Clinical Research Directory

PS IVG : Psychosocial Determinants of Late-term Abortions (14-16 Weeks' Gestation) at Avignon Hospital

Abortion is a fundamental right for women in France, where the legal time limit was extended from 14 to 16 weeks' gestation. This extension allows women, whose psychosocial determinants are poorly known, and who face various obstacles (personal, administrative, medical, or other), to access abortion. However, it may also expose them to psychological troubles and difficulties in accessing healthcare. This study aims to identify the psychosocial determinants and disruptions in the primary care pathway associated with late abortions (≥14 weeks' gestation \[WG\]) in order to propose preventive actions, particularly regarding contraception, screening, and referral, directly applicable in general practice.

Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers

The proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with Parkinson's Disease (PwPD) and their family caregivers. One hundred Chinese patient-caregiver dyads will be randomized to receive eight weekly 90-minute dyadic mindfulness sessions or usual care. Outcome measures include negative emotions (primary outcome), patient-caregiver relationship, mindfulness, HRQOL, gut microbiome, PD-related symptoms, and caregiving burden. An actor-partner interdependence model will be used to explore the interactions of treatment effects within the dyads. The dyads will be assessed at baseline(T0), post-intervention(T1), and 4-months post-intervention(T2). The investigators will also invite 25 dyads to attend in-depth interviews exploring their experiences, perceived changes, and factors attributable to the effectiveness/ineffectiveness of the intervention. Generalized linear mixed-effects (GLME) with intention-to-treat analysis will be used to compare the changes in outcomes over time within and between the two arms. The findings will be triangulated to provide a comprehensive evaluation of the intervention's effectiveness. This study will generate rigorous scientific evidence to inform the application of dyadic mindfulness as a public health practice preventing the progression of psychological distress in PwPD and caregivers to clinically severe levels. Its self-help nature also enriches the primary care for this clinical cohort.

Study Protocol for a Pilot Randomized Controlled Trial of a Psychosocial Care Intervention in Intensive Care

This Pilot-RCT is part of a feasibility study that aims to learn if the IPS-psychosocial care intervention and an RCT on its efficacy are feasible in patients, relatives and staff on icu wards. The Pilot-RCT will examine outcomes, that might indicate an improvement in psychosocial safety climate and other health- and wellbeing-related measures due to the administration of the intervention that is described in the following. The main question the Pilot-RCT aims to answer is: Is there evidence that the IPS intervention improves the psychosocial safety climate and other components of psychosocial well-being in ICU teams, patients and their relatives? Researchers will compare four intervention groups (icu wards with implementation of the IPS-Intervention) with four control groups (icu wards with regular supply of psychosocial care) to see if the comparison of two groups in this RCT is feasible. The IPS-Intervention consists of a ward psychologist who works as part of the ICU team and takes care of the staff, patients and relatives in accordance to the intervention manual that was developed in a prior phase of this project.