NCT04814576

Brief Summary

OBJECTIVES: 1. To evaluate the impact of an intervention based on collaborative nursing care in terms of the changes produced in the recovery process, in positive mental health and in the nurse-patient therapeutic relationship among users of mental health day hospitals. To explore the changes produced in the recovery process of users who receive collaborative nursing care through the co-design and implementation of group activities. DESIGN: A sequential and transformative mixed methods design is proposed. METHODS. The study is structured in three phases. In phase one (baseline) and phase three (follow-up), quantitative data will be collected from patients at a mental health day hospitals based on a two-armed, parallel-design, non-randomized trial. In phase two, two groups will be established: an intervention group (GI) in which the intervention based on collaborative nursing care will be carried out through the co-design and implementation of activities through Participatory Action Research, and a control group (CG) in which the usual care dynamics will be continued. All the users of three mental health day hospitals who agree to participate in the study will be studied consecutively until the necessary sample size is reached. The outcomes used to evaluate the impact of the intervention will be the stage of the recovery process, the quality of the therapeutic relationship and the patient's level of positive mental health. DISCUSSION: Very few collaborative nursing care interventions have been studied and shown to be effective in the context of the paradigm shift toward recovery in mental health nursing. IMPACT: Understanding the changes produced in the recovery process, as well as in the quality of the therapeutic relationship and in the maintenance and/or increase of the levels of positive mental health of people with mental health problems, can contribute to the design and implementation of new methodologies to offer effective and person- centered care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

March 26, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

March 22, 2021

Last Update Submit

July 25, 2024

Conditions

Care Acceptor, HealthNurse's RoleRelationship, Nurse PatientMental Health DisorderMental Health Wellness 1

Keywords

Collaborative carenursingrecoverytherapeutic relationshippositive mental healthparticipatory action research

Outcome Measures

Primary Outcomes (1)

  • Recovery

    Changes in the users' recovery process will be evaluated with The Stages of Recovery Instrument (STORI) It is a self-report questionnaire of 50 items grouped into 5 dimensions of 10 items. Each dimension is related to one of the recovery processes (moratorium, awareness, preparation, rebuilding and growth). The items are scored from 0 "not true at all at this time" to 5 "completely true at this time", resulting in a score for each stage, ranging from 0 to 50. The higher the score, the better the state of recovery.

    Two months

Secondary Outcomes (2)

  • Therapeutic relationship

    Two months

  • Positive mental health

    Two months

Study Arms (2)

Group 1

EXPERIMENTAL

Collaborative nursing care

Behavioral: Collaborative cares

Group 2

NO INTERVENTION

Traditional nusing care

Interventions

Collaborative caresBEHAVIORAL

The intervention consists of the co-design and implementation of therapeutic activities by the nurse and the mental health day hospital users following a collaborative care model. For this purpose, the participatory action research (PAR) method will be used and semi-structured interviews and focus groups will be used as data collection techniques.

Also known as: Co-designing and implementing activities through collaborative nursing care in mental health day hospitals.
Group 1

Eligibility Criteria

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

You may qualify if:

  • Users over 18 years of age of the selected day hospitals. Acceptance of the study conditions and informed consent.

You may not qualify if:

  • Hospital admission for a period of less than one week. Physical or psychological conditions that do not allow collaborative nursing care through co-design of group activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benito Menni CASM

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Related Publications (14)

  • Teddlie, C., & Tashakkori, A. (2012). Common "Core" Characteristics of Mixed Methods Research: A Review of Critical Issues and Call for Greater Convergence. American Behavioral Scientist, 56(6), 774-788.

    BACKGROUND

  • Baum F, MacDougall C, Smith D. Participatory action research. J Epidemiol Community Health. 2006 Oct;60(10):854-7. doi: 10.1136/jech.2004.028662.

    PMID: 16973531BACKGROUND

  • Abad Corpa, E., Delgado Hito, M., & Cabrero García, J. (2010). La investigación-acción-participativa: una forma de investigar en la práctica enfermera. Investigación y Educación En Enfermería, 28(3), 464-474.

    BACKGROUND

  • Lavoie, L., Laurin, P., & Marquis, D. (1996). La recherche-action : théorie et pratique : manuel d'autoformation. Presses de l'Université du Québec.

    BACKGROUND

  • Susman, G. I., & Evered, R. D. (1978). An Assessment of the Scientific Merits of Action Research. Administrative Science Quarterly, 23(4), 582. https://doi.org/10.2307/2392581

    BACKGROUND

  • Lemos-Giraldez S, Garcia-Alvarez L, Paino M, Fonseca-Pedrero E, Vallina-Fernandez O, Vallejo-Seco G, Fernandez-Iglesias P, Ordonez-Camblor N, Solares-Vazquez J, Mas-Exposito L, Barajas A, Andresen R. Measuring stages of recovery from psychosis. Compr Psychiatry. 2015 Jan;56:51-8. doi: 10.1016/j.comppsych.2014.09.021. Epub 2014 Oct 18.

    PMID: 25444077BACKGROUND

  • Crowe M, Inder M, Porter R. Conducting qualitative research in mental health: Thematic and content analyses. Aust N Z J Psychiatry. 2015 Jul;49(7):616-23. doi: 10.1177/0004867415582053. Epub 2015 Apr 21.

    PMID: 25900973BACKGROUND

  • Jayasekara RS. Focus groups in nursing research: methodological perspectives. Nurs Outlook. 2012 Nov-Dec;60(6):411-6. doi: 10.1016/j.outlook.2012.02.001. Epub 2012 Mar 29.

    PMID: 22464693BACKGROUND

  • Andrade-González, N., & Fernández-Liria, A. (2016). Spanish Adaptation of the Working Alliance Inventory-Short (WAI-S). Current Psychology, 35(1), 169-177. https://doi.org/10.1007/s12144-015-9365-3

    BACKGROUND

  • Lluch Canut, M. T. (1999). Construccion De Una Escala Para Evaluar La Salud Mental Positiva. In Construccion De Una Escala Para Evaluar La Salud Mental Positiva. Universitat de Barcelona.

    BACKGROUND

  • Jahoda, M. (1959). Current Concepts of Positive Mental Health. The American Journal of Nursing, 59(2), 263. https://doi.org/10.2307/3417722

    BACKGROUND

  • Roldan-Merino J, Lluch-Canut MT, Casas I, Sanroma-Ortiz M, Ferre-Grau C, Sequeira C, Falco-Pegueroles A, Soares D, Puig-Llobet M. Reliability and validity of the Positive Mental Health Questionnaire in a sample of Spanish university students. J Psychiatr Ment Health Nurs. 2017 Mar;24(2-3):123-133. doi: 10.1111/jpm.12358. Epub 2017 Feb 1.

    PMID: 28150373BACKGROUND

  • Ventosa-Ruiz A, Moreno-Poyato AR, Canete-Masse C, Roldua-Ros J, Feria-Raposo I, Campoverde K, Puig Llobet M. Impact of Collaborative Nursing Care on Health Outcomes of Mental Health Day Hospital Users: A Mixed Methods Study. J Psychiatr Ment Health Nurs. 2025 Jun;32(3):575-590. doi: 10.1111/jpm.13133. Epub 2024 Nov 11.

    PMID: 39526836DERIVED

  • Ventosa-Ruiz A, Moreno-Poyato A, Lluch-Canut T, Vaquerizo-Cubero A, Vidal-Pascual X, Gil-Guinon F, Puig-Llobet M. Impact of collaborative nursing care on the recovery process of mental health day hospital users: a mixed-methods study protocol. BMJ Open. 2022 Mar 30;12(3):e057969. doi: 10.1136/bmjopen-2021-057969.

    PMID: 35354640DERIVED

MeSH Terms

Conditions

Patient Acceptance of Health CareMental Disorders

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Antonio Moreno Poyato

    Universitat de Barceona

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: A sequential and transformative mixed methods design is proposed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mental health nurse

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

March 26, 2021

Primary Completion

March 25, 2022

Study Completion

April 30, 2022

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)