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Ensemble programme an early intervention for informal caregivers of psychiatric patients: a randomized controlled trial

English title Ensemble programme an early intervention for informal caregivers of psychiatric patients: a randomized controlled trial
Applicant Rexhaj Shyhrete
Number 185422
Funding scheme Project funding (Div. I-III)
Research institution Institut & Haute Ecole de la Santé La Source HES-SO
Institution of higher education University of Applied Sciences and Arts Western Switzerland - HES-SO
Main discipline Psychology
Start/End 01.09.2019 - 31.08.2023
Approved amount 674'540.00
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Keywords (4)

severe psychiatric disorders; informal caregivers; recovery; early intervention

Lay Summary (French)

Lead
Les proches aidants jouent un rôle majeur dans le soutien et le maintien dans la communauté des patients atteints de troubles psychiatriques sévères. Cependant, ils sont un acteur négligé du système socio-sanitaire.
Lay summary

Contenu et objectifs du travail de recherche

Cette étude s’intéresse aux difficultés à préserver un état de santé psychologique optimal et une bonne qualité de vie chez les proches aidants en psychiatrie adulte alors qu’ils s’exercent un rôle d’aide important auprès des patients atteints de troubles psychiatriques sévères. Un programme individualisé, nommé Ensemble, a été développé et testé dans une étude pilote. Les résultats préliminaires indiquent une amélioration significative de l’état de santé psychologique des proches aidants et de leur optimisme grâce au programme Ensemble. Afin de reconnaître ces résultats préliminaires et de promouvoir l'utilisation d'une telle intervention, cette présente étude vise à tester l'efficacité de ce programme à grande échelle. L’objectif de cette recherche est donc de comparer le soutien habituel (SAU : groupe traitement habituel) à l'efficacité du programme Ensemble (Ensemble : groupe expérimental + SAU).

Contexte scientifique et social du projet de recherche

Pour mieux soutenir les proches aidants des interventions précoces ciblées sur leurs besoins doivent être disponibles dans le système socio-sanitaire. Il est important d’identifier les interventions prometteuses, la recherche clinique appliquée permet de tester la plus-value de celles-ci. Les résultats de cette étude fourniront donc des renseignements essentiels sur la façon d'offrir un soutien adapté et efficace aux proches aidants.

Direct link to Lay Summary Last update: 29.08.2019

Responsible applicant and co-applicants

Employees

Abstract

Background: Informal caregivers of patients play a major role in the support and maintenance of patients with severe psychiatric disorders. However, they are a neglected actor in the health care system. With the programme Ensemble, we propose early intervention for the informal caregivers of patients with severe mental disorders. We performed a pilot study for the Ensemble programme showing that it is easy to implement in a variety of environments and is well accepted by both caregivers and patients. Preliminary results indicated that participation in the Ensemble programme leads to significant improvement in the psychological health state and in optimism. To acknowledge these preliminary results and promote the use of such intervention, we aim to test the efficacy of such a programme on a large and significant scale. Aim: This randomized clinical trial (RCT) will compare the efficacy of using Ensemble to improve the psychological health state of informal caregivers and enable them to have an active role in their situation against treatment as usual (TAU). Methods: One hundred sixty informal caregivers of patients with psychiatric disorders will undergo one of two conditions (Ensemble or TAU) for six weeks. The study’s main hypothesis is that informal caregivers who have attended five one-hour sessions of Ensemble will show improvements in their psychological health global index measured on the Global Severity Index of Brief Inventory symptoms. Participants’ wellbeing will be evaluated over time based on their optimism level (measured by the Life Orientation Test- Revised), their quality of life (measured by the 36-item Medical Outcome Study Short-Form Health Survey) and their burden level (measured by the ZBI scale). The intervention will help with the ability to deal with the patient’s problems, consider informal caregivers’ needs and difficulties, identify and manage painful emotions related to the patient’s illness, utilize effectively all available social resources and become an active actor in the health system. The study will also monitor the sustainability of Ensemble’s potential benefits at a two-month follow-up. At the end of the programme, the experiences of the 20 participants with participation in the Ensemble programme will be evaluated qualitatively. Expected results and impact: This RCT will test the clinical efficacy and potential sustainability of the Ensemble programme. It will uncover the impact of supporting informal caregivers of patients with psychiatric disorders on the caregiver’s health state by measuring their quality of life, their involvement as an active player in the health system and on the patients’ recovery processes. The results of this study will thus provide critical information on how to provide an adapted and efficient support programme to caregivers.
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