AWARE Program for Survivors of Sexual Trauma

(AWARE Trial)

Overseen By Prachi Bhiptani

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Lifespan

Disqualifiers: Suicide risk, Alcohol withdrawal, others

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the AWARE program, which is designed to assist college women who have experienced sexual trauma and are dealing with alcohol use and sexual distress. The study aims to determine if this program can reduce drinking habits, sexual distress, and the risk of further assault. Participants will engage in individual and group sessions, with follow-up assessments at 2 and 6 months. Women who may be suitable for the study have a history of sexual trauma and have exceeded recommended drinking limits (more than four drinks in a day) at least twice in the past month. As an unphased trial, this study offers participants the chance to contribute to important research that could lead to better support programs for women facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for participants?

Research shows that programs like the AWARE program, which address alcohol use and sexual distress, are generally easy for people to handle. Although specific safety data for the AWARE program is unavailable, similar programs focusing on mental health and behavior changes have shown very few negative effects. These programs typically include counseling and support, which are safe and commonly used to help people with personal challenges. Participants often experience positive results, such as reduced distress and improved coping skills, without major negative side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AWARE program because it takes a comprehensive approach to help survivors of sexual trauma by addressing alcohol use, sexual distress, and the risk of sexual revictimization all in one program. Unlike traditional therapies that might focus on just one aspect, such as cognitive-behavioral therapy for trauma or support groups for alcohol use, AWARE integrates multiple support areas into a cohesive plan. This holistic approach could lead to more effective and faster recovery for participants by providing targeted interventions tailored to the unique challenges faced by survivors.

What evidence suggests that this trial's treatments could be effective for addressing alcohol use, sexual distress, and sexual assault risk?

Research shows that the AWARE program, one of the treatment arms in this trial, might help reduce alcohol use, sexual distress, and the risk of being sexually victimized again for survivors of sexual trauma. Studies have found that focusing on these issues can lead to better outcomes for people who have experienced sexual assault. For instance, addressing alcohol use and understanding its relation to sexual distress can help lower the chances of being victimized again. Additionally, programs like AWARE, which include both group and individual sessions, have proven helpful for participants. While specific data on AWARE's effectiveness are still under review, its approach aligns with proven methods for supporting survivors. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for college women aged 18-24 who speak English and have experienced sexual victimization since age 14. They must also report heavy drinking twice or more in the past month, be sexually active, and show signs of sexual distress. Women at suicide risk or with alcohol withdrawal symptoms cannot participate.

Inclusion Criteria

I have been sexually active in the past month.

Report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation or force

Exceed the clinical cut point on the Female Sexual Functioning Index

Exclusion Criteria

Suicide risk on the Beck Depression Inventory

Screen positive on the Alcohol Use Withdrawal Checklist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in both individual and group-based interventions for alcohol use, sexual distress, and sexual assault risk

8 weeks

Follow-up

Participants are monitored for reductions in alcohol use, sexual distress, and sexual revictimization at 2- and 6-months following program completion

6 months

What Are the Treatments Tested in This Trial?

Interventions

• AWARE
• General Health Promotion

Trial Overview The study tests an intervention called AWARE aimed at reducing alcohol use, alleviating sexual distress, and lowering the risk of further sexual assault compared to a general health promotion program. Participants will receive individual and group sessions with follow-ups at 2 and 6 months after completion.

How Is the Trial Designed?

Group I: AWARE Program Experimental Treatment 1 Intervention

The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.

Group II: General Health Promotion Placebo Group 1 Intervention

The General Health Promotion program is a attention and dose-matched comparison condition.

Who Is Running the Clinical Trial?

Lifespan

Lead Sponsor

Trials

43

Recruited

41,100+

Published Research Related to This Trial

Trauma-informed care is essential for patients with a history of traumatic life events, as it addresses their unique needs and can help prevent distress during healthcare experiences.

The literature synthesis highlights the need for further research on trauma-informed care practices, emphasizing the importance of provider-patient relationships and multidisciplinary collaboration to improve care for survivors of physical and sexual abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A synthesis of the literature on trauma-informed care. Reeves, E.[2017]

Clinicians require better training in sexual assault care, and many emergency departments lack established protocols for treating sexual assault survivors, which can hinder effective care.

Sexual Assault Nurse Examiner programs are effective and preferred by survivors, who often benefit from a combination of medication and counseling, while issues like incomplete postexposure HIV prophylaxis and inconsistent offering of emergency contraception highlight gaps in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health care-based interventions for women who have experienced sexual violence: a review of the literature. Martin, SL., Young, SK., Billings, DL., et al.[2007]

The study developed a conceptual framework for managing PTSD in rape survivors in the North-West province, emphasizing the importance of PTSD assessment before any management interventions.

Utilizing Practice-Oriented Theory and Donabedian's Structure Process Outcome Model, the framework aims to improve the psychological management of rape survivors at Thuthuzela Care Centres and hospitals, addressing a significant gap in current healthcare practices in the region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptual Framework for Rape Survivors Diagnosed with PTSD in the North West Province of South Africa. Sepeng, NV., Makhado, TG., Makhado, L.[2023]

The study surveyed 303 sexual violence survivors and conducted interviews with 20 participants, revealing that most utilized multiple therapies, with psychotherapy being the most common (76.9%), followed by yoga (50.2%) and massage (32.1%).

On average, survivors delayed seeking therapy for over a decade, and the analysis identified three distinct groups based on therapy usage, highlighting the need for improved access and support for survivors in their healing journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"There Is No One Way to Get Over It": An Examination of Psychotherapy and Complementary Therapy Use Within a Sample of Survivors Who Experienced Sexual Violence. Weingarten, CA., Baker, CK., Einolf, CJ.[2023]

A trauma-informed healthcare approach is beneficial for patients who are survivors of abuse, as it recognizes and addresses their past experiences.

This type of care can lead to improved health outcomes by fostering a supportive environment that promotes healing and trust between the patient and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To Treat My Patient, I Had To Understand Her Trauma. Rittenberg, E.[2021]

A specialized outpatient program at a VA Medical Center, based on Herman's three-phased recovery model, effectively treats military sexual trauma (MST) survivors, as demonstrated in a case study of a female veteran.

Post-treatment, the veteran showed significant improvements in PTSD symptoms, quality of life, and socialization, indicating the program's potential efficacy for MST survivors with PTSD and related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evolving integrative treatment program for military sexual trauma (MST) and one veteran's experience. Ferdinand, LG., Kelly, UA., Skelton, K., et al.[2011]

The S2T (Survivor to Thriver) program, a group intervention for women survivors of childhood sexual abuse, facilitated resilience processes such as constructive rumination and coping strengths, indicating its potential as a healing method.

Participants reported significant posttraumatic growth outcomes, including a transformed life philosophy and a new identity as 'thrivers,' suggesting that the program may effectively support recovery and personal development after trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resilience enabling processes and posttraumatic growth outcomes in a group of women survivors of childhood sexual abuse. Walker-Williams, HJ., Fouché, A.[2022]

The THRIVE Clinic and PATH Collaborative are two citywide models providing trauma-informed healthcare to victims of human trafficking, serving 214 patients and receiving 560 referrals, respectively, highlighting the need for specialized health services for this vulnerable population.

Key strategies for effective intervention include conducting citywide needs assessments, employing patient navigators, fostering interdisciplinary care, and building community partnerships to address the comprehensive needs of trafficking victims, such as safe housing and medical-legal services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating a Collaborative Trauma-Informed Interdisciplinary Citywide Victim Services Model Focused on Health Care for Survivors of Human Trafficking. Jain, J., Bennett, M., Bailey, MD., et al.[2023]

A study of 837 sexual assault survivors at an academic hospital revealed that nearly 45% reported drug and/or alcohol use during the assault, highlighting a significant factor in the context of these incidents.

The analysis also found that 20.8% of survivors had a disability, emphasizing the need for tailored and sensitive care approaches for diverse survivor populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Descriptive Analysis of Sexual Assault Nurse Examiner Records From Sexual Assault Survivors at a Large University Emergency Department From 2003 to 2017. Cannon, LM., Bailey, JM., Ernst, SD., et al.[2021]

A pilot study involving five college women with rape-related PTSD showed that an online, therapist-facilitated cognitive behavioral program, called From Survivor to Thriver (S to T), led to clinically significant reductions in PTSD symptoms for four participants, who no longer met the criteria for PTSD after 7 weeks.

All participants experienced significant decreases in vulnerability fears and four reported reductions in negative trauma-related thoughts, suggesting that online treatment programs could be an effective alternative for helping distressed victims of sexual violence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Survivor to Thriver: A Pilot Study of an Online Program for Rape Victims. Littleton, H., Buck, K., Rosman, L., et al.[2021]

The Trauma Recovery and Empowerment Model (TREM) significantly reduced alcohol and drug abuse severity, anxiety symptoms, and current stressful events among 153 women trauma survivors over a 12-month period, compared to a control group of 98 women receiving standard services.

Participants in the TREM group reported increased feelings of personal safety, indicating that the intervention may enhance overall well-being, although it did not show significant differences in PTSD symptoms or quality of life compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Trauma Recovery and Empowerment Model: A Quasi-Experimental Effectiveness Study. Fallot, RD., McHugo, GJ., Harris, M., et al.[2016]

The EMPOWER Clinic in New York provides a model for integrated gynecologic and psychiatric care specifically designed for survivors of sex trafficking and sexual violence, addressing long-term health needs that are often overlooked by traditional acute care services.

Best practices from the EMPOWER Clinic emphasize trauma-sensitive medical care, including careful patient history taking, confidential examinations, and legal issue management, highlighting the importance of specialized clinics for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated, Trauma-Informed Care Model for Female Survivors of Sexual Violence: The Engage, Motivate, Protect, Organize, Self-Worth, Educate, Respect (EMPOWER) Clinic. Ades, V., Wu, SX., Rabinowitz, E., et al.[2021]

Adults with a history of sexual abuse experience significant long-term consequences that affect their emotional and physical health, as revealed through in-depth interviews with 12 participants.

Processing the trauma and disclosing the abuse can help alleviate some negative effects, highlighting the dental setting as a potential safe space for individuals to share their experiences, given that most people visit a dentist regularly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The self-perceived impact of sexual abuse on daily life and general health - an issue to consider in dental care. Wolf, E., Priebe, G.[2023]

Implementing trauma-informed practices in research with survivors of sexual violence can significantly enhance their experience and reduce the risk of retraumatization.

The THRIVE Study, a longitudinal case-control study, demonstrated that when researchers prioritize the needs of survivors, it leads to increased participation and improved quality of research outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement of Sexual Violence Survivors in Research: Trauma-Informed Research in the THRIVE Study. Anderson, KM., Karris, MY., DeSoto, AF., et al.[2023]

From 2006 to 2019, sexual assault-related emergency department visits in the US surged by over 1533%, rising from 3,607 to 55,296 visits, indicating a growing recognition of the need for medical care among survivors.

Younger, female, and lower-income individuals were more likely to seek emergency care after sexual assault, while older and Medicaid-insured patients had higher admission rates, suggesting targeted support strategies are needed for these vulnerable groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in US Emergency Department Use After Sexual Assault, 2006-2019. Vogt, EL., Jiang, C., Jenkins, Q., et al.[2022]

Citations

1. rainn.org rainn.org/help-and-healing/hotline/

RAINN's National Sexual Assault Hotline What To Expect When You Contact RAINN. Since 1994, RAINN's victim service programs have helped over 5 million survivors of sexual violence and their loved ones ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11138126/

A Systematic Review of Evidence-Based Treatments for ... Sexual assault (SA) is a serious crime that is a prevalent mental and public health problem. Addressing the needs of SA victims and providing appropriate ...

3. crimevictim.utah.gov crimevictim.utah.gov/wp-content/uploads/2021/04/Mental-Health-Treatments-for-Adolescent-and-Adult-Victims-of-Sexual-Assualt_MilesValentine_Oct2020-1.pdf

Mental-Health-Treatments-for-Adolescent-and-Adult-Victims ... Abstract. Background. Neurobiology of Trauma. Responses to Sexual Assault. Acute Stress Disorder (ASD) and Posttraumatic Stress Disorder (PTSD).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2323517/

Sexual assault and posttraumatic stress disorder: A review ... Sexual assault occurs with alarming frequency in Canada. The prevalence of Posttraumatic Stress Disorder (PTSD) in assault survivors is drastically higher.

5. ptsd.va.gov ptsd.va.gov/professional/treat/type/sexual_assault_adult.asp

Sexual Assault Experienced as an Adult - PTSD: National ... Description (for metadata and list page): Describes sexual assault, epidemiology, the cultural context that may impact the experience of survivors, and the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9326795/

Perceptions of Peer Support for Victim-Survivors of Sexual ... Experiences of sexual violence, childhood sexual abuse, and sexual assault are common across all societies. These experiences damage physical and mental ...

7. apa.org apa.org/monitor/2022/09/sexual-assault-patients

How to support patients who have experienced sexual ... Psychologists can help their patients navigate the complex contexts that survivors often face while attempting to cope with their assault.

8. wcasa.org wcasa.org/wp-content/uploads/2020/03/Evaluation_Outcome-Evaluation-Strategies-for-Sexual-Assault-Service-Programs_A-Practical-Guide.pdf

Outcome Evaluation Strategies for Sexual Assault Service ... She has presented on issues of sexual assault and counseling at numerous state conferences. She is the past president of the Southeast. Michigan Anti Rape ...