NCT05774106

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

January 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 28, 2026

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

December 21, 2022

Last Update Submit

April 22, 2026

Conditions

Keywords

action researchtherapeutic relationship

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (7)

  • 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.

    20 days

  • 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.

    20 days

  • To compare the results of the improvement intervention on the levels of therapeutic relationship with those previously identified.

    20 days

  • To compare the results of the improvement intervention on the levels of therapeutic relationship with those previously identified.

    20 days

  • To compare the results with respect to levels of global functionality and perception of recovery at the end of the improvement intervention.

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Participatory Action Research (PAR).

EXPERIMENTAL

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.

Behavioral: Participatory action research

Regular Practice

NO INTERVENTION

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

Interventions

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.

Also known as: Critical Action Research
Participatory Action Research (PAR).

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SJD Research Foundation

Barcelona, Barcelona, 08950, Spain

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • MARTI SUBIAS MIQUEL, Phd candidate

    SJD Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
A randomization of participating case managers will be performed. One intervention group will carry out the participatory action process and the other (control group) will carry out their professional activity normally.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Mental Health Nurse, Principal Investigator

Study Record Dates

First Submitted

December 21, 2022

First Posted

March 17, 2023

Study Start

January 16, 2023

Primary Completion

February 28, 2024

Study Completion

December 31, 2024

Last Updated

April 28, 2026

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations