Empathy Clinical Trial
— CFITWAOfficial title:
The Influence of the Cultural Formulation Interview on Cultural Empathy and the Therapeutic Work Alliance in Clients With a Migration Background and Their Informants
The increased cultural diversity in client populations in mental healthcare settings led to the addition of the Cultural Formulation Interview (CFI) in the Diagnostic and Statistical Manual for Mental Disorders (DSM-5). The CFI aims to clarify clients' vision, experiences, and context to improve communication about cultural backgrounds, increase mutual understanding and rapport, and prevent cultural misunderstandings. Empirical evidence of this effect in clinical practice is still lacking. This study investigates whether the CFI influences the therapeutic working alliance between a client with a migration background and a clinician, and the informant version of the CFI (CFI-I) influences the relationship between a client's informant and a clinician, focusing on the role of perceived cultural empathy as moderator, or mediator in this interaction. A Cluster-Randomized Controlled Trial (RCT) will be performed among clients with a migratory background in four mental healthcare centers in the Netherlands. The participants in this study are adults with a migratory background, aged 18 years and older, their informants, and clinicians. Participants were randomly assigned into two groups. In the intervention group, the CFI and CFI-Informant version (CFI-I) were used shortly after admission and intake, and the control group received a clinical assessment as usual. Included informants were assessed with the CFI-I or hetero-anamneses by the participating clinicians. The main outcome measure is the work alliance between clients and their clinicians. This will be evaluated using the Work Alliance Questionnaire. Perceived cultural empathy as a potential mediator or moderator will be measured with the Barrett-Lennart Relationship Inventory among clients and informants, and the Scale of Ethnocultural Empathy among clinicians. The clients and informants will be randomly assigned to the intervention group or the control group. They will all fill out a questionnaire about perceived cultural empathy after the first, and two questionnaires about work alliance, and perceived cultural empathy after five treatment sessions. The clinicians will perform the clinical assessments with or without the CFI and fill out a questionnaire about self-perceived cultural empathy after the first session and two questionnaires about work alliance and cultural empathy after a maximum of five given treatments. There is no physical, behavioral, or medical intervention included in the research protocol.
Status | Not yet recruiting |
Enrollment | 164 |
Est. completion date | December 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants can be included if they: - Are older than 18 years. - Have a first or second-generation migration background. - Are newly and voluntarily admitted to outpatient mental health care (to avoid bias by forced admissions, which might jeopardize work alliances because of the complex nature of the presented mental health problems). - Are capable to communicate their perspective, context, and expectations regarding the provided care. Exclusion Criteria: - Participants will be excluded when: - They are mentally incapable of administering questionnaires or reflecting on their personal situation. - They are incapable to communicate their perspective, context, and expectations regarding the care provided in this research project. - They suffer acute mental illnesses. - They abuse substances (for example: alcohol and/or drugs). - The absence of or objection against including an informant is no exclusion criterion. - There are no in- or exclusion criteria around diagnosis. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Onderzoek Consortium Samen Sterker | Tilburg | Brabant |
Lead Sponsor | Collaborator |
---|---|
Tilburg University | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Therapeutic Work Alliance (participants) | The Work Alliance Inventory (WAI-12) will be used to measure work alliance among participants. The WAI-12 measures the strength of the working alliance with 12 items utilizing a 5-point Likert scale. The minimum score is 0, the maximum score is 48. Higher scores indicate a stronger working alliance. | 3 months | |
Primary | Therapeutic Work Alliance (clinicians) | The Work Alliance Inventory (WAI-therapist version) will be used to measure work alliance among clinicians. The WAI for therapists measures the strength of the working alliance with 36 items utilizing a 5-point Likert scale. The minimum score is 0, the maximum score is 180. Higher scores indicate a stronger working alliance. | 3 months | |
Secondary | Cultural Empathy (participants) | The Barret-Lennard Relationship Index (BLRI) is used to measure perceived empathy in CMB and informants. The 64-item self-to-other version consists of items such as: '[clinician's name] cares for me', '[clinician's name] just tolerates me', and '[clinician's name] is truly interested in me'. The items are scored on a 6-point Likert scale (-3, -2, -1, 1, 2, 3). The minimum score is -192, and the maximum score is 192. Higher scores indicate a higher level of perceived cultural empathy. This scale will be administered twice. | 1 week and 3 months | |
Secondary | Cultural Empathy (clinicians) | The Scale of Ethnocultural Empathy (SEE) is used to measure the clinician's level of cultural empathy. The 31 items are scored in an online survey on a 6-point Likert scale. The minimum score is 0 and the maximum score is 155. Higher scores indicate a higher level of cultural empathy. This scale will be administered twice. | 1 week and 3 months |
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