Testing the effectiveness of a mindfulness-based intervention to reduce emotional distress in outpatients with diabetes (DiaMind): design of a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Approximately 20-40% of outpatients with diabetes experience elevated levels of emotional distress, varying from disease-specific distress to general symptoms of anxiety and depression. The patient's emotional well-being is related to other unfavorable outcomes, like reduced quality of life, sub-optimal self-care, impaired glycemic control, higher risk of complications, and increased mortality rates. The purpose of this study is to test the effectiveness of a new diabetes-specific, mindfulness-based psychological intervention. First, with regard to reducing emotional distress; second, with respect to improving quality of life, dispositional mindfulness, and self-esteem of patients with diabetes; third, with regard to self-care and clinical outcomes; finally, a potential effect modification by clinical and personality characteristics will be explored.</p> <p>Methods/Design</p> <p>The Diabetes and Mindfulness study (DiaMind) is a randomized controlled trial. Patients with diabetes with low levels of emotional well-being will be recruited from outpatient diabetes clinics. Eligible patients will be randomized to an intervention group or a wait-list control group. The intervention group will receive the mindfulness program immediately, while the control group will receive the program eight months later. The primary outcome is emotional distress (anxiety, stress, depressive symptoms), for which data will be collected at baseline, four weeks, post intervention, and after six months follow-up. In addition, self-report data will be collected on quality of life, dispositional mindfulness, self-esteem, self-care, and personality, while complications and glycemic control will be assessed from medical files and blood pressure will be measured. Group differences will be analyzed with repeated measures analysis of covariance.</p> <p>The study is supported by grants from the Dutch Diabetes Research Foundation and Tilburg University and has been approved by a medical ethics committee.</p> <p>Discussion</p> <p>It is hypothesized that emotional well-being, quality of life, dispositional mindfulness, self-esteem, self-care, and blood pressure will improve significantly more in the mindfulness group compared to the control group. Results of this study can contribute to a better care for patients with diabetes with lowered levels of emotional well-being. It is expected that the first results will become available in 2012.</p> <p>Trial registration</p> <p>Dutch Trial Register <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2145">NTR2145</a>.</p

Internet-based treatment for older adults with depression and co-morbid cardiovascular disease: protocol for a randomised, double-blind, placebo controlled trial

<p>Abstract</p> <p>Background</p> <p>Depression, cardiovascular disease (CVD) risk factors and cognitive impairment are important causes of disability and poor health outcomes. In combination they lead to an even worse prognosis. Internet or web-based interventions have been shown to deliver efficacious psychological intervention programs for depression on a large scale, yet no published studies have evaluated their impact among patients with co-existing physical conditions. The aims of this randomised controlled trial are to determine the effects of an evidence-based internet intervention program for depression on depressive mood symptoms, cognitive function and treatment adherence in patients at risk of CVD.</p> <p>Methods/Design</p> <p>This study is an internet-based, double-blind, parallel group randomised controlled trial. The trial will compare the effectiveness of online cognitive behavioural therapy with an online attention control placebo. The trial will consist of a 12-week intervention phase with a 40-week follow-up. It will be conducted in urban and rural New South Wales, Australia and will recruit a community-based sample of adults aged 45 to 75 years. Recruitment, intervention, cognitive testing and follow-up data collection will all be internet-based and automated. The primary outcome is a change in severity of depressive symptoms from baseline to three-months. Secondary outcomes are changes in cognitive function and adherence to treatment for CVD from baseline to three, six and 12-months.</p> <p>Discussion</p> <p>Prior studies of depression amongst patients with CVD have targeted those with previous vascular events and major depression. The potential for intervening earlier in these disease states appears to have significant potential and has yet to be tested. Scalable psychological programs using web-based interventions could deliver care to large numbers in a cost effective way if efficacy were proved. This study will determine the effects of a web-based intervention on depressive symptoms and adherence to treatment among patients at risk of CVD. In addition it will also precisely and reliably define the effects of the intervention upon aspects of cognitive function that are likely to be affected early in at risk individuals, using sensitive and responsive measures.</p> <p>Trial registration</p> <p>Australian New Zealand Clinical Trials Registry (ANZCTR): <a href="http://www.anzctr.org.au/ACTRN12610000085077.aspx">ACTRN12610000085077</a></p

Limited effect of screening for depression with written feedback in outpatients with diabetes mellitus: a randomised controlled trial

Item does not contain fulltextAIMS/HYPOTHESIS: The aim of this study was to test the effectiveness of a screening procedure for depression (SCR) vs care as usual (CAU) in outpatients with diabetes. The primary outcome measured was depression score and the secondary outcomes were mental healthcare consumption, diabetes-distress and HbA(1c). MATERIALS AND METHODS: In a multicentre parallel randomised controlled trial, 223 outpatients with diabetes, who had an elevated depression score, were randomly assigned to SCR (n = 116) or CAU (n = 107), using computer generated numbers. SCR-patients were invited for a Composite International Diagnostic Interview (CIDI) to diagnose depression and/or anxiety (interviewers were not blinded for group assignment). As part of the intervention, patients and their physicians were informed of the outcome of the CIDI in a letter and provided with treatment advice. At baseline and 6 month follow-up, depression and diabetes-distress were measured using the Centre for Epidemiologic Studies Depression Scale (CES-D) and the Problem Areas in Diabetes survey (PAID). HbA(1c) levels were obtained from medical charts. RESULTS: Mean CES-D depression scores decreased from baseline to 6 months in both groups (24 +/- 8 to 21 +/- 8 [CAU] and 26 +/- 7 to 22 +/- 10 [SCR] respectively [p < 0.001]), with no significant differences between groups. Neither diabetes-distress nor HbA(1c) changed significantly within and between groups. The percentage of patients receiving mental healthcare increased in the SCR group from 20% to 28%, compared with 15% to 18% in the CAU group. CONCLUSIONS/INTERPRETATION: Depression screening with written feedback to patient and physician does not improve depression scores and has a limited impact on mental healthcare utilisation, compared with CAU. It appears that more intensive depression management is required to improve depression outcomes in patients with diabetes

Individual-level intervention approaches

In caring for persons with diabetes (PWD), healthcare professionals (HCP) have an important role to play when it comes to offering psychosocial support as integral part of ongoing diabetes care. Inquiring about and discussing emotional health with PWD is appreciated by them and can help to identify problem areas that require further assessment. For this purpose practical, validated self-report measures of well-being and diabetes distress are available for use in routine care. Based on a needs assessment, PWD may be offered psychosocial support by one of the team members (physician, nurse educator, dietitian) or a referral to a specialized mental health professional, preferably as part of team care. There is convincing evidence that cognitive behavioral therapy (CBT) is effective in reducing emotional distress and enhancing coping skills in PWD, with subsequent improvements of self-care and glycemic control, at least on the short term. Next to diabetes distress and depression, chronic fatigue has shown to be prevalent among PWD. Here too, CBT has been shown to be effective. Internet-based CBT is increasingly used, which allows for economic and patient-friendly delivery of psychotherapy while reaching a large audience. Further research is warranted to develop effective strategies for successful implementation of integral psychological support for PWD with psychological comorbidity, addressing the medical and the psychological needs of PWD

Web-based self-management with and without coaching for type 2 diabetes patients in primary care:design of a randomized controlled trial

<p>Background: Self-management is recognized as the cornerstone of overall diabetes management. Web-based self-management programs have the potential of supporting type 2 diabetes patients with managing their diabetes and reducing the workload for the care provider, where the addition of online coaching could improve patient motivation and reduce program attrition. This study aims to test the hypothesis that a web-based self-management program with coaching will prove more effective on improving patient self-management behavior and clinical outcome measures than a web-based self-management program without coaching.</p><p>Methods: The effects of a web-based self-management program with and without coaching will be tested with a nested randomized controlled trial within a healthcare group in the Netherlands. In one year 220 type 2 diabetes patients will be randomized into an intervention group (n = 110) or a control group (n = 110). The control group will receive only the online self-management program. The intervention group will receive the online self-management program and additional online coaching. Participants will be followed for one year, with follow-up measurements at 6 and 12 months.</p><p>Discussion: The intervention being tested is set to support type 2 diabetes patients with their diabetes self-management and is expected to have beneficial effects on self-care activities, well being and clinical outcomes. When proven effective this self-management support program could be offered to other health care groups and their type 2 diabetes patients in the Netherlands.</p>