At the Core of Depression: A Diagnostic Interview of the Core Features of Depression.

INTRODUCTION: Valid and reliable methods for diagnosing depression are essential. The present study aimed to test the performance of a new diagnostic interview for depression focusing on the core symptoms of depression. METHOD: We developed a diagnostic interview for depression: the CORE Diagnostic Interview, CORE-DI, which assesses each of the core features of depression on the four dimensions: quality, reactivity, globality, and fluctuations over time. The diagnostic performance of this interview was tested in a clinical study including 83 individuals presenting with various depressive symptoms, who were interviewed independently (1) by means of the CORE-DI and the Mini-International Neuropsychiatric Interview (M.I.N.I.), and (2) by highly skilled specialists in depression representing gold standard diagnoses. RESULTS: We compared the outcome of the CORE-DI, the M.I.N.I., and the diagnosis made by clinicians, respectively, versus the gold standard diagnosis, using diagnostic efficiency statistics. The CORE-DI diagnosed depression with a high specificity (0.91, 95% CI: 0.85-0.97, for International Classification of Diseases [ICD]-10 criteria and 0.88, 95% CI: 0.81-0.95, for Diagnostic and Statistical Manual of Mental Disorders [DSM-5] criteria) compared to both M.I.N.I (specificity 0.44, 95% CI: 0.33-0.55) and clinical diagnoses (specificity 0.76, 95% CI: 0.67-0.85). The sensitivity of the CORE-DI was 0.61 (95% CI: 0.55-0.72) for ICD-10 criteria and 0.67 (95% CI: 0.57-0.77) for DSM-5 criteria. DISCUSSION/CONCLUSION: The CORE-DI increased the specificity of the depression diagnosis substantially compared to clinical diagnoses and the diagnoses obtained by M.I.N.I. The results point to the usefulness of an elaborated and systematic assessment of the core symptoms in the examination of patients with depressive symptoms and thereby indicate a way for further development of specific diagnostic tools for depression in both clinical and research settings. However, it should be noted that the sensitivity of the CORE-DI was modest, and the psychometric properties of the CORE-DI might be different in other settings with higher or lower prevalence or severity of depressive symptoms.

Transcranial pulsed electromagnetic fields for treatment-resistant depression: A multicenter 8-week single-arm cohort study.

BACKGROUND: The efficacy of antidepressant treatment is fair, but the efficacy is considerably lower in patients failing two or more trials underscoring the need for new treatment options. Our study evaluated the augmenting antidepressant effect of 8-weeks transcranial pulsed electromagnetic field (T-PEMF) therapy in patients with treatment-resistant depression. METHODS: A multicenter 8-week single-arm cohort study conducted by the Danish University Antidepressant Group. RESULTS: In total, 58 participants (20 men and 38 women) with a moderate to severe depression as part of a depressive disorder according to ICD-10 who fulfilled criteria for treatment resistance were included, with 19 participants being nonresponders to electroconvulsive therapy during the current depressive episode. Fifty-two participants completed the study period. Scores on the Hamilton Depression Scale 17-items version (HAM-D17) decreased significantly from baseline (mean = 20.6, SD 4.0) to endpoint (mean = 12.6, SD 7.1; N = 58). At endpoint, utilizing a Last Observation Carried Forward analysis, 49 and 28% of those participants with, respectively, a nonchronic current episode (≤2 years; N = 33) and a chronic current episode (>2 years; N = 25) were responders, that is, achieved a reduction of 50% or more on the HAM-D17 scale. At endpoint, respectively, 30 and 16% obtained remission, defined as HAM-D17 ≤ 7. On the Hamilton Scale 6-item version (HAM-D6), respectively, 51 and 16% obtained remission, defined as HAM-D6 ≤ 4. CONCLUSIONS: The findings indicate a potential beneficial role of T-PEMF therapy as an augmentation treatment to ongoing pharmacotherapy in treatment-resistant depression.

Construct validity of the Mechanical Restraint - Confounders, Risk, Alliance Score (MR-CRAS): a new risk assessment instrument.

Background: A new short-term risk assessment instrument, the Mechanical Restraint - Confounders, Risk, Alliance Score (MR - CRAS) checklist, including three subscales with altogether 18 items, has been developed in close collaboration with forensic mental health nurses, psychiatrists' etc., and shows evidence of being comprehensible, relevant, comprehensive and easy to use for assessing the patient's readiness to be released from mechanical restraint. Aim: The aim of this study was to investigate whether the subscales: confounders, risk and parameters of alliance constituted separate subscales and needed further revisions. Materials and methods: MR - CRAS was field-study tested among nurses, nurse assistants and social and health care assistants in 13 Danish closed forensic mental health inpatient units, and a Mokken analysis of scalability and a Spearman correlation analysis were performed. Results: MR - CRAS was completed by clinicians in 143 episodes of mechanical restraint, representing 88 patients, with a mean duration of 63.25 hours. Most patients were younger men, diagnosed within the schizophrenia spectrum. One-third of the patients had repeated mechanical restraint episodes ranging between 2 and 8 episodes. MR - CRAS and especially the parameters of alliance were perceived as usable for assessment of the patient's readiness to be released from mechanical restraint. The psychometric analyses showed that the three subscales were unidimensional. Conclusions: The study shows evidence of the construct validity of MR - CRAS among clinicians at closed forensic mental health inpatient units. MR - CRAS contributes with a common language and structured, systematic and transparent observations and assessments on an hour by hour basis during mechanical restraint.

The influence of posture duration on hand tremor during tasks with attention-distraction in persons with Parkinson's disease.

BACKGROUND: Tremor is one of the hallmarks and most bothersome symptoms in Parkinson's disease (PD). The classical PD tremor is present at rest, but postural tremor also occurs. PD tremor can be continuous or intermittently present and can have a re-emergent nature. The tremor intensity is affected by attention and stress level. Observations of PD tremor have indicated increased tremor intensity with time during 30-s tremor assessments. This phenomenon has not previously been studied systematically. Thus, in order to contribute to our understanding of the mechanisms associated with PD tremor, our aim was to investigate the influence of time during a posture holding and a resting task on hand tremor characteristics in persons with PD compared to healthy peers. METHOD: Fifty persons with PD and at least one tremoring hand (tremor intensity exceeding mean + 2SD of a healthy reference group (REF), N = 40) were included from a clinical trial population. Hand accelerations in a rest and postural condition were measured in 30-s assessments while the participants performed a self-paced simple subtraction task with eyes closed to standardize attention without inducing stress. Tremor intensity, maximal power, frequency of maximal power and tremor onset time was calculated for three consecutive 10-s time intervals. RESULTS: Tremor intensity and maximal power increased significantly during the 30-s recording in the PD-group in both conditions (1st-3rd time-interval, tremor intensity: rest + 65% p < 0.0001, postural + 55% p < 0.0001; maximal power: rest + 93% p < 0.0001, postural + 82% p < 0.001). No effect of time was found on frequency of maximal power in the PD-group or on any effect measure in the REF-group. CONCLUSION: Tremor intensity and maximal power increased with time in the PD-group during 30-s tasks, while no change with time was found in the REF-group. In contrast, frequency of maximal power remained unchanged, which may suggest that the same neural circuits were responsible for the tremor generation throughout the tasks. The increase in tremor intensity and maximal power could not solely be explained by re-emergence of tremor. This suggests an increasing or gradually more synchronized cortico-spinal drive throughout the tasks. However, this requires further studies to determine.

Diagnosing depression in primary care: a Rasch analysis of the Major Depression Inventory.

Objective: This study aimed to assess the measurement properties of the Major Depression Inventory (MDI) in a clinical sample of primary care patients. Design: General practitioners (GPs) handed out the MDI to patients aged 18-65 years on clinical suspicion of depression. Setting: Thirty-seven general practices in the Central Denmark Region participated in the study. Patients: Data for 363 patients (65% females, mean age: 49.8 years, SD: 17.7) consulting their GP were included in the analysis. Main outcome measures: The overall fit to the Rasch model, individual item and person fit, and adequacy of response categories were tested. Statistical tests for local dependency, unidimensionality, differential item functioning, and correct targeting of the scale were performed. The person separation reliability index was calculated. All analyses were performed using RUMM2030 software. Results: Items 9 and 10 demonstrated misfit to the Rasch model, and all items demonstrated disordered response categories. After modifying the original six-point to a five-point scoring system, ordered response categories were achieved for all 10 items. The MDI items seemed well targeted to the population approached. Model fit was also achieved for core symptoms of depression (items 1-3) and after dichotomization of items according to diagnostic procedure. Conclusion: Despite some minor problems with its measurement structure, the MDI seems to be a valid instrument for identification of depression among adults in primary care. The results support screening for depression based on core symptoms and dichotomization of items according to diagnostic procedure. Key points The Major Depression Inventory (MDI) is widely used for screening, diagnosis and monitoring of depression in general practice. This study demonstrates misfit of items 9 and 10 to the Rasch model and a need to modify the scoring system The findings support screening for depression based on core symptoms and dichotomization of items according to diagnostic procedure. Minor problems with measurement structure should be addressed in future revisions of the MDI.

Associations of Motor Symptom Severity and Quality of Life to Motor Task Performance in Upper and Lower Extremities Across Task Complexity in Parkinson's Disease.

The authors examined the associations between the performance of upper- and lower-extremity motor tasks across task complexity and motor symptom severity, overall disease severity, and the physical aspects of quality of life in persons with Parkinson's disease. The performance was assessed for three lower-extremity tasks and two upper-extremity tasks of different levels of complexity. The motor symptoms and overall disease severity correlated significantly with all motor tasks with higher correlation coefficients in the complex tasks. Thus, the strength of the association between disease severity or severity of motor symptoms and motor performance is task-specific, with higher values in complex motor tasks than in simpler motor tasks. Mobility-related and activity-of-daily-living-related quality of life correlated with lower-extremity tasks of low and medium complexity and with the complex upper-extremity task, respectively; this suggests that Parkinson's Disease Questionnaire-39 is capable of differentiating between the impact of gross and fine motor function on quality of life.

Physical discomfort in early pregnancy and postpartum depressive symptoms.

PURPOSE: Pregnancy examinations conducted in general practice focus mainly on identifying high-risk pregnancies and pregnancy complications. The pregnancy health record has a biomedical focus, and consequently the woman's mental well-being may receive less attention. The aim of this study was to evaluate the extent to which early pregnancy-related symptoms should be considered as indicators of an increased risk of postpartum depression. MATERIALS AND METHODS: For a prospective cohort of 1508 pregnant women, the presence of 11 pregnancy-related symptoms was recorded at the first prenatal care consultation together with background information about socio-demography and health. Depression was assessed 8 weeks postpartum with the major depression inventory (MDI) and depression was considered present if MDI > 20. Multivariable logistic regression was used to assess the association between pregnancy-related symptoms and postpartum depressive symptoms, and to adjust for potential confounders. RESULTS: A high depression score (MDI score >20) 8 weeks postpartum was found among 6.6% of the women and showed apparent associations with physical discomfort in early pregnancy, such as back pain and pelvic cavity pain. Analysis of confounding revealed, however, that signs of vulnerable mental health, present in early pregnancy, explained most of these associations. CONCLUSIONS: Indicators of an increased risk of postpartum depressive symptoms may be found in early pregnancy. Pregnancy-related pain in the first trimester may be a sign of psychological vulnerability or an aspect of an existing depressive state that calls for attention.

The effect of 8 weeks of treatment with transcranial pulsed electromagnetic fields on hand tremor and inter-hand coherence in persons with Parkinson's disease.

BACKGROUND: Parkinson's disease (PD) tremor comprises asymmetric rest and postural tremor with unilateral onset. Tremor intensity can be amplified by stress and reduced by attention, and the medical treatment is complex. Mirror movements and unintentional synchronization of bimanual movements, possibly caused by insufficient inhibition of inter-hemispheric crosstalk, have been reported in PD, indicating a lag of lateralization. Potential neuroprotective effects of pulsed electromagnetic fields (PEMF) have been reported in-vitro and in rodents, as have influences of PEMF on human tremor. The aim was to investigate the effect of 8 weeks daily transcranial PEMF treatment (T-PEMF) of persons with PD on rest and postural hand tremor characteristics and on inter-hand coherence. METHODS: Hand accelerations of 50 PD participants with uni- or bilateral tremor participating in a clinical trial were analysed. A rest and postural tremor task performed during serial subtraction was assessed before and after 8 weeks of T-PEMF (30 min/day, 50 Hz, ±50 V, 3 ms squared pulses) or placebo treatment (sham stimulation 30 min/day). Forty matched healthy persons (no treatment) were included as reference. Intensity and inter-hand coherence related measures were extracted. RESULTS: The T-PEMF treatment decreased the inter-hand coherence in the PD group with unilateral postural tremor. The PD group with unilateral postural tremor was less clinically affected by the disease than the PD group with bilateral postural tremor. However, no differences between T-PEMF and placebo treatment on either intensity related or coherence related measures were found when all persons with PD were included in the analyses. The peak power decreased and the tremor intensity tended to decrease in both treatment groups. CONCLUSIONS: Eight weeks of T-PEMF treatment decreased inter-hand coherence in the PD group with unilateral postural tremor, while no effects of T-PEMF treatment were found for the entire PD group. The unilateral postural tremor group was less clinically affected than the bilateral postural tremor group, suggesting that early treatment initiation may be beneficial. In theory, a reduced inter-hand coherence could result from a neuronal treatment response increasing inter-hemispheric inhibition. However, this requires further studies to determine. Studies of even longer treatment periods would be of interest. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02125032. Registered 29 April 2014, https://clinicaltrials.gov/ct2/show/NCT02125032?term=NCT02125032&rank=1.

Diagnosing depression in primary care: a Rasch analysis of the major depression inventory.

OBJECTIVE: This study aims to assess the measurement properties of the Major Depression Inventory (MDI) in a clinical sample of primary care patients. DESIGN: General practitioners (GPs) handed out the MDI to patients aged 18-65 years on clinical suspicion of depression. SETTING: Thirty-seven general practices in the Central Denmark Region participated in the study. PATIENTS: Data for 363 patients (65% females, mean age: 49.8 years, SD: 17.7) consulting their GP were included in the analysis. MAIN OUTCOME MEASURES: The overall fit to the Rasch model, individual item and person fit, and adequacy of response categories were tested. Statistical tests for local dependency, unidimensionality, differential item functioning, and correct targeting of the scale were performed. The person separation reliability index was calculated. All analyses were performed using RUMM2030 software. RESULTS: Items 9 and 10 demonstrated misfit to the Rasch model, and all items demonstrated disordered response categories. After modifying the original six-point to a five-point scoring system, ordered response categories were achieved for all 10 items. The MDI items seemed well targeted to the population approached. Model fit was also achieved for core symptoms of depression (items 1-3) and after dichotomization of items according to diagnostic procedure. CONCLUSION: Despite some minor problems with its measurement structure, the MDI seems to be a valid instrument for identification of depression among adults in primary care. The results support screening for depression based on core symptoms and dichotomization of items according to diagnostic procedure. Key points The Major Depression Inventory (MDI) is widely used for screening, diagnosis and monitoring of depression in general practice. This study demonstrates misfit of items 9 and 10 to the Rasch model and a need to modify the scoring system The findings support screening for depression based on core symptoms and dichotomization of items according to diagnostic procedure. Minor problems with measurement structure should be addressed in future revisions of the MDI.

The Metacognitive Anger Processing (MAP) Scale - Validation in a Mixed Clinical and a Forensic In-Patient Sample.

BACKGROUND: The metacognitive approach by Wells and colleagues has gained empirical support with a broad range of symptoms. The Metacognitive Anger Processing (MAP) scale was developed to provide a metacognitive measure on anger (Moeller, 2016). In the preliminary validation, three components were identified (positive beliefs, negative beliefs and rumination) to be positively correlated with the anger. AIMS: To validate the MAP in a sample of mixed clinical patients (n = 88) and a sample of male forensic patients (n = 54). METHOD: The MAP was administered together with measures of metacognition, anger, rumination, anxiety and depressive symptoms. RESULTS: The MAP showed acceptable scalability and excellent reliability. Convergent validity was evidenced using the general metacognitive measure (MCQ-30), and concurrent validity was supported using two different anger measures (STAXI-2 and NAS). CONCLUSIONS: The MAP has promising potential to assess anger regulation problems by providing a framework on angry rumination as well as the belief structures that proposedly drive the selection of this maladaptive processing strategy as suggested in the metacognitive model. These findings may have implications for clinical interventions. For example, conducting functional analyses on anger rumination could increase the understanding of dysregulated anger processing and lead to new interventions focused on shifting thinking style.

The prevalence of psychological distress in Parkinson's disease patients: The brief symptom inventory (BSI-18) versus the Hopkins symptom checklist (SCL-90-R).

The prevalence of psychological distress in Parkinson's disease (PD) patients has been evaluated by many different assessment instruments and with diverse control groups. The most frequently used distress symptom scale has been the Hopkins Symptom Checklist (SCL-90-R), although it contains many symptoms with problematic validity clinically. The 18-item subscale of the SCL-90-R, the Brief Symptom Inventory (BSI-18) has recently been shown to have a sufficient validity to screen for the prevalence of psychological distress (somatization) in PD patients. We have performed a clinimetric analysis by comparing the BSI-18 with SCL-90-R relevant subscales in PD patients. Our micro-analysis has focused on the Mokken model to test the scalability of the subscales. The macro-analysis has focused both on effect size statistics and the normative level of psychological distress with reference to the Italian general population data using T-score metric. The Mokken analysis indicated acceptable scalability for all the subscales of BSI-18. The effect size statistics identified somatization in both BSI-18 and SCL-90-R as the most prevalent and intense symptom of psychological distress. The T-score metric identified the phobic anxiety subscale of SCL-90-R to be clinically much more important than the BSI-18 anxiety subscale in the PD patients. We have found the SCL-90-R subscale of phobic anxiety and the BSI-18 somatization subscale most clinically valid when measuring psychological distress in PD patients.

Effects of Long-Term Treatment with T-PEMF on Forearm Muscle Activation and Motor Function in Parkinson's Disease.

Bipolar pulsed electromagnetic stimulation applied to the brain (T-PEMF) is a non-pharmacological treatment which has been shown to stimulate nerve growth, attenuate nerve abnormalities, and improve microcirculation. We report on a 62-year-old, medically well-treated man with idiopathic Parkinson's disease. He was treated with T-PEMF, 30 min per day for three 8-week periods separated by two 1-week breaks. The disease made his handwriting impossible to read mainly due to small letters and lack of fluency. Forearm EMG measured during standardized conditions showed an involuntary spiky EMG pattern with regular burst activity (on his left side) at baseline. The intervention normalized the handwriting and forearm EMG. The UPDRS-motor score decreased from 25 to 17, and UPDRS-II-handwriting decreased from a pre-intervention value of 3 to 0 after the intervention. Finally, the patient reported improved fine motor function, less muscle stiffness, less muscle cramps and tingling, and less fatigue during the day in response to the T-PEMF treatment. The improved handwriting lasted for approximately 3 months after the treatment. Our results should be considered as preliminary, and large-scale, controlled studies are recommended to elucidate the therapeutic potential of long-term treatment with T-PEMF.

Effect of transcranial pulsed electromagnetic fields (T-PEMF) on functional rate of force development and movement speed in persons with Parkinson's disease: A randomized clinical trial.

BACKGROUND: Parkinson's disease is caused by dopaminergic neurodegeneration resulting in motor impairments as slow movement speed and impaired balance and coordination. Pulsed electromagnetic fields are suggested to have neuroprotective effects, and could alleviate symptoms. OBJECTIVE: To study 1) effects of 8-week daily transcranial pulsed electromagnetic field treatment on functional rate of force development and movement speed during two motor tasks with different levels of complexity, 2) if treatment effects depend on motor performance at baseline. METHODS: Ninety-seven persons with Parkinson's disease were randomized to active transcranial pulsed electromagnetic field (squared bipolar 3 ms pulses, 50 Hz) or placebo treatment with homebased treatment 30 min/day for 8 weeks. Functional rate of force development and completion time of a sit-to-stand and a dynamic postural balance task were assessed pre and post intervention. Participants were sub-grouped in high- and low-performers according to their baseline motor performance level. Repeated measure ANOVAs were used. RESULTS: Active treatment tended to improve rate of force development during chair rise more than placebo (P = 0.064). High-performers receiving active treatment improved rate of force development during chair rise more than high-performers receiving placebo treatment (P = 0.049, active/placebo: 11.9±1.1 to 12.5±1.9 BW/s ≈ 5% / 12.4±1.3 to 12.2±1.3 BW/s, no change). No other between-treatment-group or between-treatment-subgroup differences were found. Data on rate of force development of the dynamic balance task and completion times of both motor tasks improved but did not allow for between-treatment differentiation. CONCLUSION: Treatment with transcranial pulsed electromagnetic fields was superior to placebo regarding functional rate of force development during chair rise among high-performers. Active treatment tended to increase functional rate of force development while placebo did not. Our results suggest that mildly affected persons with Parkinson's disease have a larger potential for neural rehabilitation than more severely affected persons and indicate that early treatment initiation may be beneficial.

Test-retest reliability and measurement error of the Danish WHO-5 Well-being Index in outpatients with epilepsy.

BACKGROUND: The generic questionnaire WHO-5 Well-being Index (WHO-5), which measures the construct of mental well-being has been widely used in several populations across countries. The questionnaire has demonstrated sufficient psychometric properties; however, the test- retest reliability of the WHO-5 scale has yet to be determined. The aim of this study was to evaluate the test-retest reliability and measurement error of the Danish WHO-5 Well-being Index for outpatients with epilepsy. A further aim was to evaluate whether the method of administration (web, paper, or a mixture of the two modalities) influenced the results. METHODS: Epilepsy outpatients aged ≥15 years from three outpatient clinics in Central Denmark Region were included from August 2016 to April 2017. The participants were randomly divided into four test-retest groups: web-web, paper-paper, web-paper, and paper-web. Test-retest reliability was assessed by intraclass correlation coefficients (ICC) and measurement error by calculating minimal detectable change (MDC) on the basis of the standard error of the measurement. RESULTS: A total of 554 patients completed the questionnaire at two time points. The median duration between test-retest was 22 days. The pooled test-retest reliability estimate was ICC 0.81 (95% CI 0.78; 0.84). The estimated MDC was 23.60 points (95% CI 22.27; 25.10). These estimates showed little variation across administration methods. CONCLUSIONS: WHO-5 showed acceptable test-retest reliability in a Danish epilepsy outpatient population across different method of administration; however, the relatively large measurement error should be taken into account when evaluating changes in WHO-5 scores over time. Further research should be done to explore these findings.

Inter-rater reliability of ratings on the six-item Positive and Negative Syndrome Scale (PANSS-6) obtained using the Simplified Negative and Positive Symptoms Interview (SNAPSI).

PURPOSE: The six-item version of the Positive And Negative Syndrome Scale (PANSS-6) is a brief rating scale focusing on core symptoms of schizophrenia. In order to facilitate rating of PANSS-6 and selected items from other common psychiatric rating scales, we recently developed the Simplified Negative and Positive Symptoms Interview (SNAPSI). The objective of the present study was to test the inter-rater reliability of PANSS-6 ratings obtained using the SNAPSI. MATERIALS AND METHODS: Using the SNAPSI, seven raters (psychiatrists, first-year psychiatry residents and psychologists) performed a total of 56 PANSS-6 ratings of 12 in- or outpatients with schizophrenia. As a measure of inter-rater reliability, we calculated the intra-class correlation coefficient (ICC, ≥0.75 = excellent, 0.40-0.74 = fair to good, <0.40 = poor) for the PANSS-6 total score and individual item scores. Furthermore, for the PANSS-6 total scores obtained by the six noncertified PANSS raters, we calculated the median deviation from the PANSS-6 total scores obtained by the only certified PANSS rater. RESULTS: The ICC for the PANSS-6 total score was 0.74 (F = 2.84, p = .03). The ICCs for the six individual PANSS-6 items ranged from 0.45 (N6 - Lack of spontaneity & flow of conversation) to 0.76 (P3 - Hallucinatory behavior). The PANSS-6 total scores obtained by the six noncertified PANSS raters deviated by a median of 12.7% (interquartile range: 6.2-20.0) from the PANSS-6 total scores obtained by the certified PANSS rater. CONCLUSIONS: We found a good level of inter-rater reliability of PANSS-6 ratings obtained using the SNAPSI for seven raters with varying levels of clinical and research experience.

An overview of which health domains to consider and when to apply them in measurement-based care for depression and anxiety disorders.

INTRODUCTION: Measurement-based care (MBC) transfers the scientific principle from controlled clinical trials to the daily routine treatment to improve the care of patients with anxiety and depression. AIM: Within the pharmacopsychometric triangle in which the domain of desired clinical effect of treatment is balanced against the domain of undesired treatment side effects in terms of the domain of restored well-being. The relevance of these domains both in the controlled clinical trials and in the MBC trials will be tested. METHODS: The MBC trials are compared with the controlled clinical trials focusing on the health domains of symptoms reduction (anxiety/depression), side effects of treatment, self-reported quality of life and social functioning. RESULTS: The amount of MBC trials was found rather sparse but information emerged demonstrating that the full clinician-rated Hamilton Depression Scale (HAM-D17) was sufficient for the identification of patients being in need of treatment and the HAM-D6 subscale was valid as outcome measure. From the patient-reported domains, the full Symptom Checklist (SCL-90), the 10-item anxiety/depression subscale (SCL-10) was found valid as symptom outcome. From the full Patient Reported Inventory of Side-Effects (PRISE), a subscale including Clinician Action of Response (CAR) for side effects to antidepressants was found valid (PRISE-CAR), as was the World Health Organization subscale (WHO-5) for the measure of quality of life. CONCLUSION: The pharmacopsychometric triangle is also important in the MBC trials for improving the care of patients with anxiety and depression. However, the amount of MBC trials is still rather sparse.

The Reliable Change Index (RCI) of the WHO-5 in primary prevention of mental disorders. A measurement-based pilot study in positive psychiatry.

INTRODUCTION: Primary prevention of mental disorders is a major issue in positive psychiatry. Adjustment disorder is one of the very few discrete mental disorders linked to an etiological factor, namely psychosocial stressors given rise to a maladaptive reaction with a course of symptoms vanishing with the removal of the stressor. We have focused on a measurement-based method to prevent the development of an adjustment disorder. AIM: The aim of this study has been to analyze from an ongoing Worklife Barometer Survey in which the World Health Organization Well-Being Scale (WHO-5) has been applied to prevent distress leading to an adjustment disorder. METHODS: Persons identified with a decrease of 15 points in their repeatedly WHO-5 ratings over three months were through a brief psychological intervention by experienced psychologists. The Reliable Change Index (RCI) was used to determine the clinically meaningful change in the WHO-5 ratings. RESULTS: Within the group who received the psychological intervention (N = 1338), 35% of the persons were identified by the RCI analysis to have developed a clinically reliable change in the WHO-5 at the time of the intervention. The remaining 65% of the persons obtained changes in the WHO-5 which might be considered as spontaneous fluctuations. In the month after the intervention, the persons with a clinically reliable change in the WHO-5 were restored. CONCLUSION: In this measurement-based pilot study, the repeatedly WHO-5 ratings identified a group of persons with a clinically reliable change in WHO-5 and a clinically significant improvement after a brief psychological intervention.

Patient reported outcome measures (PROMs): examination of the psychometric properties of two measures for burden of symptoms and quality of life in patients with depression or anxiety.

INTRODUCTION: Patient-reported outcome measures (PROMs) for anxiety and depressive disorders are an important aspect of measurement-based care. AIM: The aim of the study was to perform a clinimetric analysis of two PROMs scales in patents with depression and anxiety. METHODS: Patients completed a 10-item version (SCL-10) of the Symptom Checklist to measure burden of symptoms and a brief 5-item version of World Health Organization Well-being scale (WHO-5) to measure quality of life. T-scores were used to standardize the SCL-10 and WHO-5 in terms of being in need of treatment. The coefficient of alpha and the coefficient of homogeneity were used to evaluate the internal consistency or scalability respectively of SCL-10 and WHO-5. Effect size statistics and Spearman correlation coefficients were used to measure the effect of gender and age, respectively. RESULTS: A total of 801 patients were recruited from two Danish mental health centers with anxiety or depression. The standardization of the SCL-10 and WHO-5 by T-scores indicated that a T-score of 65 corresponding to being moderately in need of treatment and a T-score of 75 to be severely in need of treatment. The coefficient of alpha and the coefficient of homogeneity were both found acceptable for SCL-10 and WHO-5. No gender or age factors were found being in operation. CONCLUSION: The results from the current study supported the use of the SCL-10 and WHO-5 as potential PROMs to capture symptom burden and quality of life within groups of people with anxiety or depression undergoing psychotherapy treatment.

A clinimetric analysis of a BPRS-6 scale for schizophrenia severity.

OBJECTIVE: A restricted Brief Psychiatric Rating Scale (BPRS-6) with the six schizophrenia specific items from the Positive and Negative Syndrome Scale (PANSS) has been investigated. These six items from the PANSS have recently been found to have both clinical validity and 'unidimensionality' in measuring the severity of schizophrenic states. The primary objective of this study was to evaluate the clinical validity of the BPRS-6. The secondary objective was to evaluate the 'unidimensionality' of the BPRS-6 by an 'item response theory' model. METHODS: The BPRS-6 was scored independently by two psychiatrists and two psychologists while viewing six open-ended videotaped interviews in patients with a DSM-III diagnosis of schizophrenia. The interviews were conducted by Heinz E. Lehmann, an experienced psychiatrist. They were focused on the psychopathology that contributed most to the 'severity' of the patient's clinical state. RESULTS: The BPRS-6 with three positive symptoms (delusions, conceptual disorganisation, hallucinations) and three negative symptoms (blunted affect, emotional withdrawal, poverty of speech) was found to be clinically valid and captured the variables that contribute most to the severity of schizophrenia. The BPRS-6 was also found to have acceptable 'unidimensionality' (coefficient of homogeneity 0.45) and inter-rater reliability (inter-class-coefficient 0.81). CONCLUSION: The BPRS-6 was found to capture the information that translates into the severity of schizophrenia. It has also acceptable psychometric validity.