Understanding and Testing Recovery Processes for PTSD and Alcohol Use Following Sexual Assault
Phase: NA
Conditions: Alcohol; Use, Problem, Posttraumatic Stress Disorder
Sponsor: University of Washington

 
 
 
 
 
 
Protocol Synopsis 
 
Grant number: 1R01AA027499-01A1 
Date: September 22, 2019 
Grant Title: Understanding and testing recovery processes for PTSD and alcohol use following sexual assault 
 
NCT ID: Pending 
 
 

Section 4. Protocol Synopsis 
 
4.1 Brief Summary 
 
This phased, doubly randomized clinical trial (N = 180) will test the efficacy of either a PTSD-focused brief 
intervention, imaginal exposure, or an alcohol-focused brief intervention, alcohol skills training, compared to 
supportive telehealth in preventing long-term mental health consequences in the early aftermath of sexual 
assault (1 month to 1 year after sexual assault). A novel 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 misuse first; and 2) whether it is necessary to target both PTSD and 
alcohol misuse processes to facilitate recovery or if targeting one is sufficient. This clinical trial will further test 
mechanisms of recovery following sexual assault exploring the role of both fear and reward processes to 
elucidate the most efficacious treatment targets. Employing well-established laboratory paradigms tasks, 
discriminant conditioning and probabilistic reward tasks, to capture baseline underlying vulnerabilities in fear 
and reward systems, respectively, will allow for exploration of how these processes impact recovery. This trial 
is significant in exploring transdiagnostic mechanisms, fear and reward, implicated in recovery following sexual 
assault and using a novel design to compare efficacy, ordering, and necessity of two distinct intervention 
approaches; imaginal exposure and alcohol skills training. 
 
 
In Aim 1, we will evaluate imaginal exposure and alcohol skills training compared to supportive telehealth 
to determine relative efficacy of two primary intervention approaches in promoting recovery from PTSD and 
alcohol misuse at 1-month follow-up. Aim 2 will explore whether receiving both approaches (imaginal exposure 
and alcohol skills training) is more effective than receiving only one approach alone for decreasing PTSD and 
alcohol misuse at 2- and 6-month follow-up. Finally, Aim 3 evaluates a model of individual prediction of 
intervention response by exploring the effects of baseline fear and reward deficits and time since assault on 
response to each intervention; imaginal exposure and alcohol skills training. Key outcomes include PTSD 
symptoms and alcohol misuse (quantity, frequency). Taken together findings of this study will inform 
mechanisms of recovery and best practice intervention approaches following recent sexual assault. 
 
4.2 Study Design 
 
This study is designed as a phased, double randomization trial exploring comparative efficacy of two 
brief interventions delivered in the early recovery phase following sexual assault: imaginal exposure and 
alcohol skills training. In addition, we will explore fear and reward processes as transdiagnostic mechanisms 
that are implicated in recovery following sexual assault as predictors of individualized intervention response 
and recovery. Participants will be selected for recent sexual assault (1 month to 1 year), elevated PTSD 
symptoms, and alcohol misuse.  They complete a baseline assessment to determine eligibility, baseline tasks 
to capture fear and reward functioning, and randomization to one of three primary intervention conditions: (1) 
imaginal exposure, (2) alcohol skills training, or (3) supportive telehealth (active control condition). Following 
the primary intervention phase, participants in the first two intervention groups (imaginal exposure, alcohol 
skills training) will be randomized again to one of two secondary intervention groups: (1) the alternate 
intervention from that received in the primary phase, or (2) no additional intervention.  Participants in the 
supportive telehealth condition will continue with supportive calls and weekly symptom assessments. 
Assessments with interviewers blind to intervention assignment will assess PTSD symptoms and alcohol use 
at baseline, 1-month, 2-months, and 6-months follow-ups. All participants will complete self-report 
questionnaires at baseline and follow-ups and weekly on PTSD symptoms, alcohol use, and other constructs 
of interest (e.g., alcohol consequences, depression, fear and reward).  
 
The Specific Aims are: 
Specific Aim 1: Evaluate whether targeting PTSD via imaginal exposure or alcohol misuse via alcohol skills 
training is most efficient at promoting recovery.  
Specific Aim 2: Evaluate whether targeting PTSD or alcohol misuse alone (imaginal exposure or alcohol 
skills training) or both is most efficient at promoting recovery.  
Exploratory Aim 3: Evaluate individualized prediction of intervention response, examining baseline 
performance on fear and reward tasks and time since assault as differential intervention moderators (imaginal 
exposure vs alcohol skills training). 
  
Participants and Recruitment: 

Participants will be 180 individuals who identify as female, are ages 18-65, and report an experience of 
unwanted and distressing sexual contact (i.e., a sexual assault) in the previous 4 weeks. All participants will 
report clinically significant symptoms of PTSD and alcohol misuse (2+ heavy episodic drinking occasions [4+ 
drinks] in past month) at baseline. Exclusion criteria were established to ensure the safety and feasibility of 
delivering the interventions and include factors such as active suicidality or psychosis, medically unstable 
bipolar disorder, and an ongoing relationship with the perpetrator of the most recent sexual assault. 
  
Randomization: 
This study implements a phased randomization design. Following baseline assessments and fear and 
reward tasks, participants will be randomized to three conditions: imaginal exposure, alcohol skills training, 
supportive telehealth. After the primary intervention phase (3 weeks) participants in imaginal exposure and 
alcohol skills training will be randomized again to either the alternate intervention or no additional intervention. 
Participants in supportive telehealth will continue with supportive calls and symptom monitoring (weekly 
assessments) for the entire duration of the study. Randomization will be conducted via computerized, 
randomizer program. All team members will be blind prior to the assignment and only the study coordinator 
revealing the randomization to the participant will be aware. Block randomization will be done based on 
severity (PSS-I-5: 35 >: yes/no; TLFB: 5 drinking days/past 2 weeks >: yes/no).  Participants will be informed of 
their randomized primary intervention condition (imaginal exposure, alcohol skills training, supportive 
telehealth).  A second randomization, for those in the first two intervention conditions (imaginal exposure, 
alcohol skills training), randomization to the alternative or no additional intervention, will be conducted at 1-
month follow-up using the same procedures.   
 
Brief Interventions: 
Alcohol Intervention: Alcohol Skills Training. Six 50 min, twice weekly sessions will be provided based on 
content from existing alcohol skills training and relapse prevention protocols [80]. Each session includes in 
session skill alcohol teaching and practice on increasing use of adaptive coping skills and attainment of 
positive rewarding activities (e.g., social support, positive thinking patterns).   
 
PTSD Intervention: Brief Imaginal Exposure. Six 50 min, twice weekly sessions will be provided based on a 
published intervention for treatment for PTSD, which uses imaginal exposure to address PTSD. The protocol 
includes psychoeducation, information gathering, recounting of the trauma memory, and processing of relevant 
emotions and beliefs associated with the memory to promote extinction of fear and promote new, more 
adaptive meaning around the trauma memory [177].  
 
Supportive Telehealth. Twelve, twice weekly sessions will be provided based on existing active control 
treatments provided for PTSD [212]. The protocol involves weekly online writing about daily non-trauma related 
concerns and hassles and weekly routine therapist phone calls. These calls include a brief check in, answering 
any questions, and progress on the online writing. The goal for therapists will be to be non-directive and 
supportive, focusing on non-trauma related present-day concerns. If needed, referrals for additional resources 
will be offered.  
 
Assessments: 
For Aims 1 and 2, assessments will include gold-standard clinician administered interviews delivered by 
independent evaluators blind to intervention condition and well-validated self-report measures. Information 
collected will include symptoms of PTSD, alcohol use, fear, reward, depression, and suicidality. Aim 3 will be 
based on these same interview and self-report measures as well as behavioral performance and 
psychophysiological responding to two well-validated laboratory tasks of fear (discriminant conditioning 
AX+/BX- paradigm) and reward (probabilistic reward task) processes. 
Assessments with interviewers blind to intervention assignment will assess primary outcomes of PTSD 
symptoms [PTSD Symptom Scale-Interview (PSS-I-5); 186] and alcohol use quantity/frequency [Timeline 
Followback (TLFB); 188] at baseline, 2-months, 3-months, and 6-months post sexual assault, as well as 
related constructs of interest including other mental disorders [Structured Clinical Interview for DSM-5 (SCID-
5); 190], depression [Quick Inventory of Depressive Symptomatology-C (QIDS-C); 191], suicidality [Columbia-
Suicide Severity Rating Scale (C-SSRS); 192], and trauma history [Trauma History Questionnaire (THQ); 193].   
All participants will complete self-report questionnaires at baseline, 2-, 3-, and 6month follow-ups and 
weekly. These measures will assess PTSD symptoms [PTSD Symptom Scale-Self-Report (PSS-SR-5); 194], 

alcohol use [Daily Drinking Questionnaire (DDQ); 195], alcohol consequences [Short Inventory of Problems 
(SIP)], alcohol cravings [Penn Alcohol Craving Scale (PACS0; 199], depression [Quick Inventory of Depressive 
Symptomatology (QIDS-SR16); 201], reward [Snaith-Hamilton Pleasure Scale (SHAPS), 202], fear 
[Posttraumatic Avoidance Behavior Questionnaire (PABQ), 204], and functioning [Global Psychosocial 
Functioning (GPF) and Global Quality of Life (GQL); 205].