Trials
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Randomized Controlled Trial
The NAILED stroke risk factor trial (nurse based age independent intervention to limit evolution of disease after stroke): study protocol for a randomized controlled trial.
Secondary prevention after stroke and transient ischemic attack (TIA) is essential in order to reduce morbidity and mortality. Secondary stroke prevention studies have, however, been fairly small, or performed as clinical trials with non-representative patient selection. Long-term follow-up data is also limited. A nurse-led follow-up for risk factor improvement may be effective but the evidence is limited. The aims of this study are to perform an adequately sized, nurse-led, long-term secondary preventive follow-up with a population-based inclusion of stroke and TIA patients. The focus will be on blood pressure and lipid control as well as tobacco use and physical activity. ⋯ This study will test the hypothesis that a nurse-led, long-term follow-up after stroke with a focus on reaching set treatment goals as soon as possible, is an effective secondary preventive method. If proven effective, this method could be implemented in general practice at a low cost.
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Randomized Controlled Trial
Guided and unguided CBT for social anxiety disorder and/or panic disorder via the Internet and a smartphone application: study protocol for a randomised controlled trial.
Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effects of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a smartphone application. The effect of added therapist support will also be studied. ⋯ To our knowledge, this is the first study to investigate the effectiveness of smartphone-supplemented iCBT for anxiety disorders. Hence, the findings from this trial will constitute great advancements in the burgeoning and promising field of smartphone-administered psychological interventions. Limitations are discussed.
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Randomized Controlled Trial
The use of mindfulness-based cognitive therapy for improving quality of life for inflammatory bowel disease patients: study protocol for a pilot randomised controlled trial with embedded process evaluation.
Inflammatory bowel disease (IBD) is a chronic condition with an unpredictable disease course. Rates of anxiety and depression among IBD patients in relapse (active disease symptoms) as well as in remission are higher than in the general population. Previous studies suggest that the prolonged effect of pain, anxiety, distress and depression have a detrimental effect on patients'quality of life (QoL). Poor QoL in itself is associated with further symptom relapse. Mindfulness based cognitive therapy (MBCT) is a psychological group intervention that has the potential to improve QoL. When used in other chronic conditions, it demonstrated reduced negative effect from pain and psychological factors at completion of an 8-week MBCT course. The effect of MBCT has never been researched in IBD. The aim of this study is to obtain the information required to design a full scale randomised controlled trial (RCT) that will examine the effectiveness of MBCT in improving quality of life for IBD patients. ⋯ The outcomes of this study will help define the barriers, uptake and perceived benefits of MBCT program for IBD patients. This information will enable the design of a full-scale study assessing the effect of MBCT on quality of life for IBD patients.
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The use of restricted randomisation methods such as minimisation is increasing. This paper investigates under what conditions it is preferable to use restricted randomisation in order to achieve balance between treatment groups at baseline with regard to important prognostic factors and whether trialists should be concerned that minimisation may be considered deterministic. ⋯ In general, for smaller trials, probability of treatment allocation to the treatment group with fewer numbers requires a larger value P to keep treatment and variable groups balanced. For larger trials probability of allocation values from P = 0.5 to P = 0.8 can be used while still maintaining balance. For one prognostic variable there is no significant benefit in terms of predictability in reducing the value of P. However, for more than one prognostic variable, significant reduction in levels of predictability can be achieved with the appropriate choice of P for the given trial design.
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Randomized Controlled Trial
The cost-effectiveness of a family meetings intervention to prevent depression and anxiety in family caregivers of patients with dementia: a randomized trial.
Dementia imposes a heavy burden on health and social care systems as well as on family caregivers who provide a substantial portion of the care. Interventions that effectively support caregivers may prevent or delay patient institutionalization and hence be cost-effective. However, evidence about the cost-effectiveness of such interventions is scarce. The aim of this study was to evaluate the cost-effectiveness of a family meetings intervention for family caregivers of dementia patients in comparison with usual care over a period of 12 months. ⋯ The annual costs of caring for a person with dementia were substantial with informal care being by far the largest contributor to the total societal costs. Based on this study, family meetings cannot be considered a cost-effective intervention strategy in comparison with usual care.