Clinical trials

The MOMENT project centres pharmacists as key partners for people assigned female at birth (AFAB) in improving menopause care. Menopause is a major life event, which half of our population will experience. For many, the mental and physical symptoms of menopause can impact quality of life, relationships, and workplace productivity. There are significant inequities in menopause health care and knowledge gaps for health care providers and the public with menopause being poorly understood. Menopausal Hormone Therapy (MHT) and related treatments are under-utilized and symptom control for people AFAB is often suboptimal. Since the publication of the Women's Health Initiative (WHI) study of postmenopausal women in 2002, menopausal care changed and misinformation about the risks versus benefits of MHT continue to create fear in those AFAB and health care providers. Guideline-concordant care includes MHT as first-line therapies for symptoms and there is increasing interest to improve the care of menopausal people. When MHT is not appropriate, there are other non-hormonal options that are available. What do pharmacists already legally do in Nova Scotia for hormone therapies and other treatments commonly used for menopausal management for those assigned female at birth? * Hormones and non-hormonal therapies: Pharmacists receive prescriptions for and dispense MHT and other therapies related to menopausal symptoms, and as per the Standards of Practice, assess appropriateness of all prescriptions for patients, which includes, but is not limited to, assessing indications, contraindications, dosing and intervals, drug interactions (drug-drug, drug-disease, drug-food, etc.), and providing education on the medication, including but not limited to its proper use and storage, expectations of side effects and benefits, how to monitor progress, and when to follow-up and seek help. Pharmacists have a relationship and responsibility to patients for shared decision making. This requires that they know the benefits (e.g., symptom reduction, health outcome reduction or improvement) and risks (e.g., adverse effects, contraindications, drug interactions) of hormones, and in the specific patient context. * Pharmacists can prescribe MHT and other non-hormonal therapies with a diagnosis as set out in collaboration with another health care professional (e.g., physicians, nurse practitioners) as per the existing legal framework in Nova Scotia. * Pharmacists provide ongoing care and monitoring throughout a patient's medication journey. * Pharmacists engage in prescribing renewals and therapeutic substitutions. They assume the prescribing responsibility when deciding to lengthen the time a patient can receive the prescription after it was initially prescribed by another prescriber, and when changing, adapting, or substituting medications as clinically indicated. * Pharmacists prescribe hormones for contraception. * Pharmacists can also prescribe non-MHT medications for other conditions related to menopause (e.g., insomnia) and recommend nonpharmacological interventions (e.g., cognitive behavioural therapy for insomnia, CBTi) as this is already part of the scope of practice. What is the project proposing? This project will focus on initiation of treatments for menopausal symptoms (e.g., MHT and other guideline-concordant treatments) for AFAB participants as a part of menopause signs' and symptoms' management and adds initiation to other participant pharmacist prescribing responsibilities as described above. The Pharmacy Association of Nova Scotia will facilitate communications to pharmacies and pharmacists, to request participation in the project. This will go to community pharmacies that have a practice setting that includes dedicated time for appointment-based prescribing services. For brevity, the investigators refer to these as appointment-based pharmacies (ABPs). The additional prescribing responsibilities will be facilitated through the existing legal framework in Nova Scotia. This means that it would be considered "Prescribing in Accordance with an Approved Research or Pilot Protocol" according to the existing regulatory framework within the Nova Scotia Pharmacy Regulator. The project includes mixed methods with quantitative and qualitative approaches. The main sources of data will be anonymized data capture by pharmacist participants, surveys of both pharmacist participants and patient participants, and interviews of both groups of participants (i.e., pharmacist participants and patient participants). Initiating treatments for menopause based on the current scope of practice is a natural progression of the scope of pharmacists' practice. It provides the opportunity to improve the health of those with menopausal signs and symptoms. The project can explore feasibility of an additional MHT prescriber in the health system and whether scale and spread should be explored further.

Becoming parents exerts powerful and long-lasting effects on couples' well-being and quality of life. The transition to parenthood (TtP; pregnancy to 12-months postpartum) poses significant challenges as couples balance the task of caring for a newborn while maintaining their romantic relationship. One crucial way that couples sustain their connection is through their sexuality. Most new parents experience significant disruptions to their sexual well-being (i.e., sexual satisfaction, desire, distress), with sexual concerns such as reduced sexual frequency and lack of time and energy for sex being nearly ubiquitous. Simultaneously, most new parents lack easily accessible, reliable information on the common sexual changes associated with the TtP and there is a lack of evidence-based research aimed at helping couples navigate changes to their sexual well-being across this life transition. The investigators have identified risk (e.g., stress) and protective (e.g., intimacy) factors for couples' sexual well-being across the TtP that can be targeted in a prevention program, though no such programs exist. The goal of this two-centre randomized controlled trial is to evaluate the efficacy of STORK (Supporting the Transition to Parenthood through Online Sex and Relationship Knowledge), a novel couple-based online program to support new parents' sexual well-being. This program comprises psychoeducation about common sexual changes as well as skills that couples can develop together to manage these changes and constitutes the first evidence-based program for new parent couples' sexual well-being. The investigators expect that, compared to a waitlist control group, couples who complete STORK will have better sexual, relational, and psychological adjustment across the transition to parenthood (from 13 to 27-weeks gestation to 12-months postpartum). Given that up to 78% of new parents report receiving little-to-no information about what to expect regarding changes to their postpartum sexual relationship, this study addresses the need for accessible, couple-based supports for this commonly challenging transition. By strengthening couples' sexual relationships, the results of this research have the potential to promote the quality of new parents' relationships, strengthening the overall well-being of their families during this critical life stage.

The overall objective is to establish an influenza Controlled Human Infection Model (CHIM) in Canada that can be used to assess the safety and efficacy of candidate vaccines, biologics, and therapeutics targeting influenza viruses.

The overall goal of this study is to establish a PRN-deficient pertussis Controlled Human Infection Model (CHIM) that represents currently circulating isolates, in the context of a North American exposure (vaccination and infection) pedigree.

Depression is a highly prevalent and disabling mental health problem. One way of preventing depression is to stop it before it happens through effective self-management. Working with potential users, a coach-guided, personalized depression risk communication tool (PDRC) was developed for sharing information about individualized depression risk, risk profile (risk factors present), potential risk reduction and evidence-based self-help strategies. It is anticipate that the PDRC will greatly motivate users to actively engage in self-help and help seeking, leading to a reduced risk of depression. The proposed study will recruit 500 male and 500 female adults who are at high risk of having depression across Canada, and randomly allocate them into the intervention and control groups. Participants will be followed for 12 months. The data of the trial will allow us to answer the questions: (1) Can the coach-guided PDRC reduce the risk of depression? (2) Does the intervention motivate people to actively engage in evidence-based self-help and help-seeking behaviors? (3) For whom the intervention works best? and (4) what are the costs and potential savings associated with the intervention? If successful, this project will offer a novel and effective tool for early prevention of major depression in the Canadian general population, help us understand how it works and the cost-effectiveness of implementing such a tool in the community from the economic perspective.

Social media (SM) is a key communication tool, particularly for young women aged 15-29. While SM fosters social connections, it is also linked to negative effects on mental health, including poor body image, low self-esteem, and maladaptive perfectionism. These issues arise due to social comparison with idealized images, especially on platforms like Instagram, which can contribute to disordered eating behaviours. Research suggests that reducing SM use can improve mental well-being, body image, and eating disorder symptoms. However, current interventions have not simultaneously addressed both reducing SM exposure and strengthening protective psychological factors. To address this gap, the proposed study aims to pilot BodyScreen, an intervention app designed to limit SM exposure while enhancing self-esteem and reducing perfectionism in young women at high risk for eating disorders. The study hypothesizes that BodyScreen will be feasible, acceptable, and effective in improving body image, self-esteem, and SM use, with sustained benefits at a 3-month follow-up. The intervention includes a virtual face-to-face session, mid-intervention email support, and a four-week app-based program using Ecological Momentary Interventions (EMIs). Participants will receive reminders to complete exercises designed to improve self-perception and reduce the negative effects of SM. Additionally, Ecological Momentary Assessment (EMA) will track real-time self-esteem, perfectionism, and body image, while mobile sensing will monitor SM use to tailor interactive exercises accordingly. By integrating exposure reduction with psychological strengthening, BodyScreen aims to provide a novel, evidence-based approach to mitigating the harmful effects of SM on young women's mental health.

Sexual health is a fundamental aspect of quality of life; a satisfying sexual relationship is linked to better physical, psychological, and relationship health and well-being. In fact, people who maintain a satisfying, active sex life over time live longer than those who report lower sexual frequency and satisfaction. Yet problems with sexual function are extremely common, especially for women: chronic difficulties with sexual desire and/or arousal that are personally upsetting-Sexual Interest/Arousal Disorder (SIAD)-affects 7% to 23% of the general population. SIAD is linked to more healthcare costs, depressive symptoms and anxiety, and lower relationship satisfaction. Experts suggest that relationship factors play a critical role in SIAD and couple-based sex therapy is a common approach used by clinicians. However, there are no treatment options available for couples that have been tested in research to confirm that they work. The goal of this three-centre randomized clinical trial is to evaluate the efficacy of a novel 16-session cognitive-behavioural couple therapy (CBCT), offered online to increase accessibility, for an inclusive sample of women with SIAD compared to a waitlist control group. The investigators expect that, compared to a waitlist control group, CBCT will lead to greater improvements in SIAD symptoms (e.g., higher sexual desire/arousal, lower sexual distress) and better sexual, relational, and psychological adjustment for both partners at post-treatment and 6-months later. Given that less than a third of those affected by SIAD access treatment, this study addresses the urgent need for an accessible couple-based treatment for the most common sexual dysfunction. Results will be used by clinicians to provide couples with a scientifically based, accessible treatment option, that will improve their sexual, relationship, and psychological health.

The opioid crisis continues its devastating impact on Canada, with over 13,900 deaths recorded between 2016 and 2019. Dangerous prescription opioid usage persists, affecting 12.3% of Canadians in 2018. The crisis has escalated, particularly during the COVID-19 pandemic, resulting in increased mortality rates. While opioid agonist therapy (OAT) is a common treatment, it falls short in addressing concurrent polysubstance use, a prevalent issue in OAT clients. Recognizing the limitations of OAT alone, there is a growing recommendation to supplement it with psychosocial interventions. The PreVenture program, known for its efficacy in reducing substance use, has been adapted for OAT clients, termed "OpiVenture." This study aims to comprehensively assess OpiVenture's feasibility and limited efficacy within an OAT setting. Utilizing a mixed-methods approach, the study design integrates qualitative and quantitative data collection methods to thoroughly evaluate the program's feasibility and preliminary effectiveness. The focus extends beyond immediate outcomes, encompassing the preparation for future randomized controlled trials, including considerations for sample size calculation and recruitment effectiveness. This research addresses the urgent need for more comprehensive interventions to mitigate opioid use disorder (OUD) and associated morbidity, offering a potential solution to improve OAT retention and reduce mortality rates.