NCT05220566: RTSMHNursing

Impact of the 'Reserved Therapeutic Space' Nursing Intervention: an Intervention Study in Acute Mental Health Units

Completed NA Last updated 4 December 2023

What this trial tests

NA trial testing Reserved Therapeutic Space in Nurse-Patient Relations in 250 participants. Completed in 1 November 2023.

Timeline

1 April 2022

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	University of Barcelona
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	250
Start date	1 April 2022
Primary completion	1 November 2023
Estimated completion	1 November 2023
Sites	4 locations across Spain

Drugs / interventions tested

• Reserved Therapeutic Space

Conditions studied

• Nurse-Patient Relations — all drugs for Nurse-Patient Relations →
• Psychiatric Hospitalization — all drugs for Psychiatric Hospitalization →

Sponsor

University of Barcelona

Who can join

18 and older, any sex, with Nurse-Patient Relations or Psychiatric Hospitalization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aims:

To evaluate the effectiveness of the "Reserved Therapeutic Space" intervention for improving the nurse-patient therapeutic relationship in acute mental health units in Spain, as well as its impact in terms of quality of care and patients' perceptions of coercion.

Design:

Multicenter intervention study with control group.

Methods:

The study will be carried out in 12 mental health units in Spain. Given the conditions of evaluation in real clinical practice, paired randomization will be performed to assign centers to intervention and control groups. The "Reserved Therapeutic Space" intervention to be tested has been co-designed and validated by both nurses and patients. The quality of the therapeutic relationship, the care received, and perceived coercion among patients will be assessed at baseline and at discharge using instruments validated in our context. An estimated 131 patients per group are expected to participate. Funding was granted in July 2021 by the Institute of Health Carlos III (PI21/00605, Ministry of Science and Innovation) and in October 2021 by the College of Nurses of Barcelona (PR-487/2021). The proposal was approved by all the Research Ethics Committees of participating centers.

Discussion:

This study is expected to demonstrate the effectiveness of a specific nursing intervention on patient health outcomes including the level of the therapeutic relationship, the quality of care, the level of coercion and other specific indicators for acute mental health units.

Impact:

This project will lead to changes in clinical practice, transforming the current models of organization and care management in mental health hospitalization units, promoting the quality of the therapeutic relationship and, ultimately, the quality of person-centered care.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of the 'reserved therapeutic space' nursing intervention on patient health outcomes: An intervention study in acute mental health units.
   Moreno-Poyato AR, El Abidi K, Lluch-Canut T, Cañabate-Ros M, et al · · 2023 · cited 6× · PMID 37084278 · DOI 10.1002/nop2.1750
2. Impact of the 'Reserved Therapeutic Space' Nursing Intervention on Acute Mental Health Inpatients' Perceptions of the Therapeutic Relationship, Quality of Care, Perceived Coercion and Length of Stay: A Multicentre Quasi-Experimental Trial.
   Roviralta-Vilella M, El-Abidi K, Sanchez-Balcells S, Roldán-Merino JF, et al · · 2026 · PMID 41556199 · DOI 10.1111/jpm.70095