Mental HealthNCT07771322
Digital Mental Health for Asian Americans
A study testing Culturally-attuned digital tools in people with Mental Health and Cultural Adaptation, run by University of California, Berkeley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Cultural Adaptation, Psychotherapy
- What is being tested?
- Culturally-attuned digital tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to 30 Apr 2027
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- New clinicians who have never provided services on the Anise Health platform
- 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.
Who cannot join
- Existing clinicians on the Anise Health platform
- Client eligibility
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Anise Health (http://www.anisehealth.co)
Brooklyn, New York, 11216
Alice Zhang, MBA, 424-209-2386, alice@anisehealth.co
About this study
Official title: Anise Health: 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.
Read the detailed description
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.
- Conditions
- Mental Health, Cultural Adaptation, Psychotherapy, Mood Disorders, Culturally Responsive Care, Asian
- Being tested
- Culturally-attuned digital tools
- Keywords
- mental health, Asian American, Digital Mental Health, Anise Health, Cultural Adaptation, Asian, Digital Health
- Medical subject headings
- Psychological Well-Being, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally-attuned digital toolsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Culturally-attuned digital tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Change from baseline (assessed at baseline, mid point, and the end of the 12 week period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start20 Jul 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Anise Health, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771322
- Sponsor's protocol ID
- 2025-07-18748
- Other IDs
- 5R41MH134727-02
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to confidentiality issues of sensitive client clinical data, participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anise Health: Digital Mental Health for Asian Americans
- ClinicalTrials.gov ID
- NCT07771322
- Acronym / sponsor ID
- 2025-07-18748
- Conditions
- Mental Health, Cultural Adaptation, Psychotherapy, Mood Disorders, Culturally Responsive Care, Asian
- Keywords
- mental health, Asian American, Digital Mental Health, Anise Health, Cultural Adaptation, Asian, Digital Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Anise Health, Inc.
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Culturally-attuned digital toolsEight 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- New clinicians who have never provided services on the Anise Health platform
- 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.
Key exclusion criteria (8 listed)
- Existing clinicians on the Anise Health platform
- Client eligibility
- Individuals seeking
- treatment for serious mental illness such as bipolar disorder and psychotic disorders,
- diagnosis for ADHD or Autism Spectrum Disorder,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally-attuned digital toolsThe 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. | Other | Intervention group |
Primary outcome
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).
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).
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).
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.
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Link to digital mental health platform where the services will be providedLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to confidentiality issues of sensitive client clinical data, participant data will not be shared.
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally-attuned digital tools in people with Mental Health and Cultural Adaptation, run by University of California, Berkeley at 1 site 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Alice Zhang, MBA (424-209-2386, alice@anisehealth.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frost Multidimensional Perfectionism Scale - Brief (time frame: change from baseline (assessed at baseline and at the end of 12-week period)). The study lists 6 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 18 Aug 2026.