Culturally Affirming Therapy for Depression and Anxiety

(CARE Trial)

Recruiting at 1 trial location

Overseen By Doris F Chang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Severe symptoms, Other study, Psychotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 15 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy approach called the Culturally-Affirming Racial Equity Framework, designed to help therapists connect better with patients from different cultural backgrounds, especially in online therapy sessions. The focus is on improving the relationship between therapists and Asian American patients to enhance mental health treatment for depression and anxiety. Participants will receive up to 15 online therapy sessions. The trial seeks Asian American individuals in New York or New Jersey who are seeking short-term therapy and are comfortable with sessions being recorded and completing online surveys. As an unphased trial, this study offers a unique opportunity to contribute to innovative therapy methods that could improve mental health care for diverse communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on psychotherapy, so it's best to discuss your medications with the trial coordinators or your healthcare provider.

What prior data suggests that the CARE framework is safe for use in psychotherapy?

Research has shown that treatments like the CARE framework, adapted to fit different cultures, are usually well-received. A review of studies found that these treatments can help people engage better and improve anxiety and trauma symptoms. This suggests that therapies respecting cultural backgrounds often receive positive responses.

The CARE framework aims to strengthen the connection between therapists and patients from various cultures. Although this specific framework is new, the concept of culturally respectful therapy is not. It focuses on creating a supportive and understanding environment, which is generally safer than more invasive treatments.

No reports of serious side effects have emerged from culturally sensitive therapy approaches. This is likely because it involves talking therapy, which is typically safe and non-invasive. Overall, current evidence suggests this type of therapy should be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Culturally-Affirming Racial Equity (CARE) framework because it uniquely addresses depression and anxiety by focusing on cultural and racial dynamics within therapy. Unlike traditional treatments that often focus solely on symptom management, the CARE framework emphasizes building a strong therapeutic alliance despite cultural differences between the therapist and patient. This approach includes collaboration on personalized treatment plans and uses cultural case consultations to tailor therapy more effectively. By directly addressing cultural factors, the CARE framework has the potential to improve treatment outcomes for diverse populations.

What evidence suggests that the CARE framework is effective for improving psychotherapy for diverse populations?

Research shows that therapy tailored to a person's culture can improve mental health, especially for people from diverse backgrounds. Studies have found that when therapy considers cultural differences, patients engage more and achieve better results. In this trial, all participants will receive the CARE framework, designed to foster a strong connection between therapists and patients from different cultural backgrounds. This method employs proven techniques to enhance collaboration between therapists and patients. Early findings suggest that this approach can significantly alleviate symptoms of depression and anxiety by strengthening the therapist-patient bond. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Asian American individuals experiencing depression or anxiety who are interested in online psychotherapy. Participants should be willing to engage with non-Asian therapists using a new Culturally Affirming Racial Equity (CARE) framework and complete regular surveys.

Inclusion Criteria

Patient Participants: English-language proficient

Therapist Participants: 2+ years of clinical experience post-licensure

Patient Participants: Willingness to have sessions videorecorded and complete online assessments

Exclusion Criteria

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

I am not currently in another study or receiving psychotherapy from another provider.

My symptoms are severe and cannot be managed with short-term online treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 15 weekly sessions of individual psychotherapy using the CARE framework

15 weeks

15 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of depression and anxiety

3 months

Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Culturally-Affirming Racial Equity Framework

Trial Overview

The study tests if the CARE intervention helps improve therapy outcomes when therapists and patients have different cultural backgrounds. It involves up to 15 weekly online sessions, aiming to enhance therapist-client relationships and reduce symptoms of depression and anxiety.

How Is the Trial Designed?

Group I: CARE framework Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Published Research Related to This Trial

In a study comparing treatment outcomes of cognitive behavioral therapy (CBT) for participants of color (n = 43) and White participants (n = 136), there were no significant differences in treatment retention or symptom outcomes, indicating that CBT is equally effective across these groups.

Participants of color, including Black, Latinx, and Asian American individuals, showed moderate to large improvements in anxiety and depression symptoms after CBT, suggesting that this treatment is effective for historically excluded racial and ethnic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of People of Color in an Efficacy Trial of Cognitive-Behavioral Treatments for Anxiety, Depression, and Related Disorders: Preliminary Evidence. Cardona, ND., Ametaj, AA., Cassiello-Robbins, C., et al.[2023]

Suicide rates among youth of color are highest before age 30, and existing prevention strategies often overlook the role of structural racism in creating disparities in mental health service access and effectiveness.

The authors propose a new framework that highlights how structural racism affects suicide prevention across mental health services, schools, and crisis care, and they recommend comprehensive interventions to address these systemic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structural Racism and Suicide Prevention for Ethnoracially Minoritized Youth: A Conceptual Framework and Illustration Across Systems. Alvarez, K., Polanco-Roman, L., Samuel Breslow, A., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06625502?term=(racial%20OR%20ethnic)%20AND%20disparities&aggFilters=status:not%20rec&rank=1

Unmute's CARE Framework: A Novel Approach to ...

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 ...

2.

ctv.veeva.com

ctv.veeva.com/study/unmute-39-s-culturally-affirming-racial-equity-care-study-strengthening-the-cross-racial-allianc

Unmute's CARE Framework: A Novel Approach to Strengthen ...

In this single-arm study, all participants will receive the CARE protocol, which includes a) 3-4 session protocol aimed at cultivating the ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4228792/

Toward Culturally Centered Integrative Care for Addressing ...

For example, IMPACT is an evidence based depression care model that has demonstrated effectiveness among older African Americans (Arean et al., 2005). Also ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8842821/

Racial and Ethnic Disparities in Treatment ...

Depression treatment rates were lower for African Americans and Hispanics compared to whites, and the odds of African Americans were half that of whites for ...

5.

apa.org

apa.org/about/apa/addressing-racism/racial-equity-action-plan-progress-2024

Racial equity action plan progress and impact report

This report describes the collaborative efforts undertaken to date and the tangible progress made toward dismantling systemic racism in psychology and ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10367102/

A conceptual framework for culturally appropriate advocacy ...

This paper argues that advocacy and culturally appropriate practices are especially relevant to racialised people.

7.

link.springer.com

link.springer.com/article/10.1007/s10578-025-01833-3

Culturally Adapted Interventions for Anxiety and Trauma ...

This systematic review characterizes adaptations to anxiety treatments and their effectiveness for treatment engagement, clinical, and implementation outcomes.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2212657024000229

Priority actions for improving population youth mental health

Priority actions include the development of acceptable, culturally safe models of mental health care that are consistent with Māori and other minoritised groups ...