NCT04582695.

Study name	Public title: Early intervention following sexual assault Scientific title: Integrated early intervention for alcohol use disorder and posttraumatic stress disorder following sexual assault
Methods	Study design: randomised trial Location/setting: USA
Participants	Sample size: 64 participants (target) Inclusion criteria Female; any race or ethnicity; age 18 years to 65 years Sexual assault that occurred within the past 6 weeks Participants must be able to comprehend English A score of 3 or greater on the AUDIT‐C screen A score of 33 or greater on the PCL‐5. Participants may also meet criteria for an alcohol use disorder, previous history of PTSD, mood disorder (except bipolar affective disorder, see Exclusion Criteria) or other anxiety disorders (panic disorder, agoraphobia, social phobia, generalised anxiety disorder or obsessive‐compulsive disorder). The inclusion of participants with affective and other anxiety disorders is essential because of the marked frequency of the co‐existence of mood and other anxiety disorders among participants with alcohol use disorder and PTSD (Norman 2018; Zinzow 2012). Participants may meet the DSM‐5 criteria for another substance use disorder if alcohol is the primary substance of choice. Must consent to complete all treatment and follow‐up visits Exclusion criteria Lack of any memory of the sexual assault Participants meeting the DSM‐5 criteria for a history of or current psychotic, bipolar or dissociative identify disorder or a current eating disorder, as the study protocol may be therapeutically insufficient Participants experiencing significant withdrawal symptoms, as evidence by a score of 10 or more on the CIWA. These participants will be referred for clinical detoxification and may be reassessed for study eligibility after medically supervised detoxification has been completed. Individuals considered an immediate suicide risk, with current suicidal ideation and intent. These individuals will be referred directly for treatment Individuals on psychotropic medications must be stabilised on it for at least 2 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 Recruitment status: recruiting
Interventions	Experimental: written exposure therapy integrated with CBT Active comparator: written exposure therapy
Outcomes	Alcohol use disorder symptoms (timing of assessment: 6 weeks) Per cent drinking days (timing of assessment: 6 weeks) PTSD (timing of assessment: 6 weeks) Depression (timing of assessment: 6 weeks) Anxiety (timing of assessment: 6 weeks)
Starting date	Study start date: 15 December 2020 Study end date: 31 July 2025 (estimated)
Contact information	Name(s): Christine K Hahn, PhD; Sudie Back, PhD E‐mail: hahnc@musc.edu; backs@musc.edu
Notes	Trial registry:ClinicalTrials.Gov Trial registration number: NCT04582695 Funding source: Medical University of South Carolina

AUDIT‐C: Alcohol Use Disorders Identification Test; CAPS‐5: Clinician‐Administered PTSD Checklist for DSM‐5; CBT: cognitive behavioural therapy; CIWA: Clinical Institute Withdrawal Assessment of Alcohol; CPT: cognitive processing therapy; DSM‐5: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; GAD‐7: Generalised Anxiety Disorder‐7; IES‐R: Impact of Event Scale‐Revised; IPV: intimate partner violence; ISRCTN: International Standard Randomised Controlled Trial Number; MST: military sexual trauma; PCL‐5: PTSD Checklist for DSM‐5 criteria; PC‐PTSD: Primary Care Posttraumatic Stress Disorder; PHQ: Patient Health Questionnaire; PSS‐I: PTSD Symptom Scale‐Interview, for DSM‐5; PTSD: post‐traumatic stress disorder; QoL: quality of life; SGM: sexual‐ or gender‐minority male; WHO: World Health Organization; VA: Veterans Affairs