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

Nurse-Patient Relations Clinical Trial

— RTSMHNursing  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05220566
• Other study ID #: 2021/9835
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults hospitalized in mental health inpatient units who voluntarily consent to participate in the study

Exclusion Criteria:

• Adults hospitalized in mental health inpatient units who present a language barrier, mechanical restraint, contraindication by the clinical referent, cognitive impairment, or intellectual disability at the time of recruitment.

Related Conditions & MeSH terms

• Nurse-Patient Relations
• Psychiatric Hospitalization

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcón	Madrid
Spain	Hospital Universitario Regional	Málaga
Spain	Hospital Gil Casares	Santiago De Compostela	A Coruña
Spain	Hospital Clinic Universitari de Valencia	Valencia

Sponsors (16)

Lead Sponsor

Collaborator

University of Barcelona

Campus docent Sant Joan de Déu-Universitat de Barcelona, Colegio Oficial de Enfermeras y Enfermeros de Barcelona, Complejo Hospitalario Universitario de Vigo, Hospital Clínico Universitario de Valencia, Hospital de Galdakao, Hospital de Mataró, Hospital del Mar, Hospital Gil Casares de Santiago de Compostela, Hospital Regional de Malaga, Hospital Universitari de Bellvitge, Hospital Universitario Fundación Alcorcón, Hospital Universitario Infanta Leonor, Hospital Universitario San Juan de Alicante, Hospital Virgen de los Lirios de Alcoi, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (2)

El-Abidi K, Moreno-Poyato AR, Canabate-Ros M, Garcia-Sanchez JA, Lluch-Canut MT, Munoz-Ruoco E, Perez-Moreno JJ, Pita-De-La-Vega J, Puig-Llobet M, Rubia-Ruiz G, Santos-Pariente C, Lopez AMR, Golmar LJ, Lopez CE, Roldan-Merino JF. The therapeutic relationship from the perspective of patients and nurses in the first days of admission: A cross-sectional study in acute mental health units. Int J Ment Health Nurs. 2023 Sep 24. doi: 10.1111/inm.13227. Online ahead of print. — View Citation

Moreno-Poyato AR, El Abidi K, Lluch-Canut T, Canabate-Ros M, Puig-Llobet M, Roldan-Merino JF. Impact of the 'reserved therapeutic space' nursing intervention on patient health outcomes: An intervention study in acute mental health units. Nurs Open. 2023 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Nurse-patient therapeutic alliance at discharge assessed by WAI-Short patient version	The Working Alliance Inventory Short Questionnaire (WAI-S), patient version. This is an instrument for measuring the working alliance, and therefore, the therapeutic relationship between professional and patient (Horvath & Greenberg, 1989). Scores range from 12-84 with higher scores indicating greater levels of therapeutic alliance.	At baseline and at discharge from the inpatient unit (an average of 16 days)
Secondary	Change from baseline Quality in Psychiatric Care at discharge assessed by QPC	The Quality in Psychiatric Care scale (QPC: Schröder et al., 2007) assesses the quality of care and is the best suited to evaluate the quality of care in psychiatric units. Scores range from 30-120 with higher scores indicating greater levels of quality in psychiatric care.	At baseline and at discharge from the inpatient unit (an average of 16 days)
Secondary	Experience of coercion assessed by CES-18	The Coercion Experience Scale (CES-18: Bergk et al., 2010). This scale assesses the subjective experience of coercion during psychiatric hospitalization. Scores range from 18-90 with higher scores indicating greater levels of coercion experience.	At discharge from the inpatient unit (an average of 16 days)