AWARE Intervention: Feasibility and Efficacy Trial at Three University Health Services Centers

NCT03961633 | Completed

• 1 other identifier: 4755
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Depression; Anxiety; PTSD; Suicidal Ideation; Substance Use Disorders; Unsafe Sex; Coping Behavior

Outcome Measures

Primary Outcomes (3)

• Change in depression symptoms

  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.

  Pre/post-intervention (within 4 weeks prior / within 1 week following intervention)

• Change in anxiety symptoms

  Change in depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS). The HADS scoring scale ranges from 0 (no anxiety) to 21 (severe anxiety), and 11 or higher is the threshold for clinical anxiety disorder diagnosis.

  Pre/post-intervention (within 4 weeks prior / within 1 week following intervention)

• Change in PTSD symptoms

  Change in PTSD symptoms measured by the PTSD Checklist - Civilian Version (PCL-C). The PCL-C scoring scale ranges from 1 (no PTSD symptoms) to 85 (severe PTSD symptoms), and 30 or higher is the threshold for clinical PTSD diagnosis.

  Pre/post-intervention (within 4 weeks prior / within 1 week following intervention)

Study Arms (1)

AWARE intervention

EXPERIMENTAL

This arm is the "treatment group", which receives the intervention, and is the only arm in the study. See the "intervention" column for more descriptions.

Behavioral: AWARE intervention

Interventions

AWARE intervention BEHAVIORAL

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. For more info on each session's content, please see the "Study Description - Detailed Description" section. 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.

AWARE intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Anyone who self-identifies as an "(Asian American) woman".
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old;
• Identify as Asian American females;
• Single (unmarried);
• Have a mobile phone with a text messaging plan;
• Having depressive symptoms (CESD-R score equal to or greater than 16), or clinical anxiety (HADS-A score equal to or greater than 11), or PTSD symptoms (PCL-C score equal to or greater than 30), or exposure to physical or sexual violence during childhood (assessed using the ACE-IQ).

You may not qualify if:

• Actively suicidal and homicidal (assessed using C-SSRS);
• Participants who show psychotic symptoms such as visual or auditory hallucinations;
• Students at the trial facilities who are currently members of the research team.

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Harvard University: collaborator

Study Sites (2)

Boston University Student Health Services

Boston, Massachusetts, 02215, United States

Location

Harvard University Health Services

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Suicidal Ideation; Substance-Related Disorders; Unsafe Sex

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Suicide; Self-Injurious Behavior; Chemically-Induced Disorders; Sexual Behavior

Study Officials

• Hyeouk C Hahm, PhD, LCSW

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Chair of Social Research

Model Details: Participants are assigned to a single intervention ("treatment") group. Intervention at the two sites are not concurrent; the Boston University site intervention takes place in March - May 2018, and the Harvard University site intervention takes place in October - December 2018.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 23, 2019
• Study Start: August 1, 2016
• Primary Completion: December 10, 2018
• Study Completion: February 15, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)