NCT05235971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 10, 2024

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

February 1, 2022

Results QC Date

March 25, 2024

Last Update Submit

March 24, 2025

Conditions

Keywords

Heavy alcohol consumptionAlcohol misuse

Outcome Measures

Primary Outcomes (3)

  • 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: Number of Participants Who Rated the Intervention as Acceptable

    Number of participants with positive acceptability ratings who indicated enjoying the intervention at least a little bit. In a phone survey, participants were asked to rate their enjoyment of the intervention on a scale of 1-5, where 1 was "not at all" and 5 was "extremely". Scores of 2 ("a little bit") or more were considered to be positive indicators of acceptability.

    2 Weeks Post-Intervention

Secondary Outcomes (1)

  • Alcohol Consumption

    The 2 weeks (14-days) of the intervention period

Study Arms (4)

Episodic Future thinking (EFT)

EXPERIMENTAL

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

Volitional choice (VC)

EXPERIMENTAL

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

Episodic Future thinking plus Volitional choice

EXPERIMENTAL

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

Behavioral: Episodic Future thinkingBehavioral: Volitional choice

Monitoring only

OTHER

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

Behavioral: Monitoring only

Interventions

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

Episodic Future thinking (EFT)Episodic Future thinking plus 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.

Episodic Future thinking plus Volitional choiceVolitional choice (VC)
Monitoring onlyBEHAVIORAL

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.

Monitoring only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Does not understand English
  • currently pregnant
  • unable to provide informed consent due to medical/psychiatric reasons
  • currently in treatment for a substance use disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Hellman L, Wilkins C, Bayrakdarian N, Jannausch M, Bonar EE, Walton MA, Lin LA, Staton M, Coughlin L. Rural- and nonrural-specific themes in personalized intervention messages for adults with at-risk alcohol use living in rural areas. Exp Clin Psychopharmacol. 2026 Feb;34(1):8-17. doi: 10.1037/pha0000830.

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Results Point of Contact

Title
Lara N. Coughlin, Ph.D.
Organization
University of Michigan

Study Officials

  • Lara Coughlin, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 11, 2022

Study Start

May 17, 2022

Primary Completion

May 8, 2023

Study Completion

June 8, 2023

Last Updated

March 26, 2025

Results First Posted

July 10, 2024

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations