The clinical effectiveness of the Mind/Body Program for Infertility on wellbeing and assisted reproduction outcomes: a randomized controlled trial in search for active ingredients.

STUDY QUESTION: Does the Mind/Body Program for Infertility (MBPI) perform better, due to certain distinctive elements, than a partly matched support group in improving the wellbeing and medically assisted reproduction (MAR) outcomes of women with elevated distress levels in a clinical setting? SUMMARY ANSWER: While robust enhancements occurred in the wellbeing overall, the cognitive behavioural and formalized stress management elements of the MBPI allowed a significantly stronger improvement in trait anxiety, but not in other mental health and MAR outcomes, compared with a support group. WHAT IS KNOWN ALREADY: Mind-body psychological programmes adjacent to MAR have been found to improve women's mental states and possibly increase chances of pregnancy. However, not enough is known about the programme's effectiveness among patients with elevated distress levels in routine clinical settings, nor is it clear which of its particular ingredients are specifically effective. STUDY DESIGN, SIZE, DURATION: A pre-post design, single-centre, randomized controlled trial was performed between December 2019 and October 2022 (start and end of recruitment, respectively). The sample size (n = 168) was calculated to detect superiority of the MBPI in improving fertility-related quality of life. Randomization was computer-based, with random numbers concealing identities of patients until after allocation. PARTICIPANTS/MATERIALS, SETTING, METHODS: The trial was conducted at a large university teaching hospital. A total of 168 patients were randomly assigned to the mind-body (MBPI) group (n = 84) and the fertility support (FS) control group (n = 84). Patients received a 10-week, 135-min/week group intervention, with the FS group following the same format as the MBPI group, but with a less restricted and systematic content, and without the presumed effective factors. The number of patients analysed was n = 74 (MBPI) and n = 68 (FS) for post-intervention psychological outcomes, and n = 54 (MBPI) and n = 56 (FS) for pregnancy outcomes at a 30-month follow-up. MAIN RESULTS AND THE ROLE OF CHANCE: Significant improvements occurred in both groups in all psychological domains (adjusted P < 0.001), except for treatment-related quality of life. Linear mixed-model regression analysis did not reveal significantly greater pre-post improvements in the MBPI group than in the FS group in fertility-related quality of life (difference in differences (DD) = 4.11 [0.42, 7.80], d = 0.32, adjusted P = 0.124), treatment-related quality of life (DD = -3.08 [-7.72, 1.55], d = -0.20, adjusted P = 0.582), infertility-specific stress (DD = -2.54 [-4.68, 0.41], d = -0.36, adjusted P = 0.105), depression (DD = -1.16 [3.61, 1.29], d = -0.13, adjusted P = 0.708), and general stress (DD = -0.62 [-1.91, 0.68], d = -0.13, adjusted P = 0.708), but it did show a significantly larger improvement in trait anxiety (DD = -3.60 [-6.16, -1.04], d = -0.32, adjusted P = 0.042). Logistic regression showed no group effect on MAR pregnancies, spontaneous pregnancies, or live births. LIMITATIONS, REASONS FOR CAUTION: The follow-up only covered MAR-related medical outcomes and no psychological variables, and their rates were not equal in the two groups. Biological factors other than age, aetiology, and duration of infertility may have confounded the study results. Loss to follow-up was between 5% and 10%, which may have led to some bias. WIDER IMPLICATIONS OF THE FINDINGS: The psychologically and medically heterogeneous sample, the normal clinical setting and the low attrition rate all raise the external validity and generalizability of our study. The MBPI works not only in controlled conditions, but also in routine MAR practice, where it can be introduced as a cost-effective, low-intensity psychological intervention, within the framework of stepped care. More studies are needed to further identify its active ingredients. STUDY FUNDING/COMPETING INTEREST(S): The authors received no financial support for the research, authorship, and/or publication of this article. The authors have no conflict of interest to disclose. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT04151485. TRIAL REGISTRATION DATE: 5 November 2019. DATE OF FIRST PATIENT'S ENROLMENT: 15 December 2019.

[The role of psychological factors in the development and treatment of infertility]. / A pszichés faktorok szerepe a meddoség kialakulásában és kezelésében.

Infertility can be caused by several factors, thus the effective treatment of infertility is a complex and multidisciplinary task. While psychological support is an essential part of infertility treatment, there is growing evidence that the role of psychological factors is much greater, as personality and psychological factors have a significant impact on the development, long-term course, and treatment success of several somatic diseases. Exploring the possible mechanisms through which these psychological factors directly or indirectly contribute to infertility and the success of infertility interventions could help identify high-risk patient groups and tailor treatment to the patient, which may increase the chances of successful pregnancy and live birth in women undergoing assisted reproductive treatment. In this review we aim to summarize current knowledge and research findings on the relationship between psychological factors and infertility treatments, including clinical consequences and implications for future research. Keywords: infertility, assisted reproduction, IVF, adherence, personality, temperaments, affective temperaments, TEMPS-A, stress, depression.

The relationship between therapeutic adherence and personality.

Inadequate adherence to long-term therapies significantly affects the course and outcome of the disease, and therefore poses a serious threat to both the effectiveness and success of treatment and the long-term well-being of patients. Therapeutic adherence is an extremely complex process, with a number of risk and protective factors identified, many of which underlie the psychological characteristics of the patient. A number of medication adherence models have been developed to take into account the psychological characteristics of patients, and recent research has examined the relationship between different personality models and adherence to therapeutic recommendations. In this review we aim to summarize current knowledge, adherence models, research findings on the relationship between personality and adherence, including implications for future research.

Adherence to dietary recommendations mediates the effect of affective temperaments on infertility treatment outcomes.

Affective temperaments have been shown to robustly affect infertility treatment success. However, identification of possible mediating factors through which they exert their influence is still lacking. A growing number of results suggest that adherence to recommended treatments may be such a mediator, on the one hand, because affective temperaments are known to influence adherence and, on the other hand, because non-adherence negatively influences the treatment outcome. Recommended treatment of infertility involves, beyond medications, dietary and lifestyle changes. The aim of this retrospective cohort study was to evaluate whether adherence to physician-prescribed diet and physical activity recommendations mediates the effect of affective temperaments on infertility treatment outcomes. Among 308 women who underwent infertility treatment in an Assisted Reproduction Center, affective temperaments, adherence to diet, adherence to physical exercise, and infertility treatment success (clinical pregnancy) were assessed besides detailed medical history and demographic parameters. Associations between affective temperaments, adherence to diet and recommended physical activity, and assisted reproduction outcomes were analyzed using generalized linear models and causal mediation analysis. Adherence to physical activity didn't have an effect, but diet adherence increased the odds of infertility treatment success by 130% suggesting its role as a potential mediator. Based on causal mediation analysis, higher depressive and anxious temperament scores were directly associated with 63% and 45% lower odds of achieving clinical pregnancy, respectively, with effects not mediated by diet adherence. Higher irritable temperament scores indirectly decreased the odds of achieving clinical pregnancy by 14%, mediated by diet adherence; while higher cyclothymic temperament scores decreased the odds of achieving clinical pregnancy both directly by 51% and indirectly, mediated by diet adherence by 11%. Our results suggest that diet adherence mediates the mechanism by which irritable and cyclothymic affective temperaments influence IVF treatment success. Since adherence is a modifiable risk factor of infertility treatment success, screening for affective temperaments may help to identify potentially high-risk non-adherent patient groups and offer patient-tailored treatment, which may help increase the chances of a successful pregnancy and live birth in women undergoing IVF treatment.

The SCREENIVF Hungarian version is a valid and reliable measure accurately predicting possible depression in female infertility patients.

Infertility patients, often in high distress, are entitled to being informed about their mental status compared to normative data. The objective of this study was to revalidate and test the accuracy of the SCREENIVF, a self-reported tool for screening psychological maladjustment in the assisted reproduction context. A cross-sectional, questionnaire-based online survey was carried out between December 2019 and February 2023 in a consecutive sample of female patients (N = 645, response rate 22.9%) in a university-based assisted reproduction center in Hungary. Confirmatory factor analysis and cluster and ROC analyses were applied to test validity, sensitivity and specificity in relation to Beck Depression Inventory (BDI) scores. Model fit was optimal (chi-square = 630.866, p < 0.001; comparative fit index = 0.99; root-mean-square error of approximation = 0.018 (90% CI 0.013-0.023); standardized-root-mean-square-residual = 0.044), and all dimensions were reliable (α > 0.80). A specific combination of cutoffs correctly predicted 87.4% of BDI-scores possibly indicative of moderate-to-severe depression (χ2(1) = 220.608, p < 0.001, Nagelkerke R2 = 0.462, J = 66.4). The Hungarian version of the SCREENIVF is a valid and reliable tool, with high accuracy in predicting BDI-scores. Low response rate may affect generalizability. The same instrument with different cutoffs can serve various clinical goals.

Affective temperaments show stronger association with infertility treatment success compared to somatic factors, highlighting the role of personality focused interventions.

Infertility has a multifactorial background, where, besides somatic factors, psychological contributors also play a role in development and outcome. While affective temperaments have been associated with development, course, and outcome as well as treatment success in various somatic conditions, their association with infertility and its treatment has not been investigated so far. The purpose of our retrospective cohort study was to evaluate the influence of affective temperaments on fertility treatment outcomes. Among 578 women who underwent infertility treatment in an Assisted Reproduction Centre in Budapest, Hungary, treatment success, detailed medical history, and demographic parameters were recorded, and the Temperament Evaluation of Memphis, Pisa, Paris, and San Diego Auto-questionnaire (TEMPS-A) was administered. Possible predictors of assisted reproduction outcome were analyzed using multivariate logistic regression models, followed by a receiver operating curve (ROC) analysis in order to define ideal affective temperament cut-off values for clinical applicability. Aside from age, BMI, and previous miscarriage, cyclothymic scores > 4 (OR = 0.51 CI 0.35-0.74, p < 0.001), depressive scores > 9 (OR = 0.59 CI 0.4-0.87, p = 0.009) and anxious scores > 9 (OR = 0.45 CI 0.31-0.66, p < 0.001) significantly decreased the odds of clinical pregnancy by 49%, 41% and 55%, respectively. Irritable and hyperthymic temperaments, as well as other somatic and socio-economic factors had no effect on infertility treatment outcomes. The results suggest that affective temperaments may be related to the outcome of infertility treatments. Thus, screening for affective temperaments may help identify high-risk patient groups and offer patient-tailored treatment, which may increase the chances of a successful pregnancy and live birth for women undergoing IVF treatment.

[The association between diabetes complications and symptoms of depression and anxiety]. / A cukorbetegség szövodményeinek összefüggése a depressziós és szorongásos tünetekkel.

INTRODUCTION: The bidirectional relationship between diabetes and depression results in severe disease burden. Co-occurring depression is associated with a higher rate of diabetes complications. These complications impair quality of life, however, their impact on depressive symptoms is controversial. OBJECTIVE: In our cross-sectional study, we aimed to investigate whether the presence of diabetes complications is associated with depressive and anxiety symptoms among patients with type 2 diabetes in general practice. METHOD: We obtained patient history, anthropometric, socioeconomic, laboratory parameters. For symptom assessment, the Beck Depression Inventory (BDI) and the Hamilton Anxiety Scale (HAM-A) were used. We collected data between September 2018 and February 2020. RESULTS: We included 338 consecutive patients with type 2 diabetes. The mean age of the sample was 63.98 ± 11.51 (years ± SD), 61.2% of participants were female. We found significant univariate association between diabetes complications and older age, less physical activity, higher body mass index, insulin therapy, higher HbA1c, higher creatinine and carbamide concentrations, worse depressive and anxiety symptoms. In multivariate analysis, diabetes complications and certain socio-demographic factors (female gender, lower education, rural-dwelling) were the determinants of higher BDI and HAM-A scores. CONCLUSION: Among primary care patients with type 2 diabetes, the prevalence of depressive and anxiety symptoms was higher and more severe in patients with diabetes complications. The recommended screening for affective disorders among patients with diabetes is especially justified if complications are present. Orv Hetil. 2023; 164(3): 79-87.

A bitter pill to swallow? Impact of affective temperaments on treatment adherence: a systematic review and meta-analysis.

BACKGROUND: Predominant affective temperament may affect adherence to prescribed pharmacotherapeutic interventions, warranting systematic review and meta-analysis. METHODS: The Scopus, Web of Science, PubMed, and OVID MedLine databases were inquired since inception up to 31st of March 2022 for records of any study design documenting quantitative evidence about affective temperaments as measured by the Temperament Evaluation of Memphis, Pisa, Paris, and San Diego (TEMPS-A) questionnaire and treatment adherence measured by the means of major rating scales on the matter. People with low vs. high levels of treatment adherence, matched for otherwise clinically relevant variables, were deemed as cases and controls, respectively, using standardized mean differences (SMDs) in pertinent scores under random-effects meta-analysis. RESULTS: Nine studies encompassing 1138 subjects pointed towards significantly higher cyclothymic (SMD = -0.872; CI: [-1.51 to -0.24]; p = 0.007), irritable (SMD = -0.773; CI: [-1.17 to -0.37]; p < 0.001) and depressive (SMD = -0.758; CI: [-1.38 to -0.14]; p = 0.017) TEMPS-A scores both for psychiatric and nonpsychiatric samples with poorer adherence. LIMITATIONS: Intrinsic limitations of the present report include the heterogeneity of the operational definitions documented across different primary studies, which nonetheless reported on the sole medication-treatment adherence, thus limiting the generalizability of the present findings based on a handful of comparisons. CONCLUSIONS: Though further primary studies need to systematically account for different clinical and psychosocial moderators across different clinical populations and operational definitions, cyclothymic, depressive, and irritable temperament scores may nonetheless predict treatment adherence and, thus, overall treatment outcomes.