NCT05220566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

December 16, 2021

Last Update Submit

November 28, 2023

Conditions

Nurse-Patient RelationsPsychiatric Hospitalization

Keywords

Nurse-Patient therapeutic relationshipQuality of psychiatric careMental health nursingAcute psychiatric care

Outcome Measures

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.

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

Secondary Outcomes (2)

  • 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)

  • Experience of coercion assessed by CES-18

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

Study Arms (2)

'Reserved Therapeutic Space'

EXPERIMENTAL

Participants will receive 'Reserved Therapeutic Space' Nursing Intervention

Behavioral: Reserved Therapeutic Space

Control

NO INTERVENTION

Participants will receive usual care

Interventions

Reserved Therapeutic SpaceBEHAVIORAL

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.

'Reserved Therapeutic Space'

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Gil Casares

Santiago de Compostela, A Coruña, Spain

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, Spain

Location

Hospital Universitario Regional

Málaga, Spain

Location

Hospital Clinic Universitari de Valencia

Valencia, Spain

Location

Related 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. 2024 Feb;33(1):134-142. doi: 10.1111/inm.13227. Epub 2023 Sep 24.

    PMID: 37743558BACKGROUND

  • 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.

    PMID: 37084278RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Professor

Study Record Dates

First Submitted

December 16, 2021

First Posted

February 2, 2022

Study Start

April 1, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

December 4, 2023

Record last verified: 2023-11

Locations

ES(4)