CommunicationCFI-EANCT03044145
The Cultural Formulation Interview-Engagement Aid
A study testing The Cultural Formulation Interview-Engagement Aid in Project 1, The Cultural Formulation Interview-Engagement Aid Revised for Project 2 and Treatment as usual for Project 2 in people with Communication and Adherence, Patient, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Communication, Adherence, Patient
- What is being tested?
- The Cultural Formulation Interview-Engagement Aid in Project 1, The Cultural Formulation Interview-Engagement Aid Revised for Project 2 and Treatment as usual for Project 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2016to 5 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18-80; Method of ascertainment: Self-report.
- New patients at JHMC, referred by the intake coordinator; Method of ascertainment: Intake coordinator.
- Willingness and ability to provide written informed consent after full explanation of study procedures. Method of ascertainment: RA informed consent interview that includes a capacity to consent screening form; Clinician referral.
- Racial and ethnic minority (African-American, Latino/Hispanic, Asian-American/Pacific Islander, and Native American). Method of ascertainment: Self-report
- Male and female patients aged 18-80; Method of ascertainment: Self-report.
- New patients at JHMC, referred by the intake coordinator; Method of ascertainment: Intake coordinator.
- Willingness and ability to provide written informed consent after full explanation of study procedures. Method of ascertainment: RA informed consent interview that includes a capacity to consent screening form; Clinician referral.
- Racial and ethnic minority (African-American, Latino/Hispanic, Asian-American/Pacific Islander, and Native American). Method of ascertainment: Self-report
Who cannot join
- Actively suicidal or homicidal; Method of ascertainment: Self-report and clinician evaluation
- In need of acute detoxification services; Method of ascertainment: Self-report and clinician evaluation
- A condition that interferes with participation (i.e., dementia, mental retardation, or florid psychosis); Method of ascertainment: Clinician evaluation; patients ≥ 65 years of age will participate in a mini-cog exam.
- Caucasian race; Method of ascertainment: self-report
- For Project 2
- Actively suicidal or homicidal; Method of ascertainment: Self-report and clinician evaluation
Show all 10Show fewer
- In need of acute detoxification services; Method of ascertainment: Self-report and clinician evaluation
- A condition that interferes with participation (i.e., dementia, mental retardation, or florid psychosis); Method of ascertainment: Clinician evaluation; patients ≥ 65 years of age will participate in a mini-cog exam.
- Caucasian race; Method of ascertainment: self-report
- Patients in Project 1 will be excluded from Participation in Project 2: Method of assessment: self-report and PI/RA evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Flushing Hospital Medical Center
Flushing, New York, 11355
About this study
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.
Read more
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:
- 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
- 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:
- To test the revised CFI-EA's feasibility and acceptability among patients and clinicians in a pilot open trial against treatment as usual, and
- 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.
Read the detailed description
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.
- Conditions
- Communication, Adherence, Patient
- Being tested
- The Cultural Formulation Interview-Engagement Aid in Project 1, The Cultural Formulation Interview-Engagement Aid Revised for Project 2, Treatment as usual for Project 2
- Keywords
- Cultural Competence, Patient-Clinician communication
- Medical subject headings
- Communication, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Cultural Formulation Interview-Engagement Aid in Project 1Behavioural
Culture affects how all people communicate and understand the world. Culture is important because patients and clinicians from different cultural backgrounds may have different preferences for communication. Mismatch in the clinician's approach and the patient's expectations of care can lead to patient dissatisfaction and discontinuation with treatment. Patients and clinicians may also have different views about what caused an illness, how it functions, what makes it better or worse, and the types of treatment needed. The CFI-EA is a series of questions over three sessions that clinicians can use to clarify patient views about treatment and communication so that patients stay in treatment longer. Clinicians can use the CFI-EA to customize their current treatment plans.
The Cultural Formulation Interview-Engagement Aid Revised for Project 2Behavioural
The study team will revise the CFI-EA based on patient and clinician feedback. The study team expects that the revisions will consist of changes to the questions such as adding or subtracting specific items or revising the wording of the content. The study team do not anticipate other changes, though we will let our empirical data analyses guide revisions in consultation with the K23 mentor team.
Treatment as usual for Project 2Behavioural
Standard mental health treatment at FHMC
| Study group | Role | What they receive |
|---|---|---|
| CFI-EA arm in Project 1 - Patients | Experimental | The first project is creating the intervention through patient and clinician feedback at JHMC and expert consensus with the K23 mentoring team. The CFI-EA is a list of questions that clinicians can use to customize patient treatment plans based on a cultural competence assessment. This is the patient arm. Receives: Behavioral: The Cultural Formulation Interview-Engagement Aid in Project 1 |
| CFI-EA arm in Project 2 - Patients | Experimental | In this arm the study team will test the revised CFI-EA against treatment as usual in a pilot trial. This is the patient arm. Receives: Behavioral: The Cultural Formulation Interview-Engagement Aid Revised for Project 2 |
| Treatment as usual arm in Project 2 - Patients | Active comparator | Treatment as usual at JHMC consists of clinicians creating treatment plans for patients without any specific training in medical communication or treatment negotiation. This is the patient arm. Receives: Behavioral: Treatment as usual for Project 2 |
| CFI-EA arm in Project 1 - Clinicians | Experimental | The first project is creating the intervention through patient and clinician feedback at JHMC and expert consensus with the K23 mentoring team. The CFI-EA is a list of questions that clinicians can use to customize patient treatment plans based on a cultural competence assessment. This is the clinician arm. Receives: Behavioral: The Cultural Formulation Interview-Engagement Aid in Project 1 |
| CFI-EA arm in Project 2 - Clinicians | Experimental | In this arm the study team will test the revised CFI-EA against treatment as usual in a pilot trial. This is the clinician arm. Receives: Behavioral: The Cultural Formulation Interview-Engagement Aid Revised for Project 2 |
| Treatment as usual arm in Project 2 - Clinicians | Active comparator | Treatment as usual at JHMC consists of clinicians creating treatment plans for patients without any specific training in medical communication or treatment negotiation. This is the clinician arm. Receives: Behavioral: Treatment as usual for Project 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CFI-EA Feasibility
CFI-EA feasibility is defined as the number of participants who completed all three sessions of the CFI-EA intervention.
Measured: After the third session, approximately 1 month after the first session.
CFI-EA Acceptability
This analysis was only performed in the CFI-EA Arm Patients in Project 2 Arm/Group. CFI-EA acceptability is defined as patient scores on the 8-item Client Satisfaction Questionnaire (CSQ-8) which measures the construct of client satisfaction. A total score is reported, ranging from a minimum of 8 to a maximum of 32. Higher values represent a better outcome. This is only measured for patients in the CFI-EA arm enrolled in Project 2.
Measured: After the third session, approximately 1 month after the first session for Project 2.
Secondary outcomes (1)
Treatment Engagement
Defined as the number of eligible patients staying within treatment 2 months after the third and last session of the CFI-EA has been delivered
Measured: 2 months after the last session of the CFI-EA in Project 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start20 Sep 2016
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study follows an NIMH model known as the Stage Model of Intervention Development. The first project is creating a cross-cultural communication intervention designed to improve patient adherence in mental health services through patient and clinician feedback at JHMC and expert consensus with my K23 mentoring team. The second project is testing the intervention in a trial that compares the CFI-EA to treatment as usual.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Neil Krishan Aggarwal, New York State Psychiatric Institute
- Investigators
- Neil K Aggarwal, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044145
- Sponsor's protocol ID
- 7234
- Other IDs
- 1K23MH102334
- Acronym
- CFI-EA
- Status last verified
- May 2026
- First submitted
- 30 Jan 2017
- Last updated
- 22 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cultural Formulation Interview-Engagement Aid for Mental Health Treatment
- ClinicalTrials.gov ID
- NCT03044145
- Acronym / sponsor ID
- CFI-EA / 7234
- Conditions
- Communication, Adherence, Patient
- Keywords
- Cultural Competence, Patient-Clinician communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Posted 22 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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:
- To test the revised CFI-EA's feasibility and acceptability among patients and clinicians in a pilot open trial against treatment as usual, and
- 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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- This study follows an NIMH model known as the Stage Model of Intervention Development. The first project is creating a cross-cultural communication intervention designed to improve patient adherence in mental health services through patient and clinician feedback at JHMC and expert consensus with my K23 mentoring team. The second project is testing the intervention in a trial that compares the CFI-EA to treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| CFI-EA arm in Project 1 - Patients | Experimental | Behavioral: The Cultural Formulation Interview-Engagement Aid in Project 1The first project is creating the intervention through patient and clinician feedback at JHMC and expert consensus with the K23 mentoring team. The CFI-EA is a list of questions that clinicians can use to customize patient treatment plans based on a cultural competence assessment. This is the patient arm. |
| CFI-EA arm in Project 2 - Patients | Experimental | Behavioral: The Cultural Formulation Interview-Engagement Aid Revised for Project 2In this arm the study team will test the revised CFI-EA against treatment as usual in a pilot trial. This is the patient arm. |
| Treatment as usual arm in Project 2 - Patients | Active comparator | Behavioral: Treatment as usual for Project 2Treatment as usual at JHMC consists of clinicians creating treatment plans for patients without any specific training in medical communication or treatment negotiation. This is the patient arm. |
| CFI-EA arm in Project 1 - Clinicians | Experimental | Behavioral: The Cultural Formulation Interview-Engagement Aid in Project 1The first project is creating the intervention through patient and clinician feedback at JHMC and expert consensus with the K23 mentoring team. The CFI-EA is a list of questions that clinicians can use to customize patient treatment plans based on a cultural competence assessment. This is the clinician arm. |
| CFI-EA arm in Project 2 - Clinicians | Experimental | Behavioral: The Cultural Formulation Interview-Engagement Aid Revised for Project 2In this arm the study team will test the revised CFI-EA against treatment as usual in a pilot trial. This is the clinician arm. |
| Treatment as usual arm in Project 2 - Clinicians | Active comparator | Behavioral: Treatment as usual for Project 2Treatment as usual at JHMC consists of clinicians creating treatment plans for patients without any specific training in medical communication or treatment negotiation. This is the clinician arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients aged 18-80; Method of ascertainment: Self-report.
- New patients at JHMC, referred by the intake coordinator; Method of ascertainment: Intake coordinator.
- Willingness and ability to provide written informed consent after full explanation of study procedures. Method of ascertainment: RA informed consent interview that includes a capacity to consent screening form; Clinician referral.
- Racial and ethnic minority (African-American, Latino/Hispanic, Asian-American/Pacific Islander, and Native American). Method of ascertainment: Self-report
- Male and female patients aged 18-80; Method of ascertainment: Self-report.
Key exclusion criteria (10 listed)
- Actively suicidal or homicidal; Method of ascertainment: Self-report and clinician evaluation
- In need of acute detoxification services; Method of ascertainment: Self-report and clinician evaluation
- A condition that interferes with participation (i.e., dementia, mental retardation, or florid psychosis); Method of ascertainment: Clinician evaluation; patients ≥ 65 years of age will participate in a mini-cog exam.
- Caucasian race; Method of ascertainment: self-report
- For Project 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Cultural Formulation Interview-Engagement Aid in Project 1Culture affects how all people communicate and understand the world. Culture is important because patients and clinicians from different cultural backgrounds may have different preferences for communication. Mismatch in the clinician's approach and the patient's expectations of care can lead to patient dissatisfaction and discontinuation with treatment. Patients and clinicians may also have different views about what caused an illness, how it functions, what makes it better or worse, and the types of treatment needed. The CFI-EA is a series of questions over three sessions that clinicians can use to clarify patient views about treatment and communication so that patients stay in treatment longer. Clinicians can use the CFI-EA to customize their current treatment plans. | Behavioural | CFI-EA arm in Project 1 - Clinicians, CFI-EA arm in Project 1 - Patients |
| The Cultural Formulation Interview-Engagement Aid Revised for Project 2The study team will revise the CFI-EA based on patient and clinician feedback. The study team expects that the revisions will consist of changes to the questions such as adding or subtracting specific items or revising the wording of the content. The study team do not anticipate other changes, though we will let our empirical data analyses guide revisions in consultation with the K23 mentor team. | Behavioural | CFI-EA arm in Project 2 - Clinicians, CFI-EA arm in Project 2 - Patients |
| Treatment as usual for Project 2Standard mental health treatment at FHMC | Behavioural | Treatment as usual arm in Project 2 - Clinicians, Treatment as usual arm in Project 2 - Patients |
Primary outcome
CFI-EA Feasibility
Time frame: After the third session, approximately 1 month after the first session.
CFI-EA feasibility is defined as the number of participants who completed all three sessions of the CFI-EA intervention.
CFI-EA Acceptability
Time frame: After the third session, approximately 1 month after the first session for Project 2.
This analysis was only performed in the CFI-EA Arm Patients in Project 2 Arm/Group. CFI-EA acceptability is defined as patient scores on the 8-item Client Satisfaction Questionnaire (CSQ-8) which measures the construct of client satisfaction. A total score is reported, ranging from a minimum of 8 to a maximum of 32. Higher values represent a better outcome. This is only measured for patients in the CFI-EA arm enrolled in Project 2.
1 secondary outcome
Treatment Engagement
Time frame: 2 months after the last session of the CFI-EA in Project 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil K Aggarwal, M.D. principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Cultural Formulation Interview-Engagement Aid in Project 1, The Cultural Formulation Interview-Engagement Aid Revised for Project 2 and Treatment as usual for Project 2 in people with Communication and Adherence, Patient, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CFI-EA Feasibility (time frame: After the third session, approximately 1 month after the first session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.