Recovery Processes for PTSD and Alcohol Use After Sexual Assault
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Must not be taking: Benzodiazepines, Psychotropics
Disqualifiers: Schizophrenia, Bipolar, Severe depression, others
No Placebo Group
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.
12345Is 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.
34678How 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.
23489Eligibility 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.
+3 more
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.
+5 more
Trial 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
Participant Groups
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.
5Treatment groups
Experimental Treatment
Active Control
Group I: Imaginal Exposure First, then Alcohol SkillsExperimental Treatment2 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 treatmentExperimental Treatment1 Intervention
Imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. No additional treatment.
Group III: Alcohol Skills First, then Imaginal ExposureExperimental Treatment2 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 treatmentExperimental Treatment1 Intervention
Alcohol skills targeting alcohol misuse after sexual assault only. No additional treatment.
Group V: Supportive Counseling/TelehealthActive Control1 Intervention
Internet-based intervention focusing on providing support.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WashingtonSeattle, WA
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Pilot Study of a Telehealth-Delivered Medication-Augmented Exposure Therapy Protocol for PTSD. [2018]Posttraumatic stress disorder (PTSD) is a serious condition, with certain occupations at increased risk due to greater trauma exposure. These same individuals face multiple barriers to care. This study aimed to investigate the feasibility of conducting a research trial with exposure therapy delivered via videoconferencing. Eleven adults working in occupations at risk with PTSD enrolled and seven completed 12 to 15 sessions. Individuals were randomized to receive the cognitive enhancer D-cycloserine or placebo, and participants provided saliva samples for genetic analysis. Treatment completers demonstrated decreases in PTSD and depressive symptomatology (measured by CAPS [p
Refinement and Pilot Testing of a Brief, Early Intervention for PTSD and Alcohol Use Following Sexual Assault. [2021]Experiencing a sexual assault can have long-lasting negative consequences including development of posttraumatic stress disorder (PTSD) and alcohol misuse. Intervention provided in the initial weeks following assault can reduce the development of these chronic problems. This study describes the iterative treatment development process for refining a brief intervention targeting PTSD and alcohol misuse for women with recent sexual assault experiences. Experts, treatment providers, and patients provided feedback on the intervention materials and guided the refinement process. Based on principles of cognitive change, the final intervention consists of one in-person session and four coaching calls targeting beliefs about the assault and about drinking behavior. Initial feasibility and acceptability data are presented for patients enrolled in an open trial (N = 6). The intervention was rated as helpful, not distressing, and interesting by patients and all patients completed the entire treatment protocol. A large decrease in PTSD symptoms pre- to post-intervention was observed. A small effect on decreasing alcohol consequences also emerged, although drinks consumed per week showed a slight increase, not a decrease, over the course of the intervention. Applications of this intervention and next steps for testing efficacy are presented.
Early intervention using written exposure therapy for PTSD and AUD symptoms following sexual assault: Description of design and methodology. [2023]The co-occurrence of posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) is common following sexual assault and associated with more severe symptomology and increased likelihood of sexual revictimization. Integrated interventions aimed at reducing PTSD and AUD symptoms following recent sexual assault are needed and should address barriers to care and early treatment termination. The proposed study will test a novel, brief (5 to 7 sessions) intervention that integrates Written Exposure Therapy for PTSD and Cognitive Behavioral Therapy for AUD, and is initiated within the first six weeks post-assault. In Phase 1, qualitative analysis of content gathered during focus groups with treatment providers will be conducted to inform intervention development. In Phase 2, a proof-of-concept pilot study (n = 10) of the intervention, Substance Use Skills Training and Exposure Post-Sexual Assault (STEPS), will be conducted. In Phase 3, a pilot randomized controlled trial (RCT) among 54 recent sexual assault survivors will be implemented using the updated manualized STEPS intervention to evaluate feasibility and preliminary efficacy in reducing PTSD and AUD symptoms. Ecological momentary assessments will be used to assess daily alcohol use, craving, affect, intrusions and avoidance. The effects of STEPS on commonly associated symptoms (e.g., depression, substance use) will be examined. The proposed study has the potential to make a significant public health impact by advancing knowledge on the link between sexual assault and co-occurring PTSD and AUD and informing early intervention efforts for this high-risk population.
Pilot randomized clinical trial of an app-based early intervention to reduce PTSD and alcohol use following sexual assault. [2023]Sexual assault is associated with high risk for posttraumatic stress disorder (PTSD), and PTSD often co-occurs with alcohol misuse. Most sexual assault survivors do not access early preventative interventions for such conditions. App-based interventions are a promising means to extend the reach of early interventions and thereby reduce risk of chronic PTSD and alcohol misuse.
Cognitive processing therapy for posttraumatic stress disorder delivered to rural veterans via telemental health: a randomized noninferiority clinical trial. [2022]To compare clinical and process outcomes of cognitive processing therapy-cognitive only version (CPT-C) delivered via videoteleconferencing (VTC) to in-person in a rural, ethnically diverse sample of veterans with posttraumatic stress disorder (PTSD).
Feasibility of brief intensive exposure therapy for PTSD patients with childhood sexual abuse: a brief clinical report. [2021]Despite the strong empirical support for the effectiveness of exposure-based treatments in ameliorating post-traumatic stress disorder (PTSD), improvement of treatment is wanted given relatively high dropout rates and challenges of treating patients with high comorbidity and treatment-interfering stressors. The purpose of the current paper is to introduce an intensive exposure treatment program, illustrated by four case descriptions of PTSD patients, who suffered multiple (sexual) traumas in childhood, had high levels of comorbidity and psychosocial stressors, and failed to improve during "regular" trauma-focused treatment programs. The program consisted of psychoeducation, prolonged imaginal exposure, exposure in vivo, exposure by drawings combined with narrative reconstructing, and writing assignments about central trauma-related cognitions. The treatment included 5 working days with individual sessions (in total 30 h of treatment) provided by a team of four therapists. The PTSD symptoms of all patients decreased substantially and the effect sizes were large (Cohen's d resp. 1.5 [pre-post], 2.4 [pre-FU1 month], and 2.3 [pre-FU3 months]). Also, none of the patients showed symptom worsening or dropped out. The evaluation of these four pilot cases suggests that it is possible to intensify exposure treatment, even for multiple traumatized PTSD patients with high comorbidity. We concluded that the first results of this new, intensive exposure program for PTSD patients with childhood sexual abuse are promising.
The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans. [2021]Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD). This paper describes the rationale for and methods of a randomized controlled trial comparing the efficacy and efficiency of written exposure therapy versus imaginal exposure for PTSD delivered in a novel online and variable length format. Participants will be 300 Veterans seeking treatment for clinically significant symptoms of PTSD. Participants will be randomly assigned to either written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8 online therapy sessions facilitated by trained peer support specialists. Treatment is terminated before session 8 if the PTSD symptom improvement criterion is met. Assessments will be conducted at baseline, post-treatment, and at 3-month follow-up. The primary hypotheses are that written exposure therapy will be noninferior to imaginal exposure with respect to treatment efficacy and efficiency. Secondary hypotheses relate to identifying and comparing potential mediators of PTSD treatment outcome, including trauma-related cognitions and emotion regulation.
Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. [2023]Integrated interventions for comorbid posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) are effective, but many patients prematurely drop out from treatment. Little is known about within-treatment risk factors for dropout, limiting the ability during therapy to identify patients at risk for attrition.
mHealth Early Intervention to Reduce Posttraumatic Stress and Alcohol Use After Sexual Assault (THRIVE): Feasibility and Acceptability Results From a Pilot Trial. [2023]Sexual assault is associated with increased risk for both posttraumatic stress (PTS) and alcohol misuse. Mobile health interventions have shown promise in addressing PTS and substance use in trauma survivors and might be a promising strategy in extending the reach of early interventions to individuals who have recently experienced trauma.