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Recruiting

NCT Number: NCT07771322

Digital Mental Health for Asian Americans

Aim 1: Assess clinicians' receptiveness and potential use of Anise's online platform digital tools for managing sociocultural stressors and revise the tools for implementation. We will recruit 8 new clinicians (intervention group) who will receive training and provide feedback on the digital tools.

Aim 2: Evaluate the initial efficacy of the online platform digital tools for managing the impact of sociocultural stressors with 64 Asian American clients. The intervention group clinicians (receiving training and using the digital tools) and newly recruited 8 clinicians (not receiving training and not using the digital tools) for the control group will work with 4 clients each. The clinical outcome data of the clients will be analyzed to examine differences in the client prognosis between the control and intervention group.

A successful outcome of this project will be digital materials that effectively address the impact of sociocultural stressors for Asian Americans on Anise Health's digital health platform.

Recruiting

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Key information

Conditions

Mental Health Asian Behavior Cultural Adaptation Culturally Responsive Care Digital Health Intervention Mental Disorders Mood Disorders Personal Satisfaction Psychological Well-Being Psychotherapy

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anise Health (http://www.anisehealth.co)

Brooklyn, New York, 11216, United States

Location status: Recruiting

Location contact

Alice Zhang, MBA

CONTACT

[email protected]

424-209-2386

About this study

Unique sociocultural factors significantly impact the lived experiences and mental health of Asian Americans. Yet, these factors are often not considered or are overlooked in conventional evidence-based practices for psychotherapy. Ample research has found that these culture-specific stressors can give rise to psychopathology (e.g., depression, anxiety, trauma, problematic substance use) among Asian Americans. The current diagnosis-driven, Eurocentric models of psychotherapy often do not account for these sociocultural determinants of mental well-being and can lack cultural sensitivity, leading to unsuccessful psychotherapy outcomes and a high burden from persistent mental health issues among this population.

To address this gap, Anise Health (Anise) has been pioneering the technology-enabled delivery of mental health care for Asian Americans. Anise develops clinical protocols that incorporate culture and intersectionality into evidence-based practices and technologies that enable the delivery of personalized treatments. Anise's online platform also includes tailored digital tools for clients and clinicians to leverage in treatment.

To improve access to high-quality mental health care services for Asian Americans, we will leverage our expertise and preliminary data to expand our online digital library of materials and tools. Specifically, the overall objective of this proposal is to develop and refine Anise Health's digital tools and accompanying clinician training programs for addressing key sociocultural factors in mental health treatments and to determine the feasibility and acceptability of these online platform tools. Our preliminary data elucidated common themes related to the negative impact of sociocultural stressors on clients' mental health outcomes, and the need for clinicians to address these issues in culturally-informed ways. Digital mental health clinical tools have been found to support treatment and homework adherence as they are easily accessible for clients and are easier for therapists to integrate into their treatment plans. However, existing digital mental health clinical tools were not developed for, nor tested with, the Asian American community and do not integrate their specific historical and sociocultural experiences. This project is a foundational step toward our long-term goal of demonstrating that Anise's online platform is effective in addressing unique sociocultural factors for Asian Americans.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Clinician eligibility

Inclusion criteria

  • New clinicians who have never provided services on the Anise Health platform

Exclusion criteria

  • Existing clinicians on the Anise Health platform

Client eligibility

Inclusion criteria

  • Asian American adults (age 18-90 years) who seek mental health services
  • resides in states in which Anise Health clinicians are licensed to provide care,
  • has access to reliable internet connection,
  • has signed the Informed Consent form prior to participants' entry into the study.

Exclusion criteria

Individuals seeking

  • treatment for serious mental illness such as bipolar disorder and psychotic disorders,
  • diagnosis for ADHD or Autism Spectrum Disorder,
  • treatment for eating disorder and substance use disorder,
  • attention for active suicidal ideation with plan and intent, or
  • persons lacking relevant decision-making capacity, or otherwise requiring a personal representative to indicate consent/authorization on their behalf, would be ineligible.

Treatment and study plan

Culturally-attuned digital tools

Other

The intervention includes clinicians receiving training to provide culturally-attuned mental health services to their clients through the use of digital tools. The digital tools include (a) digital worksheets designed to guide clients to explore and address sociocultural stressors, and (b) podcasts that help inform empirical knowledge on these issues. Clinicians are provided training how how they can effectively employ these digital tools with their clients to enhance their work, particularly regarding presenting concerns related to sociocultural stressors.

Primary outcomes

  1. Frost Multidimensional Perfectionism Scale - Brief

    Time frame: change from baseline (assessed at baseline and at the end of 12-week period)

    Frost Multidimensional Perfectionism Scale - Brief (FMPS-Brief), an 8-item self-report measure assessing perfectionism across two subscales (evaluative concerns and striving). Total scores range from 8 (minimum) to 40 (maximum), with higher scores indicating greater perfectionism (worse outcome).

  2. The System Usability Scale

    Time frame: At the end of 12-week study period

    System Usability Scale (SUS), a 10-item self-report measure assessing clinicians' perceived usability and acceptability of the digital tools. Total scores range from 0 (minimum) to 100 (maximum), with higher scores indicating better usability (better outcome).

  3. Acculturative Stress Scale

    Time frame: change from baseline (assessed at baseline and at the end of 12-week period)

    Acculturative Stress Scale is a self-report measure that assesses stress experienced by immigrants and minorities due to cultural, social, and environmental adjustments. It is a 10-item self-report measure with total scores ranging from 10 (minimum) to 50 (maximum), with higher scores indicating greater acculturative stress (worse outcome).

  4. The Multigroup Ethnic Identity Measure - Revised

    Time frame: Change from baseline (assessed at baseline and at the end of the 12 week period)

    Multigroup Ethnic Identity Measure - Revised (MEIM-R), a 6-item self-report measure assessing exploration of and commitment to one's ethnic identity. Scores are the mean of all items and range from 1 (minimum) to 5 (maximum), with higher scores indicating stronger ethnic identity.

  5. Patient Health Questionnaire-9

    Time frame: Change from baseline (assessed at baseline, mid point, and the end of the 12 week period)

    Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure assessing depressive symptom severity over the past two weeks. Total scores range from 0 (minimum) to 27 (maximum), with higher scores indicating greater depression severity (worse outcome).

  6. Generalized Anxiety Disorder-7

    Time frame: Change from baseline (assessed at baseline, mid point, and the end of the 12 week period)

    Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report measure assessing anxiety symptom severity over the past two weeks. Total scores range from 0 (minimum) to 21 (maximum), with higher scores indicating greater anxiety severity (worse outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Zhang, MBA

CONTACT

[email protected]

424-209-2386

Brian Keum, PhD

CONTACT

[email protected]

510-473-7404

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • Anise Health, Inc.
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Anise Health: Digital Mental Health for Asian Americans

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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