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

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{11 12 13 14 15}

Eligibility 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

Exclusion Criteria

Suicide risk on the Beck Depression Inventory

Screen positive on the Alcohol Use Withdrawal Checklist.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

From Survivor to Thriver: A Pilot Study of an Online Program for Rape Victims. [2021]

2. England pubmed.ncbi.nlm.nih.gov

An evolving integrative treatment program for military sexual trauma (MST) and one veteran's experience. [2011]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Conceptual Framework for Rape Survivors Diagnosed with PTSD in the North West Province of South Africa. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Trauma Recovery and Empowerment Model: A Quasi-Experimental Effectiveness Study. [2016]

5. South Africa pubmed.ncbi.nlm.nih.gov

Resilience enabling processes and posttraumatic growth outcomes in a group of women survivors of childhood sexual abuse. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Trends in US Emergency Department Use After Sexual Assault, 2006-2019. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Engagement of Sexual Violence Survivors in Research: Trauma-Informed Research in the THRIVE Study. [2023]

9. United States 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Health care-based interventions for women who have experienced sexual violence: a review of the literature. [2007]

11. United States 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. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Creating a Collaborative Trauma-Informed Interdisciplinary Citywide Victim Services Model Focused on Health Care for Survivors of Human Trafficking. [2023]

13. United States 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. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

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

15. Denmark 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. [2023]