About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Mobile Intervention for Alcohol and Pain
BehavioralThe 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
BehavioralParticipants 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
Treatment groups
Trial outcomes
Primary outcomes
Pain, Enjoyment of Life, and General Activity Scale (PEG)
3-item, 0-10 numerical scale measure of pain
Average number of alcohol-containing drinks consumed per week: Time-Line Followback-30
Calendar-based measure of alcohol consumption in the past 30 days
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.
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
Sponsors and contacts
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