Unmute's CARE Framework: A Novel Approach to Strengthen the Therapeutic Alliance and Reduce Treat… (NCT06625502) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Unmute's CARE Framework: A Novel Approach to Strengthen the Therapeutic Alliance and Reduce Treatment Disparities
United States40 participantsStarted 2025-09-15
Plain-language 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 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:
* 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Has insurance coverage for therapy sessions or willing to pay for services out-of-pocket ($150/session)
. Masters' or doctoral level mental health provider licensed to practice in NY or NJ and insured
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Credibility/Expectancy Questionnaire
Timeframe: Week 4 of treatment
2
Client Satisfaction Questionnaire-8 (CSQ-8)
Timeframe: At the end of treatment, typically at 15 weeks.
3
Retention
Timeframe: Through study completion, approximately 15 weeks.
. 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