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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AA028232 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Episodic Future thinking plus Volitional choice | Experimental | Participants will receive both EFT and VC interventions with text messages. |
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| Monitoring only | Other | This is a control group in which participants will receive general psychoeducation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Episodic Future thinking | 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 |
| 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: 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The 2 weeks (14-days) of the intervention period |
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Screening Inclusion Criteria:
Baseline inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lara Coughlin, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41538227 | Derived | 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. |
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Participants were recruited from a large tertiary healthcare system from May 2022 through April 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the Intervention - Screening | Percent of participants who complete intervention phone call | Posted | Count of Participants | Participants | Day 1 of Intervention |
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From enrollment to end of follow-up (approximately 2 months)
There are no adverse events to report.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lara N. Coughlin, Ph.D. | University of Michigan | 734-936-3101 | laraco@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2023 | Jun 26, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 14, 2023 | Oct 19, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| Volitional choice | 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. |
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| Monitoring only | 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. |
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| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Alcohol Use Severity (AUDIT) | The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems. The AUDIT ranges from a score of 0 to 40 with higher values indicating riskier drinking and lower values indicating lower risk. Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, including possible alcohol dependence. The total AUDIT score will reflect the patient's level of risk related to alcohol. | Mean | Standard Deviation | scores on a scale |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| Primary | Feasibility of the Intervention - Enrollment | Percent of participants who elect to receive text messages | Posted | Count of Participants | Participants | Day 1 of Intervention |
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| 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. | This measure is reported among all intervention groups and the control group to determine their level of enjoyment with participating in the intervention. | Posted | Count of Participants | Participants | 2 Weeks Post-Intervention |
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| 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. | Posted | Mean | Standard Deviation | standard drinks per person | The 2 weeks (14-days) of the intervention period |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | 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. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG003 | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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