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

Mental Health Disorder Clinical Trial

Official title:

The Therapeutic Relationship Between the Mental Health Case Manager and the Person With Severe Mental Health Disorder: a Mixed-methods Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774106
• Other study ID #: PIC-60-22
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Fundació Sant Joan de Déu
• Contact: Marti SUBIAS MIQUEL, Phd candidate
• Phone: +34 697221753
• Email: marti.subias[@]sjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 31, 2023
• Est. primary completion date: July 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.),

Related Conditions & MeSH terms

• Case Management
• Mental Disorders
• Mental Health Disorder
• Psychiatric Nursing

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	SJD Research Foundation	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Col·legi Oficial Infermeres de Barcelona, Instituto de Investigación Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the meaning of the therapeutic relationship from the professional case manager's point of view.	It will be evaluated during the first cycle of the PAR, through the use of the discussion group (group reflection). All meetings will be recorded and coded using the Deddose platform for qualitative analysis.	8 weeks
Primary	Identify the meaning of the therapeutic relationship from the professional case manager's point of view.	It will be evaluated during the first cycle of the PAR, through the use of the reflective journal (individual self-analysis). All diaries will be transcribed and coded using the Deddose platform for qualitative analysis.	8 weeks
Primary	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	It will be evaluated during the second cycle of the PAR, through the use of the discussion group. All meetings will be recorded and coded using the Deddose platform for qualitative analysis.	8 weeks
Primary	Qualitatively evaluation of the implementation of improvement strategies in the therapeutic relationship	It will be evaluated at the end of the PAR's second cycle, through the use of the discussion group (group reflection) . All meetings will be recorded and coded using the Deddose platform for qualitative analysis.	4 weeks
Primary	Qualitatively evaluation of the implementation of improvement strategies in the therapeutic relationship	It will be evaluated at the end of the PAR's second cycle, through the use of the reflective journal (individual self-analysis). All diaries will be transcribed and coded using the Deddose platform for qualitative analysis.	4 weeks
Secondary	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.	A baseline measurement of the quality of the therapeutic relationship between the case manager and his or her patients prior to the beginning of the PAR will be carried out. "The Working Alliance Inventory - short" will be used. All data will be added to RedCap platform and analyzed with SPSS.; *The Working Alliance Inventory-Short (WAI-S) is a refined measure of the therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. It's a 12 question scale with a list of of statements and questions about experiences people might have with their therapy or therapist. Each answers range from a Likert-type scale with five options: "seldom", "sometimes", "fairly often", "very often" and "always". The total score ranges from 12 to 84. The answer with the highest value depends on the statement of the phrase.	20 days
Secondary	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.	A baseline measurement of the quality of the therapeutic relationship between the case manager and his or her patients prior to the beginning of the PAR will be carried out. The Quality of Psychiatric Care - Outpatient scale will be used. All data will be added to RedCap platform and analyzed with SPSS.; *The QPC-OP consists of 30 items and measures six dimensions: Encounter (eight items), Participation (eight items), Discharge (four items), Support (four items), Secluded environment (three items), and Secure environment (three items). Each item begins with the sentence "I experience that..." and is assessed using a Likert-type scale with four options, going from 1 (totally disagree) to 4 (totally agree). The maximum score is 120 points and the minimum is 30 points. A high score in each dimension or for the scale as a whole indicates a perception of high quality both on the professional and it's patients.	20 days
Secondary	To compare the results of the improvement intervention on the levels of therapeutic relationship with those previously identified.	When the intervention has been completed (PAR), a follow-up measurement will be taken using again "The Working Alliance Inventory - short version. All data will be added to RedCap platform and analyzed with SPSS.; *The Working Alliance Inventory-Short (WAI-S) is a refined measure of the therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. It's a 12 question scale with a list of of statements and questions about experiences people might have with their therapy or therapist. Each answers range from a Likert-type scale with five options: "seldom", "sometimes", "fairly often", "very often" and "always". The total score ranges from 12 to 84. The answer with the highest value depends on the statement of the phrase.	20 days
Secondary	To compare the results of the improvement intervention on the levels of therapeutic relationship with those previously identified.	When the intervention has been completed (PAR), a follow-up measurement will be taken using again "The The Quality of Psychiatric Care- Outpatient scale. All data will be added to RedCap platform and analyzed with SPSS.; *The QPC-OP consists of 30 items and measures six dimensions: Encounter (eight items), Participation (eight items), Discharge (four items), Support (four items), Secluded environment (three items), and Secure environment (three items). Each item begins with the sentence "I experience that..." and is assessed using a Likert-type scale with four options, going from 1 (totally disagree) to 4 (totally agree). The maximum score is 120 points and the minimum is 30 points. A high score in each dimension or for the scale as a whole indicates a perception of high quality both on the professional and it's patients.	20 days
Secondary	To compare the results with respect to levels of global functionality and perception of recovery at the end of the improvement intervention.	In addition to the quality of the therapeutic relationship, other variables will be measured. In the baseline and follow-up measurements, the patient's perception of recovery will also be measured, using the Recovery Assessment Scale.. All data will be added to RedCap platform and analyzed with SPSS.; *The Recovery Assessment Scale (RAS) is a 20-item measure developed as an outcome measure for program evaluations. All items on the RAS assessment are rated on a 5-point Likert scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Not Sure, 4 = Agree, and 5 = Strongly Agree. Responses are scored as a comprehensive total and as three separate domains: Clinical Recovery, Personal Recovery, and Social Recovery	8 weeks
Secondary	To compare the results with respect to levels of global functionality and perception of recovery at the end of the improvement intervention.	In addition to the quality of the therapeutic relationship, other variables will be measured. In the baseline and follow-up measurements, the patient's functionality, using the "Health of the Nation Outcome Scale" scale. All data will be added to RedCap platform and analyzed with SPSS.; *The Health of the Nation Outcome Scales (HoNOS) is a clinician rated instrument comprising 12 simple scales measuring behaviour, impairment, symptoms and social functioning for those in the 18 - 64 years old age group. Scores on each scale/item range from 0 (no problem) to 4 (severe problem).The total score ranging goes from 0 to 48 points.	8 weeks
Secondary	To compare the results with respect to levels of global functionality and perception of recovery at the end of the improvement intervention.	In addition to the quality of the therapeutic relationship, other variables will be measured. In the baseline and follow-up measurements, the patient's functionality, using the "Camberwell Assessment of Need Short Appraisal Schedule" scale. All data will be added to RedCap platform and analyzed with SPSS.; *The "Camberwell Assessment of Need Short Appraisal Schedule" scale assesses the health and social needs of adults across 22 domains of life, such as accommodation, food, self-care, daytime activities, psychotic symptoms, childcare, money, psychological distress, physical health and relationships. The need rating is made using the CAN rating algorithm: If the interviewee does not know or does not want to answer questions on this domain then rate ? (not known); If a current serious problem is present (regardless of cause, or whether any help is being given or not)then rate U (unmet need); If there is no serious problem because of help given then rate M (met need) otherwise Rate N	8 weeks