跳至主要内容
临床试验/NCT07771322
NCT07771322招募中不适用

Anise Health: Digital Mental Health for Asian Americans

University of California, Berkeley1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Frost Multidimensional Perfectionism Scale - Brief

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinician eligibility
  • Inclusion Criteria:
  • New clinicians who have never provided services on the Anise Health platform

排除标准

  • 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.

结局指标

主要结局

Frost Multidimensional Perfectionism Scale - Brief

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验