CClinicalTrials.gg
CompletedNCT05220566RTSMHNursingUpdated Dec 4, 2023

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

An interventional study of Reserved Therapeutic Space in Nurse-Patient Relations and Psychiatric Hospitalization, sponsored by University of Barcelona. Completed at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-04.

Sponsored by University of Barcelona · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Nurse-Patient Relations
  • Psychiatric Hospitalization

Keywords

  • Nurse-Patient therapeutic relationship
  • Quality of psychiatric care
  • Mental health nursing
  • Acute psychiatric care
03

In context

Lead sponsor

University of Barcelona is the lead sponsor of 95 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    'Reserved Therapeutic Space'

    Participants will receive 'Reserved Therapeutic Space' Nursing Intervention

    Behavioral: Reserved Therapeutic Space

  • No intervention
    Control

    Participants will receive usual care

Interventions

  • BehavioralReserved 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline and at discharge from the inpatient unit (an average of 16 days)

Secondary outcomes

  1. 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.

    Time frame: At baseline and at discharge from the inpatient unit (an average of 16 days)

  2. 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.

    Time frame: At discharge from the inpatient unit (an average of 16 days)

07

Study locations

4 sites
  • Hospital Gil Casares
    Santiago De Compostela, A Coruña, Spain
  • Hospital Universitario Fundacion Alcorcon
    Alcorcón, Madrid, Spain
  • Hospital Universitario Regional
    Málaga, Spain
  • Hospital Clinic Universitari de Valencia
    Valencia, Spain
08

References and documents

Publications

  • 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. 2024 Feb;33(1):134-142. doi: 10.1111/inm.13227. Epub 2023 Sep 24. PubMed 37743558 ↗
  • 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 Aug;10(8):5749-5757. doi: 10.1002/nop2.1750. Epub 2023 Apr 21. PubMed 37084278 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05220566
Lead sponsor
University of Barcelona
Collaborators
Campus docent Sant Joan de Déu-Universitat de Barcelona, Hospital Universitario Fundación Alcorcón, Hospital Regional de Malaga, Hospital Gil Casares de Santiago de Compostela, Hospital Universitario Infanta Leonor, Hospital Virgen de los Lirios de Alcoi, Hospital Universitari de Bellvitge, Hospital de Galdakao, Hospital de Mataró, Hospital del Mar, Complejo Hospitalario Universitario de Vigo, Hospital Universitario San Juan de Alicante, Instituto de Salud Carlos III, Colegio Oficial de Enfermeras y Enfermeros de Barcelona, Hospital Clínico Universitario de Valencia
Responsible party
Antonio R. Moreno Poyato (PhD, Professor, University of Barcelona) — Principal investigator
First posted
Feb 2, 2022
Start date
Apr 1, 2022
Primary completion
Nov 1, 2023
Completion
Nov 1, 2023
Last update
Dec 4, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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