Prevalence of adjustment disorder among cancer patients, and the reach, effectiveness, cost-utility and budget impact of tailored psychological treatment: study protocol of a randomized controlled trial.

BACKGROUND: Information on the prevalence of adjustment disorders among cancer patients and the value of psychological interventions in this group of patients is limited. This study investigates the prevalence of adjustment disorders among cancer patients as well as the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. METHOD: This study consists of two parts. Part 1 is an observational study among a representative group of mixed cancer patients after cancer treatment on the prevalence of adjustment disorder as well as the uptake (i.e. reach) of psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial. Patients will be randomized to the intervention (access to the tailored psychological intervention) or control group (waitlist period of 6 months). The psychological intervention consists of three modules: one module containing psycho-education (3 sessions, all patients) and two additional modules (maximum of 6 sessions per module) provided as continuum, in case needed. Module 2 and 3 can consist of several evidence-based interventions (e.g. group interventions, mindfulness, eHealth) The primary outcome is psychological distress (HADS). Secondary outcomes are mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). To assess the cost-utility and budget impact, quality of life (EQ-5D-5 L) and costs (iMCQ and iPCQ) will be measured. Measures will be completed at baseline and 3 and 6-months after randomization. DISCUSSION: This study will provide data of the prevalence of adjustment disorders and the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. TRIAL REGISTRATION: Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.

Forgetting ourselves: epistemic costs and ethical concerns in mindfulness exercises.

Mindfulness exercises are presented as being compatible with almost any spiritual, religious or philosophical beliefs. In this paper, we argue that they in fact involve imagining and conceptualising rather striking and controversial claims about the self, and the self's relationship to thoughts and feelings. For this reason, practising mindfulness exercises is likely to be in tension with many people's core beliefs and values, a tension that should be treated as a downside of therapeutic interventions involving mindfulness exercises, not unlike a side effect. Clients ought to be informed of these metaphysical aspects of the exercises, and mental health providers ought to take them into account in assessing which course of treatment to recommend. Given these concerns, the casual way in which mindfulness exercises are presently distributed by mental health providers to the general public is inappropriate.

Assessing the efficacy of imagery-enhanced cognitive behavioral group therapy for social anxiety disorder: Study protocol for a randomized controlled trial.

Cognitive behavior group therapy (CBGT) is effective for social anxiety disorder (SAD), but a substantial proportion of patients do not typically achieve normative functioning. Cognitive behavioral models of SAD emphasize negative self-imagery as an important maintaining factor, and evidence suggests that imagery is a powerful cognitive mode for facilitating affective change. This study will compare two group CBGT interventions, one that predominantly uses verbally-based strategies (VB-CBGT) and another that predominantly uses imagery-enhanced strategies (IE-CBGT), in terms of (a) efficacy, (b) mechanisms of change, and (c) cost-effectiveness. This study is a parallel groups (two-arm) single-blind randomized controlled trial. A minimum of 96 patients with SAD will be recruited within a public outpatient community mental health clinic in Perth, Australia. The primary outcomes will be self-reported symptom severity, caseness (SAD present: yes/no) based on a structured diagnostic interview, and clinician-rated severity and life impact. Secondary outcomes and mechanism measures include blind observer-rated use of safety behaviors, physiological activity (heart rate variability and skin conductance level) during a standardized speech task, negative self-beliefs, imagery suppression, fear of negative and positive evaluation, repetitive negative thinking, anxiety, depression, self-consciousness, use of safety behaviors, and the EQ-5D-5L and TiC-P for the health economic analysis. Homework completion, group cohesion, and working alliance will also be monitored. The outcomes of this trial will inform clinicians as to whether integrating imagery-based strategies in cognitive behavior therapy for SAD is likely to improve outcomes. Common and distinct mechanisms of change might be identified, along with relative cost-effectiveness of each intervention.

The effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial.

BACKGROUND: Mindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness or cost-effectiveness for young people. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of a mindfulness training (MT) programme to enhance mental health, wellbeing and social-emotional behavioural functioning in adolescence. METHODS/DESIGN: To address this aim, the design will be a superiority, cluster randomised controlled, parallel-group trial in which schools offering social and emotional provision in line with good practice (Formby et al., Personal, Social, Health and Economic (PSHE) Education: A mapping study of the prevalent models of delivery and their effectiveness, 2010; OFSTED, Not Yet Good Enough: Personal, Social, Health and Economic Education in schools, 2013) will be randomised to either continue this provision (control) or include MT in this provision (intervention). The study will recruit and randomise 76 schools (clusters) and 5700 school students aged 12 to 14 years, followed up for 2 years. DISCUSSION: The study will contribute to establishing if MT is an effective and cost-effective approach to promoting mental health in adolescence. TRIALS REGISTRATION: International Standard Randomised Controlled Trials, identifier: ISRCTN86619085 . Registered on 3 June 2016.

[Psychiatry and psychiatric patients : A study of the adherence after psychiatric inpatient treatment at the department of psychiatry and psychotherapy at the Clinicum Klagenfurt am Wörthersee.] / Die Psychiatrie und ihre PatientInnen : Eine Studie zur Adhärenz nach Entlassung aus der Abteilung für Psychiatrie und Psychotherapie am Klinikum Klagenfurt am Wörthersee.

BACKGROUND: Based on the data of an analysis of costs of psychopharmacological treatment by the Austrian Rechnungshof in 2011, which also revealed remarkable differences between Salzburg and Carinthia (federal states of Austria), a panel of experts discussed the potential causes. A consequence was the following prospective study, which took place at the department of psychiatry and psychotherapy in Klagenfurt/Carinthia. METHODS: The aim in this mirror design study was to analize the data of psychopharmacologic treatment, epidemiological data of the treated patients (N = 230) and utilization of healthcare ressources such as contacts to psychiatrists or practicioners after discharge. RESULTS: We could show a high adherence concerning the redeem of the prescriptions, a low proportion of generics, and a very low rate of contacts to psychiatrists contrasting contacts to practitioners. CONCLUSIONS: Beneath that in the sense of descriptive epidemiology the data help to characterize adherence behavior after discharge and details of in- and outdoor treatment.

[Outpatient Psychotherapy Under Naturalistic Conditions: A Selective Review of Results from German Speaking Countries]. / Ambulante Psychotherapie unter Routinebedingungen: Forschungsbefunde aus dem deutschsprachigen Raum.

There is a growing body of literature recognizing the importance of outpatient psychotherapy. Several studies investigated the efficacy of outpatient psychotherapy and aspects of the health care system under natural conditions. This paper gives an overview of studies from German speaking countries (TRANS-OP-, TK-, PAP-S- and QS-PSY-BAY-study).The results of the different studies indicate both, positive outcome of the therapies (e. g., reduction of symptoms with an average ES of 1,03; improvement of symptoms despite premature termination) as well as an economic benefit (end of treatment depending on treatment outcome and not limited by therapy sessions; extensions of psychotherapy only if patient is highly impaired and therapeutic alliance is positive; high reduction of supply costs and sick leave). However, the low health care density in rural areas and the waiting periods before starting therapy are indicators of structural problems of the health care system with respect to outpatient psychotherapy.The efficacy of outpatient psychotherapies under natural conditions is sufficiently supported. Future studies should investigate structural aspects of the health care system, for example by focussing on the establishment of inter-sectoral connections between different professional groups and a reduction of bureaucratic actions.

Does therapeutic writing help people with long-term conditions? Systematic review, realist synthesis and economic considerations.

BACKGROUND: Writing therapy to improve physical or mental health can take many forms. The most researched model of therapeutic writing (TW) is unfacilitated, individual expressive writing (written emotional disclosure). Facilitated writing activities are less widely researched. DATA SOURCES: Databases, including MEDLINE, EMBASE, PsycINFO, Linguistics and Language Behaviour Abstracts, Allied and Complementary Medicine Database and Cumulative Index to Nursing and Allied Health Literature, were searched from inception to March 2013 (updated January 2015). REVIEW METHODS: Four TW practitioners provided expert advice. Study procedures were conducted by one reviewer and checked by a second. Randomised controlled trials (RCTs) and non-randomised comparative studies were included. Quality was appraised using the Cochrane risk-of-bias tool. Unfacilitated and facilitated TW studies were analysed separately under International Classification of Diseases, Tenth Revision chapter headings. Meta-analyses were performed where possible using RevMan version 5.2.6 (RevMan 2012, The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark). Costs were estimated from a UK NHS perspective and three cost-consequence case studies were prepared. Realist synthesis followed Realist and Meta-narrative Evidence Synthesis: Evolving Standards guidelines. OBJECTIVES: To review the clinical effectiveness and cost-effectiveness of TW for people with long-term conditions (LTCs) compared with no writing, or other controls, reporting any relevant clinical outcomes. To conduct a realist synthesis to understand how TW might work, and for whom. RESULTS: From 14,658 unique citations, 284 full-text papers were reviewed and 64 studies (59 RCTs) were included in the final effectiveness reviews. Five studies examined facilitated TW; these were extremely heterogeneous with unclear or high risk of bias but suggested that facilitated TW interventions may be beneficial in individual LTCs. Unfacilitated expressive writing was examined in 59 studies of variable or unreported quality. Overall, there was very little or no evidence of any benefit reported in the following conditions (number of studies): human immunodeficiency virus (six); breast cancer (eight); gynaecological and genitourinary cancers (five); mental health (five); asthma (four); psoriasis (three); and chronic pain (four). In inflammatory arthropathies (six) there was a reduction in disease severity [n = 191, standardised mean difference (SMD) -0.61, 95% confidence interval (CI) -0.96 to -0.26] in the short term on meta-analysis of four studies. For all other LTCs there were either no data, or sparse data with no or inconsistent, evidence of benefit. Meta-analyses conducted across all of the LTCs provided no evidence that unfacilitated emotional writing had any effect on depression at short- (n = 1563, SMD -0.06, 95% CI -0.29 to 0.17, substantial heterogeneity) or long-term (n = 778, SMD -0.04 95% CI -0.18 to 0.10, little heterogeneity) follow-up, or on anxiety, physiological or biomarker-based outcomes. One study reported costs, no studies reported cost-effectiveness and 12 studies reported resource use; and meta-analysis suggested reduced medication use but no impact on health centre visits. Estimated costs of intervention were low, but there was insufficient evidence to judge cost-effectiveness. Realist synthesis findings suggested that facilitated TW is a complex intervention and group interaction contributes to the perception of benefit. It was unclear from the available data who might benefit most from facilitated TW. LIMITATION: Difficulties with developing realist synthesis programme theory meant that mechanisms operating during TW remain obscure. CONCLUSIONS: Overall, there is little evidence to support the therapeutic effectiveness or cost-effectiveness of unfacilitated expressive writing interventions in people with LTCs. Further research focused on facilitated TW in people with LTCs could be informative. STUDY REGISTRATION: This study is registered as PROSPERO CRD42012003343. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

The Cost-Effectiveness of the Integration of Nalmefene within the UK Healthcare System Treatment Pathway for Alcohol Dependence.

AIMS: To assess the cost-effectiveness of integrating nalmefene within the treatment pathway for alcohol dependence recommended by the National Institute for Health and Care Excellence in the UK. METHODS: A Markov model, taking a UK NHS perspective, followed a cohort with alcohol dependence and high/very high drinking risk levels (HVHDRLs), who do not require immediate detoxification and who continue at HVHDRLs after initial assessment, for 5 years. Costs and quality-adjusted life years (QALYs) from treatment with nalmefene plus psychosocial support versus psychosocial support alone were modelled. The consequent incidence of alcohol-attributable harmful events and disease progression, with the possibility of requiring other options or recurrent treatment, were captured. RESULTS: Nalmefene plus psychosocial support dominated psychosocial support alone, with lower costs and increased QALYs after 5 years. Savings are driven by the higher response to nalmefene, and the subsequent lower cost accumulation for alternatives. CONCLUSIONS: Nalmefene represents a highly cost-effective treatment option in this population. The analysis shows that integrating nalmefene within the current UK clinical treatment pathway for alcohol dependence could reduce the economic burden on the NHS by limiting harmful events and disease progression.

[Analysis and Assessment of Modifications of the PEPP System Introduced by the PEPP Catalogue 2015]. / Analyse und Beurteilung der Veränderungen des PEPP-Systems durch den Entgeltkatalog 2015.

PURPOSE: In 2015 the remuneration system for psychiatric and psychosomatic stationary treatments will be revised. The remuneration for a case is calculated by the product of base rate, a cost weight and the number of days of treatment. The cost weight varies depending on the number of days of treatment. This paper surveys the incentives, the casemix structure and the consistency of the modified PEPP system. METHODS: Under the assumption of a profit-maximising supplier it is possible to define the economically optimal length of stay by comparing marginal revenues and marginal costs. Therefore a revenue function is derived from the new structure of the PEPP system. Since the determination of the marginal revenues is not mathematically possible, the revenues per additional day of treatment are calculated. On that basis it is possible to determine the economically optimal length of stay and to assess the consistency of the system changes. RESULTS: In an early stage of treatment the revenues per additional day of treatment are degressive. After a defined amount of days these additional revenues stay constant, which will be relevant for the majority of the cases. It is economically optimal for the hospitals to treat patients as long as possible, if the marginal costs lie or sink below these constant revenues per additional day of treatment. Furthermore the system changes result in a more complex casemix structure and the calculation of the cost weights is partially inconsistent, since the marginal revenues do not monotonically decrease. CONCLUSIONS: The modifications lead to a reduction of degressive elements in the PEPP system, which might also be accompanied by a decrease of economically induced pressure on length of stay. The inconsistent calculation of the cost weights and the more complicated casemix structure can be viewed critically.

The Cost of Inpatient Care of Schizophrenia and Treatment Schedules Used in German Academic Center: Kiel.

The authors aimed at analyzing the costs of inpatient care of schizophrenia in Kiel (Germany). The study was also to present treatment regimens used at the German Academic Center. Moreover, the study is a continuation and complement of the previous study conducted in Polish and Ukrainian Academic Center. Therefore, it helps increase the awareness and knowledge of residents concerning the cost of inpatient care of schizophrenia. The analysis was based on 105 hospital records of patients treated between January 2012 and June 2013. According to inclusion criteria, 50 adult patients (27 women and 23 men) were included in the study. The study was approved by the Ethics Committee of the Medicine Faculty of CAU in Kiel. The cost of schizophrenia treatment of 50 patients in Kiel was EUR 604,280.90 ([Formula: see text] = EUR 12,085.62). The duration of hospital stay was on average [Formula: see text] = 51.02 days. The patients were treated with neuroleptics of all generations. The most popular atypical neuroleptic was amisulpride and the most popular typical neuroleptic was haloperidol. Patients from Kiel were provided a comprehensive non-pharmacological treatment. Treatment regiments and evaluations of costs of schizophrenia vary between countries. The costs of inpatient care of schizophrenia are high in Kiel. Treatment of schizophrenia seems to be comprehensive in Kiel and wide range of treatment opportunities contribute to a more effective treatment confirmed by less frequent relapses of schizophrenia than in Lviv (Ukraine), for example. Comprehensive treatment should be available everywhere, because it is a right of every patient.

[Normative-empirical determination of personnel requirements in psychosomatic medicine and psychotherapy]. / Normativ-empirische Bestimmung des Personalbedarfs in der Psychosomatischen Medizin und Psychotherapie.

OBJECTIVES: There is a high degree of misallocated medical care for patients with somatoform disorders and patients with concomitant mental diseases. This complex of problems could be reduced remarkably by integrating psychosomatic departments into hospitals with maximum medical care. Admitting a few big psychosomatic specialist clinics into the calculation basis decreased the Day-Mix Index (DMI). The massive reduction of the calculated costs per day leads to a gap in funding resulting in a loss of the necessary personnel requirements - at least in university psychosomatic departments. The objective of this article is therefore to empirically verify the reference numbers of personnel resources calculated on the basis of the new German lump-sum reimbursement system in psychiatry and psychosomatics (PEPP). METHODS: The minute values of the reference numbers of Heuft (1999) are contrasted with the minute values of the PEPP reimbursement system in the years 2013 and 2014, as calculated by the Institute for Payment Systems in Hospitals (InEK). RESULTS: The minute values derived from the PEPP data show a remarkable convergence with the minute values of Heuft's reference numbers (1999). CONCLUSIONS: A pure pricing system like the PEPP reimbursement system as designed so far threatens empirically verifiable and qualified personnel requirements of psychosomatic departments. In order to ensure the necessary therapy dosage and display it in minute values according to the valid OPS procedure codes, the minimum limit of the reference numbers is mandatory to maintain the substance of psychosomatic care. Based on the present calculation, a base rate of at least 285 e has to be politically demanded. Future developments in personnel costs have to be refinanced at 100 %.

[Concept of budget-based remuneration system for the fields of psychiatry and psychotherapy, psychosomatic medicine and psychotherapy, child and adolescent psychiatry and psychotherapy]. / Konzept eines budgetbasierten Entgeltsystems für die Fachgebiete Psychiatrie und Psychotherapie, Psychosomatische Medizin und Psychotherapie, Kinder- und Jugendpsychiatrie und -psychotherapie.

A new remuneration system is currently being developed for the hospital care of people with mental disorders. Last year, because of sharp criticism the option phase of the planned Flat-rate Charges in Psychiatry and Psychosomatics (Pauschalierende Entgelte Psychiatrie und Psychosomatik, PEPP) was extended by 2 years. During this time the Federal Ministry of Health wants to look for alternatives and possible starting points for the further development of care. Now, 16 scientific professional associations and organisations have presented a joint concept for a sustainable solution: the budget-based remuneration system. The system is suitable for ensuring that people with mental disorders are treated according to their particular needs and for promoting the appropriate further development of regional care in all treatment settings. It corresponds with the objectives as formulated in Section 17d of the Hospital Finance Act (Krankenhausfinanzierungsgesetz, KHG) and translates the PEPP system, which is currently being developed and focusses on average prices, into a performance-oriented, transparent budgetary system. The fundamental principle is the separation of the individual hospitals' budgeting on the basis of evidence-based, feature- and performance-related modules and billing in the form of advance payments from the agreed budget.

Stepped care treatment delivery for depression: a systematic review and meta-analysis.

BACKGROUND: In stepped care models patients typically start with a low-intensity evidence-based treatment. Progress is monitored systematically and those patients who do not respond adequately step up to a subsequent treatment of higher intensity. Despite the fact that many guidelines have endorsed this stepped care principle it is not clear if stepped care really delivers similar or better patient outcomes against lower costs compared with other systems. We performed a systematic review and meta-analysis of all randomized trials on stepped care for depression. METHOD: We carried out a comprehensive literature search. Selection of studies, evaluation of study quality and extraction of data were performed independently by two authors. RESULTS: A total of 14 studies were included and 10 were used in the meta-analyses (4580 patients). All studies used screening to identify possible patients and care as usual as a comparator. Study quality was relatively high. Stepped care had a moderate effect on depression (pooled 6-month between-group effect size Cohen's d was 0.34; 95% confidence interval 0.20-0.48). The stepped care interventions varied greatly in number and duration of treatment steps, treatments offered, professionals involved, and criteria to step up. CONCLUSIONS: There is currently only limited evidence to suggest that stepped care should be the dominant model of treatment organization. Evidence on (cost-) effectiveness compared with high-intensity psychological therapy alone, as well as with matched care, is required.

A systematic review of the clinical effectiveness and cost-effectiveness of sensory, psychological and behavioural interventions for managing agitation in older adults with dementia.

BACKGROUND: Agitation is common, persistent and distressing in dementia and is linked with care breakdown. Psychotropic medication is often ineffective or harmful, but the evidence regarding non-pharmacological interventions is unclear. OBJECTIVES: We systematically reviewed and synthesised the evidence for clinical effectiveness and cost-effectiveness of non-pharmacological interventions for reducing agitation in dementia, considering dementia severity, the setting, the person with whom the intervention is implemented, whether the effects are immediate or longer term, and cost-effectiveness. DATA SOURCES: We searched twice using relevant search terms (9 August 2011 and 12 June 2012) in Web of Knowledge (incorporating MEDLINE); EMBASE; British Nursing Index; the Health Technology Assessment programme database; PsycINFO; NHS Evidence; System for Information on Grey Literature; The Stationery Office Official Documents website; The Stationery National Technical Information Service; Cumulative Index to Nursing and Allied Health Literature; and The Cochrane Library. We also searched Cochrane reviews of interventions for behaviour in dementia, included papers' references, and contacted authors about 'missed' studies. We included quantitative studies, evaluating non-pharmacological interventions for agitation in dementia, in all settings. REVIEW METHOD: We rated quality, prioritising higher-quality studies. We separated results by intervention type and agitation level. As we were unable to meta-analyse results except for light therapy, we present a qualitative evidence synthesis. In addition, we calculated standardised effect sizes (SESs) with available data, to compare heterogeneous interventions. In the health economic analysis, we reviewed economic studies, calculated the cost of effective interventions from the effectiveness review, calculated the incremental cost per unit improvement in agitation, used data from a cohort study to evaluate the relationship between health and social care costs and health-related quality of life (DEMQOL-Proxy-U scores) and developed a new cost-effectiveness model. RESULTS: We included 160 out of 1916 papers screened. Supervised person-centred care, communication skills (SES = -1.8 to -0.3) or modified dementia care mapping (DCM) with implementing plans (SES = -1.4 to -0.6) were all efficacious at reducing clinically significant agitation in care home residents, both immediately and up to 6 months afterwards. In care home residents, during interventions but not at follow-up, activities (SES = -0.8 to -0.6) and music therapy (SES = -0.8 to -0.5) by protocol reduced mean levels of agitation; sensory intervention (SES = -1.3 to -0.6) reduced mean and clinically significant symptoms. Advantages were not demonstrated with 'therapeutic touch' or individualised activity. Aromatherapy and light therapy did not show clinical effectiveness. Training family carers in behavioural or cognitive interventions did not decrease severe agitation. The few studies reporting activities of daily living or quality-of-life outcomes found no improvement, even when agitation had improved. We identified two health economic studies. Costs of interventions which significantly impacted on agitation were activities, £80-696; music therapy, £13-27; sensory interventions, £3-527; and training paid caregivers in person-centred care or communication skills with or without behavioural management training and DCM, £31-339. Among the 11 interventions that were evaluated using the Cohen-Mansfield Agitation Inventory (CMAI), the incremental cost per unit reduction in CMAI score ranged from £162 to £3480 for activities, £4 for music therapy, £24 to £143 for sensory interventions, and £6 to £62 for training paid caregivers in person-centred care or communication skills with or without behavioural management training and DCM. Health and social care costs ranged from around £7000 over 3 months in people without clinically significant agitation symptoms to around £15,000 at the most severe agitation levels. There is some evidence that DEMQOL-Proxy-U scores decline with Neuropsychiatric Inventory agitation scores. A multicomponent intervention in participants with mild to moderate dementia had a positive monetary net benefit and a 82.2% probability of being cost-effective at a maximum willingness to pay for a quality-adjusted life-year of £20,000 and a 83.18% probability at a value of £30,000. LIMITATIONS: Although there were some high-quality studies, there were only 33 reasonably sized (> 45 participants) randomised controlled trials, and lack of evidence means that we cannot comment on many interventions' effectiveness. There were no hospital studies and few studies in people's homes. More health economic data are needed. CONCLUSIONS: Person-centred care, communication skills and DCM (all with supervision), sensory therapy activities, and structured music therapies reduce agitation in care-home dementia residents. Future interventions should change care home culture through staff training and permanently implement evidence-based treatments and evaluate health economics. There is a need for further work on interventions for agitation in people with dementia living in their own homes. PROTOCOL REGISTRATION: The study was registered as PROSPERO no. CRD42011001370. FUNDING: The National Institute for Health Research Health Technology Assessment programme.