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NCT03961633 · ClinicalTrials.gov registry record · NA
AWARE Intervention: Feasibility and Efficacy Trial at Three University Health Services Centers
A NA study, sponsored by Boston University Charles River Campus.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT03961633: Completed NA study, sponsored by Boston University Charles River Campus.
NCT03961633 is a NA study that has completed, run by Boston University Charles River Campus. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03961633, a NA study, has completed, sponsored by Boston University Charles River Campus.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
The goal of this study is to test the efficacy and the feasibility of the Asian Women's Action for Resilience and Empowerment (AWARE) intervention, in the real world setting -- student health service centers at Boston University, Wellesley College, and Harvard University. AWARE is an 8-week group intervention specifically designed to address mental health and sexual health issues among Asian-Pacific Islander (API) women. One AWARE group (final number of 8-10 API women who will be treated) will be held at BU Student Health Services, two groups at Wellesley College, and two groups at Harvard University Health Services for undergraduate and graduate students who meet the demographic and clinical criteria. During the intervention period, participants will attend the AWARE group counseling sessions, which are 90 minutes, once a week, for 8 weeks. Each week's session is focused on a specific theme related to the cultural and gender-specific issues typical among young Asian American women. The sessions are led by staff therapists at either institution. Participants will fill out forms that detail their therapeutic goals ("commitments") and any adverse emotional/behavioral events from the past week. Participants will also receive daily text messages that reinforce the group session themes. Participants will be assessed pre- and post-intervention on clinical outcomes, including depression, anxiety, PTSD, and suicidality, using standardized quantitative instruments. This serves to evaluate the efficacy of AWARE at improving mental health outcomes. Participants will also participate in a post-intervention focus group session to evaluate the program's implementation and suggest ways for future improvement.
Primary Outcome
Change in depression symptoms measured by the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R). The CESD-R scoring scale ranges from 0 (no depression) to 80 (severe depression), and 16 or higher is the threshold for clinical depression diagnosis.
Interventions
- BEHAVIORAL AWARE intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-08-01 |
| Est. Completion | 2019-02-15 |
| Phase | NA |
What the finished NCT03961633 record still lists
NCT03961633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which AWARE intervention is the first listed.
NCT03961633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03961633 about?
NCT03961633 is a clinical study titled "AWARE Intervention: Feasibility and Efficacy Trial at Three University Health Services Centers". The goal of this study is to test the efficacy and the feasibility of the Asian Women's Action for Resilience and Empowerment (AWARE) intervention, in the real world setting -- student health service centers at Boston University, Wellesley College, and Harvard University. AWARE is an 8-week group i...
What is the current status of trial NCT03961633?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2016-08-01. Estimated completion is 2019-02-15.
What interventions are being tested in trial NCT03961633?
The interventions under investigation include: AWARE intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03961633?
This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03961633's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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