Behavioral Economic Treatment to Enhance Rural (BETTER) Living

Alcohol Use, Unspecified Clinical Trial

Official title:

Behavioral Economic Treatment to Enhance Rural Living

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235971
• Other study ID #: HUM00181940
• Secondary ID: 1K23AA028232
• Status: Completed
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: June 8, 2023

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to get feedback to help develop programs delivered by phone and text messages to improve wellness and health behaviors. This study will enroll adult participants that have been seen in primary care settings and live in rurally designated areas.

Description:

This study will evaluate acceptability and feasibility of two remotely-delivered behavioral economic intervention components, alone and in combination, using remote text message delivery. The two intervention components are an episodic future thinking component and a volitional choice component. The goal of this work is to develop and determine acceptability and feasibility of a well-specified, accessible, and theory-driven mobile health intervention to reduce harmful alcohol use in people living in rural regions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Screening Inclusion Criteria:

• adults presenting in Michigan Medicine primary care

• home address in a rurally designated area (e.g., zip code, county),

• documented alcohol use in the Electronic Health Record (EHR) (e.g., alcohol use disorder diagnosis, alcohol misuse or heavy alcohol consumption).

Baseline inclusion criteria:

• an Alcohol Use Disorders Identification Test (AUDIT-C) score of =3 in females or =4 in males

• regular access to an internet-enabled device (e.g., smart phone, computer, tablet).

Exclusion Criteria:

• Does not understand English

• currently pregnant

• unable to provide informed consent due to medical/psychiatric reasons

• currently in treatment for a substance use disorder.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified

Intervention

Behavioral:
• Episodic Future thinking
During a visit with the study team, participants will identify personally-relevant reminders, or cues, that they will receive up to 3 messages a day via text-message over a two-week period. The messages will describe positive, non-alcohol related events at future time points to facilitate extension of temporal consideration toward future-focused perspectives. In addition, participants will have phone meetings (video or not) where health behaviors as well as survey information is noted and collected
• Volitional choice
Volitional choice creates structured if-then plans to dismantle context-linked alcohol use The messages sent over a two-week period facilitate alternative, healthier choices by identifying and linking risky cues with alternative actions. Participants will receive up to 3 messages a day for 14 days that include assessment and intervention messages. In addition, participants will have phone meetings (video or not) where health behaviors as well as survey information is noted and collected.
• Monitoring only
Participants will receive general psychoeducation about alcohol use, mental health, resources, and a description of the assessments to be completed over a two-week field testing period. In addition, participants will have phone meetings (video or not) where health behaviors as well as survey information is noted and collected.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the intervention - Screening	Percent of participants who complete intervention phone call	Day 1 of Intervention
Primary	Feasibility of the intervention - Enrollment	Percent of participants who elect to receive text messages	Day 1 of Intervention
Primary	Intervention Acceptability	Study-specific acceptability rating completed by participants (percent with positive rating)	2 Weeks Post-Intervention
Secondary	Alcohol consumption	Number of weekly drinks consumed.	In weeks 1 and 2 of the intervention