Protocol for a randomized controlled multicenter trial assessing the efficacy of leuprorelin for severe polycystic liver disease: the AGAINST-PLD study

BACKGROUND: In patients with severe polycystic liver disease (PLD), there is a need for new treatments. Estrogens and possibly other female sex hormones stimulate growth in PLD. In some patients, liver volume decreases after menopause. Female sex hormones could therefore be a target for therapy. The AGAINST-PLD study will examine the efficacy of the GnRH agonist leuprorelin, which blocks the production of estrogen and other sex hormones, to reduce liver growth in PLD. METHODS: The AGAINST-PLD study is an investigator-driven, multicenter, randomized controlled trial. Institutional review board (IRB) approval was received at the University Medical Center of Groningen and will be collected in other sites before opening these sites. Thirty-six female, pre-menopausal patients, with a very large liver volume for age (upper 10% of the PLD population) and ongoing liver growth despite current treatment options will be randomized to direct start of leuprorelin or to 18 months standard of care and delayed start of leuprorelin. Leuprorelin is given as 3.75 mg subcutaneously (s.c.) monthly for the first 3 months followed by 3-monthly depots of 11.25 mg s.c. The trial duration is 36 months. MRI scans to measure liver volume will be performed at screening, 6 months, 18 months, 24 months and 36 months. In addition, blood will be drawn, DEXA-scans will be performed and questionnaires will be collected. This design enables comparison between patients on study treatment and standard of care (first 18 months) and within patients before and during treatment (whole trial). Main outcome is annualized liver growth rate compared between standard of care and study treatment. Secondary outcomes are PLD disease severity, change in liver growth within individuals and (serious) adverse events. The study is designed as a prospective open-label study with blinded endpoint assessment (PROBE). DISCUSSION: In this trial, we combined the expertise of hepatologist, nephrologists and gynecologists to study the effect of leuprorelin on liver growth in PLD. In this way, we hope to stop liver growth, reduce symptoms and reduce the need for liver transplantation in severe PLD. Trial registration Eudra CT number 2020-005949-16, registered at 15 Dec 2020. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2020-005949-16

Types of God Representations and Mental Health: A Person-Oriented Approach

As God representations are multi-facetted psychological processes regarding the personal meaning of God/the divine to the individual, this study examines how multiple aspects of God representations are configured within individuals belonging to a sample of psychiatric patients or a non-patient sample, and how these configurations are associated with mental health. By means of cluster analyses, three types of God representations were found: a Positive-Authoritative one, a Passive-Unemotional one, and, only among psychiatric patients, a Negative-Authoritarian one. Types of God representations were significantly related to affective state, as well as religious saliency and religious background. Patients with the negative type of God representation were more distressed and depressed, and Orthodox-Reformed patients reported significantly more negative types of God representations. This study demonstrates the value of a person-oriented approach, by showing that scale scores became especially meaningful in the context of the types, which enables more nuanced distinctions regarding subgroups.FSW - Self-regulation models for health behavior and psychopathology - ou

Religious socialization and non-religious volunteering: A Dutch panel study

Contains fulltext : 102845.pdf (publisher's version ) (Closed access)Despite the fact that churches are still important sources of social capital in the Netherlands, the ongoing secularization of Dutch society has as yet not resulted in a drop of non-religious volunteering. In order to account for this apparent paradox, panel data are used to test the hypothesis that non-religious volunteering is in part an aftereffect of the religious socialization today’s volunteers enjoyed as youths. The following research question is addressed: To what extent does a religious socialization in Christian families during adolescence, independent of individual and collective religious characteristics, determine non-religious volunteering later in life? Results show that collective religious characteristics, i.e. being active in a religious community and religious affiliation, are the most important determinants in this respect. However, next to the effects of these collective aspects, also an independent effect of a religious socialization on non-religious volunteering is found. Especially a religious socialization which is not too strict was found to be influential on adult non-religious volunteering.19 p