Clinical trial NCT05788315: The Influence of the Cultural Formulation Interview on Therapeutic Work Alliance
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Therapeutic Alliance
Empathy
Keywords: Cultural Formulation Interview
Therapeutic Working Alliance
Cultural Empathy
Migrants
Migratory Background
Ethnicity
Lead sponsor: Tilburg University
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-03-28
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Mental health care for clients with a migratory background (CMB) is less effective than for clients without a migration background. For instance, CMB show higher rates of dropout, have longer care trajectories, show lower treatment effects, and are more frequently forced into clinical care. Part of the explanation for this might be higher thresholds to seek help and treatment mismatches due to a lack of adaptation of the diagnostic and treatment methods to the client's needs. Despite the positive fact that CMB have more frequently sought help over the past years, the drop-out remains high because CMB care needs are often not met. To make amends for this problem, the need for clinical instruments emerged to clarify the influence of cultural aspects in diagnostics. This led to the first draft of the Cultural Formulation Interview (CFI), which was added to the DSM-5, aiming for clinicians to gain more insight into the illness perspectives of CMB when using the instrument. This semi-structured interview contains 16-17 questions that aim to bridge gaps between differences in cultural referential frameworks of CMB and clinicians which may improve healthcare for CMB. The CFI enhances communication about culture, which increases mutual understanding and rapport based on interest and better apprehension of the client's cultural background aiming to prevent cultural misunderstandings. Research shows that the use of the CFI positively influences communication between CMB and clinicians. Empathy is crucial in this communication because an empathic clinician will better understand the client's problems and come up with more adequate diagnoses, which benefit the CMB.

Empathy refers to the emotional and cognitive reactions to the observed experiences of someone else. Empathy is defined as the accurate acknowledgment of the internal reference framework of another person integrated with the emotional components and implication to be the other, by putting oneself into someone else's position. Empathy is an important ingredient for building relationships between clients and clinicians. This is even more important when practicing effective culture-sensitive psychotherapy. Cultural empathy is the capacity to identify with the feelings, thoughts, and behavior of people with a different cultural background than one's own by listening and hearing beyond spoken words and bridging cultural differences. The level of cultural empathy can influence the strength and quality of a therapeutic relationship, which is also known as work alliance. The strength of a working alliance depends on the level of agreement with the treatment goals and given tasks within the therapy, and the affective quality of the relationship between the CMB and the clinician.

In an exploratory qualitative study during the implementation phase of the CFI-test version, tentative optimistic signs regarding satisfaction and clarity were found, whilst an earlier study reported resistance against the implementation of the CFI from both CMB and clinicians' perspectives. No research has been done to examine CFI use concerning work alliance and cultural empathy. The need to perform a random controlled trial (RCT) emerged because part of the CFI questions was experienced as problematic. Despite previous findings, it is expected that using the CFI with CMB strengthens the working alliance between CMB and clinicians, either mediated or moderated by cultural empathy. Outcomes could help to improve mental healthcare by stronger work alliance and lower drop-out rates through better communication, understanding, and empathy between CMB and clinicians.

This study empirically investigates whether using the CFI increases the clients' and informant's sense of being understood within their cultural context, and thus encounter cultural empathy and whether due to perceived cultural empathy they experience a stronger working alliance with their clinician. Outcomes might convince clinicians of the usefulness and relevance of the structural use of the CFI in clinical practice, especially when this proves to increase perceived (cultural) empathy and strengthen work alliance. It is expected that a culture-sensitive working alliance between CMBs, informants, and clinicians could be a crucial aspect in reducing the high drop-out and relatively low effect on mental health care for first and second-generation migrants. The central research question in this study is: To what extent do the use of the CFI for CMB and their informants change their work alliance with clinicians? This change could be moderated (changed in strength and direction) or mediated (explained) by cultural empathy. It is hypothesized that the use of the CFI will improve the therapeutic working alliance moderated (strengthened) by cultural empathy.

Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic Work Alliance (participants)
timeFrame: 3 months
measure: Therapeutic Work Alliance (clinicians)
timeFrame: 3 months
Secondary outcomes:
measure: Cultural Empathy (participants)
timeFrame: 1 week and 3 months
measure: Cultural Empathy (clinicians)
timeFrame: 1 week and 3 months
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: Onderzoek Consortium Samen Sterker
state: Brabant
Study officials:
affiliation: Tilburg University
name: Mario Braakman, Prof.
role: STUDY_DIRECTOR
References: