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Alcohol; Use, ProblemNCT04124380

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

A study testing Imaginal Exposure, Alcohol Skills Training and Supportive Telehealth in people with Alcohol; Use, Problem and Posttraumatic Stress Disorder, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sexual assault can lead to devastating consequences including the development of chronic conditions including posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD). Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Imaginal Exposure, Alcohol Skills Training and Supportive Telehealth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteUnited States
Study dates
2 Jun 2021to 15 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Washington

    Seattle, Washington, 98105

Other trials in United States

About this study

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.

Read the 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.

Being tested
Imaginal Exposure, Alcohol Skills Training, Supportive Telehealth
Medical subject headings
Alcoholism, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imaginal ExposureBehavioural

    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).

  • Alcohol Skills TrainingBehavioural

    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.

  • Supportive TelehealthBehavioural

    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.

Study groups in NCT04124380
Study groupRoleWhat they receive
Imaginal Exposure First, then Alcohol SkillsExperimentalImaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. After imaginal exposure, alcohol skills targeting alcohol misuse after sexual assault.
Receives: Behavioral: Imaginal Exposure; Behavioral: Alcohol Skills Training
Alcohol Skills First, then Imaginal ExposureExperimentalAlcohol skills targeting alcohol misuse after sexual assault. After alcohol skills training, imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault.
Receives: Behavioral: Imaginal Exposure; Behavioral: Alcohol Skills Training
Supportive Counseling/TelehealthActive comparatorInternet-based intervention focusing on providing support.
Receives: Behavioral: Supportive Telehealth
Alcohol Skills First, no additional treatmentExperimentalAlcohol skills targeting alcohol misuse after sexual assault only. No additional treatment.
Receives: Behavioral: Alcohol Skills Training
Imaginal Exposure First, no additional treatmentExperimentalImaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. No additional treatment.
Receives: Behavioral: Imaginal Exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Past month

  2. 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.

    Measured: Past month

  3. 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.

    Measured: Past two weeks

  4. 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.

    Measured: Past two weeks

Secondary outcomes (8)
  1. 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.

    Measured: Past two weeks

  2. 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.

    Measured: Past two weeks

  3. 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.

    Measured: Past week

  4. 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.

    Measured: Past week

  5. 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.

    Measured: Past week

  6. 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.

    Measured: Past week

  7. 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.

    Measured: Past week

  8. 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.

    Measured: Past week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2019
  2. Study start2 Jun 2021
  3. Primary completion15 Apr 2026
  4. Study completion15 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04124380
Sponsor's protocol ID
STUDY00008021
Other IDs
R01AA027499, 1F32AA029865-01A1
Status last verified
Dec 2025
First submitted
23 Sep 2019
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

    PubMed 37795783

Questions about this trial

What is this clinical trial studying?

A study testing Imaginal Exposure, Alcohol Skills Training and Supportive Telehealth in people with Alcohol; Use, Problem and Posttraumatic Stress Disorder, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol Use Interview (time frame: Past month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04124380, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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