Integrated Digital Health Approach to Reduce Hazardous Alcohol Use and Chronic Pain Among Rural Populations

Alcohol Use and Pain in Rural Populations

The current proposal seeks to test the benefit of a brief intervention combined with a digital program delivered though a smartphone app for reducing chronic pain and hazardous drinking among those in rural settings. Participants are recruited through social media and complete an online pre-screener and telephone screener to determine eligibility. All subsequent study assessment procedures are conducted through videoconferencing online. Participants complete 3 assessments over the course of 8 months. Following the first (baseline assessment) participants are randomized to either the INTERVENTION (INTV) or a treatment-as-usual CONTROL (CTL) condition. Those in the INTV condition meet with a health counselor for up to 50 minutes and then complete an 8-week smartphone-based intervention with weekly SMS based brief coaching. This in the CTL group meet with the health counselor only. Participants complete additional assessments at 3-months and 8-months post -baseline. Measures of alcohol use and pain are assessed after the intervention at 3 months and at the final outcome period at 8-months post-baseline.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Unhealthy Alcohol Use
• Intervention / Treatment: Behavioral: Control Intervention; Behavioral: Mobile Intervention for Alcohol and Pain

Detailed Description

The current proposal represents an extension of previous research on the use of a smartphone-based intervention to reduce chronic pain and hazardous drinking among those in rural settings. The study is a randomized controlled trial that tests the efficacy of digital intervention for reducing pain intensity and interference and the quantity of alcohol consumption. Participants are recruited through social media and complete an online pre-screener to determine eligibility. This is followed by a telephone screener to confirm eligibility before scheduling baseline. All subsequent study assessment procedures are conducted through videoconferencing online. Following baseline assessment guided by an RA, participants are randomized to the INTERVENTION (INTV) or a treatment-as-usual CONTROL (CTL). Those in the INTV condition meet with a health counselor for up to 50 minutes and then complete an 8-week smartphone-based intervention with weekly SMS based brief coaching. This in the CTL group meet with the health counselor only. Participants complete additional assessments at 3-months and 8-months post -baseline. The 8-month assessment is the primary timepoint and assesses pain experience and alcohol use as measured by self-report and phosphatidylethanol (PEth) from a participant administered, RA supervised, finger stick. It is hypothesized that those in the INTV condition will show lower ratings of pain and less alcohol consumption at 8-months post-baseline.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tibor P Palfai, PhD; Phone Number: 617-353-9345; Email: palfai@bu.edu
• Study Contact Backup: Name: Sarah Fraher, BA; Email: sfraher@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University
      • Contact: Tibor Palfai, PhD; Phone Number: 617-353-9345; Email: palfai@bu.edu
      • Contact: Sarah Fraher, BA; Phone Number: 617353-0962; Email: sfraher@bu.edu
      • Principal Investigator: Tibor Palfai, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Reside in a US rural area (non-metropolitan country) as defined by the Rural-Urban Commuting Codes from US Dept. of Agriculture
• At least 18 years of age
• Engage in hazardous drinking (either by exceeding weekly NIAAA guidelines of 7 standard drinks for women [>7] and those > 65 and older or 14 for men [>14] <65, and/or having at least one heavy drinking episode in the past month as measured by >3 drinks for women and those > 65 and >4 drinks for men < 65), - - Experience chronic pain (at least 3 months in duration) of at least moderate severity (4 or greater on the Numerical Pain Rating Scale)
• Fluent in English
• Use of a personal smartphone
• Able to provide the name and contact information for one or more individuals who may be contacted in case the participant cannot be reached at follow-up.

Exclusion Criteria:

• History of bipolar disorder, schizophrenia, or other psychotic disorders
• Prior history of serious alcohol-related withdrawal symptoms (i.e., withdrawal-related seizures or delirium tremens)
• Current psychological/behavioral treatment for alcohol use disorder
• Current psychological/behavioral treatment for chronic pain
• Cancer-related pain
• Intent to have surgery for a pain-related condition in the next 8-months
• If using psychoactive medications for pain management or alcohol use must be using a stable medication dose (same dose for at least 2 months).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control (CTL) arm refers to a treatment-as-usual condition.; Participants in the CTL condition receive psychoeducation about pain and alcohol and referral resources should they wish to obtain additional treatment from a health counselor	Behavioral: Control Intervention; Participants are provided with psychoeducation about the reciprocal influences of hazardous drinking and chronic pain and their joint effects on health outcomes. In addition, they are provided with information about free web-based national resources should they wish to receive more information or additional help with pain or drinking
Experimental: Intervention (INTV); The Intervention (INTV) condition consists of a brief intervention with a health counselor followed by an 8-week smartphone-based program to provide cognitive behavioral and self-management skills to reduce hazardous drinking and chronic pain	Behavioral: Mobile Intervention for Alcohol and Pain; The Intervention (INTV) is a brief motivational intervention with a health counselor followed by an 8-week smartphone-based program in which participants are provided with cognitive behavioral and self-management skills to reduce hazardous drinking and chronic pain. They practice skills using the app and have weekly contact with the health counselor through instant messaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, Enjoyment of Life, and General Activity Scale (PEG)	3-item, 0-10 numerical scale measure of pain	rating in the past week taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
Average number of alcohol-containing drinks consumed per week: Time-Line Followback-30	Calendar-based measure of alcohol consumption in the past 30 days	past 30 day drinking report taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
Number of heavy drinking days in past month: Time-Line Followback-30 [TLFB-30]	From the TLFB-30, the number of days in the past month in which a participant engaged in heavy drinking [defined as 4+ for women and 5+ for men], 4 or more for those 65 and over.	number of days in the past 30. drinking report taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline.. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for comple

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Inventory of Problems - Revised	Seventeen, 4-category Likert scale item (from never to daily/almost daily) that assesses 17 common alcohol-related consequences	consequences in past 90 days....measure taken at baseline, 12-weeks post-baseline, and 32-weeks post-baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Investigators: Principal Investigator: Tibor P Palfai, PhD, Boston University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: August 28, 2026
• First Submitted That Met QC Criteria: August 31, 2026
• First Posted (Actual): September 4, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; digital health; unhealthy alcohol use; hazardous/harmful drinking
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Organic Chemicals; Alcohols; Ethanol
• Other Study ID Numbers: 8707E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data will be shared following release within one year of the trial project period to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. A specific de-identified data set with IPD relevant to analyses will be provided to other researchers after this review. All IPD collected and deindentified will be eligible upon request

In addition, data will be shared according to the guidelines for the National Institute of Mental Health Data Archive (NDA).

• IPD Sharing Time Frame: IPD and supporting information will be available by June 2032 which is 1 year following the end of the project period. Information will be available for a minimum of 2 years
• IPD Sharing Access Criteria: Investigators will request data and submit a data analysis plan for the project investigators to review. Deidentified data will be shared after a data sharing agreement is signed with the project institution and transferred through IT-approved data sharing processes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No