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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines ways to help women recover from PTSD and alcohol problems following sexual assault. The study tests various treatment combinations, including imaginal exposure (focusing on the memory to reduce PTSD symptoms), alcohol skills training (to manage and reduce alcohol use), and supportive telehealth sessions. Women who have experienced sexual assault in the past year and are dealing with both PTSD and heavy drinking may be suitable candidates. The researchers aim to identify the most effective recovery support by understanding key processes like fear and reward systems. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new recovery strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that imaginal exposure therapy, a type of cognitive-behavioral therapy, is safe and promising for treating posttraumatic stress. This therapy guides patients in facing and working through memories of traumatic events. Studies have found it to be a well-tolerated treatment for PTSD symptoms.

For alcohol skills training, evidence indicates it effectively helps people at risk of developing alcohol problems. This program teaches ways to manage and reduce drinking. It is considered safe and has shown positive results in lowering alcohol misuse among participants.

Both treatments are generally well-tolerated, and participants in past studies have not reported major safety concerns. This suggests these methods can be safely used to help those dealing with PTSD and alcohol use issues after traumatic events like sexual assault. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for PTSD and alcohol use after sexual assault because they offer innovative approaches compared to traditional therapies. Imaginal Exposure targets PTSD by helping individuals safely confront traumatic memories, potentially offering a more direct and personalized therapy option. Alcohol Skills Training specifically addresses alcohol misuse, aiming to equip individuals with practical strategies to manage and reduce consumption effectively. Furthermore, the use of supportive telehealth provides accessible, remote support, making it easier for participants to receive help regardless of location. These methods stand out by combining psychological and behavioral interventions in a structured manner, which could lead to more comprehensive and effective recovery strategies.

What evidence suggests that this trial's treatments could be effective for PTSD and alcohol use after sexual assault?

Studies have shown that imaginal exposure therapy can help people with PTSD (posttraumatic stress disorder) after a sexual assault. This therapy involves safely revisiting traumatic memories, gradually reducing symptoms. Research also suggests that alcohol skills training, which teaches ways to manage drinking, can effectively reduce alcohol misuse after traumatic events. In this trial, some participants will first receive imaginal exposure therapy followed by alcohol skills training, while others will start with alcohol skills training followed by imaginal exposure therapy. Additionally, some participants will receive supportive telehealth, and others will receive either imaginal exposure or alcohol skills training alone. Initial studies indicate that combining both treatments could offer a more complete recovery process for survivors. ^{2 6 7 8 9}

Who Is on the Research Team?

Michele A Bedard-Gilligan, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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

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.

You have experienced sexual assault within the past year.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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