Testing an Evidence-Based Self-Help Program for Infertility-Related Distress: Protocol for a Randomized Controlled Trial.

BACKGROUND: Infertility-the inability to achieve pregnancy despite ≥12 months of focused attempts to conceive-is experienced by 1 in 6 couples. Women typically carry a disproportionate share of the psychological burden associated with infertility, experiencing poor quality of life, and 30%-40% experiencing depressive mood or anxiety. Unfortunately, currently available psychological interventions targeting infertility-related distress are associated with modest effects. OBJECTIVE: Our team, in collaboration with patient advisors, has designed a self-help intervention for infertility-related distress involving 7 weekly 10-minute videos addressing the cognitive, behavioral, and interpersonal challenges associated with infertility, delivered through a mobile app. A feasibility study suggests that it is well accepted and highly effective in reducing symptoms of anxiety and depressed mood among distressed individuals dealing with infertility. This study represents the next step in this line of research: a fully powered randomized controlled trial comparing the intervention to a waitlist control group. METHODS: We will recruit 170 individuals struggling to become pregnant in Canada or the United States to be randomized to our 7-week self-help program or a treatment-as-usual condition. The primary outcome will be fertility quality of life, while secondary outcomes will include depressive symptoms, anxious symptoms, and relationship quality, assessed before and after the program as well as biweekly for 16 weeks following completion of the program. Self-reported health care use and the presence of diagnosed mood and anxiety disorders, assessed through a structured psychiatric interview, will also be assessed immediately following the intervention and at the 16-week follow-up assessment. Treatment adherence and retention will also be recorded throughout the intervention. Multilevel modeling will compare the intervention arm to the treatment-as-usual condition in terms of all continuous outcomes across the 9 measurement points. Logistic regression will be used to assess the occurrence of mood and anxiety disorders in the 2 treatment arms at the posttreatment assessment as well as at the 16-week follow-up. Sensitivity analyses will examine potential treatment moderators: membership in the LGBTQIA+ (lesbian, gay, bisexual, transgender, queer, intersex, and asexual) communities, baseline fertility quality of life, cultural background, disability status, and pursuit of conception through medical intervention. RESULTS: We expect our intervention to be more effective than treatment-as-usual in improving all mental health parameters assessed and decreasing health care use related to both mental and reproductive health. Effects are expected to be larger with decreasing baseline quality of life and equally effective regardless of membership in the LGBTQIA+ communities, cultural background, or disability status. CONCLUSIONS: If our intervention is successful, this would suggest that it should be scaled up and made publicly available. The availability of this program would fill an important gap in light of the high rates of psychopathology among those experiencing infertility and considering the current lack of effective psychotherapy approaches for infertility. TRIAL REGISTRATION: Clinicaltrials.gov NCT06006936; https://classic.clinicaltrials.gov/ct2/show/NCT06006936. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52662.

A research and development (R&D) roadmap for broadly protective coronavirus vaccines: A pandemic preparedness strategy.

Broadly protective coronavirus vaccines are an important tool for protecting against future SARS-CoV-2 variants and could play a critical role in mitigating the impact of future outbreaks or pandemics caused by novel coronaviruses. The Coronavirus Vaccines Research and Development (R&D) Roadmap (CVR) is aimed at promoting the development of such vaccines. The CVR, funded by the Bill & Melinda Gates Foundation and The Rockefeller Foundation, was generated through a collaborative and iterative process, which was led by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and involved 50 international subject matter experts and recognized leaders in the field. This report summarizes the major issues and areas of research outlined in the CVR and identifies high-priority milestones. The CVR covers a 6-year timeframe and is organized into five topic areas: virology, immunology, vaccinology, animal and human infection models, and policy and finance. Included in each topic area are key barriers, gaps, strategic goals, milestones, and additional R&D priorities. The roadmap includes 20 goals and 86 R&D milestones, 26 of which are ranked as high priority. By identifying key issues, and milestones for addressing them, the CVR provides a framework to guide funding and research campaigns that promote the development of broadly protective coronavirus vaccines.

Fertility Knowledge Among Women Struggling to Conceive Without Medical Intervention: A Brief Report.

INTRODUCTION: Approximately 1 in 6 women experience infertility. Though medical treatments for infertility exist, they are very costly and highly burdensome for women. It is therefore desirable to optimize women's chances of conception without medical intervention by ensuring that they have adequate knowledge of the female menstrual cycle and the timing of the fertile window. The current study therefore aimed to assess the degree to which women struggling to conceive without medical intervention are knowledgeable about these topics. METHODS: One hundred and two women of reproductive age (18-45 years old) in Canada and the United States who had been struggling to conceive without medical intervention for ≥12 months completed an online survey including a questionnaire assessing knowledge related to reproduction and fertility. RESULTS: Mean accuracy score on the Fertility Knowledge Questionnaire was 67%. Seventy-two women were not aware that the week before ovulation was associated with the highest chances of conception. Women using cervical mucus tracking to increase chances of conception were more knowledgeable (p = 0.02), as were women with more formal education (p = 0.01). Conversely, women who had been attempting to conceive for longer had lower fertility knowledge (p = 0.03). Age, number of children, and family income were unrelated to fertility knowledge (p > 0.05). DISCUSSION: Our findings suggest that women who are struggling to conceive would benefit from education related to the timing and identification of the fertile window. Reproductive and primary healthcare providers can play an important role in assessing fertility knowledge and addressing knowledge gaps to improve chances of successful conception.

Endocrine and psychosocial moderators of mindfulness-based stress reduction for the prevention of perimenopausal depressive symptoms: A randomized controlled trial.

BACKGROUND: The menopause transition is associated with an increased risk of depressive symptoms. The current study aimed to test whether Mindfulness-Based Stress Reduction, an 8-week group intervention involving meditation and yoga, might reduce the risk of depressive symptoms among perimenopausal women. A secondary aim was to examine baseline characteristics, including sensitivity to estradiol fluctuation, as a moderator of treatment effects. METHODS: 104 healthy women from the community in the menopause transition were enrolled and randomized to MBSR (n = 52) or a waitlist control condition (n = 52). Randomization was carried out using a random number generator and opaque sealed envelopes. Depressive symptoms, the main outcome, were assessed every two weeks for 6 months using the Center for Epidemiologic Studies Depression Scale (CES-D). The occurrence of an elevated CES-D score (≥16) and of a major depressive episode were pre-identified secondary outcomes. The following surveys were used to assess additional outcomes of interest every two months: the Perceived Stress Scale, Spielberger Trait Anxiety Inventory, Connor-Davidson Resilience Scale, and Pittsburgh Sleep Quality Index. Baseline characteristics examined as potential moderators of treatment benefit included: baseline CES-D score, past depressive episodes, recent stressful life events, a history of physical or sexual abuse, and emotional sensitivity to reproductive hormone fluctuation. Outcome assessors were blinded to the participants' assigned treatment arm. RESULTS: Outcome data were available for 44 women assigned to MBSR and 51 women in the waitlist condition. Women randomized to MBSR reported fewer depressive symptoms, less perceived stress, less anxiety, increased resilience, and improved sleep (ps < 0.001). Furthermore, several baseline characteristics predicted a greater mood benefit of MBSR, including: a history of major depression (p for the interaction <0.001), a greater number of recent stressful life events (p < .001), being in the early menopause transition (p = .002), and an increased emotional sensitivity to reproductive hormone fluctuation (p = .004). There were no group differences in the occurrence of major depressive episodes (p > .05). CONCLUSIONS: MBSR appears to be an effective intervention for the prevention of depressive symptoms in the menopause transition.