Clinical trial NCT05774106: The Therapeutic Relationship Between the Case Manager and the Person With Severe Mental Health Disorder
Official title: The Therapeutic Relationship Between the Mental Health Case Manager and the Person With Severe Mental Health Disorder: a Mixed-methods Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Disorder
Case Management
Psychiatric Nursing
Keywords: action research
therapeutic relationship
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Marqués de Valdecilla
name: Col·legi Oficial Infermeres de Barcelona
First posted: 2023-03-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion criteria of subjects

The following inclusion criteria have been pre-defined for professionals:

* 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.
* Remain at the CMP during the 6-month duration of the intervention. Exclusion criteria for subjects. In reference to exclusion criteria, it is not contemplated to include case managers in the study who perform a substitution of less than 1 year's duration are not included in the study.

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.),

Primary outcomes:
measure: Identify the meaning of the therapeutic relationship from the professional case manager's point of view.
timeFrame: 8 weeks
measure: Identify the meaning of the therapeutic relationship from the professional case manager's point of view.
timeFrame: 8 weeks
measure: Determine strategies to improve the therapeutic relationship from the point of view of the professional case manager through reflection and discussion about evidence on therapeutic relationship avaliable
timeFrame: 8 weeks
measure: Qualitatively evaluation of the implementation of improvement strategies in the therapeutic relationship
timeFrame: 4 weeks
measure: Qualitatively evaluation of the implementation of improvement strategies in the therapeutic relationship
timeFrame: 4 weeks
Secondary outcomes:
measure: To identify the levels of prior therapeutic relationship between the professional case manager and the person with severe mental illness prior to the enhancement intervention in both the intervention and control groups.
timeFrame: 20 days
measure: To identify the levels of prior therapeutic relationship between the professional case manager and the person with severe mental illness prior to the enhancement intervention in both the intervention and control groups.
timeFrame: 20 days
measure: To compare the results of the improvement intervention on the levels of therapeutic relationship with those previously identified.
timeFrame: 20 days
measure: To compare the results of the improvement intervention on the levels of therapeutic relationship with those previously identified.
timeFrame: 20 days
measure: To compare the results with respect to levels of global functionality and perception of recovery at the end of the improvement intervention.
timeFrame: 8 weeks
measure: To compare the results with respect to levels of global functionality and perception of recovery at the end of the improvement intervention.
timeFrame: 8 weeks
measure: To compare the results with respect to levels of global functionality and perception of recovery at the end of the improvement intervention.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: SJD Research Foundation
Study officials:
affiliation: SJD Research Foundation
name: MARTI SUBIAS MIQUEL, Phd candidate
role: PRINCIPAL_INVESTIGATOR
References: