An interventional study of Culturally-attuned digital tools in Mental Health, Cultural Adaptation and Psychotherapy, sponsored by University of California, Berkeley. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of California, Berkeley · Not applicable, Interventional, and Treatment
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.
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.
561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 419 interventional studies indexed under Mood Disorders.
Browse Mood Disorders studies →University of California, Berkeley is the lead sponsor of 111 studies on the registry; 20 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Compared within Mood Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychological Well-Being. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Clinician eligibility
Inclusion Criteria:
Exclusion Criteria:
Client eligibility
Inclusion Criteria:
Exclusion Criteria:
Individuals seeking
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Change from baseline (assessed at baseline, mid point, and the end of the 12 week period)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Due to confidentiality issues of sensitive client clinical data, participant data will not be shared.
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