Feasibility randomized controlled trial of a self-guided online intervention to promote psychosocial adjustment to unmet parenthood goals.

STUDY QUESTION: Is it feasible to implement and evaluate an online self-guided psychosocial intervention for people with an unmet parenthood goal (UPG), aimed to improve well-being, in an online randomized controlled trial (RCT)? SUMMARY ANSWER: The evaluation of an online bilingual self-guided psychosocial intervention for people with a UPG is feasible, reflected by high demand, good acceptability, good adaptation and promise of efficacy, but minor adjustments to the intervention and study design of the RCT should be made to enhance practicality. WHAT IS KNOWN ALREADY: Self-identifying as having a UPG, defined as being unable to have children or as many as desired, is associated with impaired well-being and mental health. Practice guidelines and regulatory bodies have highlighted the need to address the lack of evidence-based support for this population. It is unknown if MyJourney (www.myjourney.pt), the first online self-guided intervention for people with UPGs, can be implemented and evaluated in an RCT. STUDY DESIGN, SIZE, DURATION: To evaluate the feasibility of MyJourney, we conducted a registered, two-arm, parallel group, non-blinded feasibility RCT, with a 1:1 computer-generated randomized allocation and embedded qualitative process evaluation. Participants were included between November 2020 and March 2021. Assessments were made before randomization (T1), 10 weeks (T2) and 6 months after (T3, intervention group only). Participants allocated to the intervention group received an email to access MyJourney immediately after randomization. Participants in the waitlist control group were given access to MyJourney after completing the 10-week assessment (T2). PARTICIPANTS/MATERIALS, SETTING, METHODS: Participants were recruited via social media advertising of MyJourney and its feasibility study. People who self-identified as having a UPG could click on a link to participate, and of these 235 were randomized. Outcome measures related to demand, acceptability, implementation, practicality, adaptation and limited efficacy were assessed via online surveys. The primary outcome in limited efficacy testing was hedonic well-being, measured with the World Health Organisation Wellbeing Index (WHO-5). MAIN RESULTS AND THE ROLE OF CHANCE: Participation and retention rates were 58.3%, 31.7% (T2) and 45.2% (T3, intervention group only), respectively. Of participants invited to register with MyJourney, 91 (76.5%) set up an account, 51 (47.2%) completed the first Step of MyJourney, 12 (11.1%) completed six Steps (sufficient dose) and 6 (5.6%) completed all Steps within the 10-week recommended period. Acceptability ranged from 2.79 (successful at supporting) to 4.42 (easy to understand) on a 1 (not at all) to 5 (extremely acceptable) scale. Average time to complete sufficient dose was 15.6 h (SD = 18.15) and to complete all Steps was 12.4 h (SD = 18.15), with no differences found for participants using MyJourney in Portuguese and English. Modified intention-to-treat analysis showed a moderate increase in well-being from T1 to T2 in the intervention group (ηp2 = 0.156, mean difference (MD) = 9.300 (2.285, 16.315)) and no changes in the control group (ηp2 = 0.000, MD = 0.047 (-3.265, 3.358)). Participants in the process evaluation reported MyJourney was needed and answered their needs for support (reflecting high demand and acceptability), the recommended period to engage with MyJourney was short, and their engagement was influenced by multiple factors, including personal (e.g. lack of time) and MyJourney related (e.g. reminders). LIMITATIONS, REASONS FOR CAUTION: Participants were mostly white, well-educated, employed, childless women. Non-blinded allocation, use of self-reported questionnaire assessments and high attrition in the intervention group could have triggered bias favourable to positive evaluations of MyJourney and resulted in low power to detect T2 to T3 changes in limited efficacy outcomes. WIDER IMPLICATIONS OF THE FINDINGS: MyJourney can proceed to efficacy testing, but future work should eliminate barriers for engagement and explore strategies to maximize adherence. Entities wanting to support people with UPGs now have a freely accessible and promising resource that can be further tested and evaluated in different settings. STUDY FUNDING/COMPETING INTEREST(S): MyJourney's development was funded by the charity Portuguese Fertility Association, Cardiff University and University of Coimbra (CINEICC). Dr S.G. reports consultancy fees from Ferring Pharmaceuticals A/S, speaker fees from Access Fertility, SONA-Pharm LLC, Meridiano Congress International and Gedeon Richter and grants from Merck Serono Ltd. Bethan Rowbottom holds a PhD scholarship funded by the School of Psychology, Cardiff University. The other authors have no conflicts of interest. TRIAL REGISTRATION NUMBER: Clinical Trials.gov NCT04850482.

The infertility trap: how defeat and entrapment affect depressive symptoms.

STUDY QUESTION: Does the perception of failure without a solution or way forward of infertile couples have a mediator role between the importance couples attribute to parenthood and depressive symptoms? SUMMARY ANSWER: The perception of failure without a solution or way forward, assessed by feelings of entrapment and defeat, mediates the effect of the importance of parenthood on depressive symptoms of infertile men and women. WHAT IS KNOWN ALREADY: Research has documented that the heightened importance of parenthood affects infertile couples' adjustment to infertility and medical treatments. However, it remains unclear which psychological mechanisms and perceptions may underlie the association between having parenthood as a nuclear aspect of life and presenting depressive symptoms related to difficulties in accomplishing that important life goal. Although these links have been scantly addressed in infertility, previous studies have pointed to the role that perceptions of defeat and entrapment have in several psychopathological conditions. STUDY DESIGN, SIZE, DURATION: The study was cross-sectional. Couples pursuing medical treatment for their fertility problems were invited to participate by their doctors in several public and private clinics. Data collection took place between July 2009 and 2011. PARTICIPANTS/MATERIALS, SETTING, METHODS: One hundred forty-seven infertile couples consented to participate in the study. Both couple members (147 women and 147 men) completed a set of self-report instruments for the assessment of depressive symptoms, perceptions of defeat and entrapment, importance of parenthood and rejection of a childfree lifestyle. Analyses were conducted through Structural Equation Modeling and followed a dyadic analysis strategy, allowing for controlling the interdependence of the data. MAIN RESULTS AND THE ROLE OF CHANCE: The hypothesized tested model showed a very good fit to the data [(χ(2) = 68.45, P = 0.014, comparative fit index = 0.98, standardized root-mean-square residual = 0.06 and root mean square error of approximation = 0.06] and explained 67 and 58% of the variability in depressive symptoms in women and men, respectively. Results revealed that the importance of parenthood does not have a direct effect on depressive symptoms of infertile men and women, but an indirect effect, by affecting the perception of having failed and not being able to solve it or move forward [women: estimate for indirect effect: 0.38 (bias corrected (BC) 95% confidence interval (CI) = 0.25; 0.56; P < 0.001); men: estimate for indirect effect: 0.23 (BC 95% CI = 0.06; 0.40; P = 0.013)]. LIMITATIONS, REASONS FOR CAUTION: The study was cross-sectional, which does not allow for the establishment of causality. Another limitation is the heterogeneity of the sample, as participants were recruited at various stages of their fertility care. In addition, due to the specific nature of the variables, further studies are needed to establish exactly how the relationship between defeat and entrapment and depression operates, as the mechanism may be bidirectional. WIDER IMPLICATIONS OF THE FINDINGS: This study emphasizes the role of perceptions of defeat and entrapment on the psychological adjustment to infertility and assisted reproduction. These emotional processes should be taken into consideration and targeted in psychological interventions of couples undergoing medical treatments for infertility. In fact, although parenthood may be perceived as a core purpose for many couples dealing with difficulties in conceiving, it is only when these difficulties are experienced as failures without a resolution and as inescapable, that couples are prone to develop depressive symptoms. STUDY FUNDING/COMPETING INTERESTS: This research has been supported by the first author Ph.D. Grant (SFRH/BD/68392/2010), sponsored by the Portuguese Foundation for Science and Technology (FCT). The authors have no conflict of interests. TRIAL REGISTRATION NUMBER: N/A.

The impact of shame and self-judgment on psychopathology in infertile patients.

BACKGROUND: Little is known about psychological processes of infertile couples pursuing medical treatment in comparison with fertile couples and adoption candidates who also suffer from infertility but are not seeking medical help. This study aims to contribute to a better understanding of these individuals in terms of psychological processes (such as external shame, internal shame and self-judgment) and their association with psychopathology, also attending to gender differences. METHODS: One hundred control couples without known fertility problems [fertile group (FG)], 100 couples with an infertility diagnosis and pursuing medical treatment [infertile group (IG)], and 40 couples with an infertility diagnosis who are applying for adoption [adoption group (AG)] completed the instruments: Beck Depression Inventory, Spielberger State-Trait Anxiety Inventory, Others as Shamer, Experience of Shame Scale and the Self-compassion Scale. One-way analysis of variances were used to compare the three groups demographic and study variables. Pearson correlations and linear multiple regression analysis were performed to investigate the associations between shame, self-judgment, depression and anxiety. To explore gender differences, T-tests were used. RESULTS: The IG group scored higher than FG and AG in measures of depression, anxiety, external shame, internal shame and self-judgment. In infertile couples, self-judgment, external shame and internal shame emerged as significant predictors of depressive symptomatology. Women with an infertility diagnosis tend to present higher levels of depressive and anxiety symptoms in comparison with fertile controls and adoption candidates. CONCLUSIONS: This study highlights the importance of emotional regulation processes such as internal and external shame, and self-judgment, to the understanding of psychopathological symptomatology associated with infertility. Our results suggest that these issues should be addressed in a therapeutic context with these couples. Nevertheless, the heterogeneity of the infertile group, in what concerns different stages of medical diagnosis and treatment, might represent a limitation in the interpretation of our findings.

Determinação de cetamina em plasma por HPLC: aplicação em um estudo de farmacocinética de associação medicamentosa em cães / HPLC determination of ketamine in plasma: application in a pharmacokinetic study of drug – drug association in dogs

A S(mais) cetamina é um fármaco amplamente utilizado na medicina para induzir anestesia e a associação com midazolam é empregada para minimizar seus efeitos adversos. Associações medicamentosas podem resultarem interações farmacocinéticas e a disponibilidadede métodos bioanalíticos para a determinação da cetamina em plasma constitui ferramenta útil para a avaliação do perfil cinético do fármaco administrado isoladamente ou em associação. O presente estudo teve como objetivo o desenvolvimento e validação de um método analítico para determinação da cetamina em plasma por cromatografia líquida de alta eficiência (HPLC) e a investigação do perfil farmacocinético da cetamina em quatro cães hígidos da raça Beagle. A S(mais) cetamina (10mg/kg) foi administrada pela veia cefálica em dose única isoladamente (protocolo I) ou associada ao midazolam (0.2mg/kg) (protocolo II) em estudo cruzado com intervalo de uma semana para washout. Amostras seriadas de sangue foram coletadas no intervalo de oito horas e analisadas por HPLC para a avaliação do perfil farmacocinético utilizando modelo bicompartimental. O método bioanalítico apresentou limites de confiança aceitáveis para sua aplicação em estudos de farmacocinética e os parâmetros área sob a curva (ASC0-8), volume de distribuição (Vd), clearancetotal (Clt), meia vida de eliminação (t/12 Beta), constante de eliminação (Beta), meia vida de distribuição (t1/2alfa) econstante de distribuição (alfa) não mostraram diferenças estatísticas significativas entre os grupos (p menor que 0.05, Wilcoxon). Os resultados obtidos sugerem que a redução dos efeitos colaterais da cetamina decorrente do uso da associação cetamina-midazolam não está relacionada a alterações no perfil farmacocinético da cetamina.

Reparo da luz da narina direita e oclusão de fístula oronasal decorrente de miíase em um cão (Canis familiaris)

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