Vitamin D3 supplementation and treatment outcomes in patients with depression (D3-vit-dep).

OBJECTIVE: To examine whether vitamin D supplementation in patients with depression would result in a reduction in Hamilton D-17 depression score (primary outcome) at 3 and 6 months compared to controls and to explore the correlations between serum vitamin D and symptoms of depression, wellbeing, systolic blood pressure, and waist circumference. In this outpatient multicentre study conducted between 2010 and 2013, patients, 18-65 years old, diagnosed with mild to severe depression were randomly assigned to receive D supplementation 70 micrograms daily or placebo on top of standard treatment. Participants, care givers and those assessing the outcomes were blinded to group assignment. RESULTS: At baseline, 23 patients had a normal 25(OH)D level, 22 had insufficiency (< 25 nmol/L), and 17 had deficiency (25-50 nmol/L). No significant reduction in depression was seen after vitamin D supplementation compared to placebo at Hamilton (18.4-18.0; p = 0.73 at 12 weeks). Vitamin D supplementation did not provide a reduction in symptom score among patients with depression. Trial registration The trial was registered in the National Board of Health (EudraCT: 2011-002585-20) and in ClinicalTrials.Gov (NCT01390662).

Training general practitioners in the treatment of functional somatic symptoms: effects on patient health in a cluster-randomised controlled trial (the Functional Illness in Primary Care study).

BACKGROUND: Patients with medically unexplained or functional somatic symptoms (FSS) are prevalent in primary care. In this pragmatic cluster-randomised controlled trial we aimed to test the effect of a training programme (The Extended Reattribution and Management model) for general practitioners (GPs) in the treatment of FSS. METHODS: 38 participating GPs were randomised to the control group or the training group. The GPs included consecutive 18- to 65-year-old patients presenting during a 3-week period for new health complaints. We assessed a stratified subsample with the psychiatric interview Schedules of Clinical Assessment in Neuropsychiatry. Of 701 patients interviewed, 350 fulfilled the diagnostic criteria for any ICD-10 somatoform disorder (SD) and 111 presented FSS without fulfilling these criteria (sub-threshold SD). Patients completed questionnaires at baseline and after 3, 12 and 24 months. The questionnaires included assessment of health status (36-item Medical Outcomes Study Short Form; SF-36), health anxiety (Whiteley-7) and physical symptoms (Symptom Check List-90, somatization subscale). RESULTS: Patients with SD consulting trained GPs improved more on our primary outcome of physical functioning than patients consulting control GPs at the 3-month follow-up (p = 0.004), but the improvement was not statistically significant at later follow-up. We found no significant differences in improvement between patients with SD and those with sub-threshold SD. Results for other SF-36 subscales, physical symptoms and health anxiety only showed statistically significant differences between the intervention and control groups for patients with SD; patients consulting trained GPs had less improvement in vitality, health anxiety and physical symptoms at 24 months compared with the control group. CONCLUSIONS: GP training may accelerate improvement in physical functioning for patients with SD. However, the effect is small and may not be clinically significant.

A randomized controlled trial of brief training in the assessment and treatment of somatization in primary care: effects on patient outcome.

OBJECTIVE: Our aim was to evaluate the effect of an educational program designed to improve care for somatizing patients in primary care. METHOD: Evaluation was performed during routine clinical care in a cluster randomized controlled trial. Patients were included consecutively, and those with a high score on rating scales for somatization were selected for follow-up (n=911). Follow-up was conducted 3 months (response rate=0.74) and 12 months (response rate=0.69) after inclusion using questionnaires measuring quality of life (Medical Outcomes Study 36-Item Short Form), disability days (WHO's Disability Assessment Schedule), somatization (Whiteley-7 and Symptom Checklist Somatic Symptom Scale) and patient satisfaction (European Project on Patient Evaluation of General Practice Care). We analyzed differences from baseline to follow-up and compared these for intervention and control groups. RESULTS: Self-reported health improved in both intervention and control groups during follow-up for patients with a high score for somatization, but changes were small. We could not demonstrate any difference between the control group and the intervention group with regard to our primary outcome 'physical functioning.' Patients in the intervention group tended to be more satisfied at 12-month follow-up than those in the control group, but this difference fell short of statistical significance. CONCLUSION: Training of primary care physicians showed no statistically significant effect on clinical outcome and showed nonsignificant improvement in patient satisfaction with care for patients with a high score for somatization.

Do illness perceptions predict health outcomes in primary care patients? A 2-year follow-up study.

OBJECTIVE: Little is known about whether illness perceptions affect health outcomes in primary care patients. The aim of this study was to examine if patients' illness perceptions were associated with their self-rated health in a 2-year follow-up period. METHODS: One thousand seven hundred eighty-five primary care patients presenting a new or recurrent health problem completed an adapted version of the illness perception questionnaire and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) at baseline and 3, 12, and 24 months' follow-up. Linear regressions were performed for (1) all patients, (2) patients without chronic disorders presenting physical disease, and (3) patients presenting medically unexplained symptoms (MUS). RESULTS: Negative illness perceptions were associated with poor physical and mental health at baseline. They most strongly predicted changes in health status at follow-up for the whole group of patients. Patients presenting with MUS had more negative illness perceptions and lower mental and physical components subscale of the SF-36 scores at all time points. CONCLUSIONS: Patients' perception of a new or recurrent health problem predicts self-reported physical and mental health up to 2 years after consulting the general practitioner and offers an obvious starting point for addressing nonbiomedical aspects of illness.

Symptoms and syndromes of bodily distress: an exploratory study of 978 internal medical, neurological, and primary care patients.

OBJECTIVE: Physical complaints not attributable to verifiable, conventionally defined diseases, i.e., medically unexplained or functional somatic symptoms, are prevalent in all medical settings, but their classification is contested as numerous overlapping diagnoses and syndrome labels have been introduced. This study aims to determine whether functional somatic symptoms cluster into distinct syndromes and diagnostic entities. METHODS: The 978 consecutively admitted patients from a neurological department (n = 120), a medical department (n = 157), and from primary care (n = 701) were interviewed using the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) diagnostic instrument. RESULTS: Patients complained of a median of five functional somatic symptoms; women of six, men of four (p < .0001). No single symptoms stood out as distinctive for patients with multiple symptoms. Principal component factor analysis identified a cardiopulmonary including autonomic (CP), a musculoskeletal (MS), and a gastrointestinal (GI) symptom group explaining 36.9% of the variance. Latent class analysis showed that the symptom groups are likely to materialize in the same patients, suggesting that they are different manifestations of a common latent phenomenon. Inclusion of a group of five additional general, unspecific symptoms in latent class analysis allowed construction of clinical diagnostic criteria for 'bodily distress disorder' dividing patients into three classes: nonbodily distress (n = 589), modest bodily distress (n = 329, prevalence 25.3%, men 20.4%, women 25.6%), and severe bodily distress (n = 60, prevalence 3.3%, men 1.2%, women 4.8%). CONCLUSION: The study suggests that bodily distress disorder as defined here may unite many of the functional somatic syndromes and some somatoform disorder diagnoses. Bodily distress may be triggered by stress rather than being distinct diseases of noncerebral pathology.

The uncertain consultation and patient satisfaction: the impact of patients' illness perceptions and a randomized controlled trial on the training of physicians' communication skills.

OBJECTIVE: To identify predictors of patient satisfaction among a range of patient and practitioner variables. In particular, to focus on patients' illness perceptions and the impact of a randomized controlled trial on the training of physicians in general communication skills and how to treat patients presenting with poorly defined illness. METHODS: A randomized controlled follow-up study conducted in 28 general practices in Aarhus County, Denmark. Half of the physicians were randomized into an educational program on treatment of patients presenting with medically unexplained symptoms (somatization). One thousand seven hundred eighty-five general practice attenders presenting a new health problem completed questionnaires on illness perceptions, physical functioning, and mental distress before the consultation. After the consultation, a questionnaire including relational and communicative domains of patient satisfaction with the current consultation was completed. The physicians completed a questionnaire for each patient on diagnostics and prognostics. Predictors of patient satisfaction were determined by logistic regression. RESULTS: A large number of patient and practitioner variables predicted satisfaction in univariate logistic regression models. Results from a multivariate logistic model showed that the illness perceptions "uncertainty" (patient not knowing what is wrong) and "emotional representations" (the complaint making the patient feel worried, depressed, helpless, afraid, hopeless) predicted dissatisfaction at OR (CI) = 1.8 (1.3-2.4), p < .001 and OR (CI) = 1.5 (1-2.3), p = .03 respectively. Trained physicians were associated with dissatisfaction at OR (CI) 0.7 (0.5-1), p = .06 in the multivariate model. Furthermore, uncertain patients consulting a trained physician were less likely to be dissatisfied OR (CI) = 0.6 (0.3-1), p = .04. CONCLUSIONS: A randomized controlled trial on the training of general practitioners' communication skills improved patient satisfaction. Illness perceptions predict satisfaction. In particular, patients feeling uncertain and negatively emotionally involved in their health problem were more inclined to being dissatisfied with the consultation.

The patients' illness perceptions and the use of primary health care.

OBJECTIVE: To investigate if primary care patients' perceptions of a current health problem were associated with use of health care. METHOD: One thousand seven hundred eighty-five patients presenting a new health problem to 1 of 38 physicians from 28 general practices in Aarhus County, Denmark. Patients completed a questionnaire on their illness perceptions and emotional distress before the consultation. The physicians completed a questionnaire for each patient on diagnostics and prognostics. Register data on primary health care utilization 3 years before and 2 years after baseline were obtained. Odds ratios were estimated to examine associations between previous health care use and illness perceptions. Linear regression analysis was performed to examine if illness perceptions predicted later health care use. RESULTS: Previous use: Higher use was associated with psychosocial, stress, and lifestyle attributions. Accident/chance attributions were associated with higher use for patients with a chronic disorder but with lower use for patients without a chronic disorder. A strong illness identity (number of self-reported symptoms), illness worry, a long timeline perspective, a belief that the symptoms would have serious consequences, and all emotional distress variables were associated with higher use. Use during follow-up: Infection/lowered immunity attributions were associated with higher use for patients with a chronic disorder, whereas psychosocial and lifestyle attributions were associated with higher use for all patients. Illness worry and all emotional distress variables predicted higher health care use. A strong illness identity, a long timeline perspective, a belief in serious consequences, and stress and accident/chance attributions were among the strongest predictors of health care use in a multivariate model including all variables. CONCLUSIONS: Patients' perceptions of a current health problem are associated with health care use and may offer an obvious starting point for a biopsychosocial approach in primary care.

[A new, empirically established hypochondriasis diagnosis--secondary publication]. / En ny, empirisk baseret hypokondridiagnose--sekundaerpublikation.

The narrow ICD-10 and DSM-IV definition of hypochondriasis makes it a rarely used diagnosis. Based on a latent class analysis of the symptoms exhibited by 701 patients (ages 18-65) in general practice, a new and more valid hypochondriasis diagnosis was defined in this study. The main symptom is "obsessive rumination about illnesses", and the patient must also have at least one of five other symptoms. The prevalence was 9.5 for both genders. There was a good agreement between the diagnoses made during the psychiatric interview and the physicians' assessments.

Mental disorders in primary care: prevalence and co-morbidity among disorders. results from the functional illness in primary care (FIP) study.

BACKGROUND: Prevalence and co-occurrence of mental disorders is high among patients consulting their family general practitioner (GP) for a new health problem, but data on diagnostics and socio-demographics are sketchy. METHOD: A cross-sectional two-phase epidemiological study. A total of 1785 consecutive patients with new complaints, aged 18-65 years, consulting 28 family practices during March-April 2000 in Aarhus County, Denmark were screened, in the waiting room, for mental and somatic symptoms with SCL-8 and SCL-Somatization questionnaires, for illness worry with Whitely-7 and for alcohol dependency with CAGE. In a stratified random sample of 701 patients, physician interviewers established ICD-10 diagnoses using the SCAN interview. Prevalence was calculated using weighted logistic regression, thus correcting for sample skewness. RESULTS: Half of the patients fulfilled criteria for an ICD-10 mental disorders and a third of these for more than one group of disorders. Women had higher prevalence of somatization disorder and overall mental disorders than men. Men had higher prevalence of alcohol abuse and hypochondriasis than women. Psychiatric morbidity tended to increase with age. Prevalence of somatoform disorders was 35.9% (95% CI 30.4-41.9), anxiety disorders 164% (95% CI 12.7-20.9), mood disorders 13.5% (95% CI 11.1-16.3), organic mental disorders 3.1% (95% CI 1.6-5.7) and alcohol abuse 2.2% (95% CI 1.5-3.1). Co-morbidities between these groups were highest for anxiety disorders, where 89% also had another mental diagnosis, and lowest for somatoform disorders with 39%. CONCLUSIONS: ICD-10 mental disorders are very prevalent in primary care and there is a high co-occurrence between most disorders. Somatoform disorders, however, more often than not exist without other mental disorders.

A randomised controlled trial of brief training in assessment and treatment of somatisation: effects on GPs' attitudes.

BACKGROUND: Somatising patients frequently present in primary care but GPs often express frustration in dealing with them. A negative attitude may result in missed diagnoses and ineffective treatment. OBJECTIVE: This study aimed to evaluate the effect of a novel, multifaceted training programme on GPs' attitudes towards somatisation. METHODS: The study was performed as a cluster randomised controlled trial with practices as randomisation unit and with a follow-up period of 12 months. Forty-three GPs from 27 practices in Vejle County, Denmark participated. The intervention consisted of a cognitive-oriented educational programme on assessment, treatment and management of somatisation (The Extended Reattribution and Management Model). Outcome measures were GPs' attitudes toward somatoform disorder and somatisation in general measured by the means of questionnaires at baseline and follow-up. The primary outcome was a change in response. RESULTS: Baseline values confirmed previous findings that GPs find it difficult to deal with somatising patients. Compared with the control doctors, intervention doctors' attitudes towards patients with somatoform disorders had changed significantly 12 months after training on the parameters enjoyment (P = 0.008) and anxiety (P = 0.002). Doctors also felt more comfortable in dealing with somatising patients in general (P = 0.002). Attitudes about other parameters related to the doctors feelings, aetiology and course of somatisation changed in the expected direction, but these changes were not statistically significant. CONCLUSION: A brief multifaceted training programme focussing on somatisation was accompanied by a significant change in GPs' attitude towards patients with somatoform disorders.

Screening for common mental disorders: who will benefit? Results from a randomised clinical trial.

BACKGROUND: Outcomes of studies on mental health screening in primary care are conflicting. A feasible and effective case-finding approach could benefit both GPs and their patients. OBJECTIVES: (1) to examine the effect of using a composite screening questionnaire (SQ) on GPs' recognition and provision of care, and (2) to outline useful strategies for case-finding. METHODS: 38 GPs in Aarhus County, Denmark, volunteered to participate in this trial. 1785 consecutive patients aged 18-65 years consulting with new health problems were included. Patients were screened before consultation using an SQ including scales for somatisation, anxiety, depression and alcohol abuse. Patients were randomised into one of two groups: 900 questionnaires were disclosed to and scored by GPs, 885 were blinded. Number of diagnoses, subjects of conversation, and actions taken were analysed. Additional analyses aimed to identify GP and patient factors that could predict improved outcomes. RESULTS: Overall, disclosure of SQ results increased GPs' recognition of mental disorders by 3.8% [95% confidence interval (CI) -0.5% to 8.0%], and 6.6% (95% CI 1.2% to 12.0%) for patients screened positive. There was a marked variation in GPs' detection rates, and for GPs with moderate or low recognition rates increases were significant (P = 0.001). Conversation on psychological topics increased by 3.2% (95% CI -0.7% to 7.1%), and by 7.0% (95% CI 1.8% to 12.3%) for patients screened positive. Rates of planned follow-up consultations increased by 3.9% (95% CI 0.6% to 7.3%) and by 4.9% (95% CI 0.7% to 9.1%) for patients screened positive. GPs' self-reported benefit from screening was related to better outcomes. A range of patient and GP factors suggesting added value from using SQs were identified. CONCLUSION: GPs' recognition and provision of mental health care can be influenced by the use of composite SQs. Perceived benefit from screening may serve as a useful predictor of better patient management. Pragmatic case-finding approaches need further evaluation.

A brief case-finding questionnaire for common mental disorders: the CMDQ.

OBJECTIVES: The aim of the study was to validate a new case-finding instrument for common mental disorders (CMDQ). METHODS: A cross-sectional, stratified, two-phase study was carried out in 28 general practices in Aarhus County, Denmark. 1785 consecutive patients, 18-65 years old, consulting 38 GPs with a new health problem participated. Patients were screened before consultation using a one-page screening questionnaire including subscales for somatisation (SCL-SOM and Whiteley-7), anxiety (SCL-ANX4), depression (SCL-DEP6) and alcohol abuse (CAGE). A stratified subsample of 701 patients was interviewed using the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview. We tested the external validity of the scales using the SCAN interview as gold standard. All data were analysed using appropriate weighted procedures to control for the two-phase sampling design and non-response bias. RESULTS: Estimates of sensitivity and specificity for relevant ICD-10 diagnoses at theoretical optimal cut-off points on subscales: Depressive disorder: 78/86 (SCL-DEP6); Alcohol abuse or dependence: 78/97 (CAGE); Severe anxiety disorder: 77/85 (SCL-ANX4); Somatisation disorder: 83/56 (SCL-SOM); and 75/52 (Whiteley-7); any mental disorder: 72/72 (SCL-8). At the theoretical optimal cut-off points the CMDQ demonstrated higher diagnostic accuracy than GPs on any diagnosis evaluated. CONCLUSION: The study results suggest that the CMDQ has excellent external validity for use as a diagnostic aid in primary care settings.

A new, empirically established hypochondriasis diagnosis.

OBJECTIVE: The narrow ICD-10 and DSM-IV definition of hypochondriasis makes it rarely used yet does not prevent extensive diagnosis overlap. This study identified a distinct hypochondriasis symptom cluster and defined diagnostic criteria. METHOD: Consecutive patients (N=1,785) consulting primary care physicians for new illness were screened for somatization, anxiety, depression, and alcohol abuse. A stratified subgroup of 701 patients were interviewed with the Schedules for Clinical Assessment in Neuropsychiatry and questions addressing common hypochondriasis symptoms. Symptom patterns were analyzed by latent class analysis. RESULTS: Patients fell into three classes based on six symptoms: preoccupation with the idea of harboring an illness or with bodily function, rumination about illness, suggestibility, unrealistic fear of infection, fascination with medical information, and fear of prescribed medication. All symptoms, particularly rumination, were frequent in one of the classes. Classification allowed definition of new diagnostic criteria for hypochondriasis and division of the cases into "mild" and "severe." The weighted prevalence of severe cases was 9.5% versus 5.8% for DSM-IV hypochondriasis. Compared with DSM-IV hypochondriasis, this approach produced less overlap with other somatoform disorders, similar overlap with nonsomatoform psychiatric disorders, and similar assessments by primary care physicians. Severe cases of the new hypochondriasis lasted 2 or more years in 54.3% of the subjects and 1 month or less in 27.2%. CONCLUSIONS: These results suggest that rumination about illness plus at least one of five other symptoms form a distinct diagnostic entity performing better than the current DSM-IV hypochondriasis diagnosis. However, these criteria are preliminary, awaiting cross-validation in other subject groups.

The FIP study: a randomised, controlled trial of screening and recognition of psychiatric disorders.

BACKGROUND: Research on questionnaires as screening tools for psychiatric disorders has yielded conflicting results. AIM: To examine the effect of a routinely administered questionnaire on recognition of common psychiatric disorders in general practice. DESIGN OF STUDY: Randomised controlled trial. SETTING: Twenty-eight general practices in Aarhus County, Denmark. METHOD: Thirty-eight general practitioners (GPs) and 1785 consecutive patients, aged 18-65 years old, presenting with a new health problem, participated. Before consultation, patients were screened using a brief screening questionnaire (SQ) including somatisation, anxiety, depression, and alcohol abuse scales. Patients were randomised to one of two groups: 900 questionnaires were disclosed and scored by the GPs, 885 were blinded. A stratified subsample of 701 patients was interviewed after the consultation using a standardised psychiatric research interview (SCAN). RESULTS: Overall the GPs' recognition rates were 14% (95% confidence interval [CI] = -2 to 30) better for depression and 35% (95% CI = 2 to 68) better for alcohol problems when SQs were disclosed. Recognition rates for anxiety improved 8% (95% CI = -9 to 26) overall. In the case of somatoform disorders, disclosure showed no effect overall. Among those with high SQ scores, however, disclosure increased recognition rates on any mental disorder evaluated. CONCLUSION: This study demonstrated limited usefulness for routine screening for common psychiatric disorders. However, findings suggest that the SQ may be useful for case-finding among a subgroup of patients with high SQ scores.