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Depression Scale ScoreCARENCT06625502

Unmute's CARE Framework: A Novel Approach to Strengthen the Therapeutic Alliance and Reduce Treatment Disparities

A study testing Culturally-Affirming Racial Equity Framework in people with Depression Scale Score and Anxiety Symptoms, run by New York University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Culturally-Affirming Racial Equity Framework
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
15 Sep 2025to 1 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient Participants:
  • Individuals 18 years of age or older
  • Physically residing in New York or New Jersey and willing to meet therapist over video platform
  • English-language proficient
  • Seeking telemental health treatment and willing to receive short-term treatment (maximum 15 sessions)
  • Willingness to have sessions videorecorded and complete online assessments
Show all 14Show fewer
  • Has insurance coverage for therapy sessions or willing to pay for services out-of-pocket ($150/session)
  • Therapist Participants:
  • Masters' or doctoral level mental health provider licensed to practice in NY or NJ and insured
  • 2+ years of clinical experience post-licensure
  • Training and experience with cognitive behavioral therapy or other evidence-based therapies
  • Interest in improving skills in working across therapist-patient differences
  • Willingness to complete post-session questionnaires, record treatment sessions and attend biweekly AFT sessions for training and research purposes
  • Availability to treat a caseload of 5 Unmute patients during the project period

Who cannot join

  • Patient Participants:
  • 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 greater than 20, they present a risk of harm to self or other, or otherwise require a higher level of care)
  • 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 at the New York State Office of the Professions https://www.op.nysed.gov/ or New Jersey Division of Consumer Affairs https://www.njconsumeraffairs.gov

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Unmute Enterprise Inc. [A telehealth company]

    Chelsea, Massachusetts, 02150

  • Virtual/Telehealth

    New York, New York, 10001

Other trials in United States

About this study

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.

Read more

The main questions the study aims to answer are:

  • Does the CARE framework, adapted for and delivered by therapists specifically trained to work with patients who do not share their background (e.g., mismatched dyads), improve treatment engagement and retention?
  • Is the CARE framework associated with a) the development of a positive therapeutic relationship between mismatched patient-therapist dyads 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
Read the detailed description

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.

Being tested
Culturally-Affirming Racial Equity Framework
Keywords
mental health, therapeutic relationship
Medical subject headings
Anxiety Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Culturally-Affirming Racial Equity FrameworkBehavioural

    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.

Study groups in NCT06625502
Study groupRoleWhat they receive
CARE frameworkExperimentalIn 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.
Receives: Behavioral: Culturally-Affirming Racial Equity Framework

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 4 of treatment

  2. Client Satisfaction Questionnaire-8 (CSQ-8)

    8-item measures of client satisfaction with services

    Measured: At the end of treatment, typically at 15 weeks.

  3. 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.

    Measured: Through study completion, approximately 15 weeks.

Secondary outcomes (4)
  1. PHQ-9

    The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.

    Measured: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.

  2. 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%).

    Measured: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.

  3. 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.

    Measured: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.

  4. 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

    Measured: Every 4 weeks through study completion (e.g., week 4, week 8, week 12, week 15) and 3 months after treatment ends.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2024
  2. Study start15 Sep 2025
  3. Primary completion15 Mar 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06625502
Sponsor's protocol ID
FY2024-9189
Acronym
CARE
Status last verified
Oct 2025
First submitted
24 Sep 2024
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Culturally-Affirming Racial Equity Framework in people with Depression Scale Score and Anxiety Symptoms, run by New York University at 2 sites 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 14 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Credibility/Expectancy Questionnaire (time frame: Week 4 of treatment). The study lists 3 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 Jan 2026.

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