Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT).

INTRODUCTION: Ulcerative colitis (UC) and irritable bowel syndrome (IBS) are distressing chronic diseases associated with abdominal pain and altered bowel habits of unknown aetiology. Results from previous studies indicate that, across both diseases, increased levels of illness-related anxiety and dysfunctional symptom expectations contribute to symptom persistence. Thus, comparing both disorders with regard to common and disease-specific factors in the persistence and modification of gastrointestinal symptoms seems justified. Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies. METHODS AND ANALYSIS: To assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, three-arm randomised controlled trial. A total of 117 patients with UC and 117 patients with IBS will be randomised into three groups of equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (SC, intervention 1), non-specific supportive treatment in addition to SC (intervention 2) or SC only (control). Both active intervention groups will comprise three individual online consultation sessions and a booster session after 3 months. The primary outcome is baseline to postinterventional change in gastrointestinal symptom severity. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of the Hamburg Medical Association (2020-10198-BO-ff). The study will shed light onto the efficacy and mechanisms of action of a targeted expectation management intervention for persistent gastrointestinal symptoms in patients with UC and IBS. Furthermore, the detailed analysis of the complex biopsychosocial mechanisms will allow the further advancement of aetiological models and according evidence-based intervention strategies. TRIAL REGISTRATION NUMBER: ISRCTN30800023.

Couples After Renal Transplantation: Impact of Sex and Relationship Quality on Adherence in a Prospective Study.

BACKGROUND: In patients after kidney transplantation, nonadherence to immunosuppressant medication is a common problem. Identifying factors that influence adherence could optimize medical care and prevent nonadherence. Kidney transplantation is a stressful situation for the patient and also for the relatives. The recipients of renal transplants as well as the family system have to be taken into account as potential impact factors. METHODS: Fifty-six couples with a renal transplant recipient were investigated regarding adherence, relationship satisfaction, social support, and quality of life. Moreover, sex and role differences (patient vs partner) as well as differences within the couple were analyzed. Impact factors on adherence were identified. RESULTS: Female recipients of renal transplant reported higher relationship satisfaction than male recipients, female spouses, and male spouses. Physical quality of life was lower in renal transplant recipients compared with caregivers. For male renal transplant recipients, significant predictors of adherence, such as social support, relationship quality, and quality of life emerged, whereas for female renal transplant recipients mental quality of life and education level were found to influence adherence. CONCLUSIONS: The study reveals the importance of relationship functioning of couples after kidney transplantation, as well as considering sex and role differences. There is a need to examine the posttransplantation nonadherence risk profile of women and men separately.

Psychological Distress in a Sample of Inpatients With Mixed Cancer-A Cross-Sectional Study of Routine Clinical Data.

BACKGROUND: The diagnosis and treatment of cancer are associated with psychological distress that often leads to a significant reduction in emotional and physical well-being and quality of life. Early detection of psychological distress is therefore important. This study aims to assess the psychological distress of inpatient cancer patients using routine clinical data. Furthermore, variables and problems most strongly associated with psychological distress should be identified. MATERIALS AND METHODS: N = 1,869 inpatients were investigated (mean age = 60.89 years; 35.94% female) using the National Comprehensive Cancer Network Distress Thermometer and problem checklist to assess distress as well as multiple possible problem areas. Visceral oncological cancer (31.6%) was the most common tumor diagnosis, followed by skin cancer (26.2%) and urological cancer (21.7%). RESULTS: 65.9% of the sample experienced high levels of distress (Distress Thermometer ≥ 5). Female sex, stage 4 of disease, and visceral and head and neck cancer emerged as risk factors for high distress. A younger age (<65 years) was significantly correlated with higher distress. The most frequently self-reported problems were fears (50.1%), worry (49.9%), and fatigue (49.1%). Patients with all 3 of these problems had 24 times higher risk [odds ratio (OR) = 23.9] for high levels of distress than patients without these problems. Women reported significantly more practical, emotional, and physical problems than men. Younger (<50 years) and middle-aged patients (50-64 years) reported increased levels of practical, family, and emotional problems compared with older patients (≥65 years). DISCUSSION: Almost two-thirds of the sample reported high levels of distress. The most frequently reported problem areas were emotional and physical problems. These results can help to identify patients with high risk for psychological distress and, therefore, be used to optimize psychosocial and psycho-oncological care for patients with cancer.

Depression, anxiety, fear of progression, and emotional arousal in couples after left ventricular assist device implantation.

AIMS: Left ventricular assist device (LVAD) is a common treatment option for patients with heart failure waiting for a donor heart. Living with an LVAD is associated with many burdens and worries. Patients often depend on the support of their relatives, usually their spouses. This can also put a strain on the spouses and be associated with psychological stress for both. In couples, communication proves to be an important form of emotional support. Besides verbal aspects of communication, the extent of emotional arousal (f0 ) that is vocally encoded plays an essential role as a non-verbal aspect of communication. This study aims to investigate the psychological impact of LVAD on couples in investigating to what extent depression, anxiety, and fear of progression (FoP) differ between patients and partners, the intrapersonal and interpersonal associations of anxiety, depression, and FoP, and differences in emotional arousal. METHODS AND RESULTS: In this cross-sectional study, male LVAD patients and their female partners (N = 21 couples) responded to self-report questionnaires on depression, anxiety, and FoP. Emotional arousal (f0 ) was evaluated during social support interactions between both spouses. Female partners experienced more anxiety than male patients (P = 0.016). No differences occurred in depression (P = 0.967) and FoP (P = 0.084). Regarding intrapersonal associations, for patients, correlations appeared between anxiety and depression (r = 0.859, P = 0.000), anxiety and FoP (r = 0.730, P = 0.000), and depression and FoP (r = 0.608, P = 0.004). For caregivers, correlations appeared between anxiety and depression (r = 0.906, P = 0.000), anxiety and FoP (r = 0.665, P = 0.001), and depression and FoP (r = 0.734, P = 0.000). Regarding interpersonal associations, correlations were found between patient's anxiety and caregiver's anxiety (r = 0.461, P = 0.041), caregiver's depression (r = 0.510, P = 0.018), and caregiver's FoP (r = 0.524, P = 0.015). Non-significant correlations were found for caregiver's anxiety and patient's FoP (r = 0.404, P = 0.078) and patient's depression (r = 0.286, P = 0.236). Patient's depression was associated with caregiver's FoP (r = 0.526, P = 0.017), but not with caregiver's depression (r = 0.337, P = 0.146). No significant correlations were found between caregiver's depression and patient's FoP (r = 0.386, P = 0.084) and patient's depression (r = 0.337, P = 0.146). Patient's and caregiver's FoP showed significant associations (r = 0.482, P = 0.027). Patient's and partner's f0 were interrelated. Patient's f0 was positively related with his own and his partner's psychological distress. Partner's f0 showed associations to her own depression and FoP. CONCLUSIONS: Findings indicate that women of LVAD patients are burdened similarly or even to a greater extent than men themselves. Women's psychological distress has an impact on patients' psychological distress and vice versa. Early interventions for both patient and partner represent a necessary intervention target.

Long-Acting Injections in Schizophrenia: a 3-Year Update on Randomized Controlled Trials Published January 2016-March 2019.

PURPOSE OF REVIEW: This study was conducted in order to review randomized controlled trial (RCT) data published January 2016-March 2019 on long-acting injectable antipsychotics (LAIs) for schizophrenia. RECENT FINDINGS: Thirty-one RCTs (primary studies = 7; post hoc analyses = 24; n = 4738) compared LAIs vs. placebo (studies = 11, n = 1875), LAIs vs. oral antipsychotics (OAPs) (studies = 7, n = 658), and LAI vs. LAI (studies = 13, n = 2205). LAIs included two new formulations, aripiprazole lauroxil nanocrystal dispersion and subcutaneously injectable risperidone Perseris, as well as aripiprazole lauroxil, aripiprazole once-monthly, paliperidone once-monthly, paliperidone 3-monthly, and risperidone-LAI. Regarding prevention of relapse and hospitalization, LAIs consistently outperformed placebo, being partly superior to OAPs, without relevant LAI-LAI differences. LAIs were comparable to OAPs regarding all-cause discontinuation, functioning, quality of life, and tolerability, being associated with higher patient satisfaction and service engagement. Recent meta-analyses yielded mixed results, but never favoring OAPs over LAIs. In RCTs, LAIs are superior to placebo, but only in some aspects, superior to OAPs. Comparative effectiveness of LAIs vs. OAPs requires further study, ideally in generalizable/real-world samples.

Keeping up with the therapeutic advances in schizophrenia: a review of novel and emerging pharmacological entities.

Schizophrenia remains one of the most severe medical diseases. Current dopamine modulating first-generation and second-generation antipsychotics target mainly positive symptoms, but not/inadequately negative and cognitive symptoms. Additional challenges include non-adherence and adverse effects, especially cardiometabolic dysregulation. This review evaluates new/emerging pharmacological treatments for schizophrenia. Therapies targeting total symptoms include cannabidiol, D3 antagonist/5-HT1A partial agonist F17464, lumateperone (ITI-007), phosphodiesterase 10A (PDE10A) inhibitors MK-8189 and TAK-063, sodium nitroprusside, and trace amine-associated receptor-1 (TAAR1) agonist RO5263397 and SEP-363856. Treatments targeting negative symptoms include the PDE10A inhibitor LuAF-11167, 5-HT2A inverse agonist pimavanserin, sigma-2/5-HT2A antagonist roluperidone (MIN-101), and d-amino acid oxidase (DAAO) inhibitor TAK-831. Agents targeting primarily cognitive dysfunction are the glycine transporter-1 inhibitor BI-425809 and cannabidiol. Therapies targeting residual positive symptoms/treatment-resistant schizophrenia include pimavanserin, dopamine D1/D2 antagonist LuAF-35700, and DAAO inhibitor sodium benzoate. Two new long-acting injectable antipsychotic formulations, Aripiprazole Lauroxil NanoCrystal® and the first subcutaneous injectable LAI Perseris (RBP-7000), were recently approved by U.S. Food and Drug Administration, and positive results were announced for Risperidone ISM®, each achieving therapeutic levels within 24 hours, without need for initial oral cotreatment/loading injection-strategies. Paliperidone palmitate 6-monthly intramuscularly injectable and Risperidone subcutaneously injectable TV46000 are currently under investigation. Finally, the samidorphan+olanzapine combination targets reduced weight gain liability, while maintaining olanzapine's efficacy. Most of these trial programs are still ongoing or have yielded mixed or even negative results. Thus, additional mechanisms of action and agents require study to improve schizophrenia outcomes for total/positive symptoms with reduced adverse effects, but also cognitive symptoms, negative symptoms, and treatment resistance, the areas of greatest need in schizophrenia currently.

Dyadic Coping of Kidney Transplant Recipients and Their Partners: Sex and Role Differences.

Background: Coping with stressful health issues - e.g., organ transplantation - can affect interpersonal relationships. Objective: The study examines individual and dyadic coping (DC) in kidney transplant recipients and their partners under consideration of sex and role differences. The Dyadic Coping Inventory allows analyzing partners' perception of their own DC and also of their partner's behavior and investigating different perspectives with three discrepancy indexes (similarity, perceived similarity, congruence). Methods: Fifty-six kidney transplant recipients and their partners completed self-report questionnaires (N = 112) on DC, depression, anxiety, and relationship satisfaction. The average age of the patients was 58.1 years and of the partners 57.2 years; 64.3% of the patients were male; time since transplantation was on average 9.7 years. Results: (1) Individual and dyadic functioning: In couples with male patients female caregivers showed higher own supportive DC than the males. In couples with female patients, women reported higher own stress communication, supportive DC, total positive DC and total DC as well as depression compared to men. (2) Regarding the discrepancy indexes, in couples with male patients lower levels of similarity in DC reactions of the couple was associated with higher depression of the males as well as higher anxiety of the females. Moreover, lower comparability of the own DC with partner-perception was correlated with higher depression in males. In couples with female patients, higher comparability was associated with higher DC. Higher DC of the males was associated with lower own anxiety and better similarity in DC reactions. Lower levels of similarity of the male spouse showed correlations with higher depression and anxiety of the females. (3) Sex and role differences occurred. No significant differences between male patients and male partners occurred whereas female patients showed higher own stress communication, supportive DC, common DC, total positive DC, total DC and relationship satisfaction compared to female caregivers (role differences). The same differences were found comparing female with male patients. No differences occurred between male and female caregivers (sex differences). (4) Regarding male's relationship quality, male's DC total score and similarity index seem to be important predictors in couples with male patients. Discussion: The results demonstrate the relevance of DC in couples with kidney transplantation and show differences between males and females as well as between patients and partners.

[Impact of Emotion Regulation and Emotional Arousal on Quality of Life and Adherence of Couples after Kidney Transplantation]. / Einfluss von Emotionsregulation und emotionaler Erregung auf Lebensqualität und Adhärenz bei Paaren nach Nierentransplantation.

INTRODUCTION: Nonadherence to immunosuppressive medication increases the risk of graft failure. Maladaptive emotion regulation strategies (ERS) seem to be a risk factor for nonadherence, whereas for patients in relationships spousal support appears as a protective resource. Emotional arousal, objectively measured by the fundamental frequency (f0) during spousal supportive communication is associated with supportive behavior. MATERIALS & METHODS: This study examined the relationship between beliefs about immunosuppressive medication, quality of life, ERS, emotions and emotional arousal, assessed during social support interactions of both spouses of N=50 couples after kidney transplantation. RESULTS: Maladaptive ERS of the transplant recipient were associated with lower mental quality of life of the partner, marginally higher own negative affect and lower beliefs about medication. Maladaptive ERS of the partner showed negative correlations with own mental quality of life. Regarding f0, gender differences were found. Higher f0 of the male transplant recipient were associated with more maladaptive ERS of the female partner. Marginally significate correlations were found with lower own beliefs about medication. Higher f0 of the wife of the male transplant recipient showed correlations with lower own positive affect, more negative affect of the male patient and lower beliefs about medication. Higher f0 of female transplant recipients were associated with lower own maladaptive ERS and lower maladaptive ERS of the husband. DISCUSSION: The findings support the relevance of early interventions focusing on identifying and modifying maladaptive ERS for both the patient and partner.