Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial).

BACKGROUND: Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. METHODS: In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation. DISCUSSION: To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany. TRIAL REGISTRATION: ClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.

[Treatment clusters and personnel assessment in psychosomatic medicine and psychotherapy - results of a feasibility study of the platform model]. / Behandlungscluster und Personalbemessung in der psychosomatischen Medizin und Psychotherapie ­ Ergebnisse einer Machbarkeitsstudie zum Plattformmodell.

Treatment clusters and personnel assessment in psychosomatic medicine and psychotherapy - results of a feasibility study of the platform model Objectives: In accordance with the legal requirements of the PsychVVG, it is necessary to develop criteria for inpatient and day-care psychosomatic psychotherapeutic care, which can be used to determine the appropriate staffing for different treatment areas and different care structures. For psychosomatic medicine and psychotherapy a model with four treatment clusters was developed, which is oriented on the one hand to the psychotherapeutic intensity and on the other hand to the medical expenditure. Method: In three consecutive rounds with up to 30 experts, representative selected from the three institution types university hospital, departmental psychosomatic medicine and specialized clinic, the minute values per patient required for a treatment according to the guidelines were determined using the Delphi method. Newly developed activity profiles for the six occupational groups were used, which allow the recording of all patient- and setting-related activities. Results: With the results of the feasibility study, an instrument has been developed for the first time to determine the requirements of staffing in psychosomatic medicine. Convergent minute values could be formulated for three of the four treatment clusters. Conclusions: The provision of care in psychosomatic medicine and psychotherapy is complex, so that a limitation to four treatment areas is only possible if significantly more generous equivalence rules are applied between the professional groups than those laid down in the PPP Directive.

Economic evaluation of cognitive behavioral therapy and Internet-based guided self-help for binge-eating disorder.

OBJECTIVE: To determine the cost-effectiveness of individual face-to-face cognitive behavioral therapy (CBT) compared to therapist guided Internet-based self-help (GSH-I) in overweight or obese adults with binge-eating disorder (BED). METHOD: Analysis was conducted alongside the multicenter randomized controlled INTERBED trial. CBT (n = 76) consisted of up to 20 individual therapy sessions over 4 months. GSH-I (n = 71) consisted of 11 modules combining behavioral interventions, exercises including a self-monitoring food diary, psychoeducation, and 2 face-to-face coaching sessions over 4 months. Assessments at baseline, after 4 months (post-treatment), as well as 6 and 18 months after the end of treatment included health care utilization and sick leave days to calculate direct and indirect costs. Binge-free days (BFD) were calculated as effect measure based on the German version of the Eating Disorder Examination. The incremental cost-effectiveness ratio (ICER) was determined, and net benefit regressions, adjusted for comorbidities and baseline differences, were used to derive cost-effectiveness acceptability curves. RESULTS: After controlling for baseline differences, CBT was associated with non-significantly more costs (+€2,539) and BFDs (+40.1) compared with GSH-I during the 22-month observation period, resulting in an adjusted ICER of €63 per additional BFD. CBTs probability of being cost-effective increased above 80% only if societal willingness to pay (WTP) was ≥€250 per BFD. DISCUSSION: We did not find clear evidence for one of the treatments being more cost-effective. CBT tends to be more effective but also more costly. If the societal WTP for an additional BFD is low, then our results suggest that GSH-I should rather be adopted.

[Staffing level: Survey among psychosomatic-psychotherapeutic institutions in Germany]. / Personalausstattung: Befragung psychosomatischpsychotherapeutischer Kliniken und Abteilungen in Deutschland.

Staffing level: Survey among psychosomatic-psychotherapeutic institutions in Germany Objectives: To establish the first nationwide hospital survey to assess the level of staffing for inpatient and daycare treatment in psychosomatic hospitals and specialist departments in Germany. METHODS: Using a standardized written hospital survey from the Deutsches Krankenhausinstitut (DKI), we invited a total of 218 psychosomatic-psychotherapeutic hospitals and specialist departments to participate. The participation rate of the institutions was 35%. RESULTS: In the overall sample, one psychotherapist (physician/clinical psychologist) was responsible for treating a median of 3.9 beds/patients (interquartile range 3.1-5.1) and one nurse a median of 2.9 beds/patients (interquartile range 2.3-3.9). There were significant differences for the nurse-patient ratio depending on the organizational size of the institution. To ensure quality treatment, professional experts saw increased staffing needs of about 12-17% across both professions. For the professional groups of specialist therapists and social workers, broad variances were observed for the therapist-patient ratio in the overall sample. CONCLUSIONS: The study provides an important and relevant data basis for the further discussion to determine mandatory minimal staffing levels in German psychosomatic-psychotherapeutic institutions.

When do we need to care about the caregiver? Supportive care needs, anxiety, and depression among informal caregivers of patients with cancer and cancer survivors.

BACKGROUND: Cancer not only affects patients but also their caregivers. The objective of the current study was to assess the unmet needs of cancer caregivers and to identify possible predictors of their supportive care needs. METHODS: In a cross-sectional survey, 188 dyads of patients diagnosed with lung, urological, or gastrointestinal cancer and their primary caregivers were recruited. Caregivers were asked to complete the Supportive Care Needs Survey self-report questionnaire (for partners and caregivers); patients completed the corresponding questionnaire. Both groups provided information regarding their distress (National Comprehensive Cancer Network Distress Thermometer), anxiety, and depression (Patient Health Questionnaire-4). Clinical characteristics were obtained from medical records. RESULTS: The mean age of the caregivers was 57.8 years. Approximately 72.3% were female. Patients had an average age of 62.5 years, with 33.0% being male. Caregivers were more distressed (P<.01) and exhibited higher anxiety scores (P<.01) compared with patients. Approximately 14.4% of caregivers reported no unmet need and 43.6% had at least 10 needs that were unmet. Main caregiver concerns were regarding health care service and information needs followed by emotional and psychological needs. To some degree, unmet needs in patients and caregivers' anxiety predicted unmet caregiver needs. Sociodemographic and clinical variables were not found to be significant predictors. CONCLUSIONS: A substantial percentage of caregivers have unmet needs for support, mainly with regard to fears concerning the patient's condition, receiving disease-related information, and emotional support for themselves. Prediction of unmet needs in caregivers from other clinical and psychological variables was rather poor. Therefore, by means of the frequency and disparity of caregivers unmet needs, they should be systematically assessed to direct specific offers.

Therapist adherence in individual cognitive-behavioral therapy for binge-eating disorder: assessment, course, and predictors.

While cognitive-behavioral therapy (CBT) is the most well-established treatment for binge-eating disorder (BED), little is known about process factors influencing its outcome. The present study sought to explore the assessment of therapist adherence, its course over treatment, and its associations with patient and therapist characteristics, and the therapeutic alliance. In a prospective multicenter randomized-controlled trial comparing CBT to internet-based guided self-help (INTERBED-study), therapist adherence using the newly developed Adherence Control Form (ACF) was determined by trained raters in randomly selected 418 audio-taped CBT sessions of 89 patients (25% of all sessions). Observer-rated therapeutic alliance, interview-based and self-reported patient and therapist characteristics were assessed. Three-level multilevel modeling was applied. The ACF showed adequate psychometric properties. Therapist adherence was excellent. While significant between-therapist variability in therapist adherence was found, within-therapist variability was non-significant. Patient and therapist characteristics did not predict the therapist adherence. The therapist adherence positively predicted the therapeutic alliance. The ACF demonstrated its utility to assess therapist adherence in CBT for BED. The excellent levels of therapist adherence point to the internal validity of the CBT within the INTERBED-study serving as a prerequisite for empirical comparisons between treatments. Variability between therapists should be addressed in therapist trainings and dissemination trials.

INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder. A multicenter randomized controlled trial.

BACKGROUND: Binge eating disorder (BED) is a prevalent clinical eating disorder associated with increased psychopathology, psychiatric comorbidity, overweight and obesity, and increased health care costs. Since its inclusion in the DSM-IV, a few randomized controlled trials (RCTs) have suggested efficacy of book-based self-help interventions in the treatment of this disorder. However, evidence from larger RCTs is needed. Delivery of self-help through new technologies such as the internet should be investigated in particular, as these approaches have the potential to be more interactive and thus more attractive to patients than book-based approaches. This study will evaluate the efficacy of an internet-based guided self-help program (GSH-I) and cognitive-behavioral therapy (CBT), which has been proven in several studies to be the gold standard treatment for BED, in a prospective multicenter randomized trial. METHODS: The study assumes the noninferiority of GSH-I compared to CBT. Both treatments lasted 4 months, and maintenance of outcome will be assessed 6 and 18 months after the end of treatment. A total of 175 patients with BED and a body mass index between 27 and 40 kg/m2 were randomized at 7 centers in Germany and Switzerland. A 20% attrition rate was assumed. As in most BED treatment trials, the difference in the number of binge eating days over the past 28 days is the primary outcome variable. Secondary outcome measures include the specific eating disorder psychopathology, general psychopathology, body weight, quality of life, and self-esteem. Predictors and moderators of treatment outcome will be determined, and the cost-effectiveness of both treatment conditions will be evaluated. RESULTS: The methodology for the INTERBED study has been detailed. CONCLUSIONS: Although there is evidence that CBT is the first-line treatment for BED, it is not widely available. As BED is still a recent diagnostic category, many cases likely remain undiagnosed, and a large number of patients either receive delayed treatment or never get adequate treatment. A multicenter efficacy trial will give insight into the efficacy of a new internet-based guided self-help program and will allow a direct comparison to the evidence-based gold standard treatment of CBT in Germany. TRIAL REGISTRATION: Current Controlled Trials ISRCTN40484777. German Clinical Trial Register DRKS00000409.

[Psychiatric comorbidity in medical inpatients - prevalence and effect on the length of stay]. / Psychische Komorbidität bei internistischen Krankenhauspatienten - Prävalenz und Einfluss auf die Liegedauer -

In the course of a year the prevalence of psychiatric comorbidity as well as the effect of psychiatric comorbidity on the length of stay on two internal medical wards we investigated. When examined by separate methods, the prevalence of psychiatric comorbidity reached 36 % (ICD-10 diagnosis) in a sample of 511 medical inpatients of a university hospital. The study shows that patients with psychiatric comorbidity have a significantly longer length of stay - up to 8.2 days compared with inpatients with mere internal diagnosis. This association was not influenced by the length and the severity of the illness. The findings lead to the conclusion that psychiatric comorbidity is a central contributor to one of the most important factors of medical costs - the length of stay.