- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05356533
Coping Skills for Alcohol Use
Development of an Interactive, Web-based Drinking to Cope Intervention and Tools to Assess Coping Skill Utilization
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Intervention
A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.
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Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills
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No Intervention: Assessment Control
A total of 60 young adults will be randomized to the assessment only control condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol Use-Peak Drinks
Time Frame: past month
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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);
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past month
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Alcohol Use-drinks Per Week
Time Frame: past month
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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.
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past month
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Alcohol Use-heavy Episodic Drinking
Time Frame: past month
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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);
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past month
|
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Alcohol Negative Consequences
Time Frame: Past Month
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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.
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Past Month
|
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Alcohol Coping
Time Frame: Past Month
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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.
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Past Month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Depressive Symptoms
Time Frame: 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.
|
Past month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer M Cadigan, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00008998
- 1R34AA028074 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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