Post Traumatic Stress Disorder, Problem Drinking
Conditions
Brief summary
Sexual assault victimization is a common and particularly harmful form of trauma that is associated with increased risk for high-risk drinking and other conditions of public health concern, such as PTSD. Given evidence that sexual assault survivors who have low social support or receive negative social reactions to sexual assault disclosure are more likely to experience PTSD and drinking problems, improving social support is a novel target for intervention. The proposed study will attempt to prevent the onset of high-risk drinking and PTSD in sexual assault survivors by developing and testing a web-based early intervention aimed at increasing contact with social supporters and mitigating the harm of negative social reactions; ultimately, results will contribute to advancing the field's understanding of the potential for social support to mitigate the harm of trauma.
Detailed description
This study involves developing, modifying, and preliminarily testing an intervention to prevent high-risk drinking and PTSD in women who have experienced sexual assault (SA) in the past 10 weeks. In the pilot trial phase of this study, intervention feasibility will be tested in an open trial with N = 40 women with past-10-week SA histories, active drinking, and elevated distress. Participants will complete surveys at baseline, termination, and 3-month follow-up. Participants will be randomized to either the intervention (N = 20) or assessment-only control (N = 20). We hypothesize that (H1) most participants will respond positively on items assessing satisfaction with the intervention, (H2) participants will report above-average usability on a standardized measure, (H3) completion rates for daily activities will be similar to previous web-based interventions, (H4) participants will show significant learning as evidenced by increases in correct responses to knowledge questions from baseline to post, and (H5) participants in the intervention condition will evidence less high-risk drinking and PTSD at 3-month follow-up than participants in the assessment-only condition.
Interventions
BEHAVIORALApp-based intervention
A app-based cognitive-behavioral intervention to prevent the development of PTSD and high-risk drinking in recently-victimized adults
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* informed consent * self-identification as female * sexual assault, defined as endorsement of unwanted, attempted or completed sexual contact in the past 10 weeks * age \> 18 * English fluency * smartphone and internet access at least daily for 3 weeks and at least weekly for 3 months * consumption of \>1 alcoholic drink in the past month * \>1 episode of high-risk drinking in past 6 months, defined as either more than 3 drinks on a given day or more than 7 drinks in a given week * at least 3 symptom clusters endorsed on the PTSD Checklist.
Exclusion criteria
* active suicidality * psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Problem Drinking Scores at Baseline and 3 Weeks | Baseline, post-intervention (3 weeks after baseline) | Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S), which assesses alcohol use consequences. Range: 0-64; higher scores indicate worse outcome. |
| Problem Drinking Scores at Baseline and 3 Months | Baseline, 3 month follow-up | Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S), which assesses alcohol use consequences. Range: 0-64; higher scores indicate worse outcome. |
| Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks | Baseline, post-intervention (3 weeks after baseline) | Sum scores on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5), which assesses posttraumatic stress symptom severity. Range: 0-80; higher scores indicate worse outcome. |
| Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months | Baseline, 3 month follow-up | Sum scores on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5), which assesses posttraumatic stress symptom severity. Range: 0-80; higher scores indicate worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Consumption (Frequency) | Baseline, post-intervention (3 weeks after baseline), 3 month follow-up | Number of drinking days per week reported on the Daily Drinking Questionnaire |
| Anxiety | Baseline, post-intervention (3 weeks after baseline), 3 month follow-up | Sum scores on Generalized Anxiety Disorder-7 (GAD-7), which assesses symptoms of anxiety. Range: 0-21; higher scores indicate worse outcome. |
| Alcohol Consumption (Hours) | Baseline, post-intervention (3 weeks after baseline), 3 month follow-up | Hours spent drinking per week reported on the Daily Drinking Questionnaire |
| Coping Self-efficacy | Baseline, post-intervention (3 weeks after baseline), 3 month follow-up | Mean scores on the Trauma Coping Self-Efficacy Scale (CSE-T), which assesses one's perceived ability to manage the demands of recovering from a potentially-traumatic event. Range: 1 to 7; higher scores indicate better outcome. |
| Depression | Baseline, post-intervention (3 weeks after baseline), 3 month follow-up | Sum scores on the Patient Health Questionnaire-8 (PHQ-8), which assesses symptoms of depression. Range: 0-24; higher scores indicate worse outcome. |
| Alcohol Consumption (Quantity) | Baseline, post-intervention (3 weeks after baseline), 3 month follow-up | Number of drinks per week reported on the Daily Drinking Questionnaire |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from January 13th, 2021 to August 24th, 2021 via mass emails sent to registered students at the University of Washington, flyers, social media ads, and provider referrals.
Pre-assignment details
Participants were considered to be enrolled in the study once they provided informed consent at baseline. They completed the baseline assessment to confirm eligibility. Participants found to be eligible at baseline were automatically randomized.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants in the intervention condition completed 3 weeks of daily activities and symptom self-monitoring in the THRIVE app. Day 1 involved identification of activities to add to a self-care activity list with guidance around selecting activities that increase social contact, reduce alcohol use, and reduce avoidance. They also completed an active-learning exercise about cognitive distortions and created a stuck point to-do list consisting of their cognitive distortions. In subsequent days, participants were prompted to complete activities from both lists. They also had access to optional activities on topics such as asking for help, preventing isolation, deciding whether to disclose an assault, coping with negative reactions to disclosure, and thinking in helpful ways about social support. They were prompted to complete brief daily surveys in the app, which populated a symptom tracker. Participants had brief weekly phone contact with a coach to monitor safety and troubleshoot issues with app use.
App-based intervention: A app-based cognitive-behavioral intervention to prevent the development of PTSD and high-risk drinking in recently-victimized adults | 20 |
| Assessment-only Control Participants in the control condition completed 3 weeks symptom self-monitoring. They had access to a version of the app that included daily surveys and a symptom tracker populated by these surveys, but without any of the other exercises included in the experimental version of the app. Participants had brief weekly phone contact with a coach to monitor safety and troubleshoot issues with app use. | 21 |
| Total | 41 |
Baseline characteristics
| Characteristic | Intervention | Assessment-only Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 21 Participants | 41 Participants |
| Age, Continuous | 21.45 years STANDARD_DEVIATION 4.31 | 20.14 years STANDARD_DEVIATION 2.15 | 20.78 years STANDARD_DEVIATION 3.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 17 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 12 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 | 12 Participants | 6 Participants | 18 Participants |
| Region of Enrollment United States | 20 participants | 21 participants | 41 participants |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 |
| other Total, other adverse events | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months
Sum scores on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5), which assesses posttraumatic stress symptom severity. Range: 0-80; higher scores indicate worse outcome.
Time frame: Baseline, 3 month follow-up
Population: Missing data are present at 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months | Baseline | 46.60 score on a scale | Standard Deviation 11.45 |
| Intervention | Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months | 3 months | 22.10 score on a scale | Standard Deviation 11.56 |
| Assessment-only Control | Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months | Baseline | 39.81 score on a scale | Standard Deviation 12.22 |
| Assessment-only Control | Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months | 3 months | 25.30 score on a scale | Standard Deviation 15.81 |
p-value: 0.04Mixed Models Analysis
Primary
Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks
Sum scores on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5), which assesses posttraumatic stress symptom severity. Range: 0-80; higher scores indicate worse outcome.
Time frame: Baseline, post-intervention (3 weeks after baseline)
Population: Missing data are present at post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks | Baseline | 46.60 score on a scale | Standard Deviation 11.45 |
| Intervention | Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks | Post-intervention | 36.53 score on a scale | Standard Deviation 14 |
| Assessment-only Control | Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks | Baseline | 39.81 score on a scale | Standard Deviation 12.22 |
| Assessment-only Control | Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks | Post-intervention | 35.62 score on a scale | Standard Deviation 15.96 |
p-value: 0.38Mixed Models Analysis
Primary
Problem Drinking Scores at Baseline and 3 Months
Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S), which assesses alcohol use consequences. Range: 0-64; higher scores indicate worse outcome.
Time frame: Baseline, 3 month follow-up
Population: Missing data are present at 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Problem Drinking Scores at Baseline and 3 Months | Baseline | 12.40 score on a scale | Standard Deviation 8.4 |
| Intervention | Problem Drinking Scores at Baseline and 3 Months | 3 months | 5.75 score on a scale | Standard Deviation 4.69 |
| Assessment-only Control | Problem Drinking Scores at Baseline and 3 Months | Baseline | 11.00 score on a scale | Standard Deviation 6.43 |
| Assessment-only Control | Problem Drinking Scores at Baseline and 3 Months | 3 months | 5.55 score on a scale | Standard Deviation 5.88 |
p-value: 0.94Mixed Models Analysis
Primary
Problem Drinking Scores at Baseline and 3 Weeks
Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S), which assesses alcohol use consequences. Range: 0-64; higher scores indicate worse outcome.
Time frame: Baseline, post-intervention (3 weeks after baseline)
Population: Missing data are present at post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Problem Drinking Scores at Baseline and 3 Weeks | Baseline | 12.40 score on a scale | Standard Deviation 8.4 |
| Intervention | Problem Drinking Scores at Baseline and 3 Weeks | Post-intervention | 10.16 score on a scale | Standard Deviation 10 |
| Assessment-only Control | Problem Drinking Scores at Baseline and 3 Weeks | Baseline | 11.00 score on a scale | Standard Deviation 6.43 |
| Assessment-only Control | Problem Drinking Scores at Baseline and 3 Weeks | Post-intervention | 7.62 score on a scale | Standard Deviation 6.26 |
p-value: 0.6Mixed Models Analysis
Secondary
Alcohol Consumption (Frequency)
Number of drinking days per week reported on the Daily Drinking Questionnaire
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Population: Missing data are present at post-intervention and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Alcohol Consumption (Frequency) | Baseline | 2.90 drinking days per week | Standard Deviation 1.83 |
| Intervention | Alcohol Consumption (Frequency) | Post-intervention | 2.37 drinking days per week | Standard Deviation 1.61 |
| Intervention | Alcohol Consumption (Frequency) | 3 months | 2.30 drinking days per week | Standard Deviation 1.81 |
| Assessment-only Control | Alcohol Consumption (Frequency) | Baseline | 2.76 drinking days per week | Standard Deviation 1.48 |
| Assessment-only Control | Alcohol Consumption (Frequency) | Post-intervention | 2.47 drinking days per week | Standard Deviation 1.36 |
| Assessment-only Control | Alcohol Consumption (Frequency) | 3 months | 2.35 drinking days per week | Standard Deviation 1.81 |
Comparison: Baseline to post-intervention onlyp-value: 0.75Mixed Models Analysis
Comparison: Baseline to 3 monthsp-value: 0.64Mixed Models Analysis
Comparison: Baseline to post-intervention only
Comparison: Baseline to 3 months
Secondary
Alcohol Consumption (Hours)
Hours spent drinking per week reported on the Daily Drinking Questionnaire
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Population: Missing data are present at post-intervention and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Alcohol Consumption (Hours) | Baseline | 8.15 drinking hours per week | Standard Deviation 8.03 |
| Intervention | Alcohol Consumption (Hours) | Post-intervention | 6.84 drinking hours per week | Standard Deviation 7.13 |
| Intervention | Alcohol Consumption (Hours) | 3 months | 5.75 drinking hours per week | Standard Deviation 5.24 |
| Assessment-only Control | Alcohol Consumption (Hours) | Baseline | 8.33 drinking hours per week | Standard Deviation 5.76 |
| Assessment-only Control | Alcohol Consumption (Hours) | Post-intervention | 7.14 drinking hours per week | Standard Deviation 6.62 |
| Assessment-only Control | Alcohol Consumption (Hours) | 3 months | 10.15 drinking hours per week | Standard Deviation 16.26 |
Comparison: Baseline to post-intervention onlyp-value: 0.86Mixed Models Analysis
Comparison: Baseline to 3 monthsp-value: 0.55Mixed Models Analysis
Comparison: Baseline to post-intervention only
Comparison: Baseline to 3 months
Secondary
Alcohol Consumption (Quantity)
Number of drinks per week reported on the Daily Drinking Questionnaire
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Population: Missing data are present at post-intervention and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Alcohol Consumption (Quantity) | Baseline | 9.35 drinks per week | Standard Deviation 7.38 |
| Intervention | Alcohol Consumption (Quantity) | Post-intervention | 7.68 drinks per week | Standard Deviation 7.81 |
| Intervention | Alcohol Consumption (Quantity) | 3 months | 6.25 drinks per week | Standard Deviation 5.5 |
| Assessment-only Control | Alcohol Consumption (Quantity) | Baseline | 11.10 drinks per week | Standard Deviation 6.79 |
| Assessment-only Control | Alcohol Consumption (Quantity) | Post-intervention | 9.57 drinks per week | Standard Deviation 6.79 |
| Assessment-only Control | Alcohol Consumption (Quantity) | 3 months | 7.70 drinks per week | Standard Deviation 5.9 |
Comparison: Baseline to post-intervention onlyp-value: 0.85Mixed Models Analysis
Comparison: Baseline to 3 monthsp-value: 0.96Mixed Models Analysis
Comparison: Baseline to post-intervention only
Comparison: Baseline to 3 months
Secondary
Anxiety
Sum scores on Generalized Anxiety Disorder-7 (GAD-7), which assesses symptoms of anxiety. Range: 0-21; higher scores indicate worse outcome.
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Population: Missing data are present at post-intervention and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Anxiety | Baseline | 13.35 score on a scale | Standard Deviation 4.52 |
| Intervention | Anxiety | Post-intervention | 11.32 score on a scale | Standard Deviation 5.69 |
| Intervention | Anxiety | 3 months | 9.05 score on a scale | Standard Deviation 6.71 |
| Assessment-only Control | Anxiety | Baseline | 12.14 score on a scale | Standard Deviation 5.34 |
| Assessment-only Control | Anxiety | Post-intervention | 11.33 score on a scale | Standard Deviation 6.49 |
| Assessment-only Control | Anxiety | 3 months | 8.80 score on a scale | Standard Deviation 5.48 |
Comparison: Baseline to post-intervention onlyp-value: 0.51Mixed Models Analysis
Comparison: Baseline to 3 monthsp-value: 0.64Mixed Models Analysis
Comparison: Baseline to post-intervention only
Comparison: Baseline to 3 months
Secondary
Coping Self-efficacy
Mean scores on the Trauma Coping Self-Efficacy Scale (CSE-T), which assesses one's perceived ability to manage the demands of recovering from a potentially-traumatic event. Range: 1 to 7; higher scores indicate better outcome.
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Population: Missing data are present at post-intervention and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Coping Self-efficacy | 3 months | 4.96 score on a scale | Standard Deviation 1 |
| Intervention | Coping Self-efficacy | Baseline | 3.59 score on a scale | Standard Deviation 0.63 |
| Intervention | Coping Self-efficacy | Post-intervention | 4.31 score on a scale | Standard Deviation 0.79 |
| Assessment-only Control | Coping Self-efficacy | 3 months | 5.08 score on a scale | Standard Deviation 1.31 |
| Assessment-only Control | Coping Self-efficacy | Baseline | 4.00 score on a scale | Standard Deviation 0.76 |
| Assessment-only Control | Coping Self-efficacy | Post-intervention | 4.15 score on a scale | Standard Deviation 1.05 |
Comparison: Baseline to post-intervention onlyp-value: 0.04Mixed Models Analysis
Comparison: Baseline to 3 monthsp-value: 0.34Mixed Models Analysis
Comparison: Baseline to post-intervention only
Comparison: Baseline to 3 months
Secondary
Depression
Sum scores on the Patient Health Questionnaire-8 (PHQ-8), which assesses symptoms of depression. Range: 0-24; higher scores indicate worse outcome.
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Population: Missing data are present at post-intervention and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Depression | Baseline | 14.30 score on a scale | Standard Deviation 5.73 |
| Intervention | Depression | Post-intervention | 11.26 score on a scale | Standard Deviation 6.69 |
| Intervention | Depression | 3 months | 9.16 score on a scale | Standard Deviation 6.72 |
| Assessment-only Control | Depression | Baseline | 10.81 score on a scale | Standard Deviation 5.14 |
| Assessment-only Control | Depression | Post-intervention | 10.14 score on a scale | Standard Deviation 5.58 |
| Assessment-only Control | Depression | 3 months | 7.65 score on a scale | Standard Deviation 6.06 |
Comparison: Baseline to post-intervention only
Comparison: Baseline to 3 months
Comparison: Baseline to post-intervention onlyp-value: 0.13Mixed Models Analysis
Comparison: Baseline to 3 monthsp-value: 0.24Mixed Models Analysis