Clinical trial NCT06625502: Unmute&#39;s Culturally Affirming Racial Equity (CARE) Study: Strengthening the Cross-Racial Alliance and Promote Equity
Official title: Unmute&Amp;#39;s Culturally Affirming Racial Equity (CARE) Framework: A Novel Approach to Strengthen the Therapeutic Alliance and Reduce Treatment Disparities With Racial/Ethnic Minority Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression Scale Score
Anxiety Symptoms
Functioning, Psychosocial
Working Alliance
Keywords: Asian Americans
mental health
therapeutic relationship
culturally-responsive treatment
cross-racial
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if a new Culturally Affirming Racial Equity (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 non-Asian therapists working with Asian American participants receiving short-term individual psychotherapy delivered online.

The main questions the study aims to answer are:

* Does the CARE framework, adapted for and delivered by non-Asian therapists, work to engage and retain Asian American participants in treatment?
* Is the CARE framework associated with a) the development of a positive therapeutic relationship between non-Asian therapists and Asian American participants and b) significant improvements in participants' presenting problems?

Participants will:

* Receive up to 15 weekly sessions of individual psychotherapy
* Complete different online surveys after every session and on a monthly basis

Detailed description: Despite decades of research exploring culturally-responsive approaches to mental health service delivery, racial/ethnic minorities remain significantly underserved. Black, Asian, and Latino Americans with a mental disorder are significantly more likely than White Americans to delay or never seek mental health services. Those who do seek help report lower satisfaction and are significantly more likely to drop out after their first session than White patients, resulting in worsening overall health and higher healthcare costs 5, as high as $153B a year. Two promising approaches to improving the cultural responsiveness of care -cultural competence training and culturally-adapted treatments (CATs)-have failed to reduce treatment disparities. First, studies of cultural competence training find a limited focus on practice and skill development, contributing to their limited effectiveness9. Second, although CATs are more effective than unadapted treatments, system constraints (time, cost) limit capacity to train clinicians to deliver multiple CATS to diverse patients with fidelity. Therefore, a major challenge is how to most feasibly and effectively train a largely White provider workforce to deliver effective mental health care to an increasingly diverse patient population.

Unmute has begun to address this challenge by developing a Culturally Affirming Racial Equity (CARE) framework, an innovative process-focused, protocol-based, and modular approach that addresses a general preference among racial/ethnic minorities for short-term, problem-focused, and culturally-affirming treatment to promote racial equity. Unmute's CARE framework targets the assessment and engagement phase of treatment to reduce dropout, emphasizing skills-training for therapists 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 racial/cultural difference. Clinicians receive training in 3 core areas: 1) general cultural competence skills (e.g., culturally-focused assessment, racial/cultural broaching), 2) alliance- focused training, an evidence-based approach to repairing breakdowns in the alliance, and 3) culture-specific consultation with an expert to guide culturally-informed case conceptualization and treatment planning.

To date, Unmute's CARE framework has been tested with Asian Americans, who report the lowest mental health service use18, due to cultural and structural barriers. A pilot study with 10 diverse Asian American clients and 3 therapists found that 100% returned after the first session, with evidence of feasibility and acceptability of core model components. Building on these promising results, the focus of this Phase I proposal is to train non-Asian clinicians, who represent the majority of the mental health workforce, to implement Unmute's CARE framework. We hypothesize that this innovative modular approach, culturally-tailored for Asian Americans, will increase the feasibility, acceptability, and preliminary effectiveness of non-Asian clinicians' efforts to cultivate a strong alliance, reduce dropout rates, and improve treatment engagement and outcome.

Aim 1 will be to adapt the CARE framework to train non-Asian therapists to cultivate a strong early alliance with Asian American patients. Guided by pilot data and a community advisory board, we will develop two new modules: a) an Asian American Cultural Foundations module, and b) a Cultural Bridging module, to strengthen the cross-racial alliance with a focus on White clinician-Asian American client dyads.

Aim 2 will be to establish the feasibility, acceptability, and preliminary effectiveness of the adapted CARE framework with 40 Asian American patients receiving 15 sessions of teletherapy from 8 non-Asian American therapists. We will collect self-report and observer data for evaluation and refinement as needed.

Eligibility criteria: Inclusion Criteria:

Patient Participants:

1. Individuals 18 years of age or older, who identify as Asian or Asian American
2. Physically residing in New York state and willing to meet therapist over video platform
3. English-language proficient
4. Seeking telemental health treatment and willing to receive short-term treatment (maximum 15 sessions)
5. Willingness to have sessions videorecorded and complete online assessments
6. Has insurance coverage for therapy sessions or willing to pay for services out-of-pocket ($150/session)

Therapist Participants:

1. Masters' level mental health provider licensed to practice in NY and insured
2. 2+ years of clinical experience post-licensure
3. Training and experience with cognitive behavioral therapy or other evidence-based therapies
4. Interest in improving skills in working with Asian American patients
5. Willingness to complete post-session questionnaires, record treatment sessions and attend biweekly AFT sessions for training and research purposes
6. Availability to treat a caseload of 5 Unmute patients during the project period

Exclusion Criteria:

Patient Participants:

1. Patient's symptom presentation is severe beyond what can be effectively managed in a short-term treatment modality via telehealth (e.g., PHQ-9 score \&gt; 20, they present a risk of harm to self or other, or otherwise require a higher level of care)
2. Patient is involved in another intervention study or currently receiving psychotherapy services from another provider.suicidal ideation or psychotic symptoms

Therapist Participants:

Licensure violations or enforcement actions as documented on the New York State Office of the Professions website https://www.op.nysed.gov/

Primary outcomes:
measure: Credibility/Expectancy Questionnaire
timeFrame: Week 4 of treatment
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: At the end of treatment, typically at 15 weeks.
measure: Retention
timeFrame: Through study completion, approximately 15 weeks.
Secondary outcomes:
measure: PHQ-9
timeFrame: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.
measure: GAD-7
timeFrame: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.
measure: Outcome Questionnaire 45.2 (OQ45.2)
timeFrame: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.
measure: Patient Progress on Goals
timeFrame: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.
Other outcomes:
measure: Session Alliance Inventory
timeFrame: 1 week (after every weekly session)
measure: Rupture Resolution Questionnaire
timeFrame: 1 week (after every weekly session)
Locations:
city: Chelsea
country: United States
facility: Unmute Enterprise Inc. [A telehealth company]
state: Massachusetts
Study officials:
References: