AWARE Program for Survivors of Sexual Trauma
(AWARE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Lifespan
Disqualifiers: Suicide risk, Alcohol withdrawal, others
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization. The main questions it aims to answer are: 1) what is the feasibility of the recruitment method, research design, interventionist training methods, and delivery of the intervention; 2) does the intervention, relatively to control, the 2- and 6-month follow-up produces reductions in the quantity/frequency of alcohol use and heavy drinking, sexual distress, and sex-related drinking motives, and sexual revictimization. Participants will engage in both individual and group based intervention for alcohol use, sexual distress, and sexual assault risk. Follow-up assessments are completed at 2- and 6-months following program completion. The intervention will be compared to a general health promotion control group.
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 data supports the effectiveness of the AWARE treatment for survivors of sexual trauma?
Research on similar programs, like the 'From Survivor to Thriver' online program, shows that structured, therapist-facilitated interventions can significantly reduce PTSD symptoms and improve mental health in sexual trauma survivors. Additionally, the Trauma Recovery and Empowerment Model has been effective in helping women trauma survivors, suggesting that group interventions can be beneficial.
12345Is the AWARE Program for Survivors of Sexual Trauma safe for participants?
The research does not provide specific safety data for the AWARE Program or similar interventions like General Health Promotion or Health Promotion Intervention. However, trauma-informed care, which is a related approach, is generally considered safe and beneficial for survivors of sexual trauma, as it focuses on minimizing distress and maximizing autonomy.
678910How does the AWARE treatment for survivors of sexual trauma differ from other treatments?
The AWARE treatment is unique because it likely incorporates a trauma-informed care approach, focusing on long-term recovery and addressing both physical and psychological needs, unlike many existing services that primarily provide immediate acute care after the trauma.
1112131415Eligibility Criteria
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
+3 more
Exclusion Criteria
Suicide risk on the Beck Depression Inventory
Screen positive on the Alcohol Use Withdrawal Checklist.
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AWARE ProgramExperimental Treatment1 Intervention
The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.
Group II: General Health PromotionPlacebo Group1 Intervention
The General Health Promotion program is a attention and dose-matched comparison condition.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rhode Island HospitalProvidence, RI
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Who Is Running the Clinical Trial?
LifespanLead Sponsor
References
From Survivor to Thriver: A Pilot Study of an Online Program for Rape Victims. [2021]Approximately 15% to 20% of women have been victims of rape and close to a third report current rape-related PTSD or clinically significant depression or anxiety. Unfortunately, very few distressed rape victims seek formal help. This suggests a need to develop alternative ways to assist the many distressed victims of sexual violence. Online treatment programs represent a potentially important alternative strategy for reaching such individuals. The current paper describes a pilot evaluation of an online, therapist-facilitated, self-paced cognitive behavioral program for rape victims. Five college women with current rape-related PTSD were recruited to complete the From Survivor to Thriver (S to T) program in a lab setting over the course of 7 weeks. After completing the program, 4 participants reported clinically significant reductions in PTSD symptoms and no longer met criteria for PTSD. All participants reported clinically significant reductions in vulnerability fears and 4 reported significant reductions in negative trauma-related cognitions. Implications of the results for further development of the S to T program and how clinicians could utilize this program in treating rape-related PTSD are discussed.
An evolving integrative treatment program for military sexual trauma (MST) and one veteran's experience. [2011]Military sexual trauma (MST) increases the risk for Posttraumatic Stress Disorder (PTSD) and multiple other comorbidities, presenting substantial challenges for nurses and psychiatric and medical clinicians. A specialized VA Medical Center outpatient program is patterned after Herman's three-phased, empirically-supported, recovery treatments. We use a case example of a female veteran MST survivor to illustrate our treatment model. She presented to our program meeting diagnostic criteria for PTSD, Major Depressive Disorder, and a history of substance abuse. Post-treatment she demonstrated improved scores on measures of PTSD, quality of life, and socialization. This model shows promise for treatment of MST survivors with PTSD.
Conceptual Framework for Rape Survivors Diagnosed with PTSD in the North West Province of South Africa. [2023]The lack of a conceptual framework that can be utilized to manage rape survivors diagnosed with Post-Traumatic Stress Disorders presents a challenge in the North-West province. The study aims to provide a conceptual framework for managing rape survivors with PTSD in the province of the North-West using Practice-Oriented Theory and Donabedian's Structure Process Outcome Model Features. The research was conducted using an explanatory, sequential and mixed-methods approach. Additionally, used was the descriptive and explorative programme evaluation design. The results of the study demonstrated the significance of PTSD assessment before management interventions for rape survivors. The study findings outlined and designed a framework to assess and manage PTSD among rape survivors consulting at Thuthuzela Care Centre and those referred to hospitals for further management. The Practice-Oriented theory by Dickoff, James and Wiedenbach, and the Structure Process Outcome model by Donabedian served as points of reference for the development of the conceptual framework. The study is limited to North-West provincial healthcare facilities and Thuthuzela care centres (TCCs), however, it highlights the lack of a conceptual framework pertaining to the psychological management of PTSD rape survivors in the province and South Africa.
The Trauma Recovery and Empowerment Model: A Quasi-Experimental Effectiveness Study. [2016]A quasi-experimental study tested the effectiveness of the Trauma Recovery and Empowerment Model (TREM), a group intervention for women trauma survivors, in comparison to services as usual.
Resilience enabling processes and posttraumatic growth outcomes in a group of women survivors of childhood sexual abuse. [2022]This study forms part of a pilot project, aiming to evaluate the benefits of a programme entitled S2T denoting from Survivor to Thriver, which is a collaborative strengths-based group intervention programme for women survivors of childhood sexual abuse. The objective of the S2T is to enable resilience processes and facilitate posttraumatic growth outcomes. A theory of change was developed to explain how these objectives are met, it outlines the theoretical approach, mediators, primary and secondary outcomes.
A synthesis of the literature on trauma-informed care. [2017]Patients with a history of traumatic life events can become distressed or re-traumatized as the result of healthcare experiences. These patients can benefit from trauma-informed care that is sensitive to their unique needs. However, despite the widespread prevalence of traumatic life experiences such as sexual assault and intimate partner violence, trauma-informed care has not been widely researched or implemented. The purpose of this synthesis of the literature is to examine existing research on trauma-informed care for survivors of physical and sexual abuse. The following themes are discussed: trauma screening and patient disclosure, provider-patient relationships, minimizing distress and maximizing autonomy, multidisciplinary collaboration and referrals, and trauma-informed care in diverse settings. This synthesis also explores implications for trauma-informed care research, practice and policy. The themes identified here could be used as a framework for creating provider and survivor educational interventions and for implementing trauma-informed care across disciplines. The findings of this synthesis support further research on patient and provider experiences of trauma-informed care, and research to test the efficacy of trauma-informed care interventions across healthcare settings. Universal implementation of trauma-informed care can ensure that the unique needs of trauma survivors as patients are met, and mitigate barriers to care and health disparities experienced by this vulnerable population.
Trends in US Emergency Department Use After Sexual Assault, 2006-2019. [2022]Adult sexual assault (SA) survivors experience numerous emergent health problems, yet few seek emergency medical care. Quantifying the number and types of survivors presenting to US emergency departments (EDs) after SA can inform health care delivery strategies to reduce survivor morbidity and mortality.
Engagement of Sexual Violence Survivors in Research: Trauma-Informed Research in the THRIVE Study. [2023]Given the potential for retraumatization among survivors of sexual violence engaged in research, we aimed to provide pertinent knowledge and exemplification of the integration of trauma-informed practice to research with survivors. Grounded in trauma-informed care, we discuss the need for trauma-informed research, drawing upon experiences and data from a longitudinal case-control study on sexual violence. Through trauma-informed research settings, we can improve research experiences for survivors of sexual violence, as demonstrated by positive experiences of participants in The THRIVE Study. By meeting the needs of survivors, researchers can increase participation while maximizing the research quality and advancement of research.
A Retrospective Descriptive Analysis of Sexual Assault Nurse Examiner Records From Sexual Assault Survivors at a Large University Emergency Department From 2003 to 2017. [2021]This retrospective descriptive analysis of 837 patients seeking postassault care at an academic hospital in the United States describes characteristics of sexual assault survivors from a sociocultural context, with a specific focus on describing survivors presenting for sexual assault nurse examiner (SANE) exams and confirming existing literature on assault characteristics, such as disabilities and alcohol and/or drug use. Assaults resulting in SANE exams increased over time. Drug and/or alcohol use at the time of the assault was reported in 44.8% of cases and 20.8% of survivors reported having a disability. Understanding the demographic and sexual assault characteristics of survivors is fundamental to providing sensitive and responsive care.
Health care-based interventions for women who have experienced sexual violence: a review of the literature. [2007]Thirty publications that evaluated health care-based interventions for women who experienced sexual violence were reviewed. The findings highlight that clinicians often need training in the provision sexual assault care, and that not all emergency departments have sexual assault care protocols. Studies examining effectiveness found that Sexual Assault Nurse Examiner programs are very helpful, that health care-based sexual assault treatment settings attract more women than do forensic-based settings, that sexual assault survivors often prefer a combination of medication and counseling treatment, and that preexam administration of a video explaining the collection of forensic evidence may reduce women's stress during the procedure. Studies on postexposure HIV prophylaxis found that many women did not complete the treatment regimen, often because of side effects. Emergency contraception to prevent postrape pregnancy is not consistently offered to women. Only one study reported on abortion as part of the range of sexual assault services.
An Integrated, Trauma-Informed Care Model for Female Survivors of Sexual Violence: The Engage, Motivate, Protect, Organize, Self-Worth, Educate, Respect (EMPOWER) Clinic. [2021]This article describes the Engage, Motivate, Protect, Organize, self-Worth, Educate, Respect (EMPOWER) Clinic for Survivors of Sex Trafficking and Sexual Violence located at Gouverneur Health in New York, New York, as a model for integrated gynecologic and psychiatric care of survivors of sexual and gender-based violence. Although patients with a history of sexual trauma often have critical health needs that persist long after the traumatic event, most existing services for survivors of sexual violence focus solely on the provision of acute care immediately after the violence has occurred. There are very few clinics in the United States dedicated to managing the significant long-term medical consequences and sequelae of sexual violence in a trauma-informed setting. We report on best practices for the provision of trauma-sensitive medical care to this patient population based on those employed at the EMPOWER Clinic. In particular, we outline some of the unique considerations for treating survivors relating to taking a patient history, conducting the physical and gynecologic examinations, ensuring confidentiality, and managing legal issues. Finally, we reflect on the challenges faced in sustaining the EMPOWER Clinic and the importance of the existence of a clinic dedicated to this specific population.
Creating a Collaborative Trauma-Informed Interdisciplinary Citywide Victim Services Model Focused on Health Care for Survivors of Human Trafficking. [2023]Although human trafficking is recognized as a public health issue, research on the health effects of human trafficking and best intervention practices is limited. We describe 2 citywide collaborative victim services models, the THRIVE (Trafficking, Healthcare, Resources, and Interdisciplinary Victim Services and Education) Clinic at the University of Miami and Jackson Health System in Miami, Florida, and the Greater Houston Area Pathways for Advocacy-based, Trauma-Informed Healthcare (PATH) Collaborative at Baylor College of Medicine, CommonSpirit Health, and San Jose Clinic in Houston, Texas, funded in part by the Office for Victims of Crime, which focus on trauma-informed health care delivery for victims of human trafficking. From June 2015 through September 2021, the THRIVE Clinic served 214 patients with an average age of 28.7 years at the time of their first visit. From October 2017 through September 2021, the PATH Collaborative received 560 suspected trafficking referrals, 400 of which screened positive for labor or sex trafficking. These models serve as a framework for replication of interdisciplinary practices to provide health care for this unique population and preliminary information about the strategies put in place to assist victims during their recovery. Key lessons include the importance of a citywide needs assessment, patient navigators, interdisciplinary care, and building community partnerships to ensure safe housing, transportation, identification, health insurance, vocation services, input from survivors, peer-to-peer mentorship, and medical-legal services. Further research is needed to understand the detrimental health effects of trafficking and the health care needs of victims. In addition, a need exists to develop optimal models of care for recovery and reintegration for this patient population and to address public health, legal, and medical policies to ensure access to and sustainability of comprehensive, trauma-informed, interdisciplinary victim services.
"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. [2023]Literature on sexual violence survivors' service utilization is limited due to examination of singular therapies or narrow timeframes. Using surveys (n = 303) and interviews (n = 20), this study increases understanding of survivors' healing. Results show varied therapy use including psychotherapy (76.9%), yoga (50.2%), and massage (32.1%), among others. Mean number of therapies used was over three. Service utilization was delayed over a decade on average. Latent class analysis divided respondents into classes: psychotherapy and bodywork use (42.66%), high therapy use (9.14%), and minimal therapy use (48.20%). Interviews provide additional insight and describe barriers. Recommendations for policy, practice, and future research are discussed.
To Treat My Patient, I Had To Understand Her Trauma. [2021]A patient who is a survivor of abuse benefits from a health care approach that acknowledges her past trauma.
The self-perceived impact of sexual abuse on daily life and general health - an issue to consider in dental care. [2023]To analyse, from the perspective of adults with a history of sexual abuse, the impact of the experience on their general health and well-being.