Trial Outcomes & Findings for Emotion Regulation Interventions for Alcohol-Related Sexual Aggression (NCT NCT03159468)
NCT ID: NCT03159468
Last Updated: 2019-07-26
Results Overview
Sexual Aggression Intentions Scale. Construct: Self-reported ratings of sexual aggression likelihood in a hypothetical scenario. Minimum value of 1 ("Very unlikely"). Maximum value of 7 ("Very likely"). Higher scores mean a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
209 participants
Primary outcome timeframe
Within one hour after receiving the intervention
Results posted on
2019-07-26
Participant Flow
All enrolled participants were assigned to one of the six arms.
Participant milestones
| Measure |
Cognitive Restructuring & Alcohol Condition
Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then consume an alcoholic beverage in the lab.
Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
|
Mindfulness & Alcohol Condition
Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive an alcoholic beverage in the lab.
Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.
|
Nutrition Information & Alcohol Condition
Participants receive general information about nutrition, then receive an alcoholic beverage in the lab.
|
Cognitive Restructuring & No Alcohol Condition
Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then consume a non-alcoholic beverage in the lab.
Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
|
Mindfulness & No Alcohol Condition
Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive a non-alcoholic beverage in the lab.
Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.
|
Nutrition Information & No Alcohol Condition
Participants receive general information about nutrition, then receive a non-alcoholic beverage in the lab.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
37
|
34
|
34
|
34
|
|
Overall Study
COMPLETED
|
35
|
35
|
34
|
34
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cognitive Restructuring & Alcohol Condition
Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then consume an alcoholic beverage in the lab.
Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
|
Mindfulness & Alcohol Condition
Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive an alcoholic beverage in the lab.
Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.
|
Nutrition Information & Alcohol Condition
Participants receive general information about nutrition, then receive an alcoholic beverage in the lab.
|
Cognitive Restructuring & No Alcohol Condition
Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then consume a non-alcoholic beverage in the lab.
Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
|
Mindfulness & No Alcohol Condition
Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive a non-alcoholic beverage in the lab.
Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.
|
Nutrition Information & No Alcohol Condition
Participants receive general information about nutrition, then receive a non-alcoholic beverage in the lab.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
0
|
0
|
0
|
Baseline Characteristics
Emotion Regulation Interventions for Alcohol-Related Sexual Aggression
Baseline characteristics by cohort
| Measure |
Cognitive Restructuring & Alcohol Condition
n=35 Participants
Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received an alcoholic beverage in the lab.
Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
|
Mindfulness & Alcohol Condition
n=35 Participants
Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received an alcoholic beverage in the lab.
Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.
|
Nutrition Information & Alcohol Condition
n=37 Participants
Participants received general information about nutrition, then received an alcoholic beverage in the lab.
|
Cognitive Restructuring & No Alcohol Condition
n=34 Participants
Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.
Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
|
Mindfulness & No Alcohol Condition
n=34 Participants
Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.
Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.
|
Nutrition Information & No Alcohol Condition
n=34 Participants
Participants received general information about nutrition, then received a non-alcoholic beverage in the lab.
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
24.67 years
STANDARD_DEVIATION 2.88 • n=5 Participants
|
24.06 years
STANDARD_DEVIATION 2.78 • n=7 Participants
|
25.09 years
STANDARD_DEVIATION 3.03 • n=5 Participants
|
25.32 years
STANDARD_DEVIATION 2.58 • n=4 Participants
|
24.35 years
STANDARD_DEVIATION 2.60 • n=21 Participants
|
25.08 years
STANDARD_DEVIATION 2.68 • n=8 Participants
|
24.76 years
STANDARD_DEVIATION 2.77 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
209 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
187 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
125 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Body Weight
|
175.29 pounds
STANDARD_DEVIATION 26.54 • n=5 Participants
|
170.34 pounds
STANDARD_DEVIATION 24.66 • n=7 Participants
|
170.26 pounds
STANDARD_DEVIATION 26.75 • n=5 Participants
|
184.09 pounds
STANDARD_DEVIATION 48.79 • n=4 Participants
|
173.53 pounds
STANDARD_DEVIATION 21.29 • n=21 Participants
|
170.97 pounds
STANDARD_DEVIATION 21.00 • n=8 Participants
|
174.07 pounds
STANDARD_DEVIATION 29.72 • n=8 Participants
|
PRIMARY outcome
Timeframe: Within one hour after receiving the interventionSexual Aggression Intentions Scale. Construct: Self-reported ratings of sexual aggression likelihood in a hypothetical scenario. Minimum value of 1 ("Very unlikely"). Maximum value of 7 ("Very likely"). Higher scores mean a worse outcome.
Outcome measures
| Measure |
Cognitive Restructuring & Alcohol Condition
n=35 Participants
Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received an alcoholic beverage in the lab.
Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
|
Mindfulness & Alcohol Condition
n=35 Participants
Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received an alcoholic beverage in the lab.
Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.
|
Nutrition Information & Alcohol Condition
n=34 Participants
Participants received general information about nutrition, then received an alcoholic beverage in the lab.
|
Cognitive Restructuring & No Alcohol Condition
n=34 Participants
Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.
Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
|
Mindfulness & No Alcohol Condition
n=34 Participants
Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received a non-alcoholic beverage in the lab.
Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.
|
Nutrition Information & No Alcohol Condition
n=34 Participants
Participants received general information about nutrition, then received a non-alcoholic beverage in the lab.
|
|---|---|---|---|---|---|---|
|
Sexual Aggression Intentions
|
1.58 score on a scale
Standard Deviation 1.12
|
1.90 score on a scale
Standard Deviation 1.28
|
2.18 score on a scale
Standard Deviation 1.59
|
1.53 score on a scale
Standard Deviation 1.16
|
1.38 score on a scale
Standard Deviation .90
|
1.70 score on a scale
Standard Deviation 1.15
|
Adverse Events
Cognitive Restructuring & Alcohol Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mindfulness & Alcohol Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nutrition Information & Alcohol Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Restrucuring & No Alcohol Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mindfulness & No Alcohol Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nutrition Information & No Alcohol Condition
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