NCT05356533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

April 27, 2022

Results QC Date

March 22, 2024

Last Update Submit

September 8, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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);

    past month

  • 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.

    past month

  • 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);

    past month

  • 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.

    Past Month

  • 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.

    Past Month

Secondary Outcomes (1)

  • Depressive Symptoms

    Past month

Study Arms (2)

Intervention

ACTIVE COMPARATOR

A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention.

Behavioral: Drinking to Cope CBT skills

Assessment Control

NO INTERVENTION

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

Interventions

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

Intervention

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Results Point of Contact

Title
Jennifer Cadigan
Organization
University of Washington

Study Officials

  • Jennifer M Cadigan, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, School of Medicine: Psychiatry

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 2, 2022

Study Start

April 4, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

October 1, 2024

Results First Posted

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations