AzTrials
AzTrials

Nurse-Patient RelationsRTSMHNursingNCT05220566

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

A study testing Reserved Therapeutic Space in people with Nurse-Patient Relations and Psychiatric Hospitalization, run by University of Barcelona at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Reserved Therapeutic Space
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
4 sitesSpain
Study dates
1 Apr 2022to 1 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid

  • Hospital Universitario Regional

    Málaga

  • Hospital Gil Casares

    Santiago de Compostela, A Coruña

  • Hospital Clinic Universitari de Valencia

    Valencia

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Being tested
Reserved Therapeutic Space
Keywords
Nurse-Patient therapeutic relationship, Quality of psychiatric care, Mental health nursing, Acute psychiatric care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reserved Therapeutic SpaceBehavioural

    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.

Study groups in NCT05220566
Study groupRoleWhat they receive
'Reserved Therapeutic Space'ExperimentalParticipants will receive 'Reserved Therapeutic Space' Nursing Intervention
Receives: Behavioral: Reserved Therapeutic Space
ControlNo interventionParticipants will receive usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start1 Apr 2022
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220566
Sponsor's protocol ID
2021/9835
Acronym
RTSMHNursing
Status last verified
Nov 2023
First submitted
16 Dec 2021
Last updated
4 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

  • Roviralta-Vilella M, El-Abidi K, Sanchez-Balcells S, Roldan-Merino JF, Lluch-Canut MT, Garcia-Sanchez JA, Munoz-Ruoco E, Perez-Moreno JJ, Pita-De-La-Vega J, Canabate-Ros M, Rubia-Ruiz G, Santos-Pariente C, Rodrigez Lopez AM, Golmar LJ, Esquinas Lopez C, Ghrijou-Abselam N, Pastor-Bernabeu MV, Puig-Llobet M, Moreno-Poyato AR. Impact of the 'Reserved Therapeutic Space' Nursing Intervention on Acute Mental Health Inpatients' Perceptions of the Therapeutic Relationship, Quality of Care, Perceived Coercion and Length of Stay: A Multicentre Quasi-Experimental Trial. J Psychiatr Ment Health Nurs. 2026 Apr;33(2):296-308. doi: 10.1111/jpm.70095. Epub 2026 Jan 20.

    PubMed 41556199

Questions about this trial

What is this clinical trial studying?

A study testing Reserved Therapeutic Space in people with Nurse-Patient Relations and Psychiatric Hospitalization, run by University of Barcelona at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05220566, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in