Behavioral Economic Treatment to Enhance Rural (BETTER) Living

Study Overview
=================
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.

Official Title
-----------------
Behavioral Economic Treatment to Enhance Rural Living

Conditions
-----------------
Alcohol Use, Unspecified

Intervention / Treatment
-----------------
* Behavioral: Episodic Future thinking
* Behavioral: Volitional choice
* Behavioral: Monitoring only


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Episodic Future thinking (EFT)<br>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. | Behavioral: Episodic Future thinking<br>* 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<br>|
| Experimental: Volitional choice (VC)<br>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. | Behavioral: Volitional choice<br>* 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.<br>|
| Experimental: Episodic Future thinking plus Volitional choice<br>Participants will receive both EFT and VC interventions with text messages. | Behavioral: Episodic Future thinking<br>* 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<br>Behavioral: Volitional choice<br>* 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.<br>|
| Other: Monitoring only<br>This is a control group in which participants will receive general psychoeducation. | Behavioral: Monitoring only<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the intervention - Screening | Percent of participants who complete intervention phone call | Day 1 of Intervention | 
| Feasibility of the intervention - Enrollment | Percent of participants who elect to receive text messages | Day 1 of Intervention | 
| Intervention Acceptability | Study-specific acceptability rating completed by participants (percent with positive rating) | 2 Weeks Post-Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol consumption | Number of weekly drinks consumed. | In weeks 1 and 2 of the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heavy alcohol consumption, Alcohol misuse