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

NCT05220566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-12-04

No results posted yet for this study

Summary

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.

Conditions

  • Nurse-Patient Relations
  • Psychiatric Hospitalization

Interventions

BEHAVIORAL

Reserved Therapeutic Space

The main objective of the 'Reserved Therapeutic Space' intervention is to enhance the therapeutic bond of trust, to enable the agreement of objectives and interventions in a shared manner in relation to their recovery process in the unit. The intervention is carried out through individual meetings between the nurse and the patient in a comfortable and intimate space, where there are no interruptions and which is also chosen by the person who is hospitalized. The content of the spaces must be constructed individually according to the patients' concerns at each moment of the process.

Sponsors & Collaborators

  • Campus docent Sant Joan de Déu-Universitat de Barcelona

    collaborator OTHER
  • Hospital Universitario Fundación Alcorcón

    collaborator OTHER
  • Hospital Regional de Malaga

    collaborator OTHER
  • Hospital Gil Casares de Santiago de Compostela

    collaborator UNKNOWN
  • Hospital Universitario Infanta Leonor

    collaborator OTHER
  • Hospital Virgen de los Lirios de Alcoi

    collaborator UNKNOWN
  • Hospital Universitari de Bellvitge

    collaborator OTHER
  • Hospital de Galdakao

    collaborator OTHER
  • Hospital de Mataró

    collaborator OTHER
  • Hospital del Mar

    collaborator OTHER
  • Complejo Hospitalario Universitario de Vigo

    collaborator OTHER
  • Hospital Universitario San Juan de Alicante

    collaborator OTHER
  • Instituto de Salud Carlos III

    collaborator OTHER_GOV
  • Colegio Oficial de Enfermeras y Enfermeros de Barcelona

    collaborator UNKNOWN
  • Hospital Clínico Universitario de Valencia

    collaborator OTHER
  • University of Barcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-11-01
Completion
2023-11-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05220566 on ClinicalTrials.gov