BRAI: Brief Religious Alcohol Intervention

Sponsor

University of Houston (Other)

Overall Status

Completed

CT.gov ID

NCT04075773

Collaborator

(none)

203

Enrollment

Location

Arms

11.2

Actual Duration (Months)

18.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a trial of a brief alcohol intervention, a brief expressive writing intervention that incorporates religious identity.

Condition or Disease	Intervention/Treatment	Phase
Heavy Drinking	Behavioral: Expressive Writing	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

203 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomized to either an intervention condition, where they will write about how their drinking relates to their religious identity, or to a control condition, where they will write about how their drinking relates to their age.Participants will be randomized to either an intervention condition, where they will write about how their drinking relates to their religious identity, or to a control condition, where they will write about how their drinking relates to their age.

Masking:

Double (Participant, Care Provider)

Masking Description:

Participants will not be made aware of the purpose of the study. Research assistants, who interact with the participants, will not be made aware of which writing prompt any given participant will receive.

Primary Purpose:

Treatment

Official Title:

Brief Religious Alcohol Intervention

Actual Study Start Date :

Sep 4, 2019

Actual Primary Completion Date :

Aug 11, 2020

Actual Study Completion Date :

Aug 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Religious Prompt Participants will be provided a writing prompt that describes their self-reported drinking, then asks them to write for 5 to 10 minutes about how that drinking is associated with their self-reported religious identity. After completing that writing assignment, participants will be shown their response, and asked to spend 5 to 10 minutes describing how their drinking behaviors in the next month might change.	Behavioral: Expressive Writing The participants are asked to write for a period of time about specific concepts so that they think carefully and cognitively process the information they are generating.
Sham Comparator: Age Prompt Participants will be provided a writing prompt that describes their self-reported drinking, then asks them to write for 5 to 10 minutes about how that drinking is associated with their self-reported age. After completing that writing assignment, participants will be shown their response, and asked to spend 5 to 10 minutes describing how their drinking behaviors in the next month might change.	Behavioral: Expressive Writing The participants are asked to write for a period of time about specific concepts so that they think carefully and cognitively process the information they are generating.

Arm

Intervention/Treatment

Experimental: Religious Prompt

Participants will be provided a writing prompt that describes their self-reported drinking, then asks them to write for 5 to 10 minutes about how that drinking is associated with their self-reported religious identity. After completing that writing assignment, participants will be shown their response, and asked to spend 5 to 10 minutes describing how their drinking behaviors in the next month might change.

Behavioral: Expressive Writing

The participants are asked to write for a period of time about specific concepts so that they think carefully and cognitively process the information they are generating.

Sham Comparator: Age Prompt

Participants will be provided a writing prompt that describes their self-reported drinking, then asks them to write for 5 to 10 minutes about how that drinking is associated with their self-reported age. After completing that writing assignment, participants will be shown their response, and asked to spend 5 to 10 minutes describing how their drinking behaviors in the next month might change.

Behavioral: Expressive Writing

The participants are asked to write for a period of time about specific concepts so that they think carefully and cognitively process the information they are generating.

Outcome Measures

Primary Outcome Measures

Change in the Timeline Follow-Back one month following the intervention [It will be assessed before the intervention and one month following the intervention.]
Participants report number of drinks consumed each day over the last month.

Secondary Outcome Measures

Chang in the Young Adult Alcohol Consequences Questionnaire one month following the intervention [It will be assessed before the intervention and one month following the intervention.]
Participants respond to a list of common consequences of alcohol use indicating whether or not they have experienced them. The scale name is the "Young Adult Alcohol Consequences Questionnaire" (Read, Kahler, Strong, & Colder, 2006). The construct of interest measured by this scale is the alcohol problems experienced by the participant. The total score is used, and the range for the total score is 0 to 48.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 29 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 to 29 years old
Have had a binge episode (4/5 drinks on one occasion for women/men) at least once in the past month
UH students

Exclusion Criteria:

Participants who are currently enrolled in treatment for alcohol or other substances
Participants who have been diagnosed with and/or treated for verbal learning disabilities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Houston Psychology Department	Houston	Texas	United States	77004

Sponsors and Collaborators

University of Houston

Investigators

Principal Investigator: Mary M Tomkins, M.S., University of Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mary M. Tomkins, Graduate Research Assistant, University of Houston

ClinicalTrials.gov Identifier:

NCT04075773

Other Study ID Numbers:

STUDY00001734

First Posted:

Sep 3, 2019

Last Update Posted:

Aug 14, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 14, 2020