An interventional study of Culturally-Affirming Racial Equity Framework in Depression Scale Score, Anxiety Symptoms and Functioning, Psychosocial, sponsored by New York University. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by New York University · Not applicable, Interventional, and Treatment
Aim 1: Expand and adapt the CARE framework to train providers to cultivate a strong early alliance with patients who do not share their background (e.g., mismatched dyads). Aim 2: Establish the feasibility, acceptability, and preliminary effectiveness of the adapted CARE framework in mismatched dyads involving 8 providers and 40 patients receiving 15 sessions of teletherapy.
The goal of this clinical trial is to learn if a new CARE intervention works to improve the cultural fit of psychotherapy for diverse populations, even when the therapist and patient do not share the same cultural background. We will refine and test the intervention with a sample of therapists working with Asian American participants receiving short-term individual psychotherapy delivered online.
The main questions the study aims to answer are:
Participants will:
Despite decades of research exploring approaches to tailoring mental health services to meet the needs of a heterogeneous patient population, significant disparities remain. When patients and providers do not share a similar background, it can result in patients' greater reluctance to engage in treatment, lower satisfaction, and a higher likelihood of dropping out of care, resulting in worsening overall health and contributing to over $153B in excess healthcare costs annually. Two promising approaches to addressing this problem- professional development training to raise provider awareness of the issues, and adapting treatments to specific groups- have failed to reduce treatment disparities. First, studies evaluating the effects of training to enhance providers' ability to tailor services to patient needs find that they tend to focus on abstract concepts, without practical training in skills development. Second, although treatments adapted for specific groups are more effective than unadapted treatments, system constraints (time, cost) limit capacity to train clinicians to deliver multiple adapted treatments to different groups with fidelity. Therefore, a major challenge is how to most feasibly and effectively train our provider workforce to deliver effective mental health care to an increasingly heterogeneous patient population.
Unmute has begun to address this challenge by developing the CARE framework, an innovative process-focused, protocol-based, and modular approach that addresses a preference among many patients for short- term, problem-focused, and individually-tailored treatment to reduce health disparities. Unmute's CARE framework targets the assessment and engagement phase of treatment to reduce dropout, emphasizing skills- training for providers to strengthen the therapeutic alliance, a change mechanism robustly associated with treatment outcome in both telehealth and in-person formats, but more difficult to cultivate across patient-provider differences. Providers receive training in 3 core areas: 1) evidence-informed assessment protocols to facilitate tailoring of treatment, 2) alliance-focused training, an evidence-based approach to repairing breakdowns in the alliance, and 3) consultation with experts in working with specific groups to guide the development of a customized case conceptualization and treatment plan. To date, Unmute's CARE framework has been pilot tested with 10 patients, with 100% returning after the first session, and promising evidence of feasibility and acceptability of core model components. Building on these results, the focus of this Phase I proposal is to train a larger cohort of providers to implement Unmute's CARE framework with patients whose backgrounds differ from their own. We hypothesize that this innovative modular approach to provider training and patient engagement, will increase the feasibility, acceptability, and preliminary effectiveness of providers' efforts to cultivate a strong alliance, reduce dropout rates, and improve treatment engagement and outcome.
Aim 1 will be to expand and adapt the CARE framework to train providers to cultivate a strong early alliance with patients who do not share their background (e.g., mismatched dyads). Guided by pilot data and a community advisory board, we will develop two new training modules: a) a group-specific module, and b) a bridging differences module, to strengthen the patient-provider alliance in mismatched dyads.
Aim 2 will be to establish the feasibility, acceptability, and preliminary effectiveness of the adapted CARE framework in mismatched dyads involving 8 providers and 40 patients receiving 15 sessions of teletherapy. We will collect self-report and observer data for evaluation and refinement as needed.
By combining general and group-specific alliance-building components, Unmute's CARE framework can be adapted for other populations to provide high quality, evidence-based care in an efficient and cost-effective way. Our team is well positioned to execute on this plan; Unmute is cofounded by Colleen Leung, serial entrepreneur and MBA graduate of Babson College, and Dr. Doris Chang, clinical psychologist and expert on culture and mental health and psychotherapy process and outcome in mismatched dyads, with support from the Centers of Alliance Focused Training and New York University's Silver School of Social Work.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →New York University is the lead sponsor of 120 studies on the registry; 32 are open to participants now.
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Patient Participants:
Therapist Participants:
Exclusion Criteria:
Patient Participants:
In this single-arm study, all participants will receive the CARE protocol, which includes a) 3-4 session protocol aimed at cultivating the therapeutic alliance across therapist-patient differences, b) therapist and patient collaboration on a case formulation and treatment plan, c) evidence-based approaches to treating the presenting problem, d) alliance-focused training to address ruptures, and e) cultural case consultation.
Behavioral: Culturally-Affirming Racial Equity Framework
The CARE framework is a process-focused, protocol- based, and modular approach to promote mental health equity. It focuses on cultivating the therapeutic alliance across patient-provider differences in the first 3-4 treatment sessions, the critical window for engaging patients in care. Target processes include transparent communication, client-centeredness, client activation, and an affirming and comprehensive approach to assessment and treatment planning. Case conceptualization and treatment planning is collaborative, and guided by the individual clinician based on evidence-based treatments. The therapist receives ongoing biweekly supervision in Alliance-Focused Training and consultation sessions with a group-specific expert.
Credibility/Expectancy Questionnaire
A brief scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Given that Asian American have the lowest rates of mental health service utilization and high dropout rates, we will set conservative success criteria for acceptability, defined as (a) a mean score \> 5 (on a 1-9 scale) for the 3 credibility items of the Credibility/Expectancy Questionnaire.
Time frame: Week 4 of treatment
Client Satisfaction Questionnaire-8 (CSQ-8)
8-item measures of client satisfaction with services
Time frame: At the end of treatment, typically at 15 weeks.
Retention
We will examine retention outcomes, setting the success criteria at 70% returning after the initial session and 50% retention rate (defined as completing at least 1 follow-up assessment). In general, Asian Americans tend to drop out of therapy at a high rate (as high as 80% in some studies, e.g., Presley \& Day, 2019). As a result, we will consider a 50% retention rate to be evidence of 'successful' retention in these racially mismatched therapy dyads.
Time frame: Through study completion, approximately 15 weeks.
PHQ-9
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
Time frame: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.
GAD-7
The GAD-7 is a valid and efficient tool for screening for Generalized Anxiety Disorder and assessing its severity in clinical practice and research. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%) and post-traumatic stress disorder (sensitivity 66%, specificity 81%).
Time frame: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.
Outcome Questionnaire 45.2 (OQ45.2)
The Interpersonal Relations (IR) and Social Role (SR) sub scales of the OQ-45.2, a self-report scale designed to track and measure client progress in psychotherapy.
Time frame: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.
Patient Progress on Goals
An idiographic assessment of patient\'s self-reported progress on up to 3 treatment goals. 1= Not at all Achieved ---- 9= Completely Achieved
Time frame: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.
Session Alliance Inventory
A 6-item measures of the working alliance, the key target mechanism of action.
Time frame: 1 week (after every weekly session)
Rupture Resolution Questionnaire
Six questions (Muran, Safran, Samstag, \& Winston, 2002) aimed at providing a global assessment of rupture and resolution within each session. Participants assess the following on a 5-point Likert Scale: (1) whether there was the perception of any problem or tension in the relationship during the session, (2) to what extent there was a perception of "smoothing over" or "holding back", (3) the extent to which the problem was addressed, (4) the degree to which the problem was resolved, (5) a brief description of the problem, and (6) a brief description of how the the resolution.
Time frame: 1 week (after every weekly session)
Multicultural Orientation
The Multicultural Orientation Framework conceptualizes how therapist and client cultural identities interact in therapy to influence the therapeutic relationship, and includes brief standardized measures of client ratings of Therapist Cultural Comfort, Cultural Humility, and Cultural Broaching/Missed Opportunities.
Time frame: Week 1 (Cultural Comfort) and Week 4 (Cultural Humility, and Cultural Broaching/Missed Opportunities)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Only patient and therapist survey data will be considered.Data and metadata will be stored in the NIMH Data Archive (NDA). The data will be made available within 6 months of study completion and will be available for up to 5 years.
Supporting information: Study protocol, Icf
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