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

Not Applicable

Completed

• Conditions: Psychiatric Hospitalization; Nurse-Patient Relations
• Interventions: Behavioral: Reserved Therapeutic Space

• Registration Number: NCT05220566
• Lead Sponsor: University of Barcelona

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-02
• Study Start: 2022-04-01
• Status Verified: 2023-11
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
'Reserved Therapeutic Space'	Reserved Therapeutic Space	Participants will receive 'Reserved Therapeutic Space' Nursing Intervention

Primary Outcome Measures

Name	Time	Method
Change from baseline Nurse-patient therapeutic alliance at discharge assessed by WAI-Short patient version	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 Outcome Measures

Name	Time	Method
Change from baseline Quality in Psychiatric Care at discharge assessed by QPC	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.
Experience of coercion assessed by CES-18	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.

Trial Locations

Locations (4)

Hospital Universitario Regional; 🇪🇸 Málaga, Spain

Hospital Clinic Universitari de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Fundacion Alcorcon; 🇪🇸 Alcorcón, Madrid, Spain

Hospital Gil Casares; 🇪🇸 Santiago De Compostela, A Coruña, Spain