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The goal of this study is to empirically evaluate a web-based intervention to reduce heavy drinking among college women with a history of sexual assault who display elevated levels of psychological distress. College women with a history of sexual assault often report more heavy drinking and psychological distress than women without a history of assault. Moreover, women with assault histories often have difficulty regulating their emotions and tolerating distress which can lead to a pattern of drinking to cope distress. Trauma exposure, negative mood, and poor coping strategies have been associated with poor treatment outcomes and relapse following alcohol treatment. Incorporating distress tolerance and emotion regulation skills with an alcohol intervention may enhance treatment effects among women with a history of sexual assault by decreasing their motivation to drink to cope with depression or anxiety and by building adaptive coping strategies. Therefore, the web-based intervention will include cognitive behavioral skills for reducing alcohol consumption and incorporate emotion regulation and distress tolerance skills from Dialectical Behavior Therapy.
For the small randomized controlled trial, heavy drinking college women with a history of sexual assault will be recruited and randomized to receive the intervention or an assessment only control. Online surveys will be administered at baseline, and post-treatment as well as 1-month and 6-months post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-Based Intervention | Experimental | In an effort to reduce heavy drinking, participants will be asked to complete a daily monitoring assessment each morning for 14 days. Based on their responses, they will be provided a coping skill to either directly address their alcohol use or attempt to improve their emotion regulation and distress tolerance skills. |
|
| Assessment Only Control | No Intervention | Participants will be asked to complete only the daily monitoring assessment each morning for 14 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alc-ERDT | Behavioral | Web-based cognitive behavioral skills-based alcohol intervention that incorporates emotion regulation and distress tolerance skills |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Daily Drinking Questionnaire | Assesses typical alcohol consumption over the course of a typical week in the past month | Baseline (pre-treatment), Immediately upon completion of the intervention (post-treatment), 1-month and 6-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
Self-identified as female
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Stappenbeck, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Condition | The intervention consisted of seven alcohol reduction skill modules emphasizing cognitive behavioral strategies for decreasing alcohol consumption (Cronce & Larimer, 2011; Larimer & Cronce, 2007, Monti et al., 2002) that have demonstrated effectiveness among young adults (Dimeff & McNeely, 2000; Neighbors et al., 2004; Walters et al., 2007; Weitzel et al., 2007). The intervention also consisted of seven regulatory skills that targeted emotion regulation and distress tolerance that were adapted from Dialectical Behavior Therapy (DBT; Linehan, 1993, 2014). |
| FG001 | Assessment Only Control | The Assessment only control condition consisted of all assessments that the intervention condition completed but no skill modules. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Condition | The intervention consisted of seven alcohol reduction skill modules emphasizing cognitive behavioral strategies for decreasing alcohol consumption (Cronce & Larimer, 2011; Larimer & Cronce, 2007, Monti et al., 2002) that have demonstrated effectiveness among young adults (Dimeff & McNeely, 2000; Neighbors et al., 2004; Walters et al., 2007; Weitzel et al., 2007). The intervention also consisted of seven regulatory skills that targeted emotion regulation and distress tolerance that were adapted from Dialectical Behavior Therapy (DBT; Linehan, 1993, 2014). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Daily Drinking Questionnaire | Assesses typical alcohol consumption over the course of a typical week in the past month | There was missing drinks per week data from 1 individual assigned to the assessment only control condition which resulted in 99 (rather than 100) participants in that condition. | Posted | Mean | Standard Deviation | Drinks per week | Baseline (pre-treatment), Immediately upon completion of the intervention (post-treatment), 1-month and 6-month follow-up |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Web-Based Intervention | In an effort to reduce heavy drinking, participants will be asked to complete a daily monitoring assessment each morning for 14 days. Based on their responses, they will be provided a coping skill to either directly address their alcohol use or attempt to improve their emotion regulation and distress tolerance skills. Alc-ERDT: Web-based cognitive behavioral skills-based alcohol intervention that incorporates emotion regulation and distress tolerance skills |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Stappenbeck | Georgia State University | 404-413-6321 | cstappenbeck@gsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2022 | Nov 2, 2022 | Prot_SAP_000.pdf |
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The intervention and assessments are all completed online and therefore masking is not necessary.
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| BG001 | Assessment Only Control | The Assessment only control condition consisted of all assessments that the intervention condition completed but no skill modules. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Traumatic Life Events Questionnaire | The Traumatic Life Events Questionnaire (TLEQ; Kubany et al., 2000) included four items to assess childhood sexual abuse perpetrated by someone close in age as well as by someone at least five years older before they were 13. | Count of Participants | Participants |
|
| Revised Sexual Experiences Survey (RSES) | The RSES (Koss et al., 2007) assessed adolescent/adult sexual assault severity. Participants reported how often (0 = Never to 3 = 3 or more times) they had experienced different types of unwanted sexual behavior by each tactic since age 14. We calculated a severity score utilizing a scoring method described by Davis and colleagues (2014), which involves multiplying a rank based on the severity of the outcome and tactic combination by the frequency in which each combination occurred and summing (possible range 0-63). Higher scores reflect greater sexual assault severity. | Mean | Standard Deviation | units on a scale |
|
| Daily Drinking Questionnaire (DDQ) | The DDQ assessed the number of standard drinks consumed each day of a typical week during the past month. Items were summed to attain the total number of weekly drinks. The observed range was 7-64 drinks per week, with higher numbers reflecting more drinks per week. | Mean | Standard Deviation | Number of standard drinks per week |
|
| Heavy episodic drinking (HED) frequency | One item was taken from the NIAAA Recommended Alcohol Questions (NIAAA, 2003) to assess HED frequency - how many times they consumed 4 or more drinks within a two-hour period - in the past month on a scale of 0 to 30 times. The observed range was 2-25 with greater values reflecting more episodes of HED. | Mean | Standard Deviation | Episodes per month |
|
| Difficulties in Emotion Regulation Scale (DERS) | The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) assessed emotion dysregulation. Participants responded to 36 items using a 5-point scale (e.g., "When I'm upset, I have difficulty thinking about anything else."; 1 = Almost never to 5 = Almost always) to indicate how they generally respond when they experience unpleasant or negative events. Items were summed (observed range 44-165), with higher scores indicating greater emotion dysregulation. | Mean | Standard Deviation | units on a scale |
|
| Distress Tolerance Scale (DTS) | The Distress Tolerance Scale (DTS; Simons & Gaher, 2005) assessed current ability to tolerate distress. Participants responded to 16 items utilizing a 5-point scale (e.g., "My feelings of distress are so intense that they take over."; 1 = Strongly agree to 5 = Strongly disagree) to indicate how they generally manage distress. Items were averaged with a possible range from 1-5, with higher scores indicating greater ability to tolerate distress. | Mean | Standard Deviation | units on a scale |
|
| Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) | The Post-Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5; Weathers et al., 2013) assessed past-month PTSD symptom severity. Participants responded to 20 items indicating how much they had been bothered by a variety of problems that people sometimes have in response to stressful life experiences (e.g., "Repeated, disturbing, and unwanted memories of the stressful experience."; 0 = Not at all to 4 = Extremely). Items were summed to create a PTSD symptom severity score. The observed range was 0-80 with higher scores indicating greater PTSD symptom severity. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Assessment Only Control | The Assessment only control condition consisted of all assessments that the intervention condition completed but no skill modules. |
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Assessment Only Control | Participants will be asked to complete only the daily monitoring assessment each morning for 14 days. | 0 | 100 | 0 | 100 | 0 | 100 |
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