Alcohol Use Disorders, Posttraumatic Stress Disorder
Conditions
Keywords
Sexual assault, Posttraumatic Stress Disorder, Alcohol use, Cognitive therapy
Brief summary
The broad aim of this study is to develop and test a brief intervention that can be implemented in the immediate weeks following sexual assault to decrease likelihood of developing posttraumatic stress disorder (PTSD) or alcohol misuse. The first phase of the study will enroll 6 women to complete a brief, cognitive therapy protocol and provide feedback on the intervention (open trial). The second phase of the study will recruit 76 women to complete either the intervention (38 women) or assessment only (38 women) to test the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared to natural recovery following assault.
Detailed description
Following sexual assault a substantial number of victims will go on to develop posttraumatic stress disorder (PTSD) or alcohol use disorders (AUD), and development of these disorders is costly to both the victim and society as a whole. Intervening early, in the initial weeks following sexual assault, can provide victims with coping strategies that can decrease the likelihood of developing chronic symptoms. Cognitive approaches for treating symptoms of PTSD have strong empirical support with chronic presentation of symptoms. Less is known about effective strategies for intervening acutely following sexual assault. This project is designed to adapt existing empirically supported cognitive treatment principles for both PTSD and AUD symptoms to be delivered acutely (within 10 weeks of assault) in a brief one session format followed by 4 weekly coaching calls. The first 6 participants enrolled will receive the intervention and provide us with feedback on strengths and weaknesses of the protocol to help us improve it (Open Trial). In the next phase, the pilot testing phase, the study will enroll 38 women to complete the one session intervention followed by 4 once per week coaching calls. Participants will then be assessed again for symptoms of PTSD and alcohol use behavior at 3 month follow-up. This brief intervention group will be compared at the 3 month follow-up to a group of 38 women who receive weekly symptom monitoring only. Thus, this research aims to provide information on the efficacy of the intervention compared to the natural recovery process. This research is significant in its potential to use a very brief and easy to access treatment to decrease the development of chronic psychopathology in a high risk group of women.
Interventions
BEHAVIORALBrief Cognitive Therapy
Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Identifies as female * Age \> 18 years * 2-10 weeks post sexual assault * PTSD symptoms related to recent sexual assault, specifically defined as a minimum of 1 reexperiencing, 1 avoidance, 2 negative alterations in mood/cognition, or 2 hyperarousal symptoms * Drinking more than 3 drinks on one occasion in the last month and at least two reported negative consequences of alcohol use * Capacity to provide informed consent * English fluency * No planned absences that they would be unable to complete 5 weeks of assessments and coaching calls * Access to a telephone.
Exclusion criteria
* Acutely suicidal with intent/plan * Exhibit current psychosis * Previous non-response to an adequate trial (8 or more sessions) of Cognitive Processing Therapy (CPT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) | 12 weeks | The Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) assesses severity of symptoms of posttraumatic stress disorder (PTSD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline and 3 month follow up to assess change in PTSD symptoms. The range for the scale is 0-80 with higher scores representing more severe PTSD symptoms. |
| Timeline Followback Heavy Episodic Drinking Episodes | 12 weeks | The Timeline Followback (TLFB) uses a calendar method with cued recall to assess frequency and quantity of alcoholic beverages consumed. Quantity of drinks are reported per day. Episodes of heavy episodic drinking (4+ drinks per occasion) are counted to calculate the number of HED episodes in the past month. The minimum score possible is 0 for number of HED episodes in the past month and the maximum is 30 (count of days in past 30 days in which HED occurred). Higher numbers indicate more heavy episodic drinking episodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drinking Inventory of Consequences (DrInC) | 12 weeks | Total score of alcohol related negative consequences as reported on the self-report Drinking Inventory of Consequences (DrInC). The total range of scores is 0-135 and higher scores indicate more negative consequences of alcohol use. It is administered at baseline and 3-month follow-up to assess change in alcohol related consequences. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brief Cognitive Intervention One in person session (90 minutes) of trauma focused cognitive therapy followed by 4 weekly coaching calls (20 minutes each) with the same study therapist
Brief Cognitive Therapy: Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use | 28 |
| Assessment Only Assessment session followed by weekly completion of assessment measures | 29 |
| Total | 57 |
Baseline characteristics
| Characteristic | Brief Cognitive Intervention | Total | Assessment Only |
|---|---|---|---|
| Age, Continuous | 21.1 years STANDARD_DEVIATION 4 | 21.6 years STANDARD_DEVIATION 3.7 | 22.1 years STANDARD_DEVIATION 3.4 |
| Alcohol use negative consequences | 17.7 score on a scale STANDARD_DEVIATION 24.3 | 18.74 score on a scale STANDARD_DEVIATION 20.1 | 19.8 score on a scale STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 50 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PTSD Symptom Severity | 32.4 score on a scale STANDARD_DEVIATION 8.4 | 32.8 score on a scale STANDARD_DEVIATION 8.3 | 33.2 score on a scale STANDARD_DEVIATION 8.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 38 Participants | 22 Participants |
| Region of Enrollment United States | 28 Participants | 57 Participants | 29 Participants |
| Sex: Female, Male Female | 28 Participants | 57 Participants | 29 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Timeline Followback Heavy Episodic Drinking Episodes | 5.4 episodes STANDARD_DEVIATION 4.4 | 5.6 episodes STANDARD_DEVIATION 3.9 | 5.8 episodes STANDARD_DEVIATION 3.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 |
| other Total, other adverse events | 0 / 28 | 0 / 29 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 |
Outcome results
Primary
Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
The Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) assesses severity of symptoms of posttraumatic stress disorder (PTSD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline and 3 month follow up to assess change in PTSD symptoms. The range for the scale is 0-80 with higher scores representing more severe PTSD symptoms.
Time frame: 12 weeks
Population: Analyzed data from all participants assigned to each condition regardless of completion or missing data (intent to treat).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Cognitive Intervention | Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) | 11.4 score on a scale | Standard Deviation 7 |
| Assessment Only | Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) | 22.1 score on a scale | Standard Deviation 10.4 |
Primary
Timeline Followback Heavy Episodic Drinking Episodes
The Timeline Followback (TLFB) uses a calendar method with cued recall to assess frequency and quantity of alcoholic beverages consumed. Quantity of drinks are reported per day. Episodes of heavy episodic drinking (4+ drinks per occasion) are counted to calculate the number of HED episodes in the past month. The minimum score possible is 0 for number of HED episodes in the past month and the maximum is 30 (count of days in past 30 days in which HED occurred). Higher numbers indicate more heavy episodic drinking episodes.
Time frame: 12 weeks
Population: Analyzed data from all participants assigned to each condition regardless of completion or missing data (intent to treat).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Cognitive Intervention | Timeline Followback Heavy Episodic Drinking Episodes | 2.2 episodes | Standard Deviation 2.7 |
| Assessment Only | Timeline Followback Heavy Episodic Drinking Episodes | 3.7 episodes | Standard Deviation 3.7 |
Secondary
Drinking Inventory of Consequences (DrInC)
Total score of alcohol related negative consequences as reported on the self-report Drinking Inventory of Consequences (DrInC). The total range of scores is 0-135 and higher scores indicate more negative consequences of alcohol use. It is administered at baseline and 3-month follow-up to assess change in alcohol related consequences.
Time frame: 12 weeks
Population: Analyzed data from all participants assigned to each condition regardless of completion or missing data (intent to treat).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Cognitive Intervention | Drinking Inventory of Consequences (DrInC) | 7.4 score on a scale | Standard Deviation 14 |
| Assessment Only | Drinking Inventory of Consequences (DrInC) | 19.8 score on a scale | Standard Deviation 15.3 |