Behavioral Economic Treatment to Enhance Rural (BETTER) Living

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05235971
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
75
1
4
23.5
3.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Episodic Future thinking
  • Behavioral: Volitional choice
  • Behavioral: Monitoring only
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Behavioral Economic Treatment to Enhance Rural Living
Actual Study Start Date :
May 17, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Experimental: 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.

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.

Experimental: Episodic Future thinking plus Volitional choice

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

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

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.

Other: Monitoring only

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

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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of the intervention - Screening [Day 1 of Intervention]

    Percent of participants who complete intervention phone call

  2. Feasibility of the intervention - Enrollment [Day 1 of Intervention]

    Percent of participants who elect to receive text messages

  3. Intervention Acceptability [2 Weeks Post-Intervention]

    Study-specific acceptability rating completed by participants (percent with positive rating)

Secondary Outcome Measures

  1. Alcohol consumption [In weeks 1 and 2 of the intervention]

    Number of weekly drinks consumed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Lara Coughlin, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lara Coughlin, Assistant Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier:
NCT05235971
Other Study ID Numbers:
  • HUM00181940
  • 1K23AA028232
First Posted:
Feb 11, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lara Coughlin, Assistant Professor of Psychiatry, University of Michigan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022