Recovery Processes for PTSD and Alcohol Use After Sexual Assault

Overseen By Michele A Bedard-Gilligan, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Benzodiazepines, Psychotropics

Disqualifiers: Schizophrenia, Bipolar, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

180 Participants Needed

Trial Summary

What is the purpose of this trial?

Sexual assault can lead to devastating consequences including the development of chronic conditions including posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD). Interventions delivered soon after exposure to assault can decrease the long-term negative consequences of sexual assault but existing interventions are limited in their ability to target concurrent PTSD symptoms and alcohol use and little is known about how to make best practice treatment decisions in the early period following sexual assault. A greater emphasis on transdiagnostic processes that are related to both PTSD and alcohol use, such as fear and reward systems, can elucidate mechanisms of recovery, lead to the development of more effective intervention approaches, and guide clinical decision making for patients recently exposed to sexual assault.

Will I have to stop taking my current medications?

The trial requires that you stop any current trauma-focused or substance use psychotherapy. If you are on psychotropic medications, your dose must have been stable for the past 3 months. If you are taking higher doses of benzodiazepines, you may need to adjust your dosage.

What data supports the effectiveness of the treatment for PTSD and alcohol use after sexual assault?

Research shows that early interventions, like the one being tested, can help reduce PTSD symptoms and have some effect on alcohol-related issues after a sexual assault. A study found that a brief intervention led to a large decrease in PTSD symptoms and was well-received by participants. ^{1 2 3 4 5}

Is exposure therapy safe for treating PTSD and alcohol use after sexual assault?

Exposure therapy, including imaginal exposure, has been shown to be safe in humans, with studies reporting no symptom worsening or dropouts among participants. This suggests that it is generally safe for treating PTSD, even in individuals with complex trauma histories. ^{3 4 6 7 8}

How is the treatment for PTSD and alcohol use after sexual assault different from other treatments?

This treatment is unique because it combines Alcohol Skills Training, Imaginal Exposure, and Supportive Telehealth, focusing on early intervention to prevent chronic PTSD and alcohol misuse. It includes a mix of in-person and telehealth sessions, making it accessible and potentially more engaging for patients who might not seek traditional therapy. ^{2 3 4 8 9}

Research Team

Michele A Bedard-Gilligan, PhD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for women aged 18-65 who have experienced a sexual assault within the last year and are dealing with heavy alcohol use and PTSD. Participants must have internet access, a webcam, and a certain level of PTSD severity. Those on high doses of benzodiazepines or with severe mental health conditions like schizophrenia or bipolar disorder cannot join.

Inclusion Criteria

I am between 18 and 65 years old.

You have consumed a large amount of alcohol (4 or more drinks on one occasion) at least twice in the past month.

I identify as female.

Exclusion Criteria

I am currently diagnosed with severe depression or bipolar disorder.

You are currently in a relationship with the person who committed the most recent assault against you.

You do not remember the traumatic event clearly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo interventions targeting PTSD and alcohol use, including imaginal exposure and alcohol skills training

6-8 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Supportive Counseling/Telehealth

Internet-based intervention focusing on providing support

4 weeks

Treatment Details

Interventions

• Alcohol Skills Training
• Imaginal Exposure
• Supportive Telehealth

Trial Overview The study tests how supportive telehealth, alcohol skills training, and imaginal exposure can help recovery from PTSD and reduce alcohol use after sexual assault. It aims to understand early treatment decisions that affect both fear and reward systems related to these conditions.

Participant Groups

Group I: Imaginal Exposure First, then Alcohol Skills Experimental Treatment 2 Interventions

Imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. After imaginal exposure, alcohol skills targeting alcohol misuse after sexual assault.

Group II: Imaginal Exposure First, no additional treatment Experimental Treatment 1 Intervention

Imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. No additional treatment.

Group III: Alcohol Skills First, then Imaginal Exposure Experimental Treatment 2 Interventions

Alcohol skills targeting alcohol misuse after sexual assault. After alcohol skills training, imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault.

Group IV: Alcohol Skills First, no additional treatment Experimental Treatment 1 Intervention

Alcohol skills targeting alcohol misuse after sexual assault only. No additional treatment.

Group V: Supportive Counseling/Telehealth Active Control 1 Intervention

Internet-based intervention focusing on providing support.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

A study involving 11 adults with PTSD showed that exposure therapy delivered via videoconferencing is feasible, with 7 participants completing 12 to 15 sessions and reporting significant reductions in PTSD and depressive symptoms.

Participants experienced high satisfaction with the telehealth format, and there were no significant safety issues or clinical emergencies, indicating that telehealth could be a viable option for increasing access to PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of a Telehealth-Delivered Medication-Augmented Exposure Therapy Protocol for PTSD. Olden, M., Wyka, K., Cukor, J., et al.[2018]

A brief intervention developed for women who recently experienced sexual assault showed promising results, with significant reductions in PTSD symptoms after treatment in a small open trial of 6 participants.

While the intervention was well-received and completed by all participants, it had a mixed effect on alcohol use, with a slight increase in weekly alcohol consumption despite some reduction in alcohol-related consequences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refinement and Pilot Testing of a Brief, Early Intervention for PTSD and Alcohol Use Following Sexual Assault. Bedard-Gilligan, M., Masters, NT., Ojalehto, H., et al.[2021]

The study proposes a novel intervention called STEPS, which integrates Written Exposure Therapy for PTSD and Cognitive Behavioral Therapy for AUD, aimed at recent sexual assault survivors, and will be tested in a pilot randomized controlled trial with 54 participants.

This intervention is designed to be initiated within six weeks post-assault, addressing the urgent need for integrated treatments that can reduce both PTSD and AUD symptoms, potentially improving outcomes for this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early intervention using written exposure therapy for PTSD and AUD symptoms following sexual assault: Description of design and methodology. Hahn, CK., Kilimnik, CD., Brady, KT., et al.[2023]

The THRIVE app, combined with phone coaching, significantly reduced symptoms of posttraumatic stress disorder (PTSD) and alcohol misuse among 41 female survivors of recent sexual assault over a 3-month follow-up period.

Participants using the THRIVE app showed greater improvements in PTSD and alcohol-related issues compared to those using a symptom-monitoring app, suggesting that app-based interventions can effectively support early recovery for sexual assault survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized clinical trial of an app-based early intervention to reduce PTSD and alcohol use following sexual assault. Dworkin, ER., Schallert, M., Lee, CM., et al.[2023]

Cognitive Processing Therapy-Cognitive only version (CPT-C) delivered via videoteleconferencing (VTC) was found to be as effective as in-person treatment for veterans with PTSD, with significant reductions in PTSD symptoms observed immediately after treatment and maintained at 3 and 6 months follow-up.

The study, which included 125 veterans over 12 sessions, demonstrated high levels of therapeutic alliance and satisfaction, indicating that VTC can effectively increase access to mental health care for those in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for posttraumatic stress disorder delivered to rural veterans via telemental health: a randomized noninferiority clinical trial. Morland, LA., Mackintosh, MA., Greene, CJ., et al.[2022]

An intensive exposure treatment program for PTSD, involving 30 hours of therapy over 5 days, showed substantial symptom reduction in four patients with complex trauma histories and high comorbidity, achieving large effect sizes (Cohen's d of 1.5 to 2.4).

None of the patients experienced worsening symptoms or dropped out of the program, indicating that this intensified approach may be a viable option for those who do not respond to standard trauma-focused treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of brief intensive exposure therapy for PTSD patients with childhood sexual abuse: a brief clinical report. Hendriks, L., de Kleine, R., van Rees, M., et al.[2021]

A randomized controlled trial will assess the effectiveness of online written exposure therapy compared to imaginal exposure therapy for 300 Veterans with PTSD, aiming to improve access to care.

The study will evaluate whether written exposure therapy is as effective as imaginal exposure while also exploring factors that may influence treatment outcomes, such as trauma-related thoughts and emotion regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans. McLean, CP., Miller, ML., Gengler, R., et al.[2021]

In a study of 110 veterans undergoing treatment for comorbid PTSD and alcohol use disorder, increased alcohol consumption during therapy was linked to a significantly higher risk of dropping out, particularly in those receiving integrated exposure therapy.

Specifically, for each additional drink consumed per day, the risk of dropout increased fivefold, highlighting the importance of monitoring alcohol use as a potential marker for patient retention in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. Kline, AC., Panza, KE., Harlé, KM., et al.[2023]

The THRIVE mobile health intervention, designed for recent survivors of sexual assault, demonstrated feasibility with high engagement rates: 95% of participants completed at least one cognitive behavioral exercise, and 80% attended all coaching calls over a 21-day period.

Participants rated THRIVE highly in terms of usability and satisfaction, with 94% finding the app moderately to very helpful, indicating that it is an acceptable tool for addressing posttraumatic stress and alcohol misuse in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Early Intervention to Reduce Posttraumatic Stress and Alcohol Use After Sexual Assault (THRIVE): Feasibility and Acceptability Results From a Pilot Trial. Dworkin, ER., Schallert, M., Lee, CM., et al.[2023]

References

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

Pilot Study of a Telehealth-Delivered Medication-Augmented Exposure Therapy Protocol for PTSD. [2018]

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

Refinement and Pilot Testing of a Brief, Early Intervention for PTSD and Alcohol Use Following Sexual Assault. [2021]

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

Early intervention using written exposure therapy for PTSD and AUD symptoms following sexual assault: Description of design and methodology. [2023]

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

Pilot randomized clinical trial of an app-based early intervention to reduce PTSD and alcohol use following sexual assault. [2023]

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

Cognitive processing therapy for posttraumatic stress disorder delivered to rural veterans via telemental health: a randomized noninferiority clinical trial. [2022]

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

Feasibility of brief intensive exposure therapy for PTSD patients with childhood sexual abuse: a brief clinical report. [2021]

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

The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans. [2021]

8. Ireland pubmed.ncbi.nlm.nih.gov

Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

mHealth Early Intervention to Reduce Posttraumatic Stress and Alcohol Use After Sexual Assault (THRIVE): Feasibility and Acceptability Results From a Pilot Trial. [2023]