Behavioral Economic Treatment to Enhance Rural (BETTER) Living

NCT ID: NCT05235971

Last Updated: 2025-03-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-17

Study Completion Date

2023-06-08

Brief Summary

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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

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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.

Conditions

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Alcohol Use, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Episodic Future thinking (EFT)

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.

Group Type EXPERIMENTAL

Episodic Future thinking

Intervention Type BEHAVIORAL

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 (VC)

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.

Group Type EXPERIMENTAL

Volitional choice

Intervention Type BEHAVIORAL

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.

Episodic Future thinking plus Volitional choice

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

Group Type EXPERIMENTAL

Episodic Future thinking

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

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

Group Type OTHER

Monitoring only

Intervention Type BEHAVIORAL

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.

Interventions

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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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Lara Coughlin

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lara Coughlin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1K23AA028232

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00181940

Identifier Type: -

Identifier Source: org_study_id

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