PtsdNCT04582695

Early Intervention Following Sexual Assault

A study testing Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder and Written Exposure Therapy in people with Ptsd and Alcohol Use Disorder, run by Medical University of South Carolina 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

This study is for women who have experienced a sexual assault in the past six weeks and use alcohol. The research involves completing a five week behavioral treatment for stress and alcohol use. Participants will complete surveys during visits. Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Ptsd, Alcohol Use Disorder, Sexual Assault and Rape
What is being tested?: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder and Written Exposure Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 15 Dec 2020to 23 Feb 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

Female; any race or ethnicity; age 18 to 65 years old.
Sexual assault that occurred within the past 12 months.
Subjects must be able to comprehend English.
A score of 3 or greater on the Alcohol Use Disorders Identification Test (AUDIT-C) screen.
A score of 31 or greater on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5). Subjects may also meet criteria for an alcohol use disorder, previous history of posttraumatic stress disorder, mood disorder (except bipolar affective disorder, see Exclusion Criteria) or other anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive-compulsive disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD and PTSD (Norman et al., 2018; Zinzow et al., 2012). Subjects may meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for another substance use disorder if AUD is the primary substance of choice.
Must consent to complete all treatment and follow-up visits.

Who cannot join

Lack of any memory of the sexual assault
Subjects meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a history of or current psychotic, bipolar, dissociative identify disorder, or a current eating disorder, as the study protocol may be therapeutically insufficient.
Subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA). These subjects will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed.
Individuals considered an immediate suicide risk, with current suicidal ideation and intent.
Individuals who attempted suicide in the past month. These individuals will be referred directly for treatment.
Individuals on psychotropic medications must be stabilized on it for at least two weeks prior to beginning the study.
Any other medical or psychiatric conditions that the investigators believe may compromise the individual's ability to safely participate in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault

Read the detailed description

The primary objective of the proposed Stage IA/IB study is to establish feasibility of an integrated cognitive-behavioral intervention for reducing alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) symptoms among women who experienced a sexual assault within the past six weeks. The intervention will be tested in an open label trial to make final modifications to evaluate feasibility, acceptability, and preliminary efficacy of the five to six week integrated intervention with standardized repeated measures during a one-month follow-up. Next, a pilot randomized controlled trial will be conducted among 54 recent sexual assault victims to evaluate feasibility and preliminary efficacy in reducing AUD severity and PTSD symptoms. Ecological momentary assessments (EMA) will be used to assess alcohol use, craving, and affect during the five-week treatment phase.

Conditions: Ptsd, Alcohol Use Disorder, Sexual Assault and Rape
Being tested: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder, Written Exposure Therapy
Medical subject headings: Stress Disorders, Post-Traumatic, Alcoholism

What participants receive

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

Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use DisorderBehavioural
Participants will receive 5 to 6 weeks of an integrated behavioral therapy that address posttraumatic stress disorder and alcohol use disorder. Sessions will be 60 minutes in length. It will include written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes. In addition, they will receive 20 minutes of intervention focused on cognitive behavioral therapy for alcohol use disorder which involves learning skills to cope with alcohol cravings and behavior (e.g., challenging thoughts, problem solving).
Written Exposure TherapyBehavioural
Participants will receive 5 to 6 weeks of written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes.

Study groups in NCT04582695
Study group	Role	What they receive
Written Exposure Therapy	Active comparator	Not described Receives: Behavioral: Written Exposure Therapy
Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder	Experimental	Not described Receives: Behavioral: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder

What is being measured

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

Change in Percent Drinking Days on The Time Line Follow-Back
The Time Line Follow Back (TLFB) will be used to assess heavy drinking in the past 30-days. This calendar-assisted interview yielded estimates in terms of the number of standard drinks consumed daily in the past 30 days used to obtain retrospective self-report of alcohol use by using a calendar and other memory prompts to stimulate recall.
Measured: Participants will report on drinking during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.
Change in number of standard drinks per drinking day on The Time Line Follow-Back
The Time Line Follow Back (TLFB) will be used to assess heavy drinking in the past 30-days and use. This calendar-assisted interview yielded estimates in terms of the number of standard drinks consumed daily in the past 30 days used to obtain retrospective self-report of alcohol use by using a calendar and other memory prompts to stimulate recall.
Measured: Participants will report on drinking during the 30 days prior to initiation of the study, and ever day until completion of study visits, approximately six weeks.
Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5)
Participants will be asked to complete the 20-item Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5) to measure traumatic stress symptoms corresponding with the Diagnostic and Statistical Manual of Mental Disorders -5 PTSD criteria. Items are rated on a five-point Likert scale ranging from 0 (Not at all) to 4 (Extremely) with higher scores indicating greater traumatic stress symptoms. Total scores will be used.
Measured: Baseline and after completion of study visits, approximately six weeks.
Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders
The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders (CAPS-5) is the gold standard in Posttraumatic Stress Disorder (PTSD) assessment. It is a structured 30-minute interview that can be used to diagnosis PTSD. Items focus on symptom presence, onset and duration of symptoms, subjective distress, impact on functioning, and symptom improvement.
Measured: Baseline and after completion of study visits, approximately six weeks.

Secondary outcomes (3)

Change in Depression Symptoms on The Patient Health Questionnaire-9.
The Patient Health Questionnaire-9 is a widely used self-report measure for attitudes and symptoms of depression. The PHQ-9 includes 9 self-report items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 27. A total score of 0-4 is considered minimal range, 5-9 is mild, 10-14 is moderate, 15-19 is moderately severe, and 20 or more is severe.
Measured: Baseline and after completion of study visits, approximately six weeks.
Change in Anxiety Symptoms on The Beck Anxiety Inventory
The Beck Anxiety Inventory (BAI) assesses symptoms of anxiety via 21-item self-report. The BAI reliability discriminates anxiety-disordered from non-anxiety disordered patients and demonstrates excellent convergence with related anxiety scales. The values for each item are summed yielding an overall or total score for all 21 symptoms that can range between 0 and 63 points. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe".
Measured: Baseline and after completion of study visits, approximately six weeks.
Change in Percent Days Using Substances on The Time Line Follow-Back
The Time Line Follow-Back will be used to assess illicit substance use in the past 30-days. This calendar-assisted interview yielded estimates in terms of self-report of substance use by using a calendar and other memory prompts to stimulate recall.
Measured: Participants will report on substance use during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.

Timeline

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

15 Dec 202023 Feb 2026

First posted9 Oct 2020
Study start15 Dec 2020
Primary completion23 Feb 2026
Study completion23 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PtsdStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04582695
Sponsor's protocol ID: 00099114
Other IDs: 1K23AA028055
Status last verified: May 2026
First submitted: 28 Sep 2020
Last updated: 11 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault
ClinicalTrials.gov ID: NCT04582695
Acronym / sponsor ID: 00099114
Conditions: Ptsd, Alcohol Use Disorder, Sexual Assault and Rape
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 15 Dec 2020 (actual)
Primary completion: 23 Feb 2026 (actual)
Study completion: 23 Feb 2026 (actual)
First posted: 9 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Written Exposure Therapy	Active comparator	Behavioral: Written Exposure Therapy
Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder	Experimental	Behavioral: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Female; any race or ethnicity; age 18 to 65 years old.
Sexual assault that occurred within the past 12 months.
Subjects must be able to comprehend English.
A score of 3 or greater on the Alcohol Use Disorders Identification Test (AUDIT-C) screen.
A score of 31 or greater on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5). Subjects may also meet criteria for an alcohol use disorder, previous history of posttraumatic stress disorder, mood disorder (except bipolar affective disorder, see Exclusion Criteria) or other anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive-compulsive disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD and PTSD (Norman et al., 2018; Zinzow et al., 2012). Subjects may meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for another substance use disorder if AUD is the primary substance of choice.

Key exclusion criteria (7 listed)

Lack of any memory of the sexual assault
Subjects meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a history of or current psychotic, bipolar, dissociative identify disorder, or a current eating disorder, as the study protocol may be therapeutically insufficient.
Subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA). These subjects will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed.
Individuals considered an immediate suicide risk, with current suicidal ideation and intent.
Individuals who attempted suicide in the past month. These individuals will be referred directly for treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use DisorderParticipants will receive 5 to 6 weeks of an integrated behavioral therapy that address posttraumatic stress disorder and alcohol use disorder. Sessions will be 60 minutes in length. It will include written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes. In addition, they will receive 20 minutes of intervention focused on cognitive behavioral therapy for alcohol use disorder which involves learning skills to cope with alcohol cravings and behavior (e.g., challenging thoughts, problem solving).	Behavioural	Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder
Written Exposure TherapyParticipants will receive 5 to 6 weeks of written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes.	Behavioural	Written Exposure Therapy

Primary outcome

Change in Percent Drinking Days on The Time Line Follow-Back
Time frame: Participants will report on drinking during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.
The Time Line Follow Back (TLFB) will be used to assess heavy drinking in the past 30-days. This calendar-assisted interview yielded estimates in terms of the number of standard drinks consumed daily in the past 30 days used to obtain retrospective self-report of alcohol use by using a calendar and other memory prompts to stimulate recall.
Change in number of standard drinks per drinking day on The Time Line Follow-Back
Time frame: Participants will report on drinking during the 30 days prior to initiation of the study, and ever day until completion of study visits, approximately six weeks.
The Time Line Follow Back (TLFB) will be used to assess heavy drinking in the past 30-days and use. This calendar-assisted interview yielded estimates in terms of the number of standard drinks consumed daily in the past 30 days used to obtain retrospective self-report of alcohol use by using a calendar and other memory prompts to stimulate recall.
Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5)
Time frame: Baseline and after completion of study visits, approximately six weeks.
Participants will be asked to complete the 20-item Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5) to measure traumatic stress symptoms corresponding with the Diagnostic and Statistical Manual of Mental Disorders -5 PTSD criteria. Items are rated on a five-point Likert scale ranging from 0 (Not at all) to 4 (Extremely) with higher scores indicating greater traumatic stress symptoms. Total scores will be used.
Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders
Time frame: Baseline and after completion of study visits, approximately six weeks.
The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders (CAPS-5) is the gold standard in Posttraumatic Stress Disorder (PTSD) assessment. It is a structured 30-minute interview that can be used to diagnosis PTSD. Items focus on symptom presence, onset and duration of symptoms, subjective distress, impact on functioning, and symptom improvement.

3 secondary outcomes

Change in Depression Symptoms on The Patient Health Questionnaire-9.
Time frame: Baseline and after completion of study visits, approximately six weeks.
Change in Anxiety Symptoms on The Beck Anxiety Inventory
Time frame: Baseline and after completion of study visits, approximately six weeks.
Change in Percent Days Using Substances on The Time Line Follow-Back
Time frame: Participants will report on substance use during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Derived from this study: PubMed 37795783O'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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 11 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?

Change in Percent Drinking Days on The Time Line Follow-Back (time frame: Participants will report on drinking during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.). 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 NCT04582695, 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 11 May 2026.