NCT05788315: CFITWA

The Influence of the Cultural Formulation Interview on Therapeutic Work Alliance

Status unknown NA Last updated 4 April 2023

What this trial tests

NA trial testing Cultural Formulation Interview in Therapeutic Alliance in 164 participants. Status unknown.

Timeline

1 June 2023

Primary endpoint
1 June 2024

1 December 2024

Quick facts

Lead sponsor	Tilburg University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	164
Start date	1 June 2023
Primary completion	1 June 2024
Estimated completion	1 December 2024
Sites	1 location across Netherlands

Drugs / interventions tested

• Cultural Formulation Interview

Conditions studied

• Therapeutic Alliance — all drugs for Therapeutic Alliance →
• Empathy — all drugs for Empathy →

Sponsor

Tilburg University

Who can join

18 and older, any sex, with Therapeutic Alliance or Empathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effect of the cultural formulation interview on therapeutic working alliance: a study protocol.
   Brand AM, Groen SPN, Destoop N, Jongsma HE, et al · · 2024 · cited 2× · PMID 38501082 · DOI 10.3389/fpsyt.2024.1322356