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

November 28, 2023 updated by: Antonio R. Moreno Poyato, University of Barcelona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain
        • Hospital Universitario Regional
      • Valencia, Spain
        • Hospital Clínic Universitari de Valencia
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain
        • Hospital Gil Casares
    • Madrid
      • Alcorcón, Madrid, Spain
        • Hospital Universitario Fundacion Alcorcon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 'Reserved Therapeutic Space'
Participants will receive 'Reserved Therapeutic Space' Nursing 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.
No Intervention: Control
Participants will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Nurse-patient therapeutic alliance at discharge assessed by WAI-Short patient version
Time Frame: At baseline and at discharge from the inpatient unit (an average of 16 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Quality in Psychiatric Care at discharge assessed by QPC
Time Frame: At baseline and at discharge from the inpatient unit (an average of 16 days)
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)
Experience of coercion assessed by CES-18
Time Frame: At discharge from the inpatient unit (an average of 16 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

December 16, 2021

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021/9835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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