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Coping Skills for Alcohol Use

Development of an Interactive, Web-based Drinking to Cope Intervention and Tools to Assess Coping Skill Utilization

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05356533
Enrollment
120
Registered
2022-05-02
Start date
2022-04-04
Completion date
2022-12-30
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Coping Skills

Brief summary

A total of 120 young adults who drink to cope with negative affect will be randomized to a 4-week, web-based intervention with interactive modules on cognitive-behavioral skills (n=60) or an assessment only control (n=60). Participants will complete 4 weekly assessments and a 1- and 3-month follow-up.

Interventions

BEHAVIORALDrinking to Cope CBT skills

Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

\- Eligibility criteria at recruitment include: 1)18-25 years old; 2) Currently live in the state of WA, 3) Have a valid email address and phone number, 4) Drank alcohol at least once in the past month, 5) report at least 1 alcohol-related problem in the past month, 6) report using alcohol to cope with distress via negative reinforcement (i.e., to provide relief or reduction of stress or depressed mood) in the past month

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Alcohol Use-Peak Drinkspast monthPeak 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);
Alcohol Use-drinks Per Weekpast monthThe 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.
Alcohol Use-heavy Episodic Drinkingpast monthHeavy 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);
Alcohol Negative ConsequencesPast MonthAlcohol 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.
Alcohol CopingPast MonthThe 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.

Secondary

MeasureTime frameDescription
Depressive SymptomsPast monthdepressive 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
60
Assessment Control
A total of 60 young adults will be randomized to the assessment only control condition.
60
Total120

Baseline characteristics

CharacteristicInterventionAssessment ControlTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
60 Participants60 Participants120 Participants
Age, Continuous21.76 years
STANDARD_DEVIATION 2.095
21.84 years
STANDARD_DEVIATION 2.154
21.80 years
STANDARD_DEVIATION 2.117
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants7 Participants17 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
50 Participants53 Participants103 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
13 Participants22 Participants35 Participants
Race (NIH/OMB)
Black or African American
3 Participants3 Participants6 Participants
Race (NIH/OMB)
More than one race
5 Participants9 Participants14 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants5 Participants
Race (NIH/OMB)
White
36 Participants22 Participants58 Participants
Region of Enrollment
United States
60 participants60 participants120 participants
Sex: Female, Male
Female
35 Participants37 Participants72 Participants
Sex: Female, Male
Male
25 Participants23 Participants48 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 60
other
Total, other adverse events
0 / 600 / 60
serious
Total, serious adverse events
0 / 600 / 60

Outcome results

Primary

Alcohol Coping

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.

Time frame: Past Month

ArmMeasureValue (MEAN)Dispersion
InterventionAlcohol Coping1.24 score on a scaleStandard Deviation 0.48
Assessment ControlAlcohol Coping1.62 score on a scaleStandard Deviation 0.86
p-value: >0.05Mixed Models Analysis
Primary

Alcohol Negative Consequences

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.

Time frame: Past Month

ArmMeasureValue (MEAN)Dispersion
InterventionAlcohol Negative Consequences3.79 number of consequencesStandard Deviation 4.7
Assessment ControlAlcohol Negative Consequences4.64 number of consequencesStandard Deviation 5.91
p-value: <0.05Mixed Models Analysis
Primary

Alcohol Use-drinks Per Week

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.

Time frame: past month

ArmMeasureValue (MEAN)Dispersion
InterventionAlcohol Use-drinks Per Week5.40 drinks per weekStandard Deviation 5.51
Assessment ControlAlcohol Use-drinks Per Week6.09 drinks per weekStandard Deviation 6.56
p-value: >0.05Mixed Models Analysis
Primary

Alcohol Use-heavy Episodic Drinking

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);

Time frame: past month

ArmMeasureValue (MEAN)Dispersion
InterventionAlcohol Use-heavy Episodic Drinking1.69 score on a scaleStandard Deviation 0.92
Assessment ControlAlcohol Use-heavy Episodic Drinking1.79 score on a scaleStandard Deviation 1.03
p-value: >0.05Mixed Models Analysis
Primary

Alcohol Use-Peak Drinks

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);

Time frame: past month

ArmMeasureValue (MEAN)Dispersion
InterventionAlcohol Use-Peak Drinks4.71 number of drinksStandard Deviation 3.25
Assessment ControlAlcohol Use-Peak Drinks4.79 number of drinksStandard Deviation 3.64
p-value: >0.05Mixed Models Analysis
p-value: >0.05ANOVA
Secondary

Depressive Symptoms

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.

Time frame: Past month

ArmMeasureValue (MEAN)Dispersion
InterventionDepressive Symptoms6.98 score on a scaleStandard Deviation 5.31
Assessment ControlDepressive Symptoms7.98 score on a scaleStandard Deviation 5.41
p-value: >0.05Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026