The Therapeutic Relationship Between the Case Manager and the Person With Severe Mental Health Disorder

NCT ID: NCT05774106

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-16
• Study Completion Date: 2023-12-31

Brief Summary

The first mental health case management programs appear progressively in Spain from the trend towards community mental health with the aim of caring for people with severe mental health disorders outside from hospitals, accompanying them in their recovery process. The mental health nurse case manager is an example of advanced practice in in terms of assistance to the most seriously ill in the community mental health network.

The use of the therapeutic relationship as the central axis of care for the person is becomes an essential tool for patient recovery. This study aims, through participatory action, to inquire about the relationship therapy and its effect on the person's recovery. There will be a mixed methods research. First, a participatory intervention with nurses through the recording of four focus groups with the aim of understand, plan, change and maintain the practices surrounding the relationship therapy with their patients. Second, this intervention will be measured by administering scales to patients linked to the mental health case management program that provides service to different areas of the Barcelona Metropolitan Area. The variables to measure will be the quality of the therapeutic relationship, the recovery of the person and the overall functionality. These variables will be measured before and after finishing the participatory intervention. All data will be anonymized, transcribed and analyzed using the software correspondent.

Detailed Description

Two circular spirals following Kemmis & Mctaggart Participative Action Research (PAR) principles will be conducted. Each spiral includes the following stages: planning, action, observation and reflection.

Initially ( stage 0), the principal investigator will conduct an analysis of the current situation by observing, recording and analyzing the situation. The field diary will be used as a tool to assist in the data collection. Afterwards, a baseline measurement of the selected variables will be made by the principal investigator to both patients and participating professionals.

The first PAR cycle begins in January 2023: agreement and planning about how the observation of the therapeutic relationship will be carried out (focus group), the subsequent action-observation, which will be collected using a reflective diary, and the reflection in the discussion group based on the contributions of the reflective diaries, which will be contrasted with the available evidence with the aim of creating a dialogue.

The estimated duration of the first cycle is 2 months. The second cycle of PRA starts in March 2023: it begins with a focus group to discuss a new planning of strategies to implement changes. After a new period of action and self-observation of the changes (through reflective diary), the fourth and last group discussion group is held, with the purpose of sharing and evaluating the whole process. The estimated duration of this second cycle is 2 months.

At the end of the second cycle (May 2023), a follow-up measurement (post-test) will be carried out by the principal investigator. The estimated duration for this process is 1 month.

Note: the PAR process will be conducted only with case managers.

Conditions

Mental Health Disorder; Case Management; Psychiatric Nursing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Participatory Action Research (PAR).

Two circular spirals following Kemmis & Mctaggart PAR principles. Each spiral includes the following stages: planning, action, observation and reflection.

Four discussions groups and two reflective diaries will be carried out in total.

Note: the PAR process will be conducted only with case managers.

Group Type: EXPERIMENTAL

Participatory action research

Intervention Type: BEHAVIORAL

First, a participatory intervention with nurses through the recording of four focus groups with the aim of understand, plan, change and maintain the practices surrounding the relationship therapy with their patients. Second, this intervention will be measured by administering scales to patients linked to the mental health case management program that provides service to different areas of the Barcelona Metropolitan Area. The variables to measure will be the quality of the therapeutic relationship, the recovery of the person and the overall functionality. These variables will be measured before and after finishing the participatory intervention.

Regular Practice

The other group will continue working as usual in their daily practice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Participatory action research

First, a participatory intervention with nurses through the recording of four focus groups with the aim of understand, plan, change and maintain the practices surrounding the relationship therapy with their patients. Second, this intervention will be measured by administering scales to patients linked to the mental health case management program that provides service to different areas of the Barcelona Metropolitan Area. The variables to measure will be the quality of the therapeutic relationship, the recovery of the person and the overall functionality. These variables will be measured before and after finishing the participatory intervention.

Intervention Type: BEHAVIORAL

Other Intervention Names

Critical Action Research

Eligibility Criteria

Inclusion Criteria

• Be a case management professional with one year of seniority in the program.
• To be available to carry out the PAR.

Regarding participating patients:

• To be treated at the Case management program (CMP). Have been diagnosed with a Severe Mental Health Disorder.
• No severe intellectual disability.
• Be between 18 and 65 years of age.

Exclusion Criteria

Similarly, exclusion from the study based on professional category is not contemplated.

Nor is it contemplated to include patients in whom the target intervention for which they were referred to the CMP program was the CMP program is less than 6 months (e.g., social emergencies, symptom control, psychoeducation at home, etc.),

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Marqués de Valdecilla

OTHER

Sponsor Role: collaborator

Col·legi Oficial Infermeres de Barcelona

UNKNOWN

Sponsor Role: collaborator

Fundació Sant Joan de Déu

OTHER

Sponsor Role: lead

Responsible Party

Marti Subias Miquel

Registered Mental Health Nurse, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MARTI SUBIAS MIQUEL, Phd candidate

Role: PRINCIPAL_INVESTIGATOR

SJD Research Foundation

Locations

SJD Research Foundation

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Marti SUBIAS MIQUEL, Phd candidate

Role: CONTACT

marti.subias@sjd.es

+34 697221753

Hilari ANDRÉS MORA, Case Manager's Program Chief

Role: CONTACT

handres@sjd.es

+34 687894159

Facility Contacts

Mari Luz Andrés Prada, Office Management

Role: primary

marialuz.andres@sjd.es

+34 93 600 97 33 ext. 70043

Montserrat Solà Collado, Clinical Project Manager

Role: backup

montserrat.sola@sjd.es

+34 678043256 ext. 80363

Other Identifiers

PIC-60-22

Identifier Type: -

Identifier Source: org_study_id