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Completed

NCT Number: NCT05220566

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Gil Casares, Santiago de Compostela, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reserved Therapeutic Space

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Collaborators

  • 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 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
  • Hospital de Galdakao
  • Hospital de Mataró
  • Hospital del Mar
  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: RTSMHNursing

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2022
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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