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Recovery Processes for PTSD and Alcohol Use After Sexual Assault
N/A
Recruiting
Led By Michele Bedard-Gilligan, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the age of 18 and 65.
Identifies as female.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up past month
Awards & highlights
Study Summary
This trial will focus on understanding how to better treat people who have recently experienced sexual assault, in order to mitigate any long-term effects.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed for this psychological intervention trial, participants may experience discomfort discussing traumatic events or changes in their drinking habits during the course of therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I identify as female.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ past month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~past month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alcohol Use Interview
Alcohol Use Self-Report
Posttraumatic Stress Disorder Severity (PTSD) Interview
+1 moreSecondary outcome measures
Alcohol Consequences
Alcohol Cravings
Depression Interview
+5 moreTrial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imaginal Exposure
2017
N/A
~40
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,758 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
800 Previous Clinical Trials
1,362,817 Total Patients Enrolled
Michele Bedard-Gilligan, PhDPrincipal Investigator - University of Washington
University of Washington
1 Previous Clinical Trials
63 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.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.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.I cannot or will not stop my current therapy for trauma or substance use.My mental health medication dose has been stable for the last 3 months.I am taking a high dose of benzodiazepines.I have been diagnosed with schizophrenia, delusional disorder, or another serious mental health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Imaginal Exposure First, then Alcohol Skills
- Group 2: Alcohol Skills First, then Imaginal Exposure
- Group 3: Supportive Counseling/Telehealth
- Group 4: Alcohol Skills First, no additional treatment
- Group 5: Imaginal Exposure First, no additional treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit for participants in this experiment restricted to those under 45 years?
"This trial requires applicants to be between 18 and 65 years of age. There are 65 studies specifically targeting minors, while those over the senior citizen threshold have access to 480 different trials."
Answered by AI
Is this research project currently open for enrollment?
"According to the clinicaltrials.gov registry, this medical study is recruiting patients from its inception on June 2nd 2021 until present day with an update made on August 19th 2022."
Answered by AI
What is the capacity for participants in this trial?
"Affirmative. According to data on clinicaltrials.gov, this medical trial is currently recruiting participants. The study was first created on June 2nd 2021 and has been recently updated as of August 19th 2022. This research necessitates the enrolment of 180 patients at a single site."
Answered by AI
Does my profile meet the requirements for participation in this trial?
"Eligible candidates for this trial must be between 18 and 65 years of age, as well as have been affected by moral injury. The study is seeking to enrol 180 participants in total."
Answered by AI
What are the projected outcomes of this clinical experiment?
"The primary outcome to be tracked throughout the trial is Posttraumatic Stress Disorder Severity (PTSD) Interview. Secondary measurements include Reward, Quality of Life Functioning and Alcohol Consequences which are evaluated using the Snaith-Hamilton Pleasure Scale (SHAPS), a single-item Global Quality of Life item, and Short Inventory of Problems scale respectively within a Past month to past week timeframe."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
What portion of applicants met pre-screening criteria?
Did not meet criteria
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