Digital Mental Health for Asian Americans

NCT07771322 | Recruiting

• 2 other identifiers: 2025-07-187485R41MH134727-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health; Cultural Adaptation; Psychotherapy; Mood Disorders; Culturally Responsive Care; Asian; Digital Health Intervention

Keywords

mental health; Asian American; Digital Mental Health; Anise Health; Cultural Adaptation; Asian; Digital Health

Outcome Measures

Primary Outcomes (6)

• Frost Multidimensional Perfectionism Scale - Brief

  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).

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

• The System Usability Scale

  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).

  At the end of 12-week study period

• Acculturative Stress Scale

  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).

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

• The Multigroup Ethnic Identity Measure - Revised

  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.

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

• Patient Health Questionnaire-9

  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).

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

• Generalized Anxiety Disorder-7

  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).

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

Study Arms (2)

Control group

NO INTERVENTION

Eight clinicians new to the Anise Health digital mental health platform will be recruited to provide 12 weeks of mental health services to 4 clients each. The clinicians will provide clinical data that will be analyzed in comparison to the intervention group.

Intervention group

EXPERIMENTAL

Eight clinicians new to the Anise Health digital mental health platform will be recruited to receive training to use digital tools developed to enhance their work on racial trauma, bicultural tension, and intergenerational conflict. They will then use these tools while providing 12 weeks of mental health services to 4 clients each. The clinicians will provide clinical data that will be analyzed in comparison to the intervention group.

Other: Culturally-attuned digital tools

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Existing clinicians on the Anise Health platform
• Client eligibility
• 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.
• 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.

Sponsors & Collaborators

• Anise Health, Inc.: collaborator
• National Institute of Mental Health (NIMH): collaborator
• University of California, Berkeley: lead

Study Sites (1)

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

Brooklyn, New York, 11216, United States

RECRUITING

Related Links

• Link to digital mental health platform where the services will be provided

MeSH Terms

Conditions

Psychological Well-Being; Mood Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders

Central Study Contacts

Alice Zhang, MBA

CONTACT

424-209-2386; alice@anisehealth.co

Brian Keum, PhD

CONTACT

510-473-7404; briankeum@berkeley.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will test whether there are significant differences in clients' outcomes related to presenting concerns between the intervention group (the 8 clinicians who were recruited and trained to use the digital tools) and the control group (another 8 clinicians recruited to work with clients without training and use of the digital tools). Both groups (control and intervention) will work with their clients as they normally would, with the difference being that the intervention group will be using the digital tools.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 18, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)