Alcohol Use, Unspecified
Conditions
Keywords
Heavy alcohol consumption, Alcohol misuse
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.
Interventions
BEHAVIORALEpisodic 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
BEHAVIORALVolitional 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.
BEHAVIORALMonitoring 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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention - Screening | Day 1 of Intervention | Percent of participants who complete intervention phone call |
| Feasibility of the Intervention - Enrollment | Day 1 of Intervention | Percent of participants who elect to receive text messages |
| Intervention Acceptability: Number of Participants Who Rated the Intervention as Acceptable | 2 Weeks Post-Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Consumption | The 2 weeks (14-days) of the intervention period | Average number of standard drinks consumed during the 2-week intervention period per person. A standard drink was considered to be 12 oz beer, 1.5 ounce shot of liquor, or 5 oz glass of wine. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from a large tertiary healthcare system from May 2022 through April 2023.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 17 |
| 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.
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. | 21 |
| Episodic Future Thinking Plus Volitional Choice Participants will receive both EFT and VC interventions with text messages.
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
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. | 19 |
| Monitoring Only This is a control group in which participants will receive general psychoeducation.
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. | 18 |
| Total | 75 |
Baseline characteristics
| Characteristic | Volitional Choice (VC) | Episodic Future Thinking Plus Volitional Choice | Episodic Future Thinking (EFT) | Monitoring Only | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 6 Participants | 5 Participants | 6 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 13 Participants | 12 Participants | 12 Participants | 54 Participants |
| Age, Continuous | 54.7 years STANDARD_DEVIATION 13.4 | 58.0 years STANDARD_DEVIATION 14.8 | 54.0 years STANDARD_DEVIATION 19.8 | 53.9 years STANDARD_DEVIATION 16.5 | 55.2 years STANDARD_DEVIATION 15.9 |
| Alcohol Use Severity (AUDIT) | 7.5 scores on a scale STANDARD_DEVIATION 6.8 | 8.4 scores on a scale STANDARD_DEVIATION 8 | 7.2 scores on a scale STANDARD_DEVIATION 5.7 | 8.6 scores on a scale STANDARD_DEVIATION 6.8 | 7.9 scores on a scale STANDARD_DEVIATION 6.8 |
| Race/Ethnicity, Customized Race/Ethnicity American Indian/Alaskan Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black/African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Don't know/Refuse | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity More than one race | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 21 Participants | 19 Participants | 17 Participants | 17 Participants | 74 Participants |
| Region of Enrollment United States | 21 Participants | 19 Participants | 17 Participants | 18 Participants | 75 Participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 10 Participants | 12 Participants | 47 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 7 Participants | 6 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 21 | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 0 / 17 | 0 / 21 | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 21 | 0 / 19 | 0 / 18 |
Outcome results
Primary
Feasibility of the Intervention - Enrollment
Percent of participants who elect to receive text messages
Time frame: Day 1 of Intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episodic Future Thinking (EFT) | Feasibility of the Intervention - Enrollment | 17 Participants |
| Volitional Choice (VC) | Feasibility of the Intervention - Enrollment | 21 Participants |
| Episodic Future Thinking Plus Volitional Choice | Feasibility of the Intervention - Enrollment | 19 Participants |
| Monitoring Only | Feasibility of the Intervention - Enrollment | 18 Participants |
Primary
Feasibility of the Intervention - Screening
Percent of participants who complete intervention phone call
Time frame: Day 1 of Intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episodic Future Thinking (EFT) | Feasibility of the Intervention - Screening | 17 Participants |
| Volitional Choice (VC) | Feasibility of the Intervention - Screening | 21 Participants |
| Episodic Future Thinking Plus Volitional Choice | Feasibility of the Intervention - Screening | 19 Participants |
| Monitoring Only | Feasibility of the Intervention - Screening | 18 Participants |
Primary
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.
Time frame: 2 Weeks Post-Intervention
Population: This measure is reported among all intervention groups and the control group to determine their level of enjoyment with participating in the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Episodic Future Thinking (EFT) | Intervention Acceptability: Number of Participants Who Rated the Intervention as Acceptable | 17 Participants |
| Volitional Choice (VC) | Intervention Acceptability: Number of Participants Who Rated the Intervention as Acceptable | 19 Participants |
| Episodic Future Thinking Plus Volitional Choice | Intervention Acceptability: Number of Participants Who Rated the Intervention as Acceptable | 19 Participants |
| Monitoring Only | Intervention Acceptability: Number of Participants Who Rated the Intervention as Acceptable | 17 Participants |
Secondary
Alcohol Consumption
Average number of standard drinks consumed during the 2-week intervention period per person. A standard drink was considered to be 12 oz beer, 1.5 ounce shot of liquor, or 5 oz glass of wine.
Time frame: The 2 weeks (14-days) of the intervention period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Episodic Future Thinking (EFT) | Alcohol Consumption | 22.1 standard drinks per person | Standard Deviation 25.5 |
| Volitional Choice (VC) | Alcohol Consumption | 17.9 standard drinks per person | Standard Deviation 14.9 |
| Episodic Future Thinking Plus Volitional Choice | Alcohol Consumption | 28.1 standard drinks per person | Standard Deviation 50.4 |
| Monitoring Only | Alcohol Consumption | 23.9 standard drinks per person | Standard Deviation 22.8 |