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Behavioral Economic Treatment to Enhance Rural (BETTER) Living

Primary Purpose

Alcohol Use, Unspecified

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Episodic Future thinking
Volitional choice
Monitoring only
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use, Unspecified focused on measuring Heavy alcohol consumption, Alcohol misuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Episodic Future thinking (EFT)

Volitional choice (VC)

Episodic Future thinking plus Volitional choice

Monitoring only

Arm Description

Participants will receive up to 3 messages a day that include assessment and intervention messages.The messages will describe positive, non-alcohol related events at future time points to facilitate extension of temporal consideration toward future-focused perspectives.

VC creates structured if-then plans to dismantle context-linked alcohol use. Participants will receive up to 3 messages a day that include assessment and intervention messages.

Participants will receive both EFT and VC interventions with text messages.

This is a control group in which participants will receive general psychoeducation.

Outcomes

Primary Outcome Measures

Feasibility of the intervention - Screening
Percent of participants who complete intervention phone call
Feasibility of the intervention - Enrollment
Percent of participants who elect to receive text messages
Intervention Acceptability
Study-specific acceptability rating completed by participants (percent with positive rating)

Secondary Outcome Measures

Alcohol consumption
Number of weekly drinks consumed.

Full Information

First Posted
February 1, 2022
Last Updated
October 20, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05235971
Brief Title
Behavioral Economic Treatment to Enhance Rural (BETTER) Living
Official Title
Behavioral Economic Treatment to Enhance Rural Living
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
May 8, 2023 (Actual)
Study Completion Date
June 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Unspecified
Keywords
Heavy alcohol consumption, Alcohol misuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Episodic Future thinking (EFT)
Arm Type
Experimental
Arm Description
Participants will receive up to 3 messages a day that include assessment and intervention messages.The messages will describe positive, non-alcohol related events at future time points to facilitate extension of temporal consideration toward future-focused perspectives.
Arm Title
Volitional choice (VC)
Arm Type
Experimental
Arm Description
VC creates structured if-then plans to dismantle context-linked alcohol use. Participants will receive up to 3 messages a day that include assessment and intervention messages.
Arm Title
Episodic Future thinking plus Volitional choice
Arm Type
Experimental
Arm Description
Participants will receive both EFT and VC interventions with text messages.
Arm Title
Monitoring only
Arm Type
Other
Arm Description
This is a control group in which participants will receive general psychoeducation.
Intervention Type
Behavioral
Intervention Name(s)
Episodic Future thinking
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Volitional choice
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Monitoring only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the intervention - Screening
Description
Percent of participants who complete intervention phone call
Time Frame
Day 1 of Intervention
Title
Feasibility of the intervention - Enrollment
Description
Percent of participants who elect to receive text messages
Time Frame
Day 1 of Intervention
Title
Intervention Acceptability
Description
Study-specific acceptability rating completed by participants (percent with positive rating)
Time Frame
2 Weeks Post-Intervention
Secondary Outcome Measure Information:
Title
Alcohol consumption
Description
Number of weekly drinks consumed.
Time Frame
In weeks 1 and 2 of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Coughlin, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Behavioral Economic Treatment to Enhance Rural (BETTER) Living

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