Effectiveness of a minimal psychological intervention to reduce mild to moderate depression and chronic fatigue in a working population: the design of a randomized controlled trial

Abstract Background In a working population, common mental complaints like depressed mood and chronic fatigue are highly prevalent and often result in further deterioration of mental health and consequently absence from work. In a large occupational health setting, we will evaluate the (cost-) effectiveness of a Minimal Psychological Intervention (MPI), in reducing symptoms of depression and chronic fatigue in a working population. The MPI is also evaluated regarding its appreciation by worker, nurse, and occupational health physician (process evaluation). The tailor-made intervention is administered by nurses, who are trained in the principles of cognitive behavioural therapy and self-management. Methods/design The presented WoPaCoM study (Work Participation of Workers with Common Mental complaints) is a two-armed randomized controlled trial, comparing MPI with usual care. A total number of 124 workers suffering from (chronic) mental fatigue or mild to moderate depression will be included. A stratified and block randomization will be applied, stratifying by customer organisation, income, and gender, using a block size of four. It will include a baseline measurement and subsequently follow up measurements after 4, 6 and 12 months. The primary outcome measures are symptoms of either fatigue (using the Checklist Individual Strength) and/or depression (using the Beck Depression Inventory) and secondary outcome measures include sickness absence, self efficacy, costs and quality of life. Analysis will include both univariate and multivariate techniques and data will be analysed according to the intention to treat principle. Discussion Patient recruitment in an occupational setting proves to be complicated and time consuming. Shift work for instance proved to be an obstacle for making appointments for consultation with the nurse. Furthermore, economic developments might have created job insecurity which negatively influenced participation in the study, with workers being anxious to be detected as having psychological problems. Additionally, long-term follow-up in a working population is time-consuming and continuously engages occupational health staff and administrative personnel to control the process of data gathering. However, if the intervention proves to be effective, occupational medicine will have a manageable option for treatment of workers who are at risk of loss of productivity or sickness absence. Trial registration Nederlands Trialregister NTR3162</p

Good friends, high income or resilience? What matters most for elderly patients?

Background: Chronically ill patients need to adapt to their impaired life condition. Social (e.g. social support), material (e.g. income) and personal (e.g. mastery) resources are needed to cope with this challenge. It is, however, less clear whether these factors also contribute to 'relatively successful functioning' and whether these effects are disease specific or generic across chronic diseases. Methods: Baseline data from 361 Dutch men and women aged epsilon 60 years who were mildly depressed and diagnosed with type 2 diabetes or chronic obstructive pulmonary disease (COPD) were used. These persons participated in the 'Depression in Elderly with Long-Term Afflictions' (DELTA) study. Logistic regression analyses were used to study the independent association of social support, income and mastery (independent variables) with physical, mental and social functioning (dependent variables). Results: A high level of mastery is significantly associated with physical, mental and social functioning in the total study population, as well as in subgroups of patients with COPD or diabetes. This relationship remained significant after controlling for confounding factors such as gender, age, educational level and the other remaining resources. In diabetes patients, high levels of social support and income also contributed significantly to successful social functioning. Conclusion: Our findings suggest that rather than having good friends and a high income, having a high level of mastery (resilience) might best help chronically ill patients in coping with and adapting to their often co-morbid condition. Further longitudinal research is necessary to unravel the long-term effects of mastery, income and social support on 'relatively successful functioning' in chronically ill patients

On the accuracy of history, physical examination, and erythrocyte sedimentation rate in diagnosing low back pain in general practice a criteria-based review of the literature

Study Design, A criteria-based review of the literature was conducted regarding ttie accuracy of history, physical examination, and erythrocyte sedimentation rate in diagnosing low buck pain. Objectives. To perform meta-analysis of the literature regarding signs and symptoms fn diagnosing radiculopathy, ankylosing spondylitis, and vertebral cancer Summary of Background Data. Diagnosing low back pain, especiaKy in general practice, depends largely on history taking, physical examination; and the erythrocyte sedimentation rale, No previous review has assessed tho diagnostic accuracy of signs and symptoms in a systematic way, taking into account the methodo/ ogical quaJity of studies, Methods. The literature was reviewed for relevant studies. Retriaved studies were independently rated for rrethOfJdlogical quality by 1wo reviewers. The reported sensitivity and specificity in the rated studies were reviewed. Results. Thiriy-six eligible studies were retrieved. Major methodological shortcomings were absented, and only 19 studios scored s 6 5 points (maximal scare 100). Nat one single test appeared to have high sensitivity and high specificity in radiculopathy. Ttio combined history arid the erythrocyte sedimentation rate had relatively high diagnostic accuracy in vertebral cancer. Getting out of bed at night and reduced lateral mobility teemed to be the only moderately accurate items in ankylosing spondylitis. Cgnclusiorts. Additional studies that take into account tho shortcomings identified would be needed to produce definite contusions. Few of t h e studied signs end symptoms seemed to be valuable diagnostics for radiculopathy, ankylosing spondylitis, and vertebral cancer. Reproducibility of signs and symptoms over time might bs a valuable diagnostic criterion. However, this was neglected In aim-set all studies

Pain and health status of primary care patients with low back pain

BACKGROUND. In addition to the pain caused by low back problems, suffering may also adversely affect other aspects of patients' lives. Since there is little knowledge about the suffering caused by low back pain, a prospective cohort study was undertaken to study pain intensity, perceived health, and daily functioning of consecutive patients with low back pain presenting in general practice. METHODS. During a period of 2 years, 15 general practitioners enlisted consecutive patients with both chronic and recent-onset low back pain in the study. From the initial visit, each patient was monitored for a period of 6 months prospectively. The follow-up consisted of questionnaires mailed every 4 weeks to determine the intensity of the pain, perceived health, and daily functioning. RESULTS. Of the 605 patients identified, 430 were included in the follow-up; 6 months after the initial visit, 167 patients were lost to follow-up. At baseline, the analyses did not reveal any important differences between acute, subacute, and chronic low back pain. Pain intensity, perceived health, and daily functioning in all patients tended to resolve over time. This tendency was strongest in patients with acute low back pain. The change in pain intensity was not strongly correlated with changes in perceived health and daily functioning. CONCLUSIONS. All aspects of suffering caused by low back pain tend to diminish and resolve over time. No evidence was found of a relationship between perceived health or daily functioning and the duration of the low back pain

On the course of low back pain in general practice: A one year follow up study

Objectives - Knowledge on the clinical course of low back pain presented in general practice is poor. Preceding studies offer a fragmentary view only, whereas further knowledge is important to enable the assessment of the prognosis. The object of this study is to investigate the course of low back pain presented in general practice to enable the assessment of the prognosis. Methods - A one year follow up study on the clinical course of low back pain in consecutive cases receiving usual care in general practice. During a period of two years 15 general practitioners from Amsterdam and surrounding areas included consecutive patients with both chronic and recent onset low back pain. After the initial visit, each patient was monitored for a period of 12 months. The follow up consisted of monthly postal questionnaires on the course of the low back pain and the related disability. Results - A total of 443 of 605 patients identified were included in the follow up, which was fully completed by 269 patients. In general, patients with less serious low back pain participated less often or did not complete the follow up. At 12 weeks 35% and at the end of the follow up 10% of the population, respectively, still suffered from low back pain. Both the pain and the disability seemed to diminish quickly after the initial visit, and both seemed to stabilise at a lower level if the low back pain did not disappear completely. About three of four patients, whose pain disappeared before the end of the follow up, endured one or more relapses within a year. The median time to a relapse was about seven weeks, and its median duration about six weeks. Both the pain and the disability turned out to be less severe during relapses. The median time to recovery for patients whose low back pain developed more than seven weeks before the initial visit, was four weeks longer than for patients with more recently developed low back pain at the initial visit. Conclusions - The clinical course of low back pain presented in general practice, for the most patients, clearly is less than just a few weeks to recover, and relapses occur within a year in most cases. Fortunately, both the pain and the disability quickly diminish, oven if the low back pain does not resolve within a few weeks

The inter-observer reproducibility of Lasegue's sign in patients with low back pain in general practice

Background. The spectrum of low back pain patients in general practice differs significantly from that in an orthopaedic clinic. The most frequent specific cause of low back pain is nerve-root irritation or compression caused by intervertebral protrusion, and the diagnosis is still problematic. Testing for Lasegue's sign could be a useful way of detecting high-risk patients, but so far the reproducibility of the test has been measured only in hospital-based studies. Aim. To assess the inter-observer reproducibility of Lasegue's sign in general practice. Method. Fifteen General practitioners from Amsterdam and the surrounding areas tested all consecutive low back pain patients who visited them during a period of two years for Lasegue's sign. The test was repeated within two weeks in two samples: sample I consisted of 50 consecutive low back pain patients; sample II consisted of all patients who had pelvic tilt, scoliosis, or positive Lasegue's sign. Results. In sample I, the observation was repeated in 49 patients. The Kappa coefficient was 0.33, and the proportions of positive and negative agreement were 33% and 96%, respectively. In sample II, the observation was repeated in 48 patients. The Kappa coefficient was 0.56, whereas the proportion of positive agreement was 67% and the proportion of negative agreement was 91%. Conclusions. The reproducibility of Lasegue's sign in routine general practice seems to be low, but may be similar to the reproducibility observed in hospital settings in selected patients who have a high chance of low back pain owing to a specific disease

Prescribing Antidepressants and Benzodiazepines in the Netherlands: Is Chronic Physical Illness Involved?

In this study we assessed differences in new and repeat prescriptions of psycho-tropics between patients receiving prescriptions for drugs to treat a common chronic disease and people without such prescriptions. The study used the databases of two Dutch health insurance companies (3 million people). We selected all Dutch men and women aged 45 and older who were registered for six consecutive years (1999)(2000)(2001)(2002)(2003)(2004). Our analyses both found a consistent relation between psycho-tropics on the one hand and physical illness on the other. People with multi-morbidity were prescribed these drugs most often, especially men and those younger than 65. Epidemiological studies showed a prevalence of depression among people with multi-morbidity to be twice as high as among people without such conditions. According to recent guidelines non-drug treatment may be the first therapy option for patients with non severe depression. If prescribed for a long time, benzodiazepine prescriptions are especially known to be addictive. Our data raise the question to what extent patients with a chronic physical disease suffering from co-occurring mental problems are prescribed psycho-tropics in accord with the guidelines that also advise mental support in case of non severe mental problems. Further research can answer this important question

Cost-utility estimates in depression: Does the valuation method matter?

Background: Depression imposes a substantial burden on society. In view of the economic burden of depression, studies evaluating depression treatment increasingly incorporate a cost-utility analysis. Outcomes of these analyses are used by decision makers to prioritize healthcare. Although generic preference-based instruments have been recommended for measuring utility, depression research often uses a disease-specific method, based on depression-free days (DFD), to measure utilities. Aims of the Study: The objective of this study was to compare utility measurement techniques in the context of a randomized controlled trial. In particular, we studied the agreement between QALYs measured with the EuroQol (EQ-5D), the Short Form 6D (SF-6D), and the DFD method, using the EQ-5D as the reference method. We also studied whether the use of different techniques leads to different conclusions for decision makers. Methods: Data were derived from the Depression in Elderly with Long-Term Afflictions (DELTA) study. This randomized controlled trial was designed to study the effectiveness and cost-effectiveness of a minimal psychological intervention for chronically ill patients with co-occurring minor or mild to moderate major depression. The EQ-5D, SF-6D and Beck Depression Inventory (to estimate DFDs) were assessed at baseline, and at three, six and twelve months after baseline. Results: Poor agreement was found between the EQ-5D and DFD (Kendall's Tau: 0.33; ICC: 0.21 (95% CI:-0.07-0.45)) and moderate agreement between the EQ-5D and SF-6D (Kendall's Tau: 0.60; ICC: 0.47 (95% CI: 0.36-0.57)). The incremental cost-utility ratio led to similar conclusions for decision makers across techniques. Discussion: In conclusion, utilities from the disease-specific DFD method should not be compared directly with utilities derived from the EQ-5D. Although a disease-specific method might yield similar cost-utility ratios as generic instruments, generic instruments remain the preferred option for prioritizing healthcare. Limitations of this study include the presence of minor depression and chronic illnesses in our study population. Implications: Generic instruments remain preferred for cost-utility analyses, especially when results are used to prioritize healthcare. If the DFD method is a way forward, further research is required to validate utility weights assigned to the DFDs