Trial Outcomes & Findings for Coping Skills for Alcohol Use (NCT NCT05356533)

Last Updated: 2024-10-01

Results Overview

Peak number of drinks; Item measuring peak alcohol consumption, "Think of the occasion you drank the most this past month. How much did you drink?", response options ranged from 0 (0 drinks) to 25 (25+ drinks);

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

past month

Results posted on

2024-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. Drinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills	Assessment Control A total of 60 young adults will be randomized to the assessment only control condition.
Overall Study STARTED	60	60
Overall Study COMPLETED	49	57
Overall Study NOT COMPLETED	11	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coping Skills for Alcohol Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=60 Participants A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. Drinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills	Assessment Control n=60 Participants A total of 60 young adults will be randomized to the assessment only control condition.	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	21.76 years STANDARD_DEVIATION 2.095 • n=5 Participants	21.84 years STANDARD_DEVIATION 2.154 • n=7 Participants	21.80 years STANDARD_DEVIATION 2.117 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	53 Participants n=7 Participants	103 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	22 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	22 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	60 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: past month

Outcome measures

Outcome measures
Measure	Intervention n=48 Participants A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. Drinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills	Assessment Control n=56 Participants A total of 60 young adults will be randomized to the assessment only control condition.
Alcohol Use-Peak Drinks	4.71 number of drinks Standard Deviation 3.25	4.79 number of drinks Standard Deviation 3.64

PRIMARY outcome

Timeframe: past month

The DDQ (Collins, Parks, \& Marlatt, 1985) was used to measure the quantity of alcohol consumed by asking participants to estimate the typical number of drinks consumed on each day of the week, on average during the past month. A sum score of weekly total drinks per week was then calculated as the sum of the total number of drinks per week reported.

Outcome measures

Outcome measures
Measure	Intervention n=48 Participants A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. Drinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills	Assessment Control n=56 Participants A total of 60 young adults will be randomized to the assessment only control condition.
Alcohol Use-drinks Per Week	5.40 drinks per week Standard Deviation 5.51	6.09 drinks per week Standard Deviation 6.56

PRIMARY outcome

Timeframe: past month

Heavy Episodic Drinking; NIAAA item assessing binge drinking, "During the past month, how often did you have \[4 or more drinks (for women) /5 or more drinks (for men)\] containing any kind of alcohol within a two-hour period?", response options ranged from 0 (Never) to 7 (Every day);

Outcome measures

Outcome measures
Measure	Intervention n=49 Participants A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. Drinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills	Assessment Control n=57 Participants A total of 60 young adults will be randomized to the assessment only control condition.
Alcohol Use-heavy Episodic Drinking	1.69 score on a scale Standard Deviation 0.92	1.79 score on a scale Standard Deviation 1.03

PRIMARY outcome

Timeframe: Past Month

Alcohol Negative Consequences, Sum score (count) of negative consequences taken from Brief Young Adult Alcohol Consequences Questionnaire; Scores ranged from 0-24, with higher scores associated with more consequences.

Outcome measures

Outcome measures
Measure	Intervention n=48 Participants A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. Drinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills	Assessment Control n=55 Participants A total of 60 young adults will be randomized to the assessment only control condition.
Alcohol Negative Consequences	3.79 number of consequences Standard Deviation 4.70	4.64 number of consequences Standard Deviation 5.91

PRIMARY outcome

Timeframe: Past Month

The Drinking Motives Questionnaire-Revised (DMQR; Grant V.V., Stewart S.H., O'Connor R.M., Backwell E., \& Conrod P.J. (2007). Psychometric evaluation of the five-factor Modified Drinking Motives Questionnaire-Revised in undergraduates. Addictive Behaviors, 32(11), 2611-2632. Doi: 10.1016/j.addbeh.2007.07.004 ) was used to assess reasons for drinking. Using a 5-point scale (ranging from 'almost never/never' to 'almost always/always' participants rate how frequently they use alcohol for various reasons. The alcohol coping motives subscale was used which takes the average of the 9 items on the coping-depression subscale. Average scores ranged from 1-5, with higher scores are associated with greater use of coping.

Outcome measures

Outcome measures
Measure	Intervention n=48 Participants A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. Drinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills	Assessment Control n=56 Participants A total of 60 young adults will be randomized to the assessment only control condition.
Alcohol Coping	1.24 score on a scale Standard Deviation 0.48	1.62 score on a scale Standard Deviation 0.86

SECONDARY outcome

Timeframe: Past month

depressive symptoms; The eight-item Patient Health Questionnaire depression scale (PHQ-8) was used to assess for symptoms of depression. A sum of the 8 items was used, with the summed score ranging from 0-24. Higher scores represent greater symptoms of depression.

Outcome measures

Outcome measures
Measure	Intervention n=46 Participants A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. Drinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills	Assessment Control n=54 Participants A total of 60 young adults will be randomized to the assessment only control condition.
Depressive Symptoms	6.98 score on a scale Standard Deviation 5.31	7.98 score on a scale Standard Deviation 5.41

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Assessment 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

Jennifer Cadigan

University of Washington

Phone: 206-543-5689

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place