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Background The Zarit Burden Interview (ZBI) was originally developed to assess the level of subjective burden in caregivers of people with dementia. The Involvement Evaluation Questionnaire (IEQ) is amongst the leading scales to assess caregiving consequences in severe mental illness. We aimed to compare the psychometric properties of the ZBI, a generic tool, and of the IEQ, a more specific tool to assess the consequences of caregiving in schizophrenia and related disorders. Methods Secondary analyses of a 16-week, randomized controlled trial of a psychoeducational intervention in 223 primary caregivers of patients with schizophrenia or schizoaffective disorder. Psychometric properties (internal consistency, convergent and discriminative validity, and sensitivity to change) were evaluated for both ZBI and IEQ. Results Internal consistency was good and similar for both scales (ZBI: 0.91, 95% CI: 0.89, 0.94; IEQ: 0.86, 95% CI: 0.83, 0.89). Convergent validity was relevant for similar domains (e.g. ZBI total score vs IEQ-tension r  = 0.69, 95% CI: 0.61, 0.75) and at least moderate for the rest of domains (ZBI total score, personal strain and role strain vs IEQ-urging and supervision). Discriminative validity against psychological distress and depressive symptoms was good (Area Under the Curve [AUC]: 0.77, 95% CI: 0.71, 0.83; and 0.69, 95% CI: 0.63, 0.78 – for ZBI against GHQ-28 and CES-D respectively; and AUC: 0.72, 95% CI: 0.65, 0.78; and 0.69, 95% CI: 0.62, 0.77 – for IEQ against GHQ-28 and CES-D respectively). AUCs against the reference criteria did not differ significantly between the two scales. After the intervention, both scales showed a significant decrease at endpoint ( p -values < 0.001) with similar standardised effect sizes for change (-0.36, 95% CI: -0.58, -0.15 – for ZBI; -0.39, 95% CI: -0.60, -0.18 – for IEQ). Conclusions Both ZBI and IEQ have shown satisfactory psychometric properties to assess caregiver burden in this sample. We provided further evidence on the performance of the ZBI as a general measure of subjective burden. Trial registration ( ISRCTN32545295 ).

Background: Evidence of a mode effect has raised concerns about the comparability and validity of self- versus interviewer-administered versions of the Center for Epidemiological Studies Depression (CES-D) scale. Response anonymity has been proposed to explain this effect. However, the factors that contribute to this mode effect are not well understood. We used item response theory (IRT) to examine the nature of the CES-D mode effect. Methods: A sample of depressed primary care patients from the Partners-in-Care Study were randomized to receive either a phone interview (N = 139) or a mail survey (N = 139) of the CES-D. We used likelihood ratio tests to identify differentially functioning items in the 2 groups. Category response curves are used to describe these effects. Results: Twelve items manifested differential functioning. Category response curves consistently indicate that phone respondents had a lower probability of endorsing the third of 4 response categories than mail respondents, suggesting a possible cognitive effect. Conclusion: Although response anonymity could be important in mode effects observed in surveys of sensitive topics, cognitive factors appear more important to the mode effect in the CES-D.

Introduction Successful implementation and embedding of new health care practices relies on co-ordinated, collective behaviour of individuals working within the constraints of health care settings. Normalization Process Theory (NPT) provides a theory of implementation that emphasises collective action in explaining, and shaping, the embedding of new practices. To extend the practical utility of NPT for improving implementation success, an instrument (NoMAD) was developed and validated. Methods Descriptive analysis and psychometric testing of an instrument developed by the authors, through an iterative process that included item generation, consensus methods, item appraisal, and cognitive testing. A 46 item questionnaire was tested in 6 sites implementing health related interventions, using paper and online completion. Participants were staff directly involved in working with the interventions. Descriptive analysis and consensus methods were used to remove redundancy, reducing the final tool to 23 items. Data were subject to confirmatory factor analysis which sought to confirm the theoretical structure within the sample. Results We obtained 831 completed questionnaires, an average response rate of 39% (range: 22–77%). Full completion of items was 50% ( n  = 413). The confirmatory factor analysis showed the model achieved acceptable fit (CFI = 0.95, TLI = 0.93, RMSEA = 0.08, SRMR = 0.03). Construct validity of the four theoretical constructs of NPT was supported, and internal consistency (Cronbach’s alpha) were as follows: Coherence (4 items, α = 0.71); Collective Action (7 items, α = 0.78); Cognitive Participation (4 items, α = 0.81); Reflexive Monitoring (5 items, α = 0.65). The normalisation scale overall, was highly reliable (20 items, α = 0.89). Conclusions The NoMAD instrument has good face validity, construct validity and internal consistency, for assessing staff perceptions of factors relevant to embedding interventions that change their work practices. Uses in evaluating and guiding implementation are proposed.

Different diagnostic interviews are used as reference standards for major depression classification in research. Semi-structured interviews involve clinical judgement, whereas fully structured interviews are completely scripted. The Mini International Neuropsychiatric Interview (MINI), a brief fully structured interview, is also sometimes used. It is not known whether interview method is associated with probability of major depression classification.AimsTo evaluate the association between interview method and odds of major depression classification, controlling for depressive symptom scores and participant characteristics. Data collected for an individual participant data meta-analysis of Patient Health Questionnaire-9 (PHQ-9) diagnostic accuracy were analysed and binomial generalised linear mixed models were fit. A total of 17 158 participants (2287 with major depression) from 57 primary studies were analysed. Among fully structured interviews, odds of major depression were higher for the MINI compared with the Composite International Diagnostic Interview (CIDI) (odds ratio (OR) = 2.10; 95% CI = 1.15-3.87). Compared with semi-structured interviews, fully structured interviews (MINI excluded) were non-significantly more likely to classify participants with low-level depressive symptoms (PHQ-9 scores ≤6) as having major depression (OR = 3.13; 95% CI = 0.98-10.00), similarly likely for moderate-level symptoms (PHQ-9 scores 7-15) (OR = 0.96; 95% CI = 0.56-1.66) and significantly less likely for high-level symptoms (PHQ-9 scores ≥16) (OR = 0.50; 95% CI = 0.26-0.97). The MINI may identify more people as depressed than the CIDI, and semi-structured and fully structured interviews may not be interchangeable methods, but these results should be replicated.Declaration of interestDrs Jetté and Patten declare that they received a grant, outside the submitted work, from the Hotchkiss Brain Institute, which was jointly funded by the Institute and Pfizer. Pfizer was the original sponsor of the development of the PHQ-9, which is now in the public domain. Dr Chan is a steering committee member or consultant of Astra Zeneca, Bayer, Lilly, MSD and Pfizer. She has received sponsorships and honorarium for giving lectures and providing consultancy and her affiliated institution has received research grants from these companies. Dr Hegerl declares that within the past 3 years, he was an advisory board member for Lundbeck, Servier and Otsuka Pharma; a consultant for Bayer Pharma; and a speaker for Medice Arzneimittel, Novartis, and Roche Pharma, all outside the submitted work. Dr Inagaki declares that he has received grants from Novartis Pharma, lecture fees from Pfizer, Mochida, Shionogi, Sumitomo Dainippon Pharma, Daiichi-Sankyo, Meiji Seika and Takeda, and royalties from Nippon Hyoron Sha, Nanzando, Seiwa Shoten, Igaku-shoin and Technomics, all outside of the submitted work. Dr Yamada reports personal fees from Meiji Seika Pharma Co., Ltd., MSD K.K., Asahi Kasei Pharma Corporation, Seishin Shobo, Seiwa Shoten Co., Ltd., Igaku-shoin Ltd., Chugai Igakusha and Sentan Igakusha, all outside the submitted work. All other authors declare no competing interests. No funder had any role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.

Background The effectiveness of psychosocial interventions in community mental healthcare has been shown to depend on the setting in which they are implemented. Recently structured patient–clinician communication was found to be effective in a multi-centre trial in six European countries, the DIALOG trial. In the overall study, differences between centres were controlled for, not studied. Here, we test whether the effectiveness of structured patient–clinician communication varies between services in different countries, and explore setting characteristics associated with outcome. Methods The study is part of the DIALOG trial, which included 507 patients with schizophrenia or related disorder, treated by 134 keyworkers. The keyworkers were allocated to intervention or treatment as usual. Results Positive effects were found on quality of life (effect size 0.20: 95% CI 0.01–0.39) and treatment satisfaction (0.27: 0.06–0.47) in all centres, but reductions in unmet needs for care were only seen in two centres (−0.83 and −0.60), and in positive, negative and general symptoms in one (−0.87, −0.78, −0.87). The intervention was most effective in settings with patient populations with many unmet needs for care and high symptom levels. Conclusions Psychosocial interventions in community mental healthcare may not be assumed to have uniform effectiveness across settings. Differences in patient population served and mental healthcare provided, should be studied for their influence on the effectiveness of the intervention. Structured patient–clinician communication has a uniform effect on quality of life and treatment satisfaction, but on unmet needs for care and symptom levels its effect differs between mental healthcare settings.

Diagnostic tools, such as the Mini International Neuropsychiatric Interview (MINI) 7.0.2 and the Structured Clinical Interview for the DSM-5 (SCID), aim to increase the validity and reliability of diagnostic assessment. However, these tools were created in high-income countries (HICs) with limited investigation of the psychometrics of these tools when used in low- and middle-income countries (LMICs). Thus, there is a need to examine the psychometric properties of these measures in LMICs. The present investigation aimed to examine the use of the MINI in Ethiopia, Kenya, and Uganda. A multicountry comparison of the validity and reliability of the MINI was conducted in a study of 954 participants (  = 667 cases;  = 287 controls) with and without a psychotic spectrum disorder, defined as any psychotic or bipolar spectrum disorder for the NeuroGAP - Psychosis study. Test-retest reliability of the MINI was examined in a subset of 303 participants (  = 164 cases;  = 139 controls) from the overall sample. Results revealed the MINI and SCID provided excellent diagnostic accuracy with area under the curve (AUC) values of .91 (  = .01) for the MINI and .95 (  = .01) for the SCID. Positive predictive values (PPV) were the highest for the SCID (93.8%) and slightly lower for the MINI (88.7%). Reliability analyses revealed substantial agreement for psychotic and bipolar diagnostic groups. Similar patterns of results were observed at the country level with a few notable differences. Limitations and future directions are discussed.

Background and Hypothesis Negative symptoms are very important for the overall loss of functioning observed in patients with schizophrenia. There is a need for valid tools to assess these symptoms. Study Design We used the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) systematic review guideline to evaluate the quality of the clinical assessment interview for negative symptoms (CAINS) as a clinician-rated outcome measurement (ClinROM). Study Results The search strategy resulted in the retrieval of 13 articles, 11 of which were included in this evaluation. In terms of risk of bias, most articles reported on measures of internal consistency and construct validity, which were overall of good quality. Structural validity, reliability, measurement error, and cross-cultural validity were reported with less than optimum quality. There was a risk of bias in ClinROM development. According to the updated criteria of good measurement properties, structural validity, internal consistency, and reliability showed good results. In contrast, hypothesis testing was somewhat poorer. Results for cross-cultural validity were indeterminate. According to the updated GRADE approach from the COSMIN group the scale received a moderate grade. Conclusions The COSMIN standard allows a judgment of the CAINS as an instrument with the potential to be recommended for use, but which requires further research to assess its quality, in particular in the domains of content validity, internal consistency, and cross-cultural validity.

There is a need for clinical tools to identify cultural issues in diagnostic assessment. To assess the feasibility, acceptability and clinical utility of the DSM-5 Cultural Formulation Interview (CFI) in routine clinical practice. Mixed-methods evaluation of field trial data from six countries. The CFI was administered to diagnostically diverse psychiatric out-patients during a diagnostic interview. In post-evaluation sessions, patients and clinicians completed debriefing qualitative interviews and Likert-scale questionnaires. The duration of CFI administration and the full diagnostic session were monitored. Mixed-methods data from 318 patients and 75 clinicians found the CFI feasible, acceptable and useful. Clinician feasibility ratings were significantly lower than patient ratings and other clinician-assessed outcomes. After administering one CFI, however, clinician feasibility ratings improved significantly and subsequent interviews required less time. The CFI was included in DSM-5 as a feasible, acceptable and useful cultural assessment tool.

Inconsistent findings exist for the activity of the hypothalamic-pituitary-adrenal (HPA) axis in patients with stress related disorders. Recent studies point towards early life stress as a potential modulator. We investigated the impact of childhood sexual abuse on phasic (saliva cortisol reactivity) and tonic (hair cortisol) regulation. Furthermore, we assessed predictors on cortisol accumulation in hair. Women (N = 43) with stress-related disorders underwent a standardized assessment of idiographic adverse and traumatic experiences and psychopathology, while measuring salivary cortisol and, heart rate and blood pressure. Comparing women with and without childhood sexual abuse revealed lower rates of responders and distinct levels of salivary cortisol to the interview in conjunction with a lower heart rate for the abused group. Childhood adversities, traumatic experiences, and depression contributed to higher hair cortisol levels. Our finding of lower response rate and distinct salivary cortisol pattern in individuals with childhood sexual abuse compared to individuals without early sexual abuse supports the role of environmental programming for the HPA axis. Both, childhood adversities and traumatic stress emerge as crucial factors for long-term cortisol secretion. Lower or suppressed phasic cortisol responses to trauma-related stimuli may therefore be associated with higher tonic values. Thus, early exposure to adversities may result in a biological distinct phenotype in adult patients with stress-related disorders.

Prolonged Grief Disorder (PGD) is a new disorder. A structured clinical interview for ICD-11 and DSM-5-TR PGD is a necessary tool in diagnosing PGD needed as PGD is implemented as a mental disorder in health services across the world. This study developed and validated The Aarhus PGD Interview (A-PGDi) to provide clinicians with free access to a valid method to diagnose PGD in alignment with recent diagnostic requirements in ICD-11 and DSM-5-TR and to training materials. The A-PGDi was developed in close collaboration between scientists, clinicians, and bereaved individuals. First, all PGD-symptoms underwent two rounds of item-formulations by clinicians and researchers. Then, a first version of the A-PGDi was tested in a group of bereaved adults with PGD symptoms, who were interviewed about the A-PGDi. The A-PGDi was refined according to their responses, piloted in 13 bereaved adults and further refined to its final version. The validity of A-PGDi was then tested with clinical interviews for PGD, PTSD, depression, and anxiety performed by carefully trained clinical interviewers in a sample of 124 bereaved adults (mean age 47 years (range 19-83 years); 85% female). Benchmarked against a self-report measure of PGD and moderate to substantial inter-diagnostic agreement between ICD-11 and DSM-5-TR diagnoses the A-PGDi had sufficient content validity. Significant relations between PGD-diagnosis and other mental disorders estimated with clinical interviews and self-report scales and moderate to substantial inter-diagnostic and test-retest agreement indicated sufficient criterion validity and reliability. small non-probability sample with PGD symptoms; self-identified for participation; mostly female. The results indicate that A-PGDi with some limitations is a valid structured clinical interview for diagnosing both ICD-11 and DSM-5-TR PGD that is relevant to administer in mental health settings to ensure correct diagnostics and the most helpful treatment plan for people with PGD.