An integrated mental health video consultations model for patients with somatic symptom disorder in primary care: The randomized VISION pilot trial.

OBJECTIVE: Symptoms of somatic symptom disorder (SSD) are one of the most common reasons for consultations in primary care. However, specialized psychological services are mostly unavailable. This pilot trial aimed to determine the feasibility, acceptability, and safety of the integrated mental health video consultations VISION model for patients with SSD in primary care. METHODS: We conducted a parallel group, randomized controlled pilot trial involving fifty-one patients with SSD from ten primary care practices in Germany, who we randomized to the VISION model or enhanced treatment-as-usual (eTAU). The VISION model comprised five video consultations which featured diagnostic clarification, psychoeducation (acknowledging and legitimizing of symptoms), and brief psychological therapy. eTAU included training primary care practice teams on the DSM-5 concept of SSD and on current guideline recommendations for its treatment in primary care. We assessed feasibility as the primary outcome at 6-months, measuring efficiency of recruitment, intervention acceptability, and safety. RESULTS: Recruitment was efficient reflected in an overall recruitment yield (number randomized per number screened) of 55% (51/92) and a consent rate (number randomized per number eligible) of 94% (51/54). Acceptability of the intervention was high with 98% (123/125) of the video consultations conducted as planned. No serious adverse events were reported in either group. CONCLUSION: An integrated mental health video consultations VISION model for patients with SSD presenting to primary care is feasible, acceptable, and safe. Potential clinical effectiveness of the model should be evaluated in confirmatory trial implementing the multifaceted approach tailored to the individual patient with SSD directly into primary care practice. TRIAL REGISTRATION: The trial protocol was registered at German Clinical Trials Register (number: DRKS00026075, https://www.drks.de).

An Online Decision Aid for Patients With Metastatic Melanoma­Results of the Randomized Controlled Trial "PEF-Immun".

BACKGROUND: Treatment decisions in metastatic melanoma (MM) depend on patient preferences and require the patients' involvement in the decision-making process. Patients often feel overwhelmed by the complexity of treatment options with their individual advantages and disadvantages. We developed an online patient decision aid (PtDA) to facilitate shared decision making (SDM). METHODS: We conducted a two-center, two-armed, prospective, open randomized controlled trial with MM patients who were facing a decision about first-line treatment. They were randomly allotted (1:1) to the use or non-use of the PtDA before discussing the choice of treatment with a physician (intervention group [IG] and control group [CG], respectively). The primary endpoint of the study was patient knowledge about first-line treatment options (multiple-choice test, 10 items, range 0-40 points). The secondary endpoints were the degree of SDM (ratings of audio recordings of the patient-physician discussions by third-party observers) and satisfaction with the decision that was taken on later follow-up. RESULTS: 120 of the 128 randomized patients completed the baseline questionnaire and were included in the analysis (59% male, median age 66 years). The primary endpoint, i.e., the mean difference in knowledge after discussion with a physician, was significantly higher in the intervention group (mean difference -3.22, 95% CI [-6.32;-0.12], p = 0.042). No difference was found in either of the secondary endpoints (SDM and satisfaction with the decision). The patients in the intervention group rated the PtDA as very useful. CONCLUSION: PtDA improved MM patients' knowledge about their options for treatment. Both patients who used it and patients who did not were highly satisfied with their treatment decisions. Additional physician training seems necessary to promote SDM.

Oncology clinicians' feelings towards patients presented in supervision: A pre-post assessment using the feeling word checklist.

OBJECTIVE: Clinical supervision of oncology clinicians by psycho-oncologists is an important means of psychosocial competence transfer and support. Research on this essential liaison activity remains scarce. The aim of this study was to assess the impact of supervision on oncology clinicians' feelings towards patients presented in supervision. METHODS: Oncology clinicians' (n = 23) feelings towards patients presented in supervision were assessed with the Feeling Word Checklist (FWC). The FWC was filled in by supervisees prior and after their supervision sessions (n = 91), which were conducted by experienced supervisors (n = 6). Pre- post-modification of feelings was evaluated based on a selection of FWC items, which were beforehand considered as likely to change in a beneficial supervision. Items were evaluated on session level using t-tests for dependent groups. Composite scores were calculated for feelings expected to raise and feelings expected to decrease and analysed on the level of supervisees. RESULTS: Feelings related to threats, loss of orientation or hostility such as "anxious", "overwhelmed", "impotent", "confused", "angry", "depreciated" and "guilty" decreased significantly after supervision, while feelings related to the resume of the relationship ("attentive", "happy"), a better understanding of the patient ("empathic"), a regain of control ("confident") and being "useful" significantly increased. Feeling "interested" and "calm" remained unchanged. Significant increase or decrease in the composite scores for supervisees confirmed these results. CONCLUSIONS: This study demonstrates modification of feelings towards patients presented in supervision. This modification corresponds to the normative, formative, and especially restorative function (support of the clinician) of supervision.

Outpatient Psychotherapy in Germany­An Evaluation of the Structural Reform.

BACKGROUND: A structural reform of the German psychotherapy guideline in 2017 was intended to facilitate access to outpatient guideline psychotherapy. In the present study, we evaluate the effects of this reform in particular for patients a comorbidity of mental disorders and chronic physical conditions (cMP). METHODS: Pre-post analyses of the two primary endpoints "percentage of mentally ill persons who have made an initial contact with a psychotherapist" and "waiting time for guideline psychotherapy" were carried out employing population-based and weighted routine statutory health insurance data from the German BARMER. The secondary endpoints included evaluations from the patients' perspective, based on a representative survey of patients in psychotherapy, and an overview of the health care situation based on data from the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, KBV) (study registration number: DRKS00020344). RESULTS: From 2015 to 2018, the percentage of mentally ill persons who had made an initial contact with a psychotherapist rose moderately, from 3.7% (95% confidence interval, [3.6; 3.7]) to 3.9% [3.8; 3.9] among persons with cMP and from 7.3% [7.2; 7.4] to 7.6% [7.5; 7.7] among those with mental disorders but without any chronic phyisical condition (MnoP). The new structural elements were integrated into patient care. The interval of time between the initial contact and the beginning of guideline psychotherapy became longer in both groups, from a mean of 80.6 [79.4; 81.8] to 114.8 [113.4; 116.2] days among persons with complex disease and from 80.2 [79.2; 81.3] to 109.6 [108.4; 111.0] days among persons with non-complex disease; most patients considered the waiting time. Approximately 8% of the patients who sought psychotherapy reported that they had not obtained access to a psychotherapist. CONCLUSION: Neither in general nor for patients with cMP did the introduction of the structural reform appreciably lower the access barriers to psychotherapy. Further steps are needed so that outpatient care can meet the needs of all patients and particularly those with cMP.

From inpatient to outpatient mental health care: Protocol for a randomised feasibility trial of a care transition intervention for patients with depression and anxiety (the AMBITION-trial).

INTRODUCTION: Despite guideline recommendations, inpatients with mental health disorders often do not receive appropriate treatment after discharge. This leads to high readmission rates, problems with medication adherence, increased risk of chronicity and suicide, and exclusion from the labour market accompanied by high individual and social costs. The causes are both system-related, such as limited treatment availability, and patient-related, such as ambivalent motivation to continue treatment and lack of information about available treatment options. The aim of this trial is to assess the feasibility of a Care Transition Intervention (CTI) which supports patients in the psychosocial follow-up treatment process after discharge from a psychotherapy ward. METHODS AND ANALYSIS: Fifty patients with depression and/or anxiety who are treated as inpatients at a psychotherapy ward will be included and randomised into two groups with a 1:1 ratio. In the intervention group, patients will receive five CTI sessions with a Care Transition Navigator before and after discharge. The sessions will focus on individual patient support including a) identification and tackling of barriers to initiate follow-up treatment, b) reflection on the inpatient stay and individual progress, with focus on the helpful aspects and c) motivation of patients to organise and take up outpatient treatment. Patients in the control group will receive treatment-as-usual during discharge. We will evaluate the following outcomes: effectiveness of recruitment strategies, patient acceptance of randomisation, practicability of implemented workflows, feasibility of data collection, and clinical outcomes.

Words count in psychotherapy: Differentiating language characteristics of cognitive behavioral therapy and focal psychodynamic therapy for anorexia nervosa.

It is generally assumed that psychodynamic therapy and cognitive behavioral therapy (CBT) differ in terms of applied techniques and processes. To date, however, little is known about whether and how such differences can actually be observed at a basic linguistic level and in what the two treatment approaches differ most strongly (i.e., how psychodynamic and CBT therapists differ in what they actually say word-by-word in therapy sessions). Building on theoretical models and previous research that used observer ratings, we formulated specific hypotheses regarding which word categories psychodynamic and CBT therapists who treat patients with an eating disorder should differ in. To investigate these hypotheses, we used verbatim transcripts from 297 therapy sessions of a randomized controlled trial in which patients with anorexia nervosa (n = 88) received either focal psychodynamic therapy (FPT) or CBT. These transcripts were then examined using computerized quantitative text analysis. In line with our hypotheses, we found that CBT therapists overall spoke more than their FPT counterparts and that they used more words related to eating. Also in line with our hypotheses, FPT therapists used more words related to social processes. Contrary to our expectations, CBT therapists did not show a stronger focus on the future but talked more about emotions than FPT therapists. The latter effect, however, appears to be driven by a stronger focus on positive emotions. These findings suggest that computerized quantitative text analysis can differentiate meaningful language characteristics of CBT and FPT on spoken-word level and that it holds potential as a tool for researchers and therapists. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Gender-specific association of loneliness and health care use in community-dwelling older adults.

BACKGROUND: Loneliness in older adults is common, particularly in women. In this article, gender differences in the association of loneliness and health care use are investigated in a large sample of community-dwelling older adults. METHODS: Data of 2525 persons (ages 55-85 years)-participants of the fourth follow- up (2011-2014) of the ESTHER study- were analyzed. Loneliness and health care use were assessed by study doctors in the course of a home visit. Gender-specific regression models with Gamma-distribution were performed using loneliness as independent variable to predict outpatient health care use, adjusted for demographic variables. RESULTS: In older women, lonely persons were shown to have significantly more visits to general practitioners and mental health care providers in a three-month period compared to less lonely persons (p = .005). The survey found that outpatient health care use was positively associated with loneliness, multimorbidity, and mental illness in older women but not in older men. Older men had significantly more contact with inpatient care in comparison to women (p = .02). CONCLUSIONS: It is important to consider gender when analyzing inpatient and outpatient health care use in older persons. In older women loneliness is associated with increased use of outpatient services.

Integrative-interpersonal dynamic therapy for poststroke depression (INID): study protocol of a randomised controlled pilot trial.

INTRODUCTION: Depression is the most frequent psychiatric disorder following stroke, affecting about one-third of stroke survivors. Patients experience poorer recovery, lower quality of life and higher mortality compared with stroke survivors without depression. Despite these well-known malign consequences, poststroke depression (PSD) is regarded underdiagnosed and undertreated. Evidence of beneficial effects of psychotherapy to treat PSD remains scarce and inconclusive and is limited by heterogeneity in design, content and timing of the intervention. This pilot study aims to assess the feasibility of a newly developed integrative-interpersonal dynamic PSD intervention in an outpatient setting and provide a first estimation of the potential effect size as basis for the sample size estimation for a subsequent definite trial. METHOD AND ANALYSIS: Patients will be recruited from two German stroke units. After discharge from inpatient rehabilitation, depressed stroke survivors will be randomised to short-term psychotherapy (12 weeks, ≤16 sessions) or enhanced treatment as usual. The manualised psychotherapy integrates key features of the Unified Psychodynamic and Cognitive-Behavioural Unified Protocol for emotional disorders and was adapted for PSD. Primary endpoints are recruitment feasibility and treatment acceptability, defined as a recruitment rate of ≥20% for eligible patients consenting to randomisation and ≥70% completion-rate of patients participating in the treatment condition. A preliminary estimation of the treatment effect based on the mean difference in Patient Health Questionnaire-9 (PHQ-9) scores between intervention and control group six months poststroke is calculated. Secondary endpoints include changes in depression (PHQ-9/Hamilton Depression Scale) and anxiety (Generalised Anxiety Disorder 7) of all participants across all follow-ups during the first year poststroke. ETHICS AND DISSEMINATION: The INID pilot study received full ethical approval (S-321/2019; 2022-2286_1). Trial results will be published in a peer-reviewed journal in the first half of 2025. One-year follow-ups are planned to be carried out until summer 2025. TRIAL REGISTRATION NUMBER: DRKS00030378.

The role of general change mechanisms in sudden gains in the treatment of anorexia nervosa.

Previous research has shown a robust association between sudden gains (SGs) and treatment outcome in psychotherapy for various mental disorders including anorexia nervosa (AN). However, little is known about factors contributing to SGs. This study investigated the role of general change mechanisms in body-weight related SGs in AN. Data were drawn from a randomized-controlled trial on cognitive-behavioral therapy (CBT) and focal psychodynamic therapy (FPT) for adult outpatients with AN. Session-level data on the general change mechanisms 'clarification' (insight), 'mastery' (coping), and 'therapeutic relationship' were analyzed. Pre-gain sessions were compared with control (pre-pre-gain) sessions in 99 patients with a SG in body weight. Additionally, propensity score matching was used to compare data from pre-gain sessions from 44 patients with SG and data from the corresponding session from 44 patients without SG. In the pre-gain session, patients experienced higher levels of clarification and mastery but not therapeutic relationship. Compared to patients without a SG, patients with a SG likewise experienced more clarification and mastery but not a better therapeutic relationship in the pre-gain/corresponding session. CBT and FPT did not differ regarding these effects. The findings suggest that general change mechanisms contribute to SGs in CBT and FPT for AN.

Prevalence of adverse childhood experiences and effect on outcomes in bariatric surgery patients: a systematic review and meta-analysis.

Adverse childhood experiences (ACEs) are defined as childhood maltreatment (sexual, physical, and emotional abuse and neglect) and other childhood traumatic experiences. Published prevalence estimates for ACEs in bariatric samples vary greatly and evidence on the association between ACEs and bariatric surgery weight loss and psychosocial outcomes is inconclusive. A systematic literature search on PubMed/Medline, PsycInfo, Web of Science, CINAHL (Cumulative Index of Nursing and Allied Health Literature), and Open Grey for studies published until August 30, 2021, yielded 21 publications for qualitative synthesis: 20 reporting on prevalence of ACEs in bariatric surgery candidates and patients, and 10 on the association of ACEs with outcomes. In meta-analysis, overall moderate to high heterogeneity was observed for prevalence estimates and moderate heterogeneity was observed for associations. Prevalence estimate for at least 1 form of ACEs (6 studies, n = 1368 patients) was 51% (95% confidence interval [CI]: 32%-70%). Effect size (Hedge's g) for the difference between the groups of patients reporting any or a high number of ACEs versus no or a low number of ACEs was calculated from means, standard deviations and group size, or P values. Based on 7 studies (n = 946 patients), the association between ACEs and weight loss was not significant (Hedge's g = -.15 [95% CI: -.38 to .09]; I2 = 53%), regardless of short- or long-term follow-up (P = .413) and the proportion of patients in each study receiving Roux-en-Y gastric bypass (RYGB) (ß = .0005, P = .868). Preliminary findings based on 3 short- and long-term studies (n = 414 patients) showed that ACEs were significantly (P = .001) associated with higher postoperative depressive symptoms (Hedge's g = .50 [95% CI: .22-.78]; I2 = 36%). Associations between ACEs and other psychosocial outcomes such as eating pathology were reported narratively. There is a need for additional long-term studies using validated assessment tools for ACEs to evaluate the effect of ACEs on weight and psychosocial outcomes after bariatric surgery.

Mentalization-enhancing therapeutic interventions in the psychotherapy of anorexia nervosa: An analysis of use and influence on patients' mentalizing capacity.

OBJECTIVE: Improvement in patients' mentalizing capacities is considered a possible mechanism of change in psychotherapy. This improvement might take place via mentalization-enhancing interventions (MEIs) performed by psychotherapists. The study aimed to explore the use of MEIs in two evidence-based psychotherapeutic treatments for patients with anorexia nervosa (enhanced cognitive-behavior therapy, focal psychodynamic therapy) and their association with the patients' capacity to mentalize in sessions ("in-session reflective functioning" / in-session RF). Additionally, it was explored, if the amount of MEIs used could either predict change in in-session RF or outcome (end of treatment, one year follow-up). METHOD: 84 audiotapes from psychotherapy sessions of 28 patients of the ANTOP-study (three sessions per patient) were transcribed and rated with both the MEI Rating Scale and the In-Session RF Scale by trained raters. RESULTS: MEIs were applied in both treatments. A moderate correlation between the amount of MEIs and patients' in-session RF as well as its change over the course of treatment was found, but no relation to change in BMI or eating disorder symptoms. CONCLUSION: A greater use of MEIs was related to patients' in-session-mentalizing. However, there seems to be no simple relation between RF as shown in sessions and symptom change.

Temporal Relationships Between Abdominal Pain, Psychological Distress and Coping in Patients With IBS - A Time Series Approach.

Objective: Irritable bowel syndrome (IBS) is a chronic disease leading to abdominal pain that is often related to psychological distress. The aim of the study was to investigate the temporal relationships between abdominal pain and psychological variables in patients with IBS. Methods: This longitudinal diary study included eight patients from a waiting group, recruited in the frame of a pilot intervention study. During their waiting time of 3 months the patients answered questions daily regarding somatic and psychological variables using an online diary. All patients were considered and analyzed as single cases. The temporal dynamics between the time series of psycho-somatic variables were analyzed using a vector autoregressive (VAR) modeling approach. Results: For all patients, positive same-day correlations between somatic and psychological time series were observed. The highest same-day correlations were found between somatic symptoms and pain-related discomfort (r = 0.40 to r = 0.94). Altogether, n = 26 significant lagged relationships were identified; n = 17 (65%) indicated that somatic values were predictive of psychological complaints on the following days. N = 9 (35%) lagged relationships indicated an opposite relationship in that psychological complaints were predictive of somatic symptoms. Three patients showed a significant positive same-day correlation between abdominal pain and use of a positive coping strategy. However, significant lagged relationships in two patients showed that for these patients the use of positive thinking as a coping strategy was unhelpful in reducing pain on the following days. Conclusions: In patients with IBS abdominal symptoms appear to be closely related to psychological symptoms. For some patients, somatic complaints predict psychological complaints, in other patients the directionality is opposite. The impact of coping strategies on somatic symptoms varies among patients, therefore their role for a possible reduction of pain should be further explored. The results suggest the need of characterizing patientsindividually for effective health interventions. Individual time series analyses provide helpful tools for finding reasonable person-level moderators.

In-Session-Reflective-Functioning in Anorexia Nervosa: An Analysis of Psychotherapeutic Sessions of the ANTOP Study.

Objective: Previous research suggests that patients with anorexia nervosa (AN) show an impaired capacity to mentalize (reflective functioning, RF). RF is discussed as a possible predictor of outcome in psychotherapeutic processes. The study aimed to explore RF in sessions of patients with AN and its association with outcome and type of treatment. Methods: A post-hoc data analysis of selected cases from a randomized trial on outpatient psychotherapy for AN was conducted. Transcripts from 84 sessions of 28 patients (early phase, middle phase, and end of treatment) were assessed using the In-Session-Reflective-Functioning-Scale [14 cognitive-behavior therapy, enhanced (CBT-E); 14 focal psychodynamic therapy (FPT); 16 with good, 12 with poor outcome after 1 year]. Relations between the level of RF, type of treatment, and outcome were investigated using mixed linear models. Additionally, associations with depressive symptoms, weight gain, and therapeutic alliance were explored. Results: Mean in-session RF was low. It was higher in FPT when compared to CBT-E treatments. The findings point to an association between RF increase and a positive outcome. An increase in BMI in the first half of treatment was associated with higher subsequent in-session RF. There was no association between RF and depressive symptoms or the therapeutic alliance. Discussion: Patients with AN show a low capacity to mentalize in sessions, which seems to be at least partly dependent on the degree of starvation. The results suggest a possible relationship between an increase in in-session RF and outcome, which has to be replicated by further studies.

Time course and reaction types of serum IGF-1 and its relationship to BMI and leptin regarding inpatients with anorexia nervosa.

OBJECTIVE: Anorexia nervosa (AN) is a severe mental disorder that is characterized by restriction of energy intake, low weight, and endocrine abnormalities. One of the known endocrine changes in relation to underweight is in the GH/IGF-I axis. The aim of the study was (a) to investigate longitudinal characteristics of the IGF-I-change during therapy and weight gain in adult AN, (b) to determine relationships between IGF-I and leptin, (c) to characterize patients with weak and pronounced hormonal reactions to underweight. DESIGN: Data was assessed from 19 AN patients. Over the first two months, serum IGF-I concentrations were assessed on a weekly basis; thereafter on a monthly basis. The trend of IGF-I values over time was analyzed using individual growth models. RESULTS: In total, n = 177 IGF-I measurements were analyzed. IGF-I increased significantly dependent on BMI (slope = 20.81, p < 0.001), not modulated by duration of disease. The increase in IGF-I was significantly related to the increase in leptin concentrations over time (slope = 15.57, p < 0.001). Patients with a weaker hormonal reaction to underweight were significantly older compared to patients with a pronounced hormonal reaction (t(17) = 3.07, p = 0.007). CONCLUSIONS: During treatment, IGF-I change is clearly related to BMI as well as to leptin. Age appears to be associated with the IGF-I response to underweight.

Preferred and perceived participation roles of oncological patients in medical decision-making: Results of a survey among users of the German Cancer Information Service.

BACKGROUND: Cancer patients are facing a variety of treatment and other disease-related decisions. This study aims to provide insights into preferred and perceived participation roles in decision-making among patients with diverse tumors using the German Cancer Information Service (CIS). METHODS: Patients' decision-making preferences and experiences were assessed as a part of a cross-sectional survey among CIS users. An adapted version of the Control Preferences Scale (CPS) was used to assess preferred and perceived participation roles in eight different areas of medical decision-making (e.g., choice of medication, termination of treatment). Logistic regression analyses were applied to explore preference matching and to analyze associations between participation roles and sociodemographic variables. Moreover, we examined preferences and perceptions of participation roles across different decision situations. RESULTS: In the final sample (N = 1566, 64.9% female, mean age = 61.6), almost half of the patients (47.1%) preferred to take a collaborative role in decisions on treatment methods, whereas 36.3% preferred an active role and 15.9% a passive role. Collaborative role preferences frequently (40.7%) coincided with experiencing a passive role and predicted a reduced chance of a match between preferences and experiences (OR = 0.57, p = .001). A higher level of education was associated with a lower chance of preferring and perceiving a passive role (OR = 0.85, p < .01). Compared with men, women had increased odds of preferring (OR = 1.45, p < .05) and of actually taking (OR = 2.04, p < .001) a passive role in medical encounters. Preferred participation roles regarding treatment methods were highly correlated with preferences in all other decision areas (r > .50, p < .001) except decisions about family involvement. CONCLUSIONS: The study reveals well-known deficits in the fulfilment of patients' collaborative role preferences across different areas of medical decision-making in a sample of CIS users characterized by high information-seeking behavior. Participation roles were not only influenced by the patients' level of education but also by their gender. The gender effect may be more pronounced than previous studies suggest. These effects should be considered in the development of interventions to promote shared decision-making. Additionally, study results indicate that preferences for participation in decisions about treatment methods, as assessed by the CPS, can be generalized to other areas of medical decision-making.

Unmet Needs of Parents of Children with Urea Cycle Disorders.

(1) Background: Phenotypic diversity and long-term health outcomes of individuals with urea cycle disorders (UCDs) have been described in detail. However, there is limited information on the burden on affected families. (2) Methods: To evaluate the family burden in parents with children suffering from UCDs, we used validated questionnaires. Socio-demographic characteristics were evaluated, and an adapted version of the Parental Need Scale for Rare Diseases questionnaire was used. The survey was conducted in families of UCD patients cared for at the University Children's Hospital Heidelberg. (3) Results: From April to November 2021, 59 participants were interviewed (mothers n = 34, fathers n = 25). The affected patients most frequently suffered from ornithine transcarbamylase deficiency (OTC-D) (female n = 12, male n = 12), followed by argininosuccinate synthetase deficiency (ASS-D, n = 13) and argininosuccinate lyase deficiency (ASL-D, n = 8). About one-third of the participants were "dissatisfied" or "extremely dissatisfied" with health professionals' disease knowledge. In addition, 30% of the participants reported a medium or high need for "additional information on the development of their children", and 44% reported a medium or high need "for information on available services". A majority of 68% reported a need for additional support regarding services such as support groups (42%) or psychological counseling (29%). (4) Conclusions: Our study indicates that there is an unmet need for sufficient information about the development of children with UCDs, as well as for information about available support services for families with UCD patients. Furthermore, the results highlight the importance of establishing or improving family-centered care approaches. This pilot study may serve as a template for the assessment of the family burden associated with other inherited metabolic diseases.

Mental health specialist video consultations for patients with somatic symptom disorder in primary care: protocol for a randomised feasibility trial (the VISION trial).

INTRODUCTION: General practitioners (GP) report increasing difficulties in referring patients with somatic symptom disorder (SSD) in specialised psychosocial care. Barriers are structural conditions of the respective healthcare system and patients' reservations against receiving specialised psychosocial care. As patients with SSD often predominantly assume somatic influencing factors for the development and maintenance of their somatic complaints, close collaboration between the GP and mental health specialist (MHS) seems particularly important. Integrating internet-based video consultations by remotely located MHS and primary care can improve effective treatment of patients with SSD by overcoming structural barriers and provide low-threshold and timely care. The aim of this randomised controlled feasibility trial is to investigate the feasibility of implementing MHS video consultations in primary care practices. METHODS AND ANALYSIS: Fifty primary care patients with SSD will be individually randomised in two groups receiving either enhanced treatment as usual as provided by their GP (control group) or two versus five video consultations conducted by an MHS additionally to enhanced treatment as usual. The video consultations focus on (a) diagnostic clarification, (b) the development of a biopsychosocial disorder model, and (c) development of a treatment plan against the background of a stepped-care algorithm based on clinical outcomes. We will investigate the following outcomes: effectiveness of the recruitment strategies, patient acceptance of randomisation, practicability of the technical and logistical processes related to implementing video consultations in the practices' workflows, feasibility of the data collection and clinical parameters. ETHICS AND DISSEMINATION: This trial has undergone ethical scrutiny and has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (S-620/2021). The findings will be disseminated to the research community through presentations at conferences and publications in scientific journals. This feasibility trial will prepare the ground for a large-scale, fully powered randomised controlled trial. TRIAL REGISTRATION NUMBER: DRKS00026075.

Focal psychodynamic therapy, cognitive behaviour therapy, and optimised treatment as usual in female outpatients with anorexia nervosa (ANTOP study): 5-year follow-up of a randomised controlled trial in Germany.

BACKGROUND: Anorexia nervosa is a serious illness leading to substantial morbidity and mortality. The Anorexia Nervosa Treatment of Outpatients (ANTOP) study is the largest randomised controlled trial (RCT) globally that uses psychotherapy in outpatients with anorexia nervosa. In this Article, we report the results of the 5-year follow-up. METHODS: The ANTOP study is an open-label, multicentre RCT involving 242 adult female outpatients with anorexia nervosa. Participants were recruited from ten university hospitals in Germany, had to be aged at least 18 years and female, and have a diagnosis of anorexia nervosa with a body-mass index (BMI) of 15·0-18·5 kg/m2. Participants were randomly allocated (1:1:1) to 10 months of treatment with focal psychodynamic therapy, enhanced cognitive behaviour therapy, or optimised treatment as usual; complete masking of the participants was not possible. The mean duration of the follow-up was 5·96 years (SD 0·2) after randomisation. The primary outcome was change in BMI from baseline at the end of treatment; here, we present the change in BMI from baseline to the 5-year follow-up, using an intention-to-treat approach with a mixed model for repeated measurements. Groups were also compared according to global outcome (based on the combination of BMI and measures of anorexia severity), eating pathology (based on the Eating Disorder Inventory 2), and other secondary mental health outcomes. We did a linear regression analysis to identify the predictors of BMI at follow-up. FINDINGS: Between May, 2007, and June, 2009, we screened 727 patients for eligibility; at baseline, 242 patients with a mean BMI of 16·7 kg/m2 (SD 1·0) were included and randomly allocated to 10 months of treatment with focal psychodynamic therapy, enhanced cognitive behaviour therapy, or optimised treatment as usual. 154 (64%) of 242 patients completed the 5-year follow-up assessment (53 [66%] of 80 in the focal psychodynamic therapy group, 55 [69%] of 80 in the enhanced cognitive behaviour therapy group, and 46 [56%] of 82 in the optimised treatment-as-usual group), with a mean age of 32·4 years; all reported their ethnicity as White. At the 5-year follow-up, there was an improvement in mean BMI, eating pathology, and global outcome in all treatment groups with no significant differences between treatment groups. Estimated mean BMI was: 18·64 kg/m2 (95% CI 18·07-19·21) in the focal psychodynamic therapy group (with an estimated mean BMI gain from baseline to 5-year follow-up of 1·91 kg/m2 [1·34-2·48]); 18·70 kg/m2 (18·15-19·25) in the enhanced cognitive behaviour therapy group (with an estimated mean BMI gain of 1·98 kg/m2 [1·43-2·53]); and 18·99 kg/m2 (18·39-19·59) in the optimised treatment-as-usual group (with an estimated mean BMI gain of 2·26 kg/m2 [1·67-2·86]). There were no significant differences between treatment groups regarding BMI at the 5-year follow-up; the estimated difference was -0·06 (-0·85 to 0·73) between the focal psychodynamic therapy and enhanced cognitive behaviour therapy groups; -0·35 (-1·18 to 0·47) between the focal psychodynamic therapy and optimised treatment-as-usual groups; and -0·29 (-1·10 to 0·52) between the enhanced cognitive behaviour therapy and optimised treatment-as-usual groups. On the basis of observed data, global outcome at the 5-year follow-up showed 41% (33-49) full recoveries, 41% (33-49) partial recoveries, and 18% (12-24) with full-syndrome anorexia nervosa. One patient initially treated in the enhanced cognitive behaviour therapy group died by suicide between the 1-year and 5-year follow-up. BMI at the 5-year follow-up was predicted by BMI at baseline (p=0·0021), illness duration (p=0·0004), and depression at baseline (p=0·012). INTERPRETATION: The long-term results of the ANTOP trial confirm the improvement in BMI of patients with anorexia nervosa in all groups; however, a substantial proportion of patients had a poor global outcome. The predictors for the long-term course of anorexia nervosa in our ANTOP study show that we need to treat patients with anorexia nervosa at an earlier stage of the disease, with a clear focus on weight gain and considering other comorbidities (especially depression). FUNDING: German Federal Ministry of Education and Research.

The cardiac autonomic response to acute psychological stress in type 2 diabetes.

BACKGROUND: Impaired cardiac autonomic control is common among people with type 2 diabetes. The autonomic nervous system and its regulatory influence on the cardiovascular system also play a key role in the physiological response to psychosocial stressors. It is unclear whether the disease-related impairment of cardiac autonomic control in people with type 2 diabetes affects the stress response. The aim of this study was therefore to examine the cardiac autonomic and the psychological stress response of people with type 2 diabetes compared to healthy control participants. METHODS: We used the trier social stress test to induce stress in n = 51 participants with type 2 diabetes and n = 47 healthy controls. We assessed heart rate (HR) and heart rate variability (HRV) using six ECG samples before, during and after the stress test. We measured participants' psychological stress response using visual analogue scales. RESULTS: Longitudinal multilevel models showed an attenuated HR increase in response to the stress test combined with a slower HR recovery after the stress test, in people with type 2 diabetes. This pattern was accompanied by significantly lower low frequency HRV but no differences in high frequency HRV between the groups. Additionally, people with type 2 diabetes showed an increased level of self-reported psychological tension 45 minutes after the stress test. CONCLUSIONS: The impairment of the autonomic nervous system found in people with type 2 diabetes is reflected in the HR response to stress-but not in the HRV response-and partially mirrored in the psychological stress response. Our results underline the importance of considering the interplay of psychosocial stress and disease-related changes in the physiological stress response system in research and treatment of type 2 diabetes.