Communication Clinical Trial
Official title:
The Cultural Formulation Interview-Engagement Aid for Mental Health Treatment
This study consists of two projects:
Project 1: The study team will create and refine the CFI-EA by enrolling 3 clinicians and
9-12 patients to test the CFI-EA's feasibility and acceptability from patient and clinician
feedback in a pre-pilot trial. The study team will first train clinicians in the CFI-EA by
reading over the CFI-EA treatment manual and practicing how they can use it in behavioral
simulations, and then check whether participants think they can do it (feasibility) and like
it (acceptability) through standard measures. Following this the study team will revise the
CFI-EA based on their feedback for the comparative open trial in Phase 2.
Project 2: The study team will test the revised CFI-EA against treatment as usual in a pilot
trial. 3 clinicians and 12-15 patients will be enrolled in each arm. As before, the study
team will first train clinicians in the revised CFI-EA by reading over the CFI-EA treatment
manual and practicing how they can use it in behavioral simulations. Then, the study team
will check whether participants think they can do it (feasibility) and like it
(acceptability) through standard measures, and in addition will also explore any initial
effects on communication behaviors among patients and clinicians and treatment engagement
based on treatment retention.
The specific aims are:
For Project 1:
1. To pretest the CFI-EA intervention in a mental health setting through a pre-pilot open
trial that explores communication mechanisms of action in terms of communication
behavior and cultural content, and
2. To revise the CFI-EA intervention based on patient and clinician feedback on its
feasibility and acceptability.
As real-world community stakeholders for whom the CFI-EA is being developed, patients and
clinicians can provide helpful perspectives on how the CFI-EA can help clinicians tailor
treatment plans around patient cultural views and treatment preferences to keep patients in
care. The CFI-EA will be revised around areas of maximal agreement among patients and
clinicians with the help of health disparities and communication experts.
For Project 2:
1. To test the revised CFI-EA's feasibility and acceptability among patients and clinicians
in a pilot open trial against treatment as usual, and
2. To explore the relationship between the revised CFI-EA's effects on patient-clinician
communication and treatment engagement.
The study team hypothesize that clinicians using the revised CFI-EA will show more positive
communication behaviors compared to clinicians delivering treatment as usual and that CFI-EA
patients will stay in treatment longer. Communication behaviors will be assessed through
communication analysis techniques such as the Roter Interaction Analysis System.
Members of underserved racial/ethnic minority groups who participate more actively in the
treatment process have almost three times the odds of staying in treatment and following up
with appointments compared to standard treatment. Improving patient-clinician communication
may therefore improve treatment engagement, from starting and participating in treatment
actively to maintaining treatment for the successful resolution of symptoms and improvements
in quality of life. Interventions that enhance communication behaviors by asking patients
about their cultural views, using open-ended questions, establishing rapport, and using
patient terms can increase patient participation and satisfaction. Interventions that expose
clinicians to cultural content by asking patients about preferences for treatment, barriers
to accessing services, the role of support from family or friends, and that encourage
information exchange also improve treatment engagement. The goal of this study is to develop
a communication intervention that improves treatment engagement for members of underserved
racial and ethnic minority groups by improving clinician communication behaviors and exposing
them to patient cultural content. Here, culture is understood as a dynamic process of meaning
making between the patient and clinician. This intervention is not designed for patients
belonging to a specific racial or ethnic group, but to improve general communication between
patients and clinicians. The intervention improves communication by making communication
behaviors and cultural content topics of explicit conversation rather than allowing
clinicians to make cultural assumptions and take them for granted. We are focusing on racial
and ethnic minorities because of significant evidence documenting disparities in health
communication and care.
In session 1, the clinician does the full CFI in DSM-5 (~15 minutes) and then completes the
full standard intake with information not already obtained through the CFI (~35 minutes). In
sessions 2 and 3, the clinician integrates the CFI-EA (~5 minutes) within regular care in
standard appointments. At JHMC, Session 2 lasts 60 minutes and is for treatment initiation.
Session 3 lasts 20-30 minutes and is to check for treatment continuation. Because this is a
grant to train in developing mental health interventions, the study team is following an NIMH
model known as the Stage Model of Intervention Development. The first project is creating the
intervention through patient and clinician feedback at JHMC and expert consensus with the K23
mentoring team. The second project is testing the intervention in a trial that compares the
CFI-EA to treatment as usual. Patients for Project 1 will be recruited through a sample of
convenience among patients accessing care on the days the research assistant is in the
waiting area. For project 2, patients will be sampled consecutively by the JHMC's intake
coordinator from the time that the project starts until the target enrollment is reached. The
intake coordinator will keep a record of all patients who agree and do not agree to enroll in
the study. Patients who agree to be enrolled during Project 2 will be recruited by the
research assistant in the waiting area and then assigned randomly to either CFI-EA clinicians
or treatment-as-usual clinicians based on a random number generator. The study team is using
the same study measures in both projects to examine whether revisions to the CFI-EA conducted
at the end of Project 1 show improvements in outcomes after Project 2.
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