Viewing Study NCT06625502



Ignite Creation Date: 2024-10-26 @ 3:41 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06625502
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-24

Brief Title: Unmute39s Culturally Affirming Racial Equity CARE Study Strengthening the Cross-Racial Alliance and Promote Equity
Sponsor: None
Organization: None

Study Overview

Official Title: UnmuteAmp39s Culturally Affirming Racial Equity CARE Framework A Novel Approach to Strengthen the Therapeutic Alliance and Reduce Treatment Disparities With RacialEthnic Minority Patients
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CARE
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 racialethnic 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 racialethnic minorities for short-term problem-focused and culturally-affirming treatment to promote racial equity Unmutes 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 racialcultural difference Clinicians receive training in 3 core areas 1 general cultural competence skills eg culturally-focused assessment racialcultural 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 Unmutes 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 Unmutes 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None