Trial Outcomes & Findings for Web-Based Treatment of Heavy Drinking Among Women With a History of Sexual Trauma (NCT NCT03111056)
NCT ID: NCT03111056
Last Updated: 2026-05-14
Results Overview
Assesses typical alcohol consumption over the course of a typical week in the past month
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Baseline (pre-treatment), Immediately upon completion of the intervention (post-treatment), 1-month and 6-month follow-up
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
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).
|
Assessment Only Control
The Assessment only control condition consisted of all assessments that the intervention condition completed but no skill modules.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
90
|
95
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
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).
|
Assessment Only Control
The Assessment only control condition consisted of all assessments that the intervention condition completed but no skill modules.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
5
|
Baseline Characteristics
Web-Based Treatment of Heavy Drinking Among Women With a History of Sexual Trauma
Baseline characteristics by cohort
| Measure |
Intervention Condition
n=100 Participants
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).
|
Assessment Only Control
n=100 Participants
The Assessment only control condition consisted of all assessments that the intervention condition completed but no skill modules.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.1 years
STANDARD_DEVIATION 3.6 • n=1512 Participants
|
20.8 years
STANDARD_DEVIATION 1.6 • n=504 Participants
|
20.9 years
STANDARD_DEVIATION 2.8 • n=2016 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=1512 Participants
|
100 Participants
n=504 Participants
|
200 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=1512 Participants
|
15 Participants
n=504 Participants
|
27 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=1512 Participants
|
69 Participants
n=504 Participants
|
138 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=1512 Participants
|
10 Participants
n=504 Participants
|
25 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=1512 Participants
|
4 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=1512 Participants
|
10 Participants
n=504 Participants
|
20 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=1512 Participants
|
90 Participants
n=504 Participants
|
180 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=1512 Participants
|
100 participants
n=504 Participants
|
200 participants
n=2016 Participants
|
|
Traumatic Life Events Questionnaire
|
33 Participants
n=1512 Participants
|
16 Participants
n=504 Participants
|
49 Participants
n=2016 Participants
|
|
Revised Sexual Experiences Survey (RSES)
|
26.4 units on a scale
STANDARD_DEVIATION 16.2 • n=1512 Participants
|
26.9 units on a scale
STANDARD_DEVIATION 15.2 • n=504 Participants
|
26.7 units on a scale
STANDARD_DEVIATION 15.7 • n=2016 Participants
|
|
Daily Drinking Questionnaire (DDQ)
|
15.9 Number of standard drinks per week
STANDARD_DEVIATION 8.7 • n=1512 Participants
|
14.0 Number of standard drinks per week
STANDARD_DEVIATION 6.4 • n=504 Participants
|
14.9 Number of standard drinks per week
STANDARD_DEVIATION 7.7 • n=2016 Participants
|
|
Heavy episodic drinking (HED) frequency
|
5.9 Episodes per month
STANDARD_DEVIATION 3.9 • n=1512 Participants
|
4.9 Episodes per month
STANDARD_DEVIATION 3.6 • n=504 Participants
|
5.4 Episodes per month
STANDARD_DEVIATION 3.8 • n=2016 Participants
|
|
Difficulties in Emotion Regulation Scale (DERS)
|
96.6 units on a scale
STANDARD_DEVIATION 25.2 • n=1512 Participants
|
93.9 units on a scale
STANDARD_DEVIATION 24.9 • n=504 Participants
|
95.3 units on a scale
STANDARD_DEVIATION 25.0 • n=2016 Participants
|
|
Distress Tolerance Scale (DTS)
|
2.9 units on a scale
STANDARD_DEVIATION 0.9 • n=1512 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 0.8 • n=504 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.8 • n=2016 Participants
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
|
23.0 units on a scale
STANDARD_DEVIATION 19.1 • n=1512 Participants
|
21.1 units on a scale
STANDARD_DEVIATION 15.7 • n=504 Participants
|
22.1 units on a scale
STANDARD_DEVIATION 17.5 • n=2016 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment), Immediately upon completion of the intervention (post-treatment), 1-month and 6-month follow-upPopulation: 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.
Assesses typical alcohol consumption over the course of a typical week in the past month
Outcome measures
| Measure |
Intervention Condition
n=100 Participants
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).
|
Assessment Only Control
n=99 Participants
The Assessment only control condition consisted of all assessments that the intervention condition completed but no skill modules.
|
|---|---|---|
|
Changes in Daily Drinking Questionnaire
Pre-Treatment
|
15.9 Drinks per week
Standard Deviation 8.7
|
14.0 Drinks per week
Standard Deviation 6.4
|
|
Changes in Daily Drinking Questionnaire
Post-Treatment
|
10.1 Drinks per week
Standard Deviation 6.7
|
11.6 Drinks per week
Standard Deviation 7.0
|
|
Changes in Daily Drinking Questionnaire
1-month follow-up
|
9.5 Drinks per week
Standard Deviation 8.0
|
9.9 Drinks per week
Standard Deviation 7.3
|
|
Changes in Daily Drinking Questionnaire
6-month follow-up
|
8.7 Drinks per week
Standard Deviation 7.3
|
8.6 Drinks per week
Standard Deviation 10.2
|
Adverse Events
Web-Based Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Assessment Only Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place