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.

A confirmative clinimetric analysis of the 36-item Family Assessment Device.

BACKGROUND: The Family Assessment Device (FAD) is a 60-item questionnaire widely used to evaluate self-reported family functioning. However, the factor structure as well as the number of items has been questioned. A shorter and more user-friendly version of the original FAD-scale, the 36-item FAD, has therefore previously been proposed, based on findings in a nonclinical population of adults. AIMS: We aimed in this study to evaluate the brief 36-item version of the FAD in a clinical population. METHODS: Data from a European multinational study, examining factors associated with levels of family functioning in adult cancer patients' families, were used. Both healthy and ill parents completed the 60-item version FAD. The psychometric analyses conducted were Principal Component Analysis and Mokken-analysis. RESULTS: A total of 564 participants were included. Based on the psychometric analysis we confirmed that the 36-item version of the FAD has robust psychometric properties and can be used in clinical populations. CONCLUSIONS: The present analysis confirmed that the 36-item version of the FAD (18 items assessing 'well-being' and 18 items assessing 'dysfunctional' family function) is a brief scale where the summed total score is a valid measure of the dimensions of family functioning. This shorter version of the FAD is, in accordance with the concept of 'measurement-based care', an easy to use scale that could be considered when the aim is to evaluate self-reported family functioning.

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.

The Validity of the Different Versions of the Hamilton Depression Scale in Separating Remission Rates of Placebo and Antidepressants in Clinical Trials of Major Depression.

Our objective was to validate the different versions of the Hamilton Depression Scale (HAM-D) both psychometrically (scalability) and clinically in discriminating antidepressants from placebo in terms of remission rates in an 8-week clinical trial in the acute treatment of major depression. The traditional HAM-D17 version was compared with the shorter HAM-D6 and the longer HAM-D21 or HAM-D24 in a fixed-dose placebo-controlled vortioxetine study. Clinical Global Impression of Severity scores were used to establish standardized cutoff scores for remission across each scale. Using these cutoff scores, we compared the ability of each scale to separate drug-placebo remission rates, evaluated by the number needed to treat for clinical evidence. The HAM-D6 was superior to HAM-D17 in separating drug-placebo remission rates at the end point, defined as number needed to treat of less than 10. More items in the longer HAM-D versions indicated smaller discriminating validity over placebo. The HAM-D6 indicated a dose effect on remission for vortioxetine in both moderate and severe major depression. The brief HAM-D6 was thus found superior to HAM-D17, HAM-D21, and HAM-D24 both in terms of scalability and in discriminating antidepressants from placebo.

[Family psychoeducation for affective disorders].

The aim of this article was to examine the evidence of family psychoeducation (FPE) for affective disorders. Evidence indicates that FPE can be an effective supplement to the standard treatment of patients with affective disorders. FPE can effectively reduce the patients' risk of relapse and reduce the burden experienced by the relatives. However, current studies are very heterogeneous and therefore difficult to compare. Up to this point the evidence regarding the effect of FPE on unipolar depression is still very sparse and further research is needed.

[Positive psychiatry]. / Positiv psykiatri.

Positive psychiatry (PP) is a field within psychiatry with a particular focus on promoting well-being in people who already have or are at high risk of developing mental or physical illness. PP should be considered a supplement to trad-tional psychiatry and a call for therapists in psychiatry to focus on the person as a whole rather than just as a patient. PP is in line with current national and international health policy focus on promoting positive mental health.

Family psychoeducation for major depressive disorder - study protocol for a randomized controlled trial.

BACKGROUND: Major depressive disorder has been shown to affect many domains of family life including family functioning. Conversely, the influence of the family on the course of the depression, including the risk of relapse, is one reason for targeting the family in interventions. The few studies conducted within this area indicate that family psychoeducation as a supplement to traditional treatment can effectively reduce the risk of relapse in patients with major depression as well as being beneficial for the relatives involved. However, the evidence is currently limited. This study will investigate the effect of family psychoeducation compared to social support on the course of the illness in patients with major depressive disorder. METHOD/DESIGN: The study is designed as a dual center, two-armed, observer-blinded, randomized controlled trial. Relatives are randomized to participate in one of two conditions: either four sessions of manualized family psychoeducation or four sessions in a social support group led by a health care professional. Patients will not participate in the groups and will continue their treatment as usual. A total of 100 patients, each accompanied by one relative, will be recruited primarily from two outpatient clinics in the Capital Region of Denmark. The primary outcome is the occurrence of depressive relapse at 9-month follow-up defined as a score ≥7 on the Hamilton six-item subscale. Secondary outcomes will include time to relapse. DISCUSSION: It is hoped that the results from this study will help to clarify the mechanisms behind any beneficial changes due to family psychoeducation and provide information on the long-term effect of this intervention for both patient and relatives. If the results are positive, the family psychoeducation program may be suitable for implementation within a clinical setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02348827 , registered 5 January 2015.

Affect regulation and psychopathology in women with borderline personality disorder.

INTRODUCTION: Dysfunction in affect regulation is a prominent feature that grossly impairs behavioural and interpersonal domains of experience and underlies a great deal of the psychopathology in borderline personality disorder (BPD). However, no study has yet been published that evaluates the psychometric properties of the translated Danish version of self-report measures sensitive to the different aspects and dimensions of dysfunction in affect regulation prevalent in BPD. MATERIAL AND METHODS: This study comprised a group of women diagnosed with BPD (n = 29) and a comparison group of healthy subjects (n = 29) who reported psychopathology and levels of affective instability, aggression, impulsivity and alexithymia by self-report measures. RESULTS: Our results demonstrated that women with BPD have significant psychopathology and report significantly higher levels of dysfunction in separate components of affect regulation by self-report measures than the comparison group of healthy subjects. Our results also provided partial support for the psychometric appropriateness and clinical relevance of the translated Danish version of affect regulation measures. CONCLUSION: The normative reference range indicated by our results makes the measures useful as a practical assessment tool. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.