and follow-up monitoring for at least a further 6 months. The primary outcome is increased exercise capacity of patients, which will be measured using the 6-minute walking test (6MWT). The secondary outcomes include composite endpoints: all-cause mortality, frequency of hospitalization or emergency due to cardiovascular events, brain natriuretic peptide levels, left ventricular ejection fraction, and cardiothoracic ratio will be documented, as well as scores on the New York Heart Association classification and Minnesota quality of life index, and information obtained from the four TCM diagnostic methods. Blood lipid tests will also be administered.DiscussionThe integrative treatment model of TCM alongside Western medicine has developed into a treatment model in China. The rigorous design of the trial will assure an objective and scientific assessment of the efficacy and safety of QSYQ in the treatment of IHF.Trial registration: Clinical trials.gov number: NCT01555320 http://www.trialsjournal.com/content/14/1/138 Shuai Wang Ya Hou Zhi Zhao Xian Wang Bin Li Shan Soh Jing Mao Trials 2013, null:138 2013-05-14T00:00:00Z doi:10.1186/1745-6215-14-138 /content/figures/1745-6215-14-138-toc.gif Trials 1745-6215 ${item.volume} 138 2013-05-14T00:00:00Z PDF Background: Sufficient evidence is lacking to draw final conclusions on the efficiency of medical and psychological treatments of traumatized refugees with PTSD. The pharmacological treatments of choice today for post-traumatic stress disorder are antidepressants from the subgroup selective serotonin reuptake inhibitors, especially Sertraline. The evidence for the use of selective serotonin reuptake inhibitors in the treatment of complex post-traumatic stress disorder in traumatized refugees is very limited. Venlafaxine is a dual-action antidepressant that works on several pathways in the brain. It influences areas in the brain which are responsible for the enhanced anxiety and hyper-arousal experienced by traumatized refugees and which some studies have found to be enlarged among patients suffering from post-traumatic stress disorder.DesignThis study will include approximately 150 patients, randomized into two different groups treated with either Sertraline or Venlafaxine. Patients in both groups will receive the same manual-based cognitive behavioral therapy, which has been especially adapted to this group of patients. The treatment period will be 6 to 7 months. The trial endpoints will be post-traumatic stress disorder and depressive symptoms and social functioning, all measured on validated ratings scales. Furthermore the study will examine the relation between a psycho-social resources and treatment outcome based on 15 different possible outcome predictors.DiscussionThis study is expected to bring forward new knowledge on treatment and clinical evaluation of traumatized refugees and the results are expected to be used in reference programs and clinical guidelines.Trial registration: ClinicalTrials.gov NCT01569685 http://www.trialsjournal.com/content/14/1/137 Charlotte Sonne Jessica Carlsson Ask Elklit Erik Mortensen Morten Ekstrøm Trials 2013, null:137 2013-05-11T00:00:00Z doi:10.1186/1745-6215-14-137 /content/figures/1745-6215-14-137-toc.gif Trials 1745-6215 ${item.volume} 137 2013-05-11T00:00:00Z PDF Background: The COINCIDE trial aims to evaluate the effectiveness and cost-effectiveness of a collaborative care intervention for depression in people with diabetes and/or coronary heart disease attending English general practices.DesignThis update details changes to the cluster and patient recruitment strategy for the COINCIDE study. The original protocol was published in Trials (http://www.trialsjournal.com/content/pdf/1745-6215-13-139.pdf). Modifications were made to the recruitment targets in response to lower-than-expected patient recruitment at the first ten general practices recruited into the study. In order to boost patient numbers and retain statistical power, the number of general practices recruited was increased from 30 to 36. Follow-up period was shortened from 6 months to 4 months to ensure that patients recruited to the trial could be followed up by the end of the study. Results: Patient recruitment began on the 01/05/2012 and is planned to be completed by the 30/04/2013. Recruitment for general practices was completed on 31/10/2012, by which time the target of 36 practices had been recruited. The main trial results will be published in a peer-reviewed journal. Conclusion: The data from the trial will provide evidence on the effectiveness and cost-effectiveness of collaborative care for depression in people with diabetes and/or coronary heart disease.Trial registration: Trial registration number: ISRCTN80309252 http://www.trialsjournal.com/content/14/1/136 Peter Coventry Karina Lovell Chris Dickens Peter Bower Carolyn Chew-Graham Andrea Cherrington Charlotte Garrett Chris Gibbons Clare Baguley Kate Roughley Isabel Adeyemi Chris Keyworth Waquas Waheed Mark Hann Linda Davies Farheen Jeeva Chris Roberts Sarah Knowles Linda Gask Trials 2013, null:136 2013-05-11T00:00:00Z doi:10.1186/1745-6215-14-136 /content/figures/1745-6215-14-136-toc.gif Trials 1745-6215 ${item.volume} 136 2013-05-11T00:00:00Z PDF Background: Light-emitting diodes (LED) have been used to minimize muscle fatigue in athletes and healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible to early muscle fatigue.ObjectiveThe objective of this study is to investigate the acute effects of LED on muscle function, exercise capacity and cardiorespiratory responses during isometric and dynamic exercise in patients with COPD. Methods: This study will assess 30 patients with moderate to severe obstruction (forced expiratory volume-one second,FEV1 ≤70% predicted). Isometric and dynamic protocols will be conducted in two visits each, for a total of four visits a week apart. First, venous blood will be taken from the patients. The isometric protocol will start with the determination of the maximum voluntary isometric contraction (MIVC) to determine the workload (60% of MIVC) for the isometric endurance test (IET). Patients will be randomized to receive either the placebo or LED application (each point will be irradiated for 30 s and the energy received at each point will be 41.7 J). Immediately after finishing this procedure, the patients will carry out the IET until the limit of tolerance or until a 20% fall of strength is observed. After the test, another blood draw will be taken. In another visit (one week later), the same order of procedures will be performed, except with the opposite (LED or placebo). For the dynamic endurance test (DET), the same procedures described above will be followed, except with 75% of the maximal workload obtained from the incremental cycle ergometer test used instead of the IET. The electromyography will be recorded during the isometric and dynamic protocols. Differences in muscle function, exercise capacity and cardiorespiratory responses between the LED and placebo applications will be analyzed. The therapeutic effects of LED could minimize muscle fatigue in patients with COPD by increasing exercise tolerance.Trial registrationTrial registration number: NCT01448564 http://www.trialsjournal.com/content/14/1/134 Eduardo Miranda Ernesto Junior Paulo Marchetti Simone Dal Corso Trials 2013, null:134 2013-05-10T00:00:00Z doi:10.1186/1745-6215-14-134 /content/figures/1745-6215-14-134-toc.gif Trials 1745-6215 ${item.volume} 134 2013-05-10T00:00:00Z XML