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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University Charles River Campus
Study ID
NCT07804914
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain
  • Unhealthy Alcohol Use

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mobile Intervention for Alcohol and Pain — BEHAVIORAL
    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
  • Control Intervention — BEHAVIORAL
    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

Study Details

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.

Key Dates

First listed
Sep 4, 2026
Start date
Feb 1, 2027
Status verified
Aug 2026
Primary completion
Nov 30, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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

Primary Outcome Measure

Pain, Enjoyment of Life, and General Activity Scale (PEG) [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston UniversityBostonMassachusetts02215
Tibor Palfai, PhD
[email protected]
617-353-9345
Sarah Fraher, BA
[email protected]
617353-0962
Tibor Palfai, PhD (PRINCIPAL_INVESTIGATOR)

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