search
Back to results

Understanding and Testing Recovery Processes for PTSD and Alcohol Use Following Sexual Assault

Primary Purpose

Alcohol; Use, Problem, Posttraumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imaginal Exposure
Alcohol Skills Training
Supportive Telehealth
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol; Use, Problem

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Imaginal Exposure First, then Alcohol Skills

Alcohol Skills First, then Imaginal Exposure

Supportive Counseling/Telehealth

Alcohol Skills First, no additional treatment

Imaginal Exposure First, no additional treatment

Arm Description

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

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.

Internet-based intervention focusing on providing support.

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

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

Outcomes

Primary Outcome Measures

Alcohol Use Interview
Alcohol use will be measured using the Timeline Followback Interview (TLFB) to measure frequency and quantity of drinking behavior over the past month. The TLFB is a count of total drinks per day over the last month. Higher number of drinks on the TLFB represents higher alcohol use and worse outcomes.
Alcohol Use Self-Report
Alcohol use will be measured using the Daily Drinking Questionnaire (DDQ) to assess for self report of typical weekly drinking (quantity, frequency). The DDQ asks for an estimated number of drinks consumed on each day in a typical week over the last month. Higher estimates for number of typical drinks each day on the DDQ represents higher alcohol use and worse outcomes.
Posttraumatic Stress Disorder Severity (PTSD) Interview
PTSD symptom severity will be measured using the Posttraumatic Stress Symptoms Scale- Interview Version for DSM-5 (PSS-I-5). The PSS-I-5 is a 20 item scale, with a minimum score of 0 and a maximum score of 80; higher values represent increased PTSD symptom severity and worse outcomes.
Posttraumatic Stress Disorder Severity (PTSD) Self-Report
PTSD symptom severity will be measured using the Posttraumatic Stress Symptoms Scale- Self-report Version for DSM-5 (PSS-SR-5). The PSS-SR-5 is a 20 item scale, with a minimum score of 0 and a maximum score of 80; higher values represent increased PTSD symptom severity and worse outcomes.

Secondary Outcome Measures

Psychosocial Functioning
The single-item Global Psychosocial Functioning (GPF) item will be used as an indicator of functioning. The GPF will be reworded so as to be disorder non-specific. It is rated on a scale from 0 - 100 with higher scores representing better outcomes.
Quality of Life Functioning
The single-item Global Quality of Life (GQL) item will be used as an indicator of functioning. It is rated on a scale from 0 - 100 with higher scores representing better outcomes.
Alcohol Cravings
The 5-item Penn Alcohol Craving Scale (PACS) will be given to assess current urges and cravings to drink alcohol. Items assess frequency, intensity, and duration of thoughts about drinking and participants rate their perceived ability to resist drinking. Total sum score on this measure ranges from 0 to 30. Higher scores represent more alcohol cravings and worse outcomes.
Alcohol Consequences
The Short Inventory of Problems (SIP) will be given to assess alcohol related negative consequences. The SIP is a 15 item scale, with 3 items per subscale. This measure was adapted to use a time frame of the past week for responses. This measure has a minimum score of 0 and a maximum score of 15. Higher values represent increased alcohol-related problems and worse outcomes.
Depression Self-Report
Depression will be measured with the Quick Inventory of Depressive Symptoms (QIDS-SR16) self report version. The QIDS-SR16 is a 16 item scale, with a minimum score of 0 and a maximum score of 48; higher values represent increased depression and worse outcomes.
Depression Interview
Depression will be measured with the Quick Inventory of Depressive Symptoms (QIDS-C16) interview version. The QIDS-C16 is a 16 item scale, with a minimum score of 0 and a maximum score of 27; higher values represent increased depression and worse outcomes.
Reward
Reward functioning will be measured with the Snaith-Hamilton Pleasure Scale (SHAPS), self-report. The SHAPS is a 14 item scale, with a minimum score of 0 and a maximum score of 14; higher values represent increased anhedonia and worse outcomes.
Fear
Fear will be measured with the Posttrauma Avoidance Behavior Questionnaire (PABQ), self-report. The PABQ is a 25 item scale, with a minimum score of 25 and a maximum score of 100; higher values represent increased fear and worse outcomes.

Full Information

First Posted
September 23, 2019
Last Updated
January 17, 2023
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04124380
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol; Use, Problem, Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaginal Exposure First, then Alcohol Skills
Arm Type
Experimental
Arm Description
Imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. After imaginal exposure, alcohol skills targeting alcohol misuse after sexual assault.
Arm Title
Alcohol Skills First, then Imaginal Exposure
Arm Type
Experimental
Arm Description
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.
Arm Title
Supportive Counseling/Telehealth
Arm Type
Active Comparator
Arm Description
Internet-based intervention focusing on providing support.
Arm Title
Alcohol Skills First, no additional treatment
Arm Type
Experimental
Arm Description
Alcohol skills targeting alcohol misuse after sexual assault only. No additional treatment.
Arm Title
Imaginal Exposure First, no additional treatment
Arm Type
Experimental
Arm Description
Imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. No additional treatment.
Intervention Type
Behavioral
Intervention Name(s)
Imaginal Exposure
Intervention Description
Six 50 min, twice weekly video telehealth sessions will be provided based on prolonged exposure therapy for PTSD. This brief intervention includes psycho-education and focuses on imaginal exposure only based on Zoellner et al., (2016).
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Skills Training
Intervention Description
Six 50 min, twice weekly video telehealth sessions will be provided based on content from the alcohol skills training program and CBT protocols. Each session includes teaching skills and practice, focusing on mitigating rewarding aspects of alcohol, addressing cravings, and increasing other natural rewards.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Telehealth
Intervention Description
The supportive counseling intervention, modeled after Litz et al. (2007), will ask participants to self-monitor their experience of weekly symptoms and complete weekly online writing about daily non-trauma related concerns and hassles. Participants will talk with a therapist on the telephone twice per week.
Primary Outcome Measure Information:
Title
Alcohol Use Interview
Description
Alcohol use will be measured using the Timeline Followback Interview (TLFB) to measure frequency and quantity of drinking behavior over the past month. The TLFB is a count of total drinks per day over the last month. Higher number of drinks on the TLFB represents higher alcohol use and worse outcomes.
Time Frame
Past month
Title
Alcohol Use Self-Report
Description
Alcohol use will be measured using the Daily Drinking Questionnaire (DDQ) to assess for self report of typical weekly drinking (quantity, frequency). The DDQ asks for an estimated number of drinks consumed on each day in a typical week over the last month. Higher estimates for number of typical drinks each day on the DDQ represents higher alcohol use and worse outcomes.
Time Frame
Past month
Title
Posttraumatic Stress Disorder Severity (PTSD) Interview
Description
PTSD symptom severity will be measured using the Posttraumatic Stress Symptoms Scale- Interview Version for DSM-5 (PSS-I-5). The PSS-I-5 is a 20 item scale, with a minimum score of 0 and a maximum score of 80; higher values represent increased PTSD symptom severity and worse outcomes.
Time Frame
Past two weeks
Title
Posttraumatic Stress Disorder Severity (PTSD) Self-Report
Description
PTSD symptom severity will be measured using the Posttraumatic Stress Symptoms Scale- Self-report Version for DSM-5 (PSS-SR-5). The PSS-SR-5 is a 20 item scale, with a minimum score of 0 and a maximum score of 80; higher values represent increased PTSD symptom severity and worse outcomes.
Time Frame
Past two weeks
Secondary Outcome Measure Information:
Title
Psychosocial Functioning
Description
The single-item Global Psychosocial Functioning (GPF) item will be used as an indicator of functioning. The GPF will be reworded so as to be disorder non-specific. It is rated on a scale from 0 - 100 with higher scores representing better outcomes.
Time Frame
Past two weeks
Title
Quality of Life Functioning
Description
The single-item Global Quality of Life (GQL) item will be used as an indicator of functioning. It is rated on a scale from 0 - 100 with higher scores representing better outcomes.
Time Frame
Past two weeks
Title
Alcohol Cravings
Description
The 5-item Penn Alcohol Craving Scale (PACS) will be given to assess current urges and cravings to drink alcohol. Items assess frequency, intensity, and duration of thoughts about drinking and participants rate their perceived ability to resist drinking. Total sum score on this measure ranges from 0 to 30. Higher scores represent more alcohol cravings and worse outcomes.
Time Frame
Past week
Title
Alcohol Consequences
Description
The Short Inventory of Problems (SIP) will be given to assess alcohol related negative consequences. The SIP is a 15 item scale, with 3 items per subscale. This measure was adapted to use a time frame of the past week for responses. This measure has a minimum score of 0 and a maximum score of 15. Higher values represent increased alcohol-related problems and worse outcomes.
Time Frame
Past week
Title
Depression Self-Report
Description
Depression will be measured with the Quick Inventory of Depressive Symptoms (QIDS-SR16) self report version. The QIDS-SR16 is a 16 item scale, with a minimum score of 0 and a maximum score of 48; higher values represent increased depression and worse outcomes.
Time Frame
Past week
Title
Depression Interview
Description
Depression will be measured with the Quick Inventory of Depressive Symptoms (QIDS-C16) interview version. The QIDS-C16 is a 16 item scale, with a minimum score of 0 and a maximum score of 27; higher values represent increased depression and worse outcomes.
Time Frame
Past week
Title
Reward
Description
Reward functioning will be measured with the Snaith-Hamilton Pleasure Scale (SHAPS), self-report. The SHAPS is a 14 item scale, with a minimum score of 0 and a maximum score of 14; higher values represent increased anhedonia and worse outcomes.
Time Frame
Past week
Title
Fear
Description
Fear will be measured with the Posttrauma Avoidance Behavior Questionnaire (PABQ), self-report. The PABQ is a 25 item scale, with a minimum score of 25 and a maximum score of 100; higher values represent increased fear and worse outcomes.
Time Frame
Past week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Individuals who identify as female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Identifies as female. Between the age of 18 and 65. Reports a sexual assault in the last 4 weeks to 1 year. Current PTSD severity of 23+ on the PSS-I-5. Current heavy alcohol use (2+ heavy episodic drinking occasions [4+ drinks on one occasion] in past month). Access to the internet and a device with a webcam. Exclusion Criteria: Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-5. 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). Unwilling or unable to discontinue current trauma-focused psychotherapy or current substance use psychotherapy. Unstable dose of psychotropic medications in the prior 3 months. Ongoing intimate relationship with the perpetrator of most recent assault. Current diagnosis of a severe substance use disorder according to DSM-5, other than alcohol in the last month. No clear trauma memory. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Bedard-Gilligan, PhD
Phone
206-616-4215
Email
mab29@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Bedard-Gilligan, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele A Bedard-Gilligan, PhD
Phone
206-685-3617
First Name & Middle Initial & Last Name & Degree
Michele A Bedard-Gilligan, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Understanding and Testing Recovery Processes for PTSD and Alcohol Use Following Sexual Assault

We'll reach out to this number within 24 hrs