Addressing psychosocial needs in patients with Long-COVID (PsyLoCo-Study): study protocol of a pilot-study of a specialized modular intervention.

Introduction: After an acute infection with the corona virus 10-20% of those affected suffer from ongoing or new symptoms. A causal therapy for the phenomenon known as Long/Post-COVID is still lacking and specific therapies addressing psychosocial needs of these patients are imperatively needed. The aim of the PsyLoCo-study is developing and piloting a psychotherapeutic manual, which addresses Long/Post-COVID-related psychosocial needs and supports in coping with persistent bodily symptoms as well as depressive or anxiety symptoms. Methods and analysis: This pilot trial implements a multi-centre, 2-arm (N=120; allocation ratio: 1:1), parallel group, randomised controlled design. The pilot trial is designed to test the feasibility and estimate the effect of 1) a 12-session psychotherapeutic intervention compared to 2) a wait-list control condition on psychosocial needs as well as bodily and affective symptoms in patients suffering from Long/Post-COVID. The intervention uses an integrative, manualized, psychotherapeutic approach. The primary study outcome is health-related quality of life. Outcome variables will be assessed at three timepoints, pre-intervention (t1), post-intervention (t2) and three months after completed intervention (t3). To determine the primary outcome, changes from t1 to t2 are examined. The analysis will be used for the planning of the RCT to test the efficacy of the developed intervention. Discussion: The pilot study will evaluate a 12-session treatment manual for Long/Post-COVID sufferers and the therapy components it contains. The analysis will provide insights into the extent to which psychotherapeutic treatment approaches improve the symptoms of Long/Post-COVID sufferers. The treatment manual is designed to be carried out by psychotherapists as well as people with basic training in psychotherapeutic techniques. This approach was chosen to enable a larger number of practitioners to provide therapeutic support for Long/Post-COVID patients. After completion of the pilot study, it is planned to follow up with a randomized controlled study and to develop a treatment guideline for general practitioners and interested specialists. Trial registration: The pilot trial has been registered with the German Clinical Trials Register (Deutsches Register Klinischer Studien; Trial-ID: DRKS00030866; URL: https://drks.de/search/de/trial/DRKS00030866) on March 7, 2023.

Risk factors and health behaviors associated with loneliness among cancer survivors during the COVID-19 pandemic.

Loneliness may exacerbate poor health outcomes particularly among cancer survivors during the COVID-19 pandemic. Little is known about the risk factors of loneliness among cancer survivors. We evaluated the risk factors of loneliness in the context of COVID-19 pandemic-related prevention behaviors and lifestyle/psychosocial factors among cancer survivors. Cancer survivors (n = 1471) seen at Huntsman Cancer Institute completed a survey between August-September 2020 evaluating health behaviors, medical care, and psychosocial factors including loneliness during COVID-19 pandemic. Participants were classified into two groups: 'lonely' (sometimes, usually, or always felt lonely in past month) and 'non-lonely' (never or rarely felt lonely in past month). 33% of cancer survivors reported feeling lonely in the past month. Multivariable logistic regression showed female sex, not living with a spouse/partner, poor health status, COVID-19 pandemic-associated lifestyle factors including increased alcohol consumption and marijuana/CBD oil use, and psychosocial stressors such as disruptions in daily life, less social interaction, and higher perceived stress and financial stress were associated with feeling lonely as compared to being non-lonely (all p < 0.05). A significant proportion of participants reported loneliness, which is a serious health risk among vulnerable populations, particularly cancer survivors. Modifiable risk factors such as unhealthy lifestyle behaviors and psychosocial stress were associated with loneliness. These results highlight the need to screen for unhealthy lifestyle factors and psychosocial stressors to identify cancer survivors at increased risk of loneliness and to develop effective management strategies.

Understanding communication between patients and healthcare professionals regarding comprehensive biomarker testing in precision oncology: A scoping review.

BACKGROUND: Precision oncology, using comprehensive biomarker testing (cBT) to inform individual cancer diagnosis, prognosis and treatment, includes increasingly complex technology and clinical data sets. People impacted by cancer (patients and caregivers) and healthcare professionals (HCPs) face distinct challenges in navigating the cBT and personalized treatment landscape. This review summarizes evidence regarding cBT-related communication between people impacted by cancer and HCPs and identifies important avenues for future research in precision oncology. METHODS: A scoping review was conducted using records published in PubMed during January 2017-August 2022, focusing on the breadth of topics on patient-HCP communication and knowledge resources used by HCPs as guidance in cBT-related communication. Data were extracted from records meeting inclusion criteria, and findings were summarized according to main topics. RESULTS: The search identified 287 unique records and data were extracted from 42 records, including nine from expert input. Most records originated from the United States included patients with different types of cancer, and oncologists were the main HCPs. Patients' motivation for undergoing cBT and receiving results was generally high in different settings. However, patients' understanding of cBT-related concepts was limited, and their knowledge and information preferences changed based on cBT implications and significance to family members. HCPs were valued by patients as a trusted source of information. Limited evidence was available on HCPs' information-seeking behavior and factors influencing cBT-related knowledge and confidence, often self-reported as insufficient. CONCLUSIONS: Patient education by knowledgeable and confident HCPs, information management and a caring patient-HCP relationship communicating continuity of care regardless of cBT results are crucial to empower patients and shared decision-making in precision oncology. More data on the process and structure of cBT-related communication, distinction between and characterization of different timepoints of patient-HCP interactions are needed.

Training in medical communication competence through video-based e-learning: How effective are video modeling and video reflection?

OBJECTIVE: The present study investigated the efficacy of the didactic approaches of video modeling (VM, best-practice examples), video reflection (VR, problem-based approach), and the combination of both (VMR) in fostering medical communication competence in a video-based digital learning environment. METHODS: N = 126 third-year medical students who participated in the pre-post study were assigned to either the intervention groups (VM, VR, and VMR) or the wait-list control group. The efficacy of the three approaches was assessed by means of a situational judgment test (SJT) of medical communication competence. To investigate the differences between the wait-list control and the intervention groups (H1), between the single-mode and combined conditions (H2), and between VM and VR (H3), we applied planned contrast analyses. RESULTS: The planned contrasts showed that the VR condition significantly improved learning outcomes in comparison to the VM condition (H3). The decreased mean scores of the VM condition offset the increased mean scores of VR, and thus no significant differences could be found in H1 and H2. CONCLUSIONS: Our study provides promising evidence that VR fosters medical communication competence more effectively than VM. PRACTICAL IMPLICATIONS: Medical students' learning in video-based digital environments can be facilitated by the use of interactive VR.

Prevalence, lifestyle, and risk factors of erectile dysfunction, premature ejaculation, and low libido in middle-aged men: first results of the Bavarian Men's Health-Study.

BACKGROUND: Erectile dysfunction (ED), premature ejaculation (PE), and low libido (LL) are reported as the most common male sexual dysfunctions. OBJECTIVE: To evaluate the prevalence of ED, PE, and LL and associations with lifestyle risk factors and comorbidities in middle-aged men. MATERIALS AND METHODS: This study included a population-based random sample of 2500 50-year-old men who completed validated questionnaires, including the International Index of Erectile Function, the Erection Hardness Score, the Sexual Complaints Screener, and further questionnaires. Multiple logistic regression of outcomes ED, PE, and LL was used to model the association with explanatory factors. RESULTS: The prevalence of at least one sexual dysfunction was 30%. 21%, 5.2%, and 7.2% of men had ED, PE, and LL, respectively. The risk of ED increased with PE (odds ratio [OR]: 1.94, 95% confidence interval [95%CI]: 1.22-3.08), LL (OR: 2.04, 95%CI: 1.26-3.29), higher waist circumference (OR: 2.23, 95%CI: 1.67-2.96), and lower urinary tract symptoms (LUTS) (OR: 1.88, 95%CI: 1.39-2.55), partnership was associated with a lower risk (OR: 0.57, 95%CI: 0.39-0.85). The risk of PE increased with ED (OR: 1.94, 95%CI: 1.23-3.07), partnership (OR:5.42, 95%CI: 1.30-22.60), depression (OR: 2.37, 95%CI: 1.09-5.14), and LUTS (OR: 2.42, 95%CI: 1.52-3.87), and decreased with physical activity (OR: 0.44, 95%CI: 0.21-0.93). The risk of LL increased with ED (OR: 2.09, 95%CI: 1.31-3.34) and poorer self-rated health (OR: 2.97, 95%CI: 1.54-5.71). DISCUSSION AND CONCLUSIONS: Roughly one in three 50-year-old men experience some form of sexual dysfunction and risk factors identified in this study underline the multifactorial nature of ED, PE, and LL. Many risk factors are modifiable which underlines the role of patient education. Modifiable risk factors should be addressed in patient education and men should take active measures to remove the risk posed by these factors.

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).

Prevalence and determinants of decision regret in long-term prostate cancer survivors following radical prostatectomy.

BACKGROUND: Patients with localized prostate cancer (PC) are faced with a wide spectrum of therapeutic options at initial diagnosis. Following radical prostatectomy (RP), PC patients may experience regret regarding their initial choice of treatment, especially when oncological and functional outcomes are poor. Impacts of psychosocial factors on decision regret, especially after long-term follow-up, are not well understood. This study aimed to investigate the prevalence and determinants of decision regret in long-term PC survivors following RP. METHODS: 3408 PC survivors (mean age 78.8 years, SD = 6.5) from the multicenter German Familial PC Database returned questionnaires after an average of 16.5 (SD = 3.8) years following RP. The outcome of decision regret concerning the initial choice of RP was assessed with one item from the Decision Regret Scale. Health-related quality of life (HRQoL), PC-anxiety, PSA-anxiety, as well as anxiety and depressive symptoms were considered for independent association with decision regret via multivariable logistic regression. RESULTS: 10.9% (373/3408) of PC survivors reported decision regret. Organ-confined disease at RP (OR 1.39, 95%CI 1.02-1.91), biochemical recurrence (OR 1.34, 1.00-1.80), low HRQoL (OR 1.69,1.28-2.24), depressive symptoms (OR 2.32, 1.52-3.53), and prevalent PSA anxiety (OR 1.88,1.17-3.01) were significantly associated with increased risk of decision regret. Shared decision-making reduced the odds of decision regret by 40% (OR 0.59, 0.41-0.86). CONCLUSIONS: PC survivors may experience decision regret even after 16 years following RP. Promoting shared decision-making in light of both established and novel, potentially less invasive treatments at initial diagnosis may help mitigate long-term regret. Awareness regarding patients showing depressive symptoms or PSA anxiety should be encouraged to identify patients at risk of decision regret in need of additional psychological support.

Stressors related to the COVID-19 pandemic and their association with distress, depressive, and anxiety symptoms in cancer out-patients.

Patients with cancer might be particularly prone to stress caused by the COVID-19 pandemic. The aim of this study was to investigate the impact of pandemic-related stressors on oncological patients' psychological well-being. During the second wave of the COVID-19 pandemic in Germany 122 cancer out-patients of the Comprehensive Cancer Center Munich reported on COVID-19-related stressors (information satisfaction, threat perception, and fear of disease deterioration) and answered standardized questionnaires for psychosocial distress (DT) as well as depression and anxiety symptoms (PHQ-2, GAD-2). Multiple linear regression analyses were used to identify associations of the COVID-19-related stressors with psychological symptoms, controlling for sociodemographic, psychological (self-efficacy, ASKU) and clinical (somatic symptom burden, SSS-8) variables. Initially, satisfaction with information was significantly negatively associated with all three outcome variables. Fear of disease deterioration was associated with distress and depressive symptoms. After controlling for additional variables, only satisfaction with information remained an independent determinant of anxiety (ß = -0.35, p < 0.001). All three outcomes were most strongly determined by somatic symptom burden (ß ≥ 0.40, p < 0.001). The results of this study tentatively suggest that physical well-being overrides the relevance of some COVID-19-related stressors for oncological patients' psychological wellbeing. Physical symptoms are strongly tied to personal wellbeing as they are associated with suffering from cancer, which might be more central to personal wellbeing than the possibility of getting infected with SARS-CoV-2. However, satisfaction with the information received seems to be important beyond physical wellbeing, as this emerged as an independent determinant of anxiety.

Benefit finding in men affected by prostate cancer prior to and following radical prostatectomy - a cross-sectional study with a stratified sample.

BACKGROUND: Benefit finding (BF) - the occurrence of positive life-changes in the aftermath of traumatic live events - has been repeatedly reported in prostate cancer (PCa) survivors, but it remains unclear in which way BF might vary over time. The current study aimed to investigate the extent of BF and associated factors in different phases of the survivorship continuum. METHODS: In this cross-sectional study, men affected by PCa who were either already treated with radical prostatectomy or going to be treated with radical prostatectomy at a large German PCa center were included. These men were stratified into four groups (prior to surgery, up to 12 months after surgery, 2-5 years and ≥ 6-10 years after surgery). BF was assessed using the German version of the 17-item Benefit Finding Scale (BFS). The items are rated on a five-point Likert scale ranging from 1 to 5. A total mean score ≥ 3 was considered as moderate-to-high BF. Associations with clinical and psychological factors were assessed in men presenting before and in those who participated after surgery. Multiple linear regression was applied to identify intendent determinants of BF. RESULTS: 2,298 men affected by PCa (mean age at survey: 69.5,SD = 8.2; median follow-up: 3 years (25th -75th percentile 0.5-7)) were included. 49.6% of men reported moderate-to-high BF. The mean BF score was 2.91 (SD = 0.92). BF reported by men before surgery did not differ significantly from BF reported by men in the years after surgery (p = 0.56). Higher BF prior to and following radical prostatectomy was associated with higher perceived severity of the disease (pre-surgery: ß = 0.188, p = 0.008; post-surgery: ß = 0.161, p = < 0.0001) and higher cancer-related distress (pre-surgery: ß ? 0.155, p = 0.03; post-surgery: ß = 0.089, p < 0.0001). Post radical prostatectomy BF was also associated with biochemical recurrence during follow-up (ß = 0.089, p = 0.001), and higher quality of life (ß = 0.124, p < 0.001). CONCLUSIONS: Many men affected by PCa perceive BF already soon after diagnosis. The subjective perception of threat or severity associated with the diagnosis of PCa is an essential factor for higher levels of BF, probably more important than objective indicators of the severity of the disease. The early onset of BF and the high degree of similarity of BF reported across the different phases of survivorship suggests that BF is, to a large extent, a dispositional personal characteristic and a cognitive strategy of positively coping with cancer.

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.

Treatment decision regret in long-term survivors after radical prostatectomy: a longitudinal study.

OBJECTIVES: To investigate prevalence, course, and predictors of longitudinal decision regret in long-term prostate cancer (PCa) survivors treated by radical prostatectomy (RP). PATIENTS AND METHODS: A total of 1003 PCa survivors from the multicentre German Familial PCa Database completed questionnaires on average 7 years after RP in 2007 and at follow-up 13 years later in 2020. Patients completed standardised patient-reported outcome measures on decision regret, decision-making, health-related quality of life, and psychosocial factors. Hierarchical multivariable logistic regression was used to assess predictors of longitudinal decision regret. RESULTS: Decision regret increased significantly over time (9.0% after 6.9 years in 2007 and 12% after 19 years in 2020; P = 0.009). Favourable localised PCa (odds ratio [OR] 1.97, 95% confidence interval [CI] 1.05-3.68), decision regret in 2007 (OR 6.38, 95% CI 3.55-11.47), and a higher depression score (OR 1.37, 95% CI 1.03-1.83) were associated with decision regret in 2020. Shared decision-making (OR 0.55, 95% CI 0.33-0.93) was associated with less decision regret. CONCLUSION: The findings of the present study underline the perseverance of decision regret in long-term PCa survivors and the definitive need for involving patients in the decision-making process to mitigate regret over the long term.

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.

Prostate cancer-related anxiety among long-term survivors after radical prostatectomy: A longitudinal study.

BACKGROUND: Prostate cancer (PC)-related anxiety is associated with clinically significant declines in health-related quality of life (HRQoL) and psychological well-being. This longitudinal study investigates course and predictors of PC-related anxiety in long-term PC survivors treated by radical prostatectomy (RP). METHODS: Two thousand nine hundred and three survivors from the multicenter German Familial PC Database completed the Memorial Anxiety Scale for PC on average 11 years after RP at the initial assessment in 2015 and then 5 years later. Hierarchical multiple linear regression was used to assess predictors of PC-related anxiety at follow-up. RESULTS: PC-related anxiety remained stable over the 5 years. In hierarchical multiple linear regression, longitudinal predictors of PC-related anxiety 5 years later included a lower level of education (beta: -0.035, p = 0.019), biochemical recurrence (BCR; beta: 0.054, p = 0.002), late BCR (beta: 0.054, p < 0.001), PC anxiety at initial assessment (beta: 0.556, p < 0.001), HRQoL (beta: -0.076, p < 0.001), depression and anxiety symptoms (beta: 0.072, p = 0.001; beta: 0.165, p < 0.001). Predictors of prostate-specific antigen (PSA) anxiety 5 years later included late BCR (beta: 0.044, p = 0.019), PSA anxiety at initial assessment (beta: 0.339, p < 0.001), depression and anxiety symptoms (beta: 0.074, p = 0.008; beta: 0.191, p < 0.001), and treatment decision regret (beta: 0.052, p = 0.006). CONCLUSION: PC-related anxiety remains a burden to survivors many years after diagnosis and treatment. The respective disease-specific anxiety was the strongest predictor of this anxiety 5 years later, which emphasizes the need of screening and monitoring in a timely manner for PC-related anxiety. Treating urologists should screen, identify, and monitor patients at risk for targeted referrals to psychosocial services.

Mindfulness and skills-based eHealth intervention to reduce distress in cancer-affected patients in the Reduct trial: Intervention protocol of the make it training optimized.

Introduction: Cancer-affected patients experience high distress due to various burdens. One way to expand psycho-oncological support is through digital interventions. This protocol describes the development and structure of a web-based psycho-oncological intervention, the Make It Training optimized. This intervention is currently evaluated in the Reduct trial, a multicenter randomized controlled trial. Methods: The Make It Training optimized was developed in six steps: A patient need and demand assessment, development and acceptability analysis of a prototype, the formation of a patient advisory council, the revision of the training, implementation into a web app, and the development of a motivation and evaluation plan. Results: Through a process of establishing cancer-affected patients' needs, prototype testing, and patient involvement, the Make It Training optimized was developed by a multidisciplinary team and implemented in a web app. It consists of 16 interactive self-guided modules which can be completed within 16 weeks. Discussion: Intervention protocols can increase transparency and increase the likelihood of developing effective web-based interventions. This protocol describes the process and results of developing a patient-oriented intervention. Future research should focus on the further personalization of web-based psycho-oncological interventions and the potential benefits of combining multiple psychotherapeutic approaches.

The role of pornography in the sex life of young adults-a cross-sectional cohort study on female and male German medical students.

BACKGROUND: Due to easy online accessibility of pornography its consumption is popular among adolescents and young adults. Considering recently developed frameworks on the effects of sexual media, we assessed how increased consumption of pornography is associated with the experience of certain aspects of offline and online sexual activity in German medical students. METHODS: Between April 2018 and March 2020 medical students from the Technical University of Munich in Germany were anonymously surveyed with regards to their sexual behavior, consumption of pornography, and use of social media. 468 students (female: n = 293; male: n = 175) were included in the current analysis. Data was analyzed using simple and multiple Poisson regression analysis. RESULTS: Only 7.3% of female students but the majority of male students (79.1%) consumed pornography more than 4 times in the last 4 weeks. Female and male students who reported to be inspired by pornography (female: 52.0%, male: 74.6%) and who have enjoyed the experience of anal intercourse in their life (female: 17.1%, male: 32.2%) consumed pornography more frequently. Female students who have experienced a "threesome" (9.0%), have sent erotic pictures of themselves (33.5%), or use social media in their dating life (27.6%) consumed pornography more frequently. Male students who did not experience a sexual transmitted disease (82.9%) and did not cheat on their partner (68.0%) consumed pornography more frequently (results of multiple Poisson regression analysis; all p < 0.05). CONCLUSIONS: Many students consider pornography as inspiration for their sex life and frequent consumption of pornography seems to be associated with gender specific characteristics congruent with short-term sexual quality. The desire of adolescents and young adults for practical information about sexual intercourse should be addressed openly and a proper understanding of the sexuality shown in pornography should be taught.

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.

Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct.

INTRODUCTION: Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint). METHODS AND ANALYSIS: The study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18-65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate. ETHICS AND DISSEMINATION: The Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations. TRIAL REGISTRATION NUMBER: German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.

[The views of cancer out-patients on the impact of the COVID-19 pandemic]. / Die Auswirkungen der COVID-19-Pandemie aus der Sicht ambulanter Krebspatienten.

BACKGROUND: This study investigates current needs and psychosocial burden of out-patients with cancer during the COVID-19-Pandemic. MATERIAL AND METHODS: Between 11/2020 and 02/2021 122 cancer patients who underwent out-patient treatment at the Comprehensive Cancer Center Munich participated in the study. Based on a standardized, semi-structured interview, participants were asked about their knowledge and informational needs related to COVID-19, risk perception and concerns regarding continuing out-patient treatment, COVID-19 related distress, confidence in the national health system, and their readiness to get vaccinated against COVID-19. Additionally, patients filled out the distress thermometer (DT). RESULTS: More than a third of the patients (34,2 %, n = 41/120) wanted to receive more information about the effects of the coronavirus on their cancer and their treatment. 17,2 % (n = 21/122) had faced changes concerning their current or planned treatment. 42/121 (34,7 %) of the patients were clinically distressed (DT ≥ 5). A possible overload of the health care system was the most commonly reported COVID-related concern (77,9 %, n = 95/122), followed by being concerned that their family members might be additionally worried about them (56,2 %, n = 68/121). 71,2 % (n = 74/104) of the patients are willing to be vaccinated; 60 % (n = 18/30) of those undecided or refusing at the time of the survey expressed a desire to have a consultation with an oncologist before giving their final consent to vaccination. DISCUSSION: Corona-specific distress of cancer patients relates in particular to the course of therapy, but also to a possible overload of the health care system. Oncology care teams should allow space for questions from their patients, acknowledge possible uncertainties, provide emotional support, and draw attention to reliable sources of information.

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.