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

N/ANot Yet RecruitingNCT07804914

Boston University Charles River Campus260 enrolled

Overview

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.

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

Interventions

Mobile Intervention for Alcohol and PainBEHAVIORAL

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 InterventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Pain, Enjoyment of Life, and General Activity Scale (PEG)

3-item, 0-10 numerical scale measure of pain

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

Average number of alcohol-containing drinks consumed per week: Time-Line Followback-30

Calendar-based measure of alcohol consumption in the past 30 days

Time frame: 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.

Time frame: 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 Outcomes

Short Inventory of Problems - Revised

Seventeen, 4-category Likert scale item (from never to daily/almost daily) that assesses 17 common alcohol-related consequences

Time frame: 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