COVID-19 IN V ACTS.

This article follows almost chronologically the COVID crisis between March and May 2020 during what is called, at least in Europe, the "first wave". Each 'Act' of our internal and external theatre is therefore a moment with a specific date, with the questions that were then pertinent. These 'Acts' were: First was the setting up of remote sessions under health pressures and the recommendations of our psychoanalytic institutions. This change in the frame and its consequences will be presented from various technical points of view, which have ostensibly raised some original metapsychological hypotheses.Then, concerning our profession, its very status as either essential or inessential has been discussed by public authorities, and inevitably by our patients, who will après-coup have to give meaning to our reactions during this crisis.We will next study the effects of remote sessions, particularly from its psychoanalytic 'economic' perspective, and as a kind of 'credit for in-presence' in the early stages of quarantine.We will then be looking at the hypothesis of a maternal element in the sessions, imperceptible in normal times, but suddenly palpable in the context of the absence of physical bodies.Finally, we will propose developments through workshops as an option in order to find a response to this unexpected event at the global scale.

Public Funding of Evidence-Based Psychotherapy for Common Mental Disorders: Increasing Calls for Action in Canadian Provinces.

Canada's provinces are without a publicly funded psychotherapy program for common mental disorders despite evidence that psychological services help reduce the length and number of depressive episodes, symptoms of post-traumatic stress and associated negative outcomes (hospitalizations and suicide attempts). Studies also show that including psychological services as part of the service package offered under the public health plan for those without access pays for itself. We posit that a publicly funded psychotherapy program in Canada, including digitized self-guided psychotherapy platforms for common mental disorders, will lead to improved population health useful in the COVID-19 context and beyond.

Cost-effectiveness of Treatments for Opioid Use Disorder.

Importance: Opioid use disorder (OUD) is a significant cause of morbidity and mortality in the US, yet many individuals with OUD do not receive treatment. Objective: To assess the cost-effectiveness of OUD treatments and association of these treatments with outcomes in the US. Design and Setting: This model-based cost-effectiveness analysis included a US population with OUD. Interventions: Medication-assisted treatment (MAT) with buprenorphine, methadone, or injectable extended-release naltrexone; psychotherapy (beyond standard counseling); overdose education and naloxone distribution (OEND); and contingency management (CM). Main Outcomes and Measures: Fatal and nonfatal overdoses and deaths throughout 5 years, discounted lifetime quality-adjusted life-years (QALYs), and costs. Results: In the base case, in the absence of treatment, 42 717 overdoses (4132 fatal, 38 585 nonfatal) and 12 660 deaths were estimated to occur in a cohort of 100 000 patients over 5 years, and 11.58 discounted lifetime QALYs were estimated to be experienced per person. An estimated reduction in overdoses was associated with MAT with methadone (10.7%), MAT with buprenorphine or naltrexone (22.0%), and when combined with CM and psychotherapy (range, 21.0%-31.4%). Estimated deceased deaths were associated with MAT with methadone (6%), MAT with buprenorphine or naltrexone (13.9%), and when combined with CM, OEND, and psychotherapy (16.9%). MAT yielded discounted gains of 1.02 to 1.07 QALYs per person. Including only health care sector costs, methadone cost $16 000/QALY gained compared with no treatment, followed by methadone with OEND ($22 000/QALY gained), then by buprenorphine with OEND and CM ($42 000/QALY gained), and then by buprenorphine with OEND, CM, and psychotherapy ($250 000/QALY gained). MAT with naltrexone was dominated by other treatment alternatives. When criminal justice costs were included, all forms of MAT (with buprenorphine, methadone, and naltrexone) were associated with cost savings compared with no treatment, yielding savings of $25 000 to $105 000 in lifetime costs per person. The largest cost savings were associated with methadone plus CM. Results were qualitatively unchanged over a wide range of sensitivity analyses. An analysis using demographic and cost data for Veterans Health Administration patients yielded similar findings. Conclusions and Relevance: In this cost-effectiveness analysis, expanded access to MAT, combined with OEND and CM, was associated with cost-saving reductions in morbidity and mortality from OUD. Lack of widespread MAT availability limits access to a cost-saving medical intervention that reduces morbidity and mortality from OUD. Opioid overdoses in the US likely reached a record high in 2020 because of COVID-19 increasing substance use, exacerbating stress and social isolation, and interfering with opioid treatment. It is essential to understand the cost-effectiveness of alternative forms of MAT to treat OUD.

Cost-Effectiveness of Providing the Depression Care for People With Cancer Program to Patients With Prostate Cancer in the United States.

OBJECTIVES: The Depression Care for People with Cancer program (DCPC) is a cost-effective depression care model for UK patients with cancer. However, DCPC's cost-effectiveness in the United States is unknown, particularly for patients with prostate cancer in the United States. This study evaluates the health and economic impact of providing DCPC to patients with prostate cancer. METHODS: DCPC was compared with usual care in a mathematical model that simulates depression and its outcomes in a hypothetical cohort of US patients with prostate cancer. DCPC was modeled as a sequential combination of universal depression screening, post-screening evaluations, and first-line combination therapy. Primary outcomes were lifetime direct costs of depression care, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Secondary outcomes included life expectancy, number of depression-free months and lifetime depressive episodes, duration of depressive episodes, cumulative incidence of depression, lifetime depression diagnoses/misdiagnoses, and the cumulative incidence of maintenance therapy for depression. Sensitivity analyses were used to examine uncertainty. RESULTS: In the base case, DCPC dominated usual care by offering 0.11 more QALYs for $2500 less per patient (from averted misdiagnoses). DCPC also offered 5 extra depression-free months, shorter depressive episodes, and a lower chance of maintenance therapy. DCPC's trade-offs were a higher cumulative incidence of depression and more lifetime depressive episodes. Life expectancy was identical under usual care and DCPC. Sensitivity analyses indicate that DCPC was almost always preferable to usual care. CONCLUSION: Compared with usual care, DCPC may offer more value to US patients with prostate cancer. DCPC should be considered for inclusion in prostate cancer survivorship care guidelines.

Cost-Effectiveness of Depression Screening for Otolaryngology-Head and Neck Surgery Residents.

OBJECTIVES: This study aims to determine the cost-effectiveness of screening and treating otolaryngology-head and neck surgery residents for depression. METHODS: A Markov model was built using TreeAgePro, version 2019 (TreeAge Software Inc.; Williamstown, MA) to assess the cost-effectiveness of five potential treatment algorithms: 1) treat all residents with psychotherapy, 2) screen and treat depressed residents with psychotherapy, 3) screen and treat depressed residents with pharmacotherapy, 4) screen and treat depressed residents with combination psychotherapy/pharmacotherapy, and 5) no intervention. A Monte Carlo probabilistic sensitivity analysis (PSA), consisting of 1 thousand simulations over a cumulative 5-year period, was performed to evaluate both base case values and a range of values for model variables. RESULTS: Screening residents for depression and treating with combination psychotherapy/pharmacotherapy was cost-effective and the optimal strategy at a willingness-to-pay threshold of $50 thousand per quality-adjusted life year (QALY). This option demonstrated an incremental cost-effectiveness ratio of $27,578 per QALY for base case values. PSA confirmed these results and demonstrated that screening residents for depression and treating with either combination pharmacotherapy/psychotherapy, pharmacotherapy alone, or psychotherapy alone were cost-effective options in 94.9% of simulations. CONCLUSION: Depression and burnout remain crucial issues among resident physicians. This study demonstrates that actively screening residents for depression is cost-effective. Based on these results, residency programs may consider trialing standardized depression screening protocols. LEVEL OF EVIDENCE: I and II. Laryngoscope, 131:502-508, 2021.

The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD.

BACKGROUND: Chronic posttraumatic stress disorder (PTSD) is a disabling condition that generates considerable morbidity, mortality, and both medical and indirect social costs. Treatment options are limited. A novel therapy using 3,4-methylenedioxymethamphetamine (MDMA) has shown efficacy in six phase 2 trials. Its cost-effectiveness is unknown. METHODS AND FINDINGS: To assess the cost-effectiveness of MDMA-assisted psychotherapy (MAP) from the health care payer's perspective, we constructed a decision-analytic Markov model to portray the costs and health benefits of treating patients with chronic, severe, or extreme, treatment-resistant PTSD with MAP. In six double-blind phase 2 trials, MAP consisted of a mean of 2.5 90-minute trauma-focused psychotherapy sessions before two 8-hour sessions with MDMA (mean dose of 125 mg), followed by a mean of 3.5 integration sessions for each active session. The control group received an inactive placebo or 25-40 mg. of MDMA, and otherwise followed the same regimen. Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Efficacy was based on the pooled results of six randomized controlled phase 2 trials with 105 subjects; and a four-year follow-up of 19 subjects. Other inputs were based on published literature and on assumptions when data were unavailable. We modeled results over a 30-year analytic horizon and conducted extensive sensitivity analyses. Our model calculates expected medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Future costs and QALYs were discounted at 3% per year. For 1,000 individuals, MAP generates discounted net savings of $103.2 million over 30 years while accruing 5,553 discounted QALYs, compared to continued standard of care. MAP breaks even on cost at 3.1 years while delivering 918 QALYs. Making the conservative assumption that benefits cease after one year, MAP would accrue net costs of $7.6 million while generating 288 QALYS, or $26,427 per QALY gained. CONCLUSION: MAP provided to patients with severe or extreme, chronic PTSD appears to be cost-saving while delivering substantial clinical benefit. Third-party payers are likely to save money within three years by covering this form of therapy.

Burden of Illness in Alopecia Areata: A Cross-Sectional Online Survey Study.

Previous QOL and disease burden studies have not captured all relevant aspects of living with alopecia areata (AA). To better understand the burden and everyday experience of living with moderate-to-severe AA, a cross-sectional, online, quantitative-qualitative survey was developed to assess symptoms, relationships, productivity, treatments, and financial burden. Adult patients were recruited from the National Alopecia Areata Foundation database. Data were analyzed descriptively. A total of 216 patients completed the survey. Most were female (83%), aged ≥45 years (59%), and white (78%). Nearly 2 of 3 respondents (62%) made different major life decisions (regarding relationships, education, or career) owing to AA. Most respondents (85%) stated coping with AA as a daily challenge, citing mental health issues, concealing hair loss, and others' reactions; 47% reported anxiety and/or depression. Many patients (75%) persistently concealed hair loss (mean time spent, 10.3 h/wk). Treatment discontinuation was common owing to lack of efficacy, side effects, and cost. Associated expenditures included buying wigs or hairpieces and psychotherapy (mean ∼$2,000/y each). Survey respondents comprised a self-selected sample, which may not reflect the entire population. The impact of AA extends beyond cosmetic concerns and carries a considerable psychosocial burden. Efficacious, less burdensome AA treatments are needed to regrow hair and alleviate psychosocial sequelae.

Autism Spectrum Social Stories In Schools Trial 2 (ASSSIST2): study protocol for a randomised controlled trial analysing clinical and cost-effectiveness of Social Stories™ in primary schools.

BACKGROUND: Interventions designed to support children with a diagnosis of Autism Spectrum Conditions (ASC) can be time consuming, needing involvement of outside experts. Social Stories™ are a highly personalised intervention aiming to give children with ASC social information or describing an otherwise difficult situation or skill. This can be delivered daily by staff in education settings. Studies examining Social Story™ use have yielded mostly positive results but have largely been single case studies with a lack of randomised controlled trials (RCTs). Despite this numerous schools are utilising Social Stories™, and a fully powered RCT is timely. METHODS: A multi-site pragmatic cluster RCT comparing care as usual with Social Stories™ and care as usual. This study will recruit 278 participants (aged 4-11) with a clinical diagnosis of ASC, currently attending primary school in the North of England. Approximately 278 school based staff will be recruited to provide school based information about participating children with approximately 140 recruited to deliver the intervention. The study will be cluster randomised by school. Potential participants will be screened for eligibility prior to giving informed consent. Follow up data will be collected at 6 weeks and 6 months post randomisation and will assess changes in participants' social responsiveness, goal based outcomes, social and emotional health. The primary outcome measure is the Social Responsiveness Scale Second Edition (SRS-2) completed by school based staff at 6 months. Approvals have been obtained from the University of York's Research Governance Committee, Research Ethics Committee and the Health Research Authority. Study results will be submitted for publication in peer-reviewed journals and disseminated to participating families, educational staff, local authority representatives, community groups and Patient and Participant Involvement representatives. Suggestions will be made to NICE about treatment evidence dependent on findings. DISCUSSION: This study addresses a much used but currently under researched intervention and results will inform school based support for primary school children with a diagnosis of ASC. TRIAL REGISTRATION: The trial is registered on the ISRCTN registry (registration number: ISRCTN11634810). The trial was retrospectively registered on 23rd April 2019.

Psicoterapia: quanto custa a sessão? / Psychotherapy: how much should a session cost? / Psicoterapia: ¿cuanto cuesta la sesión? / Psychotherapy: how much should a session cost?

Esta pesquisa teve como objetivo conhecer as principais dificuldades enfrentadas pelos psicólogos no processo de estabelecimento dos seus honorários referente aos serviços de psicologia clínica na cidade de Caruaru/PE. Foi executada através de métodos qualitativos, sendo utilizada a entrevista semidirigida para coleta dos dados e na sistematização dos dados utilizamos a análise de conteúdo de Bardin. Participaram da pesquisa três psicólogas que residem e trabalham na cidade referida. Ficou evidente que as orientações sobre o estabelecimento dos honorários na prática clínica ou inexistiram ou foram inconsistentes; quando o assunto são as dificuldades enfrentadas ao estabelecer o valor da sessão percebemos certa ansiedade quando necessitam negociar o valor com o paciente devido à falta de instrução. Ao final, percebemos que as vivências práticas que facilitaram o manejo do dinheiro na relação, foram as trocas de experiência entre os colegas, a flexibilização do valor a partir da necessidade real do cliente e principalmente da forma de pagamento. Concluímos que se faz necessário sensibilizar as instituições de ensino de psicologia e seus professores para sistematizar discussões sobre o tema, apesar de compreendermos que não existe consenso sobre o assunto e que precisamos fomentar mais pesquisas nesta área para proporcionar um maior suporte teórico.

This research aimed to study the main difficulties faced by psychologists in the process of establishing their fees for clinical psychology services in the city of Caruaru / PE. It was performed using qualitative methods, using semi--directed interview for data collection and tabulation using Bardin content analysis. Three psychologists living and working in this city participated in the study. It became obvious that the guidelines on the establishment of fees in clinical practice either did not exist or were inconsistent when the subject faced difficulties in establishing the cost of the session. We perceived anxiety when negotiation with the patient was required and this was attributed to a lack of education. In the end, we realized that the practical experiences that facilitated the management of money in the relationship were the exchange of experience among colleagues, the flexibility needed due to client's financial issues and also payment format. We conclude that it is necessary to educate psychology teaching institutions and their teachers to systematize discussions about the subject although we understand that there is no consensus on the subject and we need to encourage more research in this area to provide greater theoretical support.

Esta investigación tuvo como objetivo conocer las principales dificultades enfrentadas por los psicólogos en el proceso de establecer sus honorarios rela-cionados con los servicios de psicología clínica en la ciudad de Caruaru / PE. Fue realizada a través de métodos cualitativos, siendo utilizada la entrevista semidirigida para la recolección de datos y en la sistematización de los datos se utilizó el análisis de contenido de Bardin. Participaron de la investigación tres psicólogas que residen y trabajan en la ciudad citada. Fue evidente que las orientaciones sobre el establecimiento de los honorarios en la practica clínica o no existieron o fueron inconsistente; cuando el asunto son las dificultades enfrentadas al establecer el valor de la sesión se notó cierta ansiedad cuando necesitan negociar el valor con el paciente debido a falta de instrucción. Al final, fue percibido que las vivencias practicas que facilitaron el manejo del dinero en la relación, fueron los intercambios de experiencia entre los colegas, la flexibilización del valor a partir de la necesidad real del cliente y principal-mente la forma de pagamento. Se concluyo que es necesario sensibilizar las instituciones de enseñanza de psicología y sus profesores para sistematizar discusiones sobre el tema, a pesar de comprender que no existe consenso sobre el asunto y que es necesario fomentar más investigaciones en esta área para proporcionar un soporte teórico mayor.

Access to psychotherapy for patients with personality disorders.

The best evidence for effective treatment of personality disorder supports the use of specialized forms of psychotherapy. However, these forms of treatment are generally unavailable in health care systems. This may be partly due to the expense of routinely offering long-term therapies. There is evidence that psychotherapy for personality disorder is cost-effective. One way to address this problem is to treat most patients more briefly. © 2020 John Wiley & Sons, Ltd.

Computerized intervention for reducing intimate partner victimization for perinatal women seeking mental health treatment: A multisite randomized clinical trial protocol.

Intimate partner victimization (IPV) is a significant social and public health problem among perinatal women. Research suggests that 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, IPV places women at high risk for several psychiatric disorders, which transforms the perinatal period from an already challenging process into a potentially overwhelming one. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. Given the high rates of IPV among women who seek mental health treatment, mental health clinics compared to other medical settings are more effective sites for focused case finding and intervention. Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment (SURE). SURE is a brief, interactive program consistent with motivational interviewing and incorporates empowerment strategies. The proposed multisite randomized clinical trial (N = 186) will test whether SURE relative to control is associated with reduced IPV, greater positive affect and well-being, and greater perceived emotional support. We will also evaluate the role of theoretical mediators of empowerment and self-efficacy. Finally, we will estimate the resources needed and costs to deliver SURE, as well as the incremental cost effectiveness of SURE compared with treatment as usual. If SURE is found to be efficacious and cost effective, it can be easily integrated into clinical care and will fill a critical gap for a vulnerable, high-risk population.

Implanting Rhizomes in Vermont: a Qualitative Study of How the Open Dialogue Approach was Adapted and Implemented.

The Open Dialogue approach was developed in Finland in the 1980s as a form of psychotherapy and a way to organize mental health systems. It has been adapted and implemented in several countries in recent years. This qualitative study sought to explore staff and developers' experiences with one adaptation of the Open Dialogue approach in the state of Vermont called the Collaborative Network Approach. In total twenty two staff members from two agencies participated in focus groups and three developers of the approach were interviewed. Three dominant topics emerged in the analysis process: impact of training; buy-in across levels; and shift in organizational culture. Findings revealed that 1) participants experienced the Collaborative Network Approach as positively impacting their clinical work, relationship with clients and families, and with colleagues; 2) buy-in across levels - colleagues, management and department of mental health - was perceived as crucial to the development and implementation of the approach; 3) the main challenges to full implementation were: inadequate billing structures, costly and lengthy training, and resistance to shift organizational culture to integrate the Collaborative Network Approach into agencies. We hope to have contributed to the field in a way that will support further efforts to develop and implement Open Dialogue-informed approaches by pointing to potential successes and challenges future program developers may face.

Research on Improving Outcomes and Reducing Costs of Psychological Interventions: Toward Delivering the Best to the Most for the Least.

Treatment and prevention efforts guided by psychological theory, research, and practice can have outcomes of greater value than the resources consumed by those efforts-and outcomes superior to those attainable by other means, often at lower costs. How can we make this hope true more often, for more of the clients who need our services, despite severe resource constraints? Routinely reporting the costs, effectiveness, and benefits of psychological interventions from client, practitioner, and societal perspectives is only a beginning. We also need to use descriptive and inferential statistics to measure, report, and analyze the cost-effectiveness and cost-benefit of our interventions to discover the strongest determinants of intervention costs and outcomes. The emerging literature on cost-inclusive research in psychology suggests that delivery systems are one primary determinant of costs and outcomes of most interventions, as are the psychological techniques applied.

Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): protocol for a stepped wedge cluster randomized trial.

BACKGROUND: The mental health treatment gap-the difference between those with mental health need and those who receive treatment-is high in low- and middle-income countries. Task-shifting has been used to address the shortage of mental health professionals, with a growing body of research demonstrating the effectiveness of mental health interventions delivered through task-shifting. However, very little research has focused on how to embed, support, and sustain task-shifting in government-funded systems with potential for scale up. The goal of the Building and Sustaining Interventions for Children (BASIC) study is to examine implementation policies and practices that predict adoption, fidelity, and sustainment of a mental health intervention in the education sector via teacher delivery and the health sector via community health volunteer delivery. METHODS: BASIC is a Hybrid Type II Implementation-Effectiveness trial. The study design is a stepped wedge, cluster randomized trial involving 7 sequences of 40 schools and 40 communities surrounding the schools. Enrollment consists of 120 teachers, 120 community health volunteers, up to 80 site leaders, and up to 1280 youth and one of their primary guardians. The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza. Lay counselors are trained and supervised in Pamoja Tunaweza by local trainers who are experienced in delivering the intervention and who participated in a Train-the-Trainer model of skills transfer. After the first sequence completes implementation, in-depth interviews are conducted with initial implementing sites' counselors and leaders. Findings are used to inform delivery of implementation facilitation for subsequent sequences' sites. We use a mixed methods approach including qualitative comparative analysis to identify necessary and sufficient implementation policies and practices that predict 3 implementation outcomes of interest: adoption, fidelity, and sustainment. We also examine child mental health outcomes and cost of the intervention in both the education and health sectors. DISCUSSION: The BASIC study will provide knowledge about how implementation of task-shifted mental health care can be supported in government systems that already serve children and adolescents. Knowledge about implementation policies and practices from BASIC can advance the science of implementation in low-resource contexts. TRIAL REGISTRATION: Trial Registration: ClinicalTrials.gov Identifier: NCT03243396. Registered 9th August 2017, https://clinicaltrials.gov/ct2/show/NCT03243396.

Cost-effectiveness of psychological interventions for children and young people with post-traumatic stress disorder.

BACKGROUND: PTSD in youth may lead to long-lasting psychological implications, educational difficulties and increased healthcare costs. Psychological interventions have been shown to be effective in its management. The objective of this study was to assess the cost-effectiveness of a range of psychological interventions for children and young people with PTSD. METHODS: A decision-analytic model was constructed to compare costs and quality-adjusted life years (QALYs) of 10 psychological interventions and no treatment for children and young people with PTSD, from the perspective of the National Health Service and personal social services in England. Effectiveness data were derived from a systematic review and network meta-analysis. Other model input parameters were based on published sources, supplemented by expert opinion. RESULTS: Cognitive therapy for PTSD, a form of individual trauma-focused cognitive behavioural therapy (TF-CBT), appeared to be the most cost-effective intervention for children and young people with PTSD (with a probability of .78 amongst the 11 evaluated options at a cost-effectiveness threshold of £20,000/QALY), followed by narrative exposure (another form of individual TF-CBT), play therapy, and other forms of individual TF-CBT. After excluding cognitive therapy from the analysis, narrative exposure appeared to be the most cost-effective option with a .40 probability of being cost-effective amongst the remaining 10 options. EMDR, parent training and group TF-CBT occupied middle cost-effectiveness rankings. Family therapy and supportive counselling were less cost-effective than other active interventions. There was limited evidence for some interventions, in particular cognitive therapy for PTSD and parent training. CONCLUSIONS: Individual forms of TF-CBT and, to a lesser degree, play therapy appear to be cost-effective in the treatment of children and young people with PTSD. Family therapy and supportive counselling are unlikely to be cost-effective relative to other interventions. There is a need for well-conducted studies that examine the long-term clinical and cost-effectiveness of a range of psychological treatments for children and young people with PTSD.

Psychotherapy in Psychiatry: Fighting Alternative Facts.

In the Canadian province of Ontario, the Ministry of Health and Long-Term Care is proposing to impose arbitrary limits on access to psychotherapy provided by physicians. This column presents and debunks 3 myths associated with this ill-conceived proposal: (1) that long-term psychotherapy costs the health care system too much money, making it necessary for the government to curb this spending; (2) that long-term psychotherapy is a non-evidence-based treatment being needlessly spent on the worried well; and (3) that we need to focus on quick treatments, not long ones.

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.

Decision-based models of the implementation of interventions in systems of healthcare: Implementation outcomes and intervention effectiveness in complex service environments.

Implementation is a crucial component for the success of interventions in health service systems, as failure to implement well can have detrimental impacts on the effectiveness of evidence-based practices. Therefore, evaluations conducted in real-world contexts should consider how interventions are implemented and sustained. However, the complexity of healthcare environments poses considerable challenges to the evaluation of interventions and the impact of implementation efforts on the effectiveness of evidence-based practices. In consequence, implementation and intervention effectiveness are often assessed separately in health services research, which prevents the direct investigation of the relationships of implementation components and effectiveness of the intervention. This article describes multilevel decision juncture models based on advances in implementation research and causal inference to study implementation in health service systems. The multilevel decision juncture model is a theory-driven systems approach that integrates structural causal models with frameworks for implementation. This integration enables investigation of interventions and their implementation within a single model that considers the causal links between levels of the system. Using a hypothetical youth mental health intervention inspired by published studies from the health service research and implementation literature, we demonstrate that such theory-based systems models enable investigations of the causal pathways between the implementation outcomes as well as their links to patient outcomes. Results from Monte Carlo simulations also highlight the benefits of structural causal models for covariate selection as consistent estimation requires only the inclusion of a minimal set of covariates. Such models are applicable to real-world context using different study designs, including longitudinal analyses which facilitates the investigation of sustainment of interventions.