The Influence of the Cultural Formulation Interview on Therapeutic Work Alliance

NCT05788315 | Unknown

• 1 other identifier: 6390039231
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Therapeutic Alliance; Empathy

Keywords

Cultural Formulation Interview; Therapeutic Working Alliance; Cultural Empathy; Migrants; Migratory Background; Ethnicity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Cultural Empathy (participants)

  1 week and 3 months

• Cultural Empathy (clinicians)

  1 week and 3 months

Study Arms (2)

Cultural Formulation Interview

EXPERIMENTAL

The 16 semi-structured questions of the CFI cover the cultural definition of the problem, cultural perception of its cause, context and support, cultural aspects of coping, and past and present help-seeking behavior. The CFI informant version consists of 17 questions about the same themes. The CFI aims to bridge cultural differences by explicitly asking about the client's cultural background and its influence on the presented problems

Other: Cultural Formulation Interview

Standard Care

ACTIVE COMPARATOR

Standard intake and care

Other: Cultural Formulation Interview

Interventions

Cultural Formulation Interview OTHER

The Cultural Formulation Interview will be used at the start of treatment in the intervention group against a standard practice intake in the control group.

Cultural Formulation Interview; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tilburg University: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Onderzoek Consortium Samen Sterker

Tilburg, North Brabant, 5000 LE, Netherlands

Location

Study Officials

• Mario Braakman, Prof.

  Tilburg University

  STUDY DIRECTOR

Central Study Contacts

Alma Brand, MSc

CONTACT

+31134668903; a.m.brand@tilburguniversity.edu

Mario Braakman, Prof.

CONTACT

+31629514366; mario.braakman@tilburguniversity.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: One half of the participants will be assessed using the Cultural Formulation Interview The other half will be assessed using the standard practice intake
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will be set up as a cluster RCT among CMBs who are admitted to outpatient care at the four participating mental healthcare centers.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 28, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, ANALYTIC CODE
• Time Frame: Immediately after the end of the study during 10 years
• Access Criteria: Data will be anonymous and stored in TiU Dataverse using DDI. We are contemplating using an archive or repository.

Locations

NL (1)