Clinical trial NCT04124380: Understanding and Testing Recovery Processes for PTSD and Alcohol Use Following Sexual Assault
Official title: Understanding and Testing Recovery Processes for PTSD and Alcohol Use Following Sexual Assault
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol; Use, Problem
Posttraumatic Stress Disorder
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-10-11
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Following sexual assault, many individuals will develop chronic problems including posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD). Intervention provided soon after assault can decrease the risk of developing chronic psychopathology and associated negative consequences. Interventions that address common underlying mechanisms of PTSD and alcohol use, such as fear and reward systems, have strong potential utility as efficacious and accessible interventions for clinicians treating patients recently exposed to sexual assault. This proposal is designed to test fear and reward as crucial processes underlying recovery following sexual assault and elucidate the most efficacious treatment targets. Employing experimental tasks (safety-signal learning paradigm and probabilistic reward task) to capture baseline underlying vulnerabilities in fear and reward systems respectively will allow for exploration of how these processes impact recovery. A randomized clinical trial (N = 180) will be conducted to test efficacy of intervention approaches that target PTSD or alcohol use compared to supportive telehealth. In addition, a phased study design will allow for exploration of efficacy of primary and secondary intervention approaches to test the questions of 1) whether it is more efficacious to target PTSD or alcohol use first; and 2) whether it is necessary to target both PTSD and alcohol use to facilitate recovery or if one is sufficient. This proposal is significant in exploring transdiagnostic mechanisms implicated in recovery following sexual assault, fear and reward, and using a novel design to compare efficacy, ordering, and necessity of two distinct intervention approaches.

Eligibility criteria: Inclusion Criteria:

1. Identifies as female.
2. Between the age of 18 and 65.
3. Reports a sexual assault in the last 4 weeks to 1 year.
4. Current PTSD severity of 23+ on the PSS-I-5.
5. Current heavy alcohol use (2+ heavy episodic drinking occasions \[4+ drinks on one occasion\] in past month).
6. Access to the internet and a device with a webcam.

Exclusion Criteria:

1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-5.
2. Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
3. Unwilling or unable to discontinue current trauma-focused psychotherapy or current substance use psychotherapy.
4. Unstable dose of psychotropic medications in the prior 3 months.
5. Ongoing intimate relationship with the perpetrator of most recent assault.
6. Current diagnosis of a severe substance use disorder according to DSM-5, other than alcohol in the last month.
7. No clear trauma memory.
8. Current higher dose use of benzodiazepines (greater than the equivalent of 4 mg of lorazepam, 2 mg alprazolam, 1.5 mg clonazepam, or 20 mg of diazepam).

Primary outcomes:
measure: Alcohol Use Interview
timeFrame: Past month
measure: Alcohol Use Self-Report
timeFrame: Past month
measure: Posttraumatic Stress Disorder Severity (PTSD) Interview
timeFrame: Past two weeks
measure: Posttraumatic Stress Disorder Severity (PTSD) Self-Report
timeFrame: Past two weeks
Secondary outcomes:
measure: Psychosocial Functioning
timeFrame: Past two weeks
measure: Quality of Life Functioning
timeFrame: Past two weeks
measure: Alcohol Cravings
timeFrame: Past week
measure: Alcohol Consequences
timeFrame: Past week
measure: Depression Self-Report
timeFrame: Past week
measure: Depression Interview
timeFrame: Past week
measure: Reward
timeFrame: Past week
measure: Fear
timeFrame: Past week
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Michele Bedard-Gilligan, PhD
role: PRINCIPAL_INVESTIGATOR
References: